Search

ObjectivesIncreasing evidence demonstrates effectiveness of Mindfulness-Based Stress Reduction (MBSR) for pain-related and functional disorders. In order to conduct successful and efficient trials of MBSR, evidence regarding the relative performance of strategies to improve recruitment, retention, and adherence is required, but few studies have examined these issues specifically.DesignIn preparation for a fully powered trial, we conducted a 2-arm, parallel comparison randomized controlled feasibility trial of MBSR vs. usual-care for 60 patients with migraine headache.SettingTwo large U.S. health systems in Northern California.InterventionMBSR is an 8-week classroom-based intervention that combines mindfulness meditation and yoga, with didactic presentations about stress psychology and group process/experiential education. Participants received the intervention at their choice of one of several existing, vetted community-based classes.Main outcome measuresSuccessful recruitment was defined a priori as 18 participants within any 9-week period or 60 participants enrolled within a 36-week period. We considered participants adherent to the intervention if they attended at least 5 of the 8 weekly classes and the day-long retreat.ResultsWe successfully enrolled 18 participants within a 7-week period, however, we did not attain our second goal of recruiting 60 participants within a 36-week period. Sixty-eight percent of our participants were adherent to the intervention.ConclusionsWe found that close monitoring of recruitment activities, flexibility in protocol modifications, and integration within the delivery system were crucial factors for successful participant recruitment, retention, and adherence in mindfulness research.

Background: People with severe mental illness experience physical health inequalities and a 15–20-year premature mortality rate. Forensic inpatients are particularly affected by restrictions on movement, long admissions, and obesogenic/sedative psychotropic medication. We aimed to establish the feasibility and acceptability of Motiv8, a multidisciplinary weight management intervention co-produced with service users for forensic inpatients. Methods: A randomised waitlist-controlled trial of Motiv8(+Treatment-As-Usual) vs.TAU was conducted in medium-secure forensic services in Greater Manchester. Motiv8 is a 9-week programme of exercise sessions, diet/cooking classes, psychology, physical health/sleep education, and peer support. Physical and mental health assessments were conducted at baseline/10-weeks/3-months. A nested qualitative study captured participant experiences. A staff sub-study explored ward environment. Results: We aimed to recruit 32 participants (four cohorts). The trial met recruitment targets (n=29, 90.9%; 4 cohorts, 100%), participants were randomised to Motiv8+TAU (n=12) or waitlist (control) (n=17). Acceptable retention rates were observed (93.1%, 10-weeks; 72.4%, 3-months), and participants engaged well with the intervention. The blind was maintained, and no safety concerns raised. Assessment completion was high suggesting acceptability (>90% for people retained and engaged in the study). Participants reported high levels of satisfaction. Conclusions: The trial was not powered to detect group differences. However, data suggests it is feasible to conduct a rigorous, methodologically robust study of Motiv8 vs.TAU for adults on forensic inpatient units. Motiv8 was acceptable with potential promise providing evidence to proceed to a definitive trial for males. A larger trial is needed to explore potential effectiveness and reduce physical health inequalities for people with SMI. Clinical trial registration: https://doi.org/10.1186/ISRCTN13539285 , identifier ISRCTN13539285. [ABSTRACT FROM AUTHOR]

Objectives: This study aims to review studies developing or validating a prediction model for transition to psychosis in individuals meeting At Risk Mental State (ARMS) criteria focussing on predictors that can be obtained as part of standard clinical practice. Prediction of transition is crucial to facilitating identification of patients who would benefit from cognitive behavioural therapy and, conversely, those that would benefit from less costly and less-intensive regular mental state monitoring. The review aims to determine whether prediction models rated as low risk of bias exist and, if not, what further research is needed within the field. Design: Bibliographic databases (PsycINFO, Medline, EMBASE, CINAHL) were searched using index terms relating to the clinical field and prognosis from 1994, the initial year of the first prospective study using ARMS criteria, to July 2024. Screening of titles, abstracts, and subsequently full texts was conducted by two reviewers independently using predefined criteria. Study quality was assessed using the Prediction model Risk Of Bias ASessment Tool (PROBAST). Setting: Studies in any setting were included. Primary and secondary outcome measures: The primary outcome for the review was the identification of prediction models considering transition risk and a summary of their risk of bias. Results: Forty-eight unique prediction models considering risk of transition to psychosis were identified. Variables found to be consistently important when predicting transition were age, gender, global functioning score, trait vulnerability, and unusual thought content. PROBAST criteria categorised four unique prediction models as having an overall low-risk bias. Other studies were insufficiently powered for the number of candidate predictors or lacking enough information to draw a conclusion regarding risk of bias. Conclusions: Two of the 48 identified prediction models were developed using current best practice statistical methodology, validated their model in independent data, and presented low risk of bias overall in line with the PROBAST guidelines. Any new prediction model built to evaluate the risk of transition to psychosis in people meeting ARMS criteria should be informed by the latest statistical methodology and adhere to the TRIPOD reporting guidelines to ensure that clinical practice is informed by the best possible evidence. External validation of such models should be carefully planned particularly considering generalisation across different countries. Systematic review registration: https://www.crd.york.ac.uk/PROSPEROFILES/108488%5fPROTOCOL%5f20191127.pdf , identifier CRD42018108488. [ABSTRACT FROM AUTHOR]

Pay for performance (P4P) and health information technology (HIT) have been used to improve health care quality, but few studies examine interventions combining P4P with HIT support at federally qualified health centers (FQHCs). An intervention comparison, pre-post study was conducted to determine the effect of a P4P+HIT intervention on emergency department (ED) visits and hospitalizations. While ED utilization decreased in both intervention and comparison groups, there were no significant differences in ED or hospital utilization between intervention and comparison groups. Additional time or support above and beyond P4P+HIT may be necessary to improve the health care provided by FQHCs to underserved communities in Hawai‛i.

The aim of this study was to conduct a preliminary evaluation of a mental health consultation process provided to staff working in residential care settings for young people. Using a semi-structured interview approach, qualitative information was gathered from six participants about their experiences of the consultation. A thematic analysis of the interviews generated four key themes, which appear to reflect the different stages of consultation. These included: initiating consultation; building the consultative relationship; overcoming obstacles; and seeing the value of consultation. These themes, along with prevalent sub-themes, are discussed with reference to the effectiveness of the consultation process and the implications for use of psychological consultation in clinical practice. Implications for future practice include providing information to potential consultees before the consultation process, being accessible informally to the consultee and adopting a variety of approaches based on the consultee's needs. The limitations of this study and recommendations for future research are also discussed.

Objectives: The Bipolar at Risk Trial (BART) was a feasibility randomized controlled trial investigating cognitive behavioral therapy (CBT) compared with treatment as usual (TAU) in young people at high risk of developing bipolar disorder (BD). This qualitative study aimed to investigate participants' experiences of trial involvement, and the acceptability of CBT for this population. Design: Participants were those identified as being at risk of bipolar disorder, determined by current symptoms or family history. A purposive sample of twenty‐one participants from both the intervention and TAU arms of the trial was recruited. Methods: Twenty‐one semi‐structured interviews were conducted by service user researchers (13 participants had received therapy and 8 TAU). Interviews were audio recorded with consent from participants and transcribed verbatim. NVivo 11 Pro software was used to conduct an inductive thematic analysis. Results: Super‐ordinate themes were "adaptability and flexibility," "feeling understood and valued," and "relevance of study and intervention" which had two sub‐themes—"value of the trial therapy" and "acceptability of trial processes." Participating in the trial and having therapy enabled participants to feel understood and valued by research assistants (RAs) and therapists. Participants viewed therapy as relevant to their current concerns and valued adaptability and flexibility of RAs and therapists. Conclusions: Findings highlight the importance and value of flexibility, adaptability, and understanding in relationships between participants and trial staff. Findings also indicate that the trial processes and CBT focusing on mood swings are acceptable and relevant to participants from this at risk population. Practitioner points: Young people at risk of bipolar disorder value a flexible approach to assessments and therapy, developing a rapport with research assistants and therapists and opening up to them when they feel comfortable to do so.CBT focusing on coping with mood swings was acceptable to the majority of participants who received it and it was perceived as helpful in ways that were personal to each participant. [ABSTRACT FROM AUTHOR]

Abstract Background There is increasing evidence for the effectiveness of structured psychological therapies for bipolar disorder. To date however there have been no psychological interventions specifically designed for individuals with early bipolar disorder. The primary objective of this trial is to establish the acceptability and feasibility of a new CBT based intervention (Recovery focused CBT; RfCBT) designed in collaboration with individuals with early bipolar disorder intended to improve clinical and personal recovery outcomes. Methods and design This article describes a single blind randomised controlled trial to assess the feasibility and acceptability of RfCBT compared with treatment as usual. Participants will be recruited from across the North West of England from specialist mental health services and through primary care and self referral. The primary outcome of the study is the feasibility and acceptability of RfCBT as indicated by recruitment to target and retention to follow-up as well as absence of untoward incidents associated with RfCBT. We also intend to estimate the effect size of the impact of the intervention on recovery and mood outcomes and explore potential process measures (self appraisal, stigma, hope and self esteem). Discussion This is the first trial of recovery informed CBT for early bipolar disorder and will therefore be of interest to researchers in this area as well as indicating the wider potential for evaluating approaches to the recovery informed treatment of recent onset severe mental illness in general. Trial registration number ISRCTN43062149