32 results on '"Mihalopoulos, Cathrine"'
Search Results
2. Low-Intensity mental health Support via a Telehealth Enabled Network for adults with diabetes (LISTEN): protocol for a hybrid type 1 effectiveness implementation trial
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Holloway, Edith E., Gray, Shikha, Mihalopoulos, Cathrine, Versace, Vincent L., Le Gautier, Roslyn, Chatterton, Mary Lou, Hagger, Virginia, Halliday, Jennifer, Henshaw, Kim, Harrap, Benjamin, Manallack, Sarah, Black, Taryn, Van Bruggen, Natasha, Hines, Carolyn, O’Neil, Adrienne, Skinner, Timothy C., Speight, Jane, and Hendrieckx, Christel
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- 2023
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- View/download PDF
3. Identifying patterns of potentially preventable hospitalisations in people living with dementia
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Engel, Lidia, Hwang, Kerry, Panayiotou, Anita, Watts, Jennifer J., Mihalopoulos, Cathrine, Temple, Jeromey, and Batchelor, Frances
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- 2022
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4. The effectiveness of a media-based intervention promoting help-seeking for mental health difficulties by Australian men: study protocol for a randomised controlled trial
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Nicholas, Angela, Requena, Simone Scotti, Ftanou, Maria, Rice, Simon, Fletcher, Justine, Mackinnon, Andrew, Seidler, Zac, Le, Long Khanh-Dao, Mihalopoulos, Cathrine, and Pirkis, Jane
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- 2022
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5. Protocol for a randomized controlled trial of the Men in Mind training for mental health practitioners to enhance their clinical competencies for working with male clients
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Seidler, Zac E., Wilson, Michael J., Toogood, Nicholas W., Oliffe, John L., Kealy, David, Ogrodniczuk, John S., Owen, Jesse, Mackinnon, Andrew, Le, Long Khanh-Dao, Mihalopoulos, Cathrine, Pirkis, Jane, and Rice, Simon
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- 2022
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6. Protocol for a cluster randomized control trial of the impact of the Breaking the Man Code workshops on adolescent boys’ intentions to seek help
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King, Kylie, Schlichthorst, Marisa, Chondros, Patty, Rice, Simon, Clark, Anna, Le, Long Khanh-Dao, Mihalopoulos, Cathrine, and Pirkis, Jane
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- 2022
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7. Study protocol for the Multimodal Approach to Preventing Suicide in Schools (MAPSS) project: a regionally based randomised trial of an integrated response to suicide risk among secondary school students
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Byrne, Sadhbh J., Bailey, Eleanor, Lamblin, Michelle, McKay, Samuel, Pirkis, Jane, Mihalopoulos, Cathrine, Spittal, Matthew J., Rice, Simon, Hetrick, Sarah, Hamilton, Matthew, Yuen, Hok Pan, Lee, Yong Yi, Boland, Alexandra, and Robinson, Jo
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- 2022
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8. Economic evaluation of a Decision Support Tool to guide intensity of mental health care in general practice: the Link-me pragmatic randomised controlled trial
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Chatterton, Mary Lou, Harris, Meredith, Burgess, Philip, Fletcher, Susan, Spittal, Matthew J., Faller, Jan, Palmer, Victoria J., Chondros, Patty, Bassilios, Bridget, Pirkis, Jane, Gunn, Jane, and Mihalopoulos, Cathrine
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- 2022
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9. INdividual Vocational and Educational Support Trial (INVEST) for young people with borderline personality disorder: study protocol for a randomised controlled trial
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Chanen, Andrew M., Nicol, Katie, Betts, Jennifer K., Bond, Gary R., Mihalopoulos, Cathrine, Jackson, Henry J., Thompson, Katherine N., Jovev, Martina, Yuen, Hok Pan, Chinnery, Gina, Ring, Judith, Allott, Kelly, McCutcheon, Louise, Salmon, Ashleigh P., and Killackey, Eoin
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- 2020
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10. A qualitative exploration of the content and face validity of preference-based measures within the context of dementia
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Engel, Lidia, Bucholc, Jessica, Mihalopoulos, Cathrine, Mulhern, Brendan, Ratcliffe, Julie, Yates, Mark, and Hanna, Lisa
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- 2020
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11. Correction to: A randomised controlled trial of dietary improvement for adults with major depression (the ‘SMILES’ trial)
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Jacka, Felice N., O’Neil, Adrienne, Opie, Rachelle, Itsiopoulos, Catherine, Cotton, Sue, Mohebbi, Mohammedreza, Castle, David, Dash, Sarah, Mihalopoulos, Cathrine, Chatterton, Mary Lou, Brazionis, Laima, Dean, Olivia M., Hodge, Allison M., and Berk, Michael
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- 2018
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12. The SMILES trial: an important first step
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Jacka, Felice N., O’Neil, Adrienne, Itsiopoulos, Catherine, Opie, Rachelle, Cotton, Sue, Mohebbi, Mohammadreza, Castle, David, Dash, Sarah, Mihalopoulos, Cathrine, Chatterton, Mary Lou, Brazionis, Laima, Dean, Olivia M., Hodge, Allison, and Berk, Michael
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- 2018
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13. Web-based intervention to improve quality of life in late stage bipolar disorder (ORBIT): randomised controlled trial protocol
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Fletcher, Kathryn, Foley, Fiona, Thomas, Neil, Michalak, Erin, Berk, Lesley, Berk, Michael, Bowe, Steve, Cotton, Sue, Engel, Lidia, Johnson, Sheri L., Jones, Steven, Kyrios, Michael, Lapsley, Sara, Mihalopoulos, Cathrine, Perich, Tania, and Murray, Greg
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- 2018
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14. Economic evaluation of a dietary intervention for adults with major depression (the “SMILES” trial)
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Chatterton, Mary Lou, Mihalopoulos, Cathrine, O’Neil, Adrienne, Itsiopoulos, Catherine, Opie, Rachelle, Castle, David, Dash, Sarah, Brazionis, Laima, Berk, Michael, and Jacka, Felice
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- 2018
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15. A randomised controlled trial of dietary improvement for adults with major depression (the ‘SMILES’ trial)
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Jacka, Felice N., O’Neil, Adrienne, Opie, Rachelle, Itsiopoulos, Catherine, Cotton, Sue, Mohebbi, Mohammedreza, Castle, David, Dash, Sarah, Mihalopoulos, Cathrine, Chatterton, Mary Lou, Brazionis, Laima, Dean, Olivia M., Hodge, Allison M., and Berk, Michael
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- 2017
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16. Systematic review and meta-analysis of preventive interventions for eating disorders
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Le, Long KD, Barendregt, Jan, Hay, Phillipa, and Mihalopoulos, Cathrine
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- 2015
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17. Efficacy of a telephone outcall program to reduce caregiver burden among caregivers of cancer patients [PROTECT]: a randomised controlled trial
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Heckel, Leila, Fennell, Kate M., Reynolds, John, Boltong, Anna, Botti, Mari, Osborne, Richard H., Mihalopoulos, Cathrine, Chirgwin, Jacqui, Williams, Melinda, Gaskin, Cadeyrn J., Ashley, David M., Livingston, Patricia M., Heckel, Leila, Fennell, Kate M., Reynolds, John, Boltong, Anna, Botti, Mari, Osborne, Richard H., Mihalopoulos, Cathrine, Chirgwin, Jacqui, Williams, Melinda, Gaskin, Cadeyrn J., Ashley, David M., and Livingston, Patricia M.
- Abstract
BACKGROUND: Informal caregivers provide extended support to people with cancer but they receive little support from the health care system to assist them in their caring role. The aim of this single-blind, multi-centre, randomised controlled trial was to test the efficacy of a telephone outcall program to reduce caregiver burden and unmet needs, and improve psychological well-being among cancer caregivers, as well as evaluating the potential impact on patient outcomes. METHODS: Cancer patient/caregiver dyads (N = 216) were randomised to a telephone outcall program (n = 108) or attention control group (n = 108). The primary outcome was self-reported caregiver burden. Secondary endpoints included depressive symptoms, unmet needs, self-esteem, self-empowerment, and health literacy. Data were collected at baseline and at both 1 and 6 months post-intervention. An intention to treat analysis was performed. RESULTS: The intervention had no effect on the primary outcome (caregiver burden), but reduced the number of caregiver unmet needs (intervention group baseline, mean = 2.66, 95% confidence interval (CI) [1.91-3.54]; intervention group 1 month post intervention, mean = 0.85, 95%CI [0.42-1.44]; control group baseline, mean = 1.30 95%CI [0.80-1.94], control group 1 month post intervention, mean = 1.02 95%CI [0.52-1.69]; p = 0.023). For caregivers at risk for depression, the intervention had a significant effect on caregivers' confidence in having sufficient information to manage their health (p = 0.040). No effects were found for patients' depressive symptoms, unmet needs, self-empowerment, and other health literacy domains. CONCLUSIONS: While caregiver burden was not reduced, the outcall program was effective in reducing unmet needs in caregivers. Provision of cancer information and support via a teleph
- Published
- 2018
18. Target-D: a stratified individually randomized controlled trial of the diamond clinical prediction tool to triage and target treatment for depressive symptoms in general practice: study protocol for a randomized controlled trial
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Gunn, Jane, Wachtler, Caroline, Fletcher, Susan, Davidson, Sandra, Mihalopoulos, Cathrine, Palmer, Victoria, Hegarty, Kelsey, Coe, Amy, Murray, Elizabeth, Dowrick, Christopher, Andrews, Gavin, Chondros, Patty, Gunn, Jane, Wachtler, Caroline, Fletcher, Susan, Davidson, Sandra, Mihalopoulos, Cathrine, Palmer, Victoria, Hegarty, Kelsey, Coe, Amy, Murray, Elizabeth, Dowrick, Christopher, Andrews, Gavin, and Chondros, Patty
- Abstract
BACKGROUND: Depression is a highly prevalent and costly disorder. Effective treatments are available but are not always delivered to the right person at the right time, with both under- and over-treatment a problem. Up to half the patients presenting to general practice report symptoms of depression, but general practitioners have no systematic way of efficiently identifying level of need and allocating treatment accordingly. Therefore, our team developed a new clinical prediction tool (CPT) to assist with this task. The CPT predicts depressive symptom severity in three months' time and based on these scores classifies individuals into three groups (minimal/mild, moderate, severe), then provides a matched treatment recommendation. This study aims to test whether using the CPT reduces depressive symptoms at three months compared with usual care. METHODS: The Target-D study is an individually randomized controlled trial. Participants will be 1320 general practice patients with depressive symptoms who will be approached in the practice waiting room by a research assistant and invited to complete eligibility screening on an iPad. Eligible patients will provide informed consent and complete the CPT on a purpose-built website. A computer-generated allocation sequence stratified by practice and depressive symptom severity group, will randomly assign participants to intervention (treatment recommendation matched to predicted depressive symptom severity group) or comparison (usual care plus Target-D attention control) arms. Follow-up assessments will be completed online at three and 12 months. The primary outcome is depressive symptom severity at three months. Secondary outcomes include anxiety, mental health self-efficacy, quality of life, and cost-effectiveness. Intention-to-treat analyses will test for differences in outcome means between study arms overall and by depressive symptom severity group. DISCUSSION: To our knowledge, this is the fir
- Published
- 2017
19. Randomised controlled trial of a digitally assisted low intensity intervention to promote personal recovery in persisting psychosis: SMART-Therapy study protocol
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Thomas, Neil, Farhall, John, Foley, Fiona, Rossell, Susan L., Castle, David, Ladd, Emma, Meyer, Denny, Mihalopoulos, Cathrine, Leitan, Nuwan, Nunan, Cassy, Frankish, Rosalie, Smark, Tara, Farnan, Sue, McLeod, Bronte, Sterling, Leon, Murray, Greg, Fossey, Ellie, Brophy, Lisa, Kyrios, Michael, Thomas, Neil, Farhall, John, Foley, Fiona, Rossell, Susan L., Castle, David, Ladd, Emma, Meyer, Denny, Mihalopoulos, Cathrine, Leitan, Nuwan, Nunan, Cassy, Frankish, Rosalie, Smark, Tara, Farnan, Sue, McLeod, Bronte, Sterling, Leon, Murray, Greg, Fossey, Ellie, Brophy, Lisa, and Kyrios, Michael
- Abstract
BACKGROUND: Psychosocial interventions have an important role in promoting recovery in people with persisting psychotic disorders such as schizophrenia. Readily available, digital technology provides a means of developing therapeutic resources for use together by practitioners and mental health service users. As part of the Self-Management and Recovery Technology (SMART) research program, we have developed an online resource providing materials on illness self-management and personal recovery based on the Connectedness-Hope-Identity-Meaning-Empowerment (CHIME) framework. Content is communicated using videos featuring persons with lived experience of psychosis discussing how they have navigated issues in their own recovery. This was developed to be suitable for use on a tablet computer during sessions with a mental health worker to promote discussion about recovery. METHODS/DESIGN: This is a rater-blinded randomised controlled trial comparing a low intensity recovery intervention of eight one-to-one face-to-face sessions with a mental health worker using the SMART website alongside routine care, versus an eight-session comparison condition, befriending. The recruitment target is 148 participants with a schizophrenia-related disorder or mood disorder with a history of psychosis, recruited from mental health services in Victoria, Australia. Following baseline assessment, participants are randomised to intervention, and complete follow up assessments at 3, 6 and 9 months post-baseline. The primary outcome is personal recovery measured using the Process of Recovery Questionnaire (QPR). Secondary outcomes include positive and negative symptoms assessed with the Positive and Negative Syndrome Scale, subjective experiences of psychosis, emotional symptoms, quality of life and resource use. Mechanisms of change via effects on self-stigma and self-efficacy will be examined. DISCUSSION: This protocol describes a novel intervention which tests new t
- Published
- 2016
20. A controlled trial of implementing a complex mental health intervention for carers of vulnerable young people living in out-of-home care: the ripple project.
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Herrman, Helen, Humphreys, Cathy, Halperin, Stephen, Monson, Katherine, Harvey, Carol, Mihalopoulos, Cathrine, Cotton, Susan, Mitchell, Penelope, Glynn, Tony, Magnus, Anne, Murray, Lenice, Szwarc, Josef, Davis, Elise, Havighurst, Sophie, McGorry, Patrick, Tyano, Sam, Kaplan, Ida, Rice, Simon, and Moeller-Saxone, Kristen
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MENTAL health of youth ,SUBSTANCE abuse ,SOCIAL services ,SUICIDAL behavior ,MEDICAL economics ,RANDOMIZED controlled trials - Abstract
Background: Out-of-home care (OoHC) refers to young people removed from their families by the state because of abuse, neglect or other adversities. Many of the young people experience poor mental health and social function before, during and after leaving care. Rigorously evaluated interventions are urgently required. This publication describes the protocol for the Ripple project and notes early findings from a controlled trial demonstrating the feasibility of the work. The Ripple project is implementing and evaluating a complex mental health intervention that aims to strengthen the therapeutic capacities of carers and case managers of young people (12-17 years) in OoHC. Methods: The study is conducted in partnership with mental health, substance abuse and social services in Melbourne, with young people as participants. It has three parts: 1. Needs assessment and implementation of a complex mental health intervention; 2. A 3-year controlled trial of the mental health, social and economic outcomes; and 3. Nested process evaluation of the intervention. Results: Early findings characterising the young people, their carers and case managers and implementing the intervention are available. The trial Wave 1 includes interviews with 176 young people, 52% of those eligible in the study population, 104 carers and 79 case managers. Conclusions: Implementing and researching an affordable service system intervention appears feasible and likely to be applicable in other places and countries. Success of the intervention will potentially contribute to reducing mental ill-health among these young people, including suicide attempts, self-harm and substance abuse, as well as reducing homelessness, social isolation and contact with the criminal justice system. [ABSTRACT FROM AUTHOR]
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- 2016
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21. Conquer fear: protocol of a randomised controlled trial of a psychological intervention to reduce fear of cancer recurrence
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Butow, Phyllis N., Bell, Melanie L., Smith, Allan B., Fardell, Joanna E., Thewes, Belinda, Turner, Jane, Gilchrist, Jemma, Beith, Jane, Girgis, Afaf, Sharpe, Louise, Shih, Sophy, Mihalopoulos, Cathrine, Butow, Phyllis N., Bell, Melanie L., Smith, Allan B., Fardell, Joanna E., Thewes, Belinda, Turner, Jane, Gilchrist, Jemma, Beith, Jane, Girgis, Afaf, Sharpe, Louise, Shih, Sophy, and Mihalopoulos, Cathrine
- Published
- 2013
22. A randomised, controlled trial of a dietary intervention for adults with major depression (the 'SMILES' trial): study protocol
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O'Neil, Adrienne, Berk, Michael, Itsiopoulos, Catherine, Castle, David, Opie, Rachelle, Pizzinga, Josephine, Brazionis, Laima, Hodge, Allison, Mihalopoulos, Cathrine, Chatterton, Mary Lou, Dean, Olivia M., Jacka, Felice N., O'Neil, Adrienne, Berk, Michael, Itsiopoulos, Catherine, Castle, David, Opie, Rachelle, Pizzinga, Josephine, Brazionis, Laima, Hodge, Allison, Mihalopoulos, Cathrine, Chatterton, Mary Lou, Dean, Olivia M., and Jacka, Felice N.
- Abstract
Despite increased investment in its recognition and treatment, depression remains a substantial health and economic burden worldwide. Current treatment strategies generally focus on biological and psychological pathways, largely neglecting the role of lifestyle. There is emerging evidence to suggest that diet and nutrition play an important role in the risk, and the genesis, of depression. However, there are limited data regarding the therapeutic impact of dietary changes on existing mental illness. Using a randomised controlled trial design, we aim to investigate the efficacy and cost-efficacy of a dietary program for the treatment of Major Depressive Episodes.
- Published
- 2013
23. The Cool Little Kids randomised controlled trial: Population-level early prevention for anxiety disorders.
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Bayer, Jordana K., Rapee, Ronald M., Hiscock, Harriet, Ukoumunne, Obioha C., Mihalopoulos, Cathrine, Clifford, Susan, and Wake, Melissa
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ANXIETY in children ,PARENTS ,CHILDREN'S health ,MENTAL health - Abstract
Background: The World Health Organization predicts that by 2030 internalising problems (e.g. depression and anxiety) will be second only to HIV/AIDS in international burden of disease. Internalising problems affect 1 in 7 school aged children, impacting on peer relations, school engagement, and later mental health, relationships and employment. The development of early childhood prevention for internalising problems is in its infancy. The current study follows two successful 'efficacy' trials of a parenting group intervention to reduce internalising disorders in temperamentally inhibited preschool children. Cool Little Kids is a population-level randomised trial to determine the impacts of systematically screening preschoolers for inhibition then offering a parenting group intervention, on child internalising problems and economic costs at school entry. Methods/Design: This randomised trial will be conducted within the preschool service system, attended by more than 95% of Australian children in the year before starting school. In early 2011, preschool services in four local government areas in Melbourne, Australia, will distribute the screening tool. The ≉16% (n≉500) with temperamental inhibition will enter the trial. Intervention parents will be offered Cool Little Kids, a 6-session group program in the local community, focusing on ways to develop their child's bravery skills by reducing overprotective parenting interactions. Outcomes one and two years post-baseline will comprise child internalising diagnoses and symptoms, parenting interactions, and parent wellbeing. An economic evaluation (costconsequences framework) will compare incremental differences in costs of the intervention versus control children to incremental differences in outcomes, from a societal perspective. Analyses will use the intention-to-treat principle, using logistic and linear regression models (binary and continuous outcomes respectively) to compare outcomes between the trial arms. Discussion: This trial addresses gaps for internalising problems identified in the 2004 World Health Organization Prevention of Mental Disorders report. If effective and cost-effective, the intervention could readily be applied at a population level. Governments consider mental health to be a priority, enhancing the likelihood that an effective early prevention program would be adopted in Australia and internationally. Trial Registration: ISRCTN30996662 RCH Human Research Ethics Approval: 30105A [ABSTRACT FROM AUTHOR]
- Published
- 2011
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24. Web-based intervention to improve quality of life in late stage bipolar disorder (ORBIT): randomised controlled trial protocol
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Fletcher, Kathryn, Foley, Fiona, Thomas, Neil, Michalak, Erin, Berk, Lesley, Berk, Michael, Bowe, Steve, Cotton, Sue, Engel, Lidia, Johnson, Sheri L, Jones, Steven, Kyrios, Michael, Lapsley, Sara, Mihalopoulos, Cathrine, Perich, Tania, and Murray, Greg
- Subjects
10. No inequality ,3. Good health - Abstract
Background: The primary objective of this randomised controlled trial (RCT) is to establish the effectiveness of a novel online quality of life (QoL) intervention tailored for people with late stage (≥ 10 episodes) bipolar disorder (BD) compared with psychoeducation. Relative to early stage individuals, this late stage group may not benefit as much from existing psychosocial treatments. The intervention is a guided self-help, mindfulness based intervention (MBI) developed in consultation with consumers, designed specifically for web-based delivery, with email coaching support. Methods/design: This international RCT will involve a comparison of the effectiveness and cost-effectiveness of two 5-week adjunctive online self-management interventions: Mindfulness for Bipolar 2.0 and an active control (Psychoeducation for Bipolar). A total of 300 participants will be recruited primarily via social media channels. Main inclusion criteria are: a diagnosis of BD (confirmed via a phone-administered structured diagnostic interview), no current mood episode, history of 10 or more mood episodes, no current psychotic features or active suicidality, under the care of a medical practitioner. Block randomisation will be used for allocation to the interventions, and participants will retain access to the program for 6 months. Evaluations will be conducted at pre- and post- treatment, and at 3- and 6- months follow-up. The primary outcome measure will be the Brief Quality of Life in Bipolar Disorder Scale (Brief QoL.BD), collected immediately post-intervention at 5 weeks (T1). Secondary measures include BD-related symptoms (mania, depression, anxiety, stress), time to first relapse, functioning, sleep quality, social rhythm stability and resource use. Measurements will be collected online and via telephone assessments at baseline (T0), 5 weeks (T1), three months (T2) and six months (T3). Candidate moderators (diagnosis, anxiety or substance comorbidities, demographics and current treatments) will be investigated as will putative therapeutic mechanisms including mindfulness, emotion regulation and self-compassion. A cost-effectiveness analysis will be conducted. Acceptability and any unwanted events (including adverse treatment reactions) will be documented and explored. Discussion: This definitive trial will test the effectiveness and cost-effectiveness of a novel QoL focused, mindfulness based, online guided self-help intervention for late stage BD, and investigate its putative mechanisms of therapeutic action. Trial registration: ClinicalTrials.gov : NCT03197974 . Registered 23 June 2017.
25. Conquer fear: protocol of a randomised controlled trial of a psychological intervention to reduce fear of cancer recurrence.
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Butow, Phyllis N, Bell, Melanie L, Smith, Allan B, Fardell, Joanna E, Thewes, Belinda, Turner, Jane, Gilchrist, Jemma, Beith, Jane, Girgis, Afaf, Sharpe, Louise, Shih, Sophy, Mihalopoulos, Cathrine, and members of the Conquer Fear Authorship Group
- Abstract
Background: Up to 70% of cancer survivors report clinically significant levels of fear of cancer recurrence (FCR). Despite the known negative impact of FCR on psychological wellbeing and quality of life, little research has investigated interventions for high FCR. Our team has developed and piloted a novel intervention (Conquer Fear) based on the Self-Regulatory Executive Function Model and Relational Frame Theory and is evaluating Conquer Fear in a randomised controlled trial (RCT). We aim to compare the efficacy and cost-efficacy of the Conquer Fear Intervention and relaxation training in reducing the impact of FCR.Methods/design: This study is a multi-centre RCT with 260 participants randomised either to the Conquer Fear Intervention or relaxation training. Both interventions will be delivered in five sessions over 10 weeks by trained psychologists, psychiatrists and social workers with five or more years experience in oncology. Conquer Fear sessions use attentional training, detached mindfulness, meta-cognitive therapy, values clarification and psycho-education to help patients change the way they regulate and respond to thoughts about cancer recurrence. Relaxation training includes training in progressive and passive muscle relaxation, meditative relaxation, visualisation and "quick relaxation" techniques. Relaxation was chosen to control for therapist time and attention and has good face-validity as an intervention. The primary outcome is fear of cancer recurrence. Secondary outcomes include distress, quality of life, unmet needs, and health care utilisation. Participants complete questionnaires prior to starting the intervention, immediately after completing the intervention, 3 and 6 months later. Eligible participants are early-stage breast or colorectal cancer survivors who have completed hospital-based treatment between 2 months and 5 years prior to study entry and report a score in the clinical range on the Fear of Cancer Recurrence Inventory. The biostatistician is blinded to group allocation and participants are blinded to which intervention is being evaluated. Randomisation is computer generated, stratified by therapist, and uses sequentially numbered sealed envelopes.Discussion: If successful, the study will provide an evidence-based intervention to reduce psychological morbidity in cancer survivors, and reduce overall health care costs due to more appropriate use of follow-up care and other health services in this very large population.Trial Registration: Trial Registration: ACTRN12612000404820. [ABSTRACT FROM AUTHOR]- Published
- 2013
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- View/download PDF
26. Efficacy of a telephone outcall program to reduce caregiver burden among caregivers of cancer patients [PROTECT]: a randomised controlled trial.
- Author
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Heckel L, Fennell KM, Reynolds J, Boltong A, Botti M, Osborne RH, Mihalopoulos C, Chirgwin J, Williams M, Gaskin CJ, Ashley DM, and Livingston PM
- Subjects
- Adult, Aged, Depression epidemiology, Depression psychology, Female, Humans, Male, Middle Aged, Neoplasms epidemiology, Neoplasms pathology, Quality of Life psychology, Single-Blind Method, Telephone, Adaptation, Psychological, Caregivers psychology, Depression prevention & control, Neoplasms psychology
- Abstract
Background: Informal caregivers provide extended support to people with cancer but they receive little support from the health care system to assist them in their caring role. The aim of this single-blind, multi-centre, randomised controlled trial was to test the efficacy of a telephone outcall program to reduce caregiver burden and unmet needs, and improve psychological well-being among cancer caregivers, as well as evaluating the potential impact on patient outcomes., Methods: Cancer patient/caregiver dyads (N = 216) were randomised to a telephone outcall program (n = 108) or attention control group (n = 108). The primary outcome was self-reported caregiver burden. Secondary endpoints included depressive symptoms, unmet needs, self-esteem, self-empowerment, and health literacy. Data were collected at baseline and at both 1 and 6 months post-intervention. An intention to treat analysis was performed., Results: The intervention had no effect on the primary outcome (caregiver burden), but reduced the number of caregiver unmet needs (intervention group baseline, mean = 2.66, 95% confidence interval (CI) [1.91-3.54]; intervention group 1 month post intervention, mean = 0.85, 95%CI [0.42-1.44]; control group baseline, mean = 1.30 95%CI [0.80-1.94], control group 1 month post intervention, mean = 1.02 95%CI [0.52-1.69]; p = 0.023). For caregivers at risk for depression, the intervention had a significant effect on caregivers' confidence in having sufficient information to manage their health (p = 0.040). No effects were found for patients' depressive symptoms, unmet needs, self-empowerment, and other health literacy domains., Conclusions: While caregiver burden was not reduced, the outcall program was effective in reducing unmet needs in caregivers. Provision of cancer information and support via a telephone service may represent a feasible approach to reducing unmet needs among cancer caregiver populations., Trial Registration: ACTRN12613000731796 ; prospectively registered on 02/07/2013.
- Published
- 2018
- Full Text
- View/download PDF
27. Target-D: a stratified individually randomized controlled trial of the diamond clinical prediction tool to triage and target treatment for depressive symptoms in general practice: study protocol for a randomized controlled trial.
- Author
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Gunn J, Wachtler C, Fletcher S, Davidson S, Mihalopoulos C, Palmer V, Hegarty K, Coe A, Murray E, Dowrick C, Andrews G, and Chondros P
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- Adolescent, Adult, Affect, Aged, Clinical Protocols, Depression psychology, Emotions, Female, Humans, Male, Middle Aged, Patient Compliance, Patient Satisfaction, Predictive Value of Tests, Research Design, Risk Assessment, Risk Factors, Severity of Illness Index, Time Factors, Treatment Outcome, Victoria, Young Adult, Decision Support Techniques, Depression diagnosis, Depression therapy, Triage
- Abstract
Background: Depression is a highly prevalent and costly disorder. Effective treatments are available but are not always delivered to the right person at the right time, with both under- and over-treatment a problem. Up to half the patients presenting to general practice report symptoms of depression, but general practitioners have no systematic way of efficiently identifying level of need and allocating treatment accordingly. Therefore, our team developed a new clinical prediction tool (CPT) to assist with this task. The CPT predicts depressive symptom severity in three months' time and based on these scores classifies individuals into three groups (minimal/mild, moderate, severe), then provides a matched treatment recommendation. This study aims to test whether using the CPT reduces depressive symptoms at three months compared with usual care., Methods: The Target-D study is an individually randomized controlled trial. Participants will be 1320 general practice patients with depressive symptoms who will be approached in the practice waiting room by a research assistant and invited to complete eligibility screening on an iPad. Eligible patients will provide informed consent and complete the CPT on a purpose-built website. A computer-generated allocation sequence stratified by practice and depressive symptom severity group, will randomly assign participants to intervention (treatment recommendation matched to predicted depressive symptom severity group) or comparison (usual care plus Target-D attention control) arms. Follow-up assessments will be completed online at three and 12 months. The primary outcome is depressive symptom severity at three months. Secondary outcomes include anxiety, mental health self-efficacy, quality of life, and cost-effectiveness. Intention-to-treat analyses will test for differences in outcome means between study arms overall and by depressive symptom severity group., Discussion: To our knowledge, this is the first depressive symptom stratification tool designed for primary care which takes a prognosis-based approach to provide a tailored treatment recommendation. If shown to be effective, this tool could be used to assist general practitioners to implement stepped mental-healthcare models and contribute to a more efficient and effective mental health system., Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR 12616000537459 ). Retrospectively registered on 27 April 2016. See Additional file 1 for trial registration data.
- Published
- 2017
- Full Text
- View/download PDF
28. Randomised controlled trial of a digitally assisted low intensity intervention to promote personal recovery in persisting psychosis: SMART-Therapy study protocol.
- Author
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Thomas N, Farhall J, Foley F, Rossell SL, Castle D, Ladd E, Meyer D, Mihalopoulos C, Leitan N, Nunan C, Frankish R, Smark T, Farnan S, McLeod B, Sterling L, Murray G, Fossey E, Brophy L, and Kyrios M
- Subjects
- Adolescent, Adult, Aged, Hope, Humans, Male, Mental Health Services, Middle Aged, Power, Psychological, Psychotic Disorders psychology, Quality of Life, Self Care psychology, Self Efficacy, Social Behavior, Social Identification, Surveys and Questionnaires, Treatment Outcome, Victoria, Young Adult, Psychotherapy methods, Psychotic Disorders therapy, Self Care methods, Telemedicine methods
- Abstract
Background: Psychosocial interventions have an important role in promoting recovery in people with persisting psychotic disorders such as schizophrenia. Readily available, digital technology provides a means of developing therapeutic resources for use together by practitioners and mental health service users. As part of the Self-Management and Recovery Technology (SMART) research program, we have developed an online resource providing materials on illness self-management and personal recovery based on the Connectedness-Hope-Identity-Meaning-Empowerment (CHIME) framework. Content is communicated using videos featuring persons with lived experience of psychosis discussing how they have navigated issues in their own recovery. This was developed to be suitable for use on a tablet computer during sessions with a mental health worker to promote discussion about recovery., Methods/design: This is a rater-blinded randomised controlled trial comparing a low intensity recovery intervention of eight one-to-one face-to-face sessions with a mental health worker using the SMART website alongside routine care, versus an eight-session comparison condition, befriending. The recruitment target is 148 participants with a schizophrenia-related disorder or mood disorder with a history of psychosis, recruited from mental health services in Victoria, Australia. Following baseline assessment, participants are randomised to intervention, and complete follow up assessments at 3, 6 and 9 months post-baseline. The primary outcome is personal recovery measured using the Process of Recovery Questionnaire (QPR). Secondary outcomes include positive and negative symptoms assessed with the Positive and Negative Syndrome Scale, subjective experiences of psychosis, emotional symptoms, quality of life and resource use. Mechanisms of change via effects on self-stigma and self-efficacy will be examined., Discussion: This protocol describes a novel intervention which tests new therapeutic methods including in-session tablet computer use and video-based peer modelling. It also informs a possible low intensity intervention model potentially viable for delivery across the mental health workforce., Trial Registration: NCT02474524 , 24 May 2015, retrospectively registered during the recruitment phase.
- Published
- 2016
- Full Text
- View/download PDF
29. A randomised, controlled trial of a dietary intervention for adults with major depression (the "SMILES" trial): study protocol.
- Author
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O'Neil A, Berk M, Itsiopoulos C, Castle D, Opie R, Pizzinga J, Brazionis L, Hodge A, Mihalopoulos C, Chatterton ML, Dean OM, and Jacka FN
- Subjects
- Adult, Australia, Clinical Protocols, Depressive Disorder, Major psychology, Female, Humans, Life Style, Male, New Zealand, Research Design, Depressive Disorder, Major diet therapy, Diet, Mediterranean, Social Support
- Abstract
Background: Despite increased investment in its recognition and treatment, depression remains a substantial health and economic burden worldwide. Current treatment strategies generally focus on biological and psychological pathways, largely neglecting the role of lifestyle. There is emerging evidence to suggest that diet and nutrition play an important role in the risk, and the genesis, of depression. However, there are limited data regarding the therapeutic impact of dietary changes on existing mental illness. Using a randomised controlled trial design, we aim to investigate the efficacy and cost-efficacy of a dietary program for the treatment of Major Depressive Episodes (MDE)., Methods/design: One hundred and seventy six eligible participants suffering from current MDE are being randomised into a dietary intervention group or a social support group. Depression status is assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS) and Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (Non Patient Edition) (SCID-I/NP). The intervention consists of 7 individual nutrition consulting sessions (of approximately 60 minutes), delivered by an Accredited Practising Dietitian (APD). Sessions commence within one week of baseline assessment. The intervention focuses on advocating a healthy diet based on the Australian Dietary Guidelines and the Dietary Guidelines for Adults in Greece. The control condition comprises a befriending protocol using the same visit schedule and length as the diet intervention. The study is being conducted at two locations in Victoria, Australia (a metropolitan and regional centre). Data collection occurs at baseline (pre-intervention), 3-months (post-intervention) and 6- months. The primary endpoint is MADRS scores at 3 months. A cost consequences analysis will determine the economic value of the intervention., Discussion: If efficacious, this program could provide an alternative or adjunct treatment strategy for the management of this highly prevalent mental disorder; the benefits of which could extend to the management of common co-morbidities including cardiovascular disease (CVD), obesity, and type 2 diabetes., Trial Registration: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12612000251820.
- Published
- 2013
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30. Protocol for a randomized controlled trial of a specialized health coaching intervention to prevent excessive gestational weight gain and postpartum weight retention in women: the HIPP study.
- Author
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Skouteris H, McCabe M, Milgrom J, Kent B, Bruce LJ, Mihalopoulos C, Herring SJ, Barnett M, Patterson D, Teale G, and Gale J
- Subjects
- Adolescent, Adult, Australia, Body Mass Index, Female, Humans, Pregnancy, Young Adult, Clinical Protocols, Health Education, Postpartum Period, Specialization, Weight Gain physiology
- Abstract
Background: Pregnancy is a time of significant physiological and physical change for women. In particular, it is a time at which many women are at risk of gaining excessive weight. We describe the rationale and methods of the Health in Pregnancy and Post-birth (HIPP) Study, a study which aims primarily to determine the effectiveness of a specialized health coaching (HC) intervention during pregnancy, compared to education alone, in preventing excessive gestational weight gain and postpartum weight retention 12 months post birth. A secondary aim of this study is to evaluate the mechanisms by which our HC intervention impacts on weight management both during pregnancy and post birth., Methods/design: The randomized controlled trial will be conducted with 220 women who have a BMI > 18.5 (American IOM cut-off for normal weight), are 18 years of age or older, English speaking, no history of disordered eating or diabetes and are less than 18 weeks gestation at recruitment. Women will be randomly allocated to either a specialized HC intervention group or an Education Alone group. Our specialized HC intervention has two components: (1) one-on-one sessions with a Health Coach, and (2) two by two hour educational group sessions led by a Health Coach. Women in the Education Alone group will receive two by two hour educational group sessions with no HC components. Body Mass Index, waist circumference, and psychological factors including motivation, readiness to change, symptoms of depression and anxiety, and body dissatisfaction will be assessed at baseline (14-16 weeks gestation), and again at follow-up: 32 weeks gestation, 6 weeks, 6 months and 12 months postpartum., Discussion: Our study responds to the urgent need to design effective interventions in pregnancy to prevent excessive gestational weight gain and postpartum weight retention. Our pregnancy HC intervention is novel and innovative and has been designed to be easily adopted by health professionals who work with pregnant women, such as obstetricians, midwives, allied health professionals and health psychologists., Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12611000331932.
- Published
- 2012
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31. Building the capacity of family day care educators to promote children's social and emotional wellbeing: an exploratory cluster randomised controlled trial.
- Author
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Davis E, Williamson L, Mackinnon A, Cook K, Waters E, Herrman H, Sims M, Mihalopoulos C, Harrison L, and Marshall B
- Subjects
- Child Welfare, Child, Preschool, Cluster Analysis, Faculty, Humans, Poverty Areas, Surveys and Questionnaires, Victoria, Capacity Building, Child Day Care Centers, Health Promotion, Inservice Training, Personal Satisfaction
- Abstract
Background: Childhood mental health problems are highly prevalent, experienced by one in five children living in socioeconomically disadvantaged families. Although childcare settings, including family day care are ideal to promote children's social and emotional wellbeing at a population level in a sustainable way, family day care educators receive limited training in promoting children's mental health. This study is an exploratory wait-list control cluster randomised controlled trial to test the appropriateness, acceptability, cost, and effectiveness of "Thrive," an intervention program to build the capacity of family day care educators to promote children's social and emotional wellbeing. Thrive aims to increase educators' knowledge, confidence and skills in promoting children's social and emotional wellbeing., Methods/design: This study involves one family day care organisation based in a low socioeconomic area of Melbourne. All family day care educators (term used for registered carers who provide care for children for financial reimbursement in the carers own home) are eligible to participate in the study. The clusters for randomisation will be the fieldworkers (n = 5) who each supervise 10-15 educators. The intervention group (field workers and educators) will participate in a variety of intervention activities over 12 months, including workshops; activity exchanges with other educators; and focused discussion about children's social and emotional wellbeing during field worker visits. The control group will continue with their normal work practice. The intervention will be delivered to the intervention group and then to the control group after a time delay of 15 months post intervention commencement. A baseline survey will be conducted with all consenting educators and field workers (n = ~70) assessing outcomes at the cluster and individual level. The survey will also be administered at one month, six months and 12 months post-intervention commencement. The survey consists of questions measuring perceived levels of knowledge, confidence and skills in promoting children's social and emotional wellbeing. As much of this intervention will be delivered by field workers, field worker-family day care educator relationships are key to its success and thus supervisor support will also be measured. All educators will also have an in-home quality of care assessment at baseline, one month, six months and 12 months post-intervention commencement. Process evaluation will occur at one month, six months and 12 months post-intervention commencement. Information regarding intervention fidelity and economics will also be assessed in the survey., Discussion: A capacity building intervention in child mental health promotion for family day care is an essential contribution to research, policy and practice. This initiative is the first internationally, and essential in building an evidence base of interventions in this extremely policy-timely setting., Trial Registration Number: 343312.
- Published
- 2011
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32. Living with prostate cancer: randomised controlled trial of a multimodal supportive care intervention for men with prostate cancer.
- Author
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Chambers SK, Newton RU, Girgis A, Nielsen L, Lepore S, Mihalopoulos C, Gardiner R, Galvão DA, and Occhipinti S
- Subjects
- Adaptation, Psychological physiology, Combined Modality Therapy, Follow-Up Studies, Humans, Male, Prostatic Neoplasms physiopathology, Prostatic Neoplasms psychology, Quality of Life psychology, Surveys and Questionnaires, Treatment Outcome, Exercise physiology, Prostatic Neoplasms therapy, Self Care, Social Support
- Abstract
Background: Prostate cancer is the most common male cancer in developed countries and diagnosis and treatment carries with it substantial morbidity and related unmet supportive care needs. These difficulties may be amplified by physical inactivity and obesity. We propose to apply a multimodal intervention approach that targets both unmet supportive care needs and physical activity., Methods/design: A two arm randomised controlled trial will compare usual care to a multimodal supportive care intervention "Living with Prostate Cancer" that will combine self-management with tele-based group peer support. A series of previously validated and reliable self-report measures will be administered to men at four time points: baseline/recruitment (when men are approximately 3-6 months post-diagnosis) and at 3, 6, and 12 months after recruitment and intervention commencement. Social constraints, social support, self-efficacy, group cohesion and therapeutic alliance will be included as potential moderators/mediators of intervention effect. Primary outcomes are unmet supportive care needs and physical activity levels. Secondary outcomes are domain-specific and health-related quality of life (QoL); psychological distress; benefit finding; body mass index and waist circumference. Disease variables (e.g. cancer grade, stage) will be assessed through medical and cancer registry records. An economic evaluation will be conducted alongside the randomised trial., Discussion: This study will address a critical but as yet unanswered research question: to identify a population-based way to reduce unmet supportive care needs; promote regular physical activity; and improve disease-specific and health-related QoL for prostate cancer survivors. The study will also determine the cost-effectiveness of the intervention., Trial Registration: ACTRN12611000392965.
- Published
- 2011
- Full Text
- View/download PDF
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