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BackgroundThe PRIDE programme aims to establish a suite of transdiagnostic psychological interventions organised around a stepped care system in Indian secondary schools. This paper describes the development of a low-intensity, first-line component of the PRIDE model.MethodContextual and global evidence informed an intervention 'blueprint' with problem solving as the primary practice element. Successive iterations were tested and modified across two pilot cohort studies (N = 45; N = 39). Participants were aged 13-20 years and presenting with elevated mental health symptoms in New Delhi schools.ResultsThe first iteration of the intervention, based on a guided self-help modality, showed promising outcomes and user satisfaction when delivered by psychologists. However, delivery was not feasible within the intended 6-week schedule, and participants struggled to use materials outside 'guidance' sessions. In Pilot 2, a modified counsellor-led problem-solving intervention was implemented by less experienced counsellors over a 3-4 week schedule. Outcomes were maintained, with indications of enhanced feasibility and acceptability. High demand was observed across both pilots, leading to more stringent eligibility criteria and a modified sensitisation plan.DiscussionFindings have shaped a first-line intervention for common adolescent mental health problems in low-resource settings. A forthcoming randomised controlled trial will test its effectiveness.

BackgroundConduct, anxiety, and depressive disorders account for over 75% of the adolescent mental health burden globally. The current protocol will test a low-intensity problem-solving intervention for school-going adolescents with common mental health problems in India. The protocol also tests the effects of a classroom-based sensitization intervention on the demand for counselling services in an embedded recruitment trial.Methods/designWe will conduct a two-arm, individually randomized controlled trial in six Government-run secondary schools in New Delhi. The targeted sample is 240 adolescents in grades 9-12 with persistent, elevated mental health symptoms and associated distress/impairment. Participants will receive either a brief problem-solving intervention delivered over 3 weeks by lay counsellors (intervention) or enhanced usual care comprised of problem-solving booklets (control). Self-reported adolescent mental health symptoms and idiographic problems will be assessed at 6 weeks (co-primary outcomes) and again at 12 weeks post-randomization. In addition, adolescent-reported distress/impairment, perceived stress, mental wellbeing, and clinical remission, as well as parent-reported adolescent mental health symptoms and impact scores, will be assessed at 6 and 12 weeks post-randomization. We will also complete a parallel process evaluation, including estimations of the costs of delivering the interventions. An embedded recruitment trial will apply a stepped-wedge, cluster (class)-randomized controlled design in 70 classes across the six schools. This will evaluate the added effect of a classroom-based sensitization intervention over and above school-level sensitization activities on the primary outcome of referral rate into the host trial. Other outcomes will be the proportion of referrals eligible to participate in the host trial, proportion of self-generated referrals, and severity and pattern of symptoms among referred adolescents in each condition. Power calculations were undertaken separately for each trial. A detailed statistical analysis plan will be developed separately for each trial prior to unblinding.DiscussionBoth trials were initiated on 20 August 2018. A single research protocol for both trials offers a resource-efficient methodology for testing the effectiveness of linked procedures to enhance uptake and outcomes of a school-based psychological intervention for common adolescent mental health problems.Trial registrationBoth trials are registered prospectively with the National Institute of Health registry ( www.clinicaltrials.gov ), registration numbers NCT03633916 and NCT03630471 , registered on 16th August, 2018 and 14th August, 2018 respectively).

Background Psychosocial interventions for adolescent mental health problems are effective, but evidence on their longer-term outcomes is scarce, especially in low-resource settings. We report on the 12-month sustained effectiveness and costs of scaling up a lay counselor-delivered, transdiagnostic problem-solving intervention for common adolescent mental health problems in low-income schools in New Delhi, India. Methods and findings Participants in the original trial were 250 school-going adolescents (mean [M] age = 15.61 years, standard deviation [SD] = 1.68), including 174 (69.6%) who identified as male. Participants were recruited from 6 government schools over a period of 4 months (August 20 to December 14, 2018) and were selected on the basis of elevated mental health symptoms and distress/functional impairment. A 2-arm, randomized controlled trial design was used to examine the effectiveness of a lay counselor-delivered, problem-solving intervention (4 to 5 sessions over 3 weeks) with supporting printed booklets (intervention arm) in comparison with problem solving delivered via printed booklets alone (control arm), at the original endpoints of 6 and 12 weeks. The protocol was modified, as per the recommendation of the Trial Steering Committee, to include a post hoc extension of the follow-up period to 12 months. Primary outcomes were adolescent-reported psychosocial problems (Youth Top Problems [YTP]) and mental health symptoms (Strengths and Difficulties Questionnaire [SDQ] Total Difficulties scale). Other self-reported outcomes included SDQ subscales, perceived stress, well-being, and remission. The sustained effects of the intervention were estimated at the 12-month endpoint and over 12 months (the latter assumed a constant effect across 3 follow-up points) using a linear mixed model for repeated measures and involving complete case analysis. Sensitivity analyses examined the effect of missing data using multiple imputations. Costs were estimated for delivering the intervention during the trial and from modeling a scale-up scenario, using a retrospective ingredients approach. Out of the 250 original trial participants, 176 (70.4%) adolescents participated in the 12-month follow-up assessment. One adverse event was identified during follow-up and deemed unrelated to the intervention. Evidence was found for intervention effects on both SDQ Total Difficulties and YTP at 12 months (YTP: adjusted mean difference [AMD] = -0.75, 95% confidence interval [CI] = -1.47, -0.03, p = 0.04; SDQ Total Difficulties: AMD = -1.73, 95% CI = -3.47, 0.02, p = 0.05), with stronger effects over 12 months (YTP: AMD = -0.98, 95% CI = -1.51, -0.45, p < 0.001; SDQ Total Difficulties: AMD = -1.23, 95% CI = -2.37, -0.09; p = 0.03). There was also evidence for intervention effects on internalizing symptoms, impairment, perceived stress, and well-being over 12 months. The intervention effect was stable for most outcomes on sensitivity analyses adjusting for missing data; however, for SDQ Total Difficulties and impairment, the effect was slightly attenuated. The per-student cost of delivering the intervention during the trial was $3 United States dollars (USD; or $158 USD per case) and for scaling up the intervention in the modeled scenario was $4 USD (or $23 USD per case). The scaling up cost accounted for 0.4% of the per-student school budget in New Delhi. The main limitations of the study's methodology were the lack of sample size calculations powered for 12-month follow-up and the absence of cost-effectiveness analyses using the primary outcomes. Conclusions In this study, we observed that a lay counselor-delivered, brief transdiagnostic problem-solving intervention had sustained effects on psychosocial problems and mental health symptoms over the 12-month follow-up period. Scaling up this resource-efficient intervention is an affordable policy goal for improving adolescents' access to mental health care in low-resource settings. The findings need to be interpreted with caution, as this study was a post hoc extension, and thus, the sample size calculations did not take into account the relatively high attrition rate observed during the long-term follow-up. Trial registration ClinicalTrials.gov NCT03630471., Author(s): Kanika Malik 1, Daniel Michelson 2, Aoife M. Doyle 3, Helen A. Weiss 3, Giulia Greco 4, Rooplata Sahu 1, James E. J. 1, Sonal Mathur 1, Paulomi Sudhir [...]

In recent years there has been widespread acceptance that cognitive behavior therapy (CBT) is the treatment of choice for bulimia nervosa. The cognitive behavioral treatment of bulimia nervosa (CBT-BN) was first described in 1981. Over the past decades the theory and treatment have evolved in response to a variety of challenges. The treatment has been adapted to make it suitable for all forms of eating disorder--thereby making it "transdiagnostic" in its scope--and treatment procedures have been refined to improve outcome. The new version of the treatment, termed "enhanced CBT" (CBT-E) also addresses psychopathological processes "external" to the eating disorder, which, in certain subgroups of patients, interact with the disorder itself. In this paper we discuss how the development of this broader theory and treatment arose from focusing on those patients who did not respond well to earlier versions of the treatment. (Contains 2 figures and 1 table.)

Objectives: There is limited understanding of change processes and long‐term effects of low‐intensity psychosocial interventions. We investigated these aspects in two brief problem‐solving intervention formats for adolescents with elevated mental health symptoms and associated distress/impairment. Methods: This qualitative study was nested within a school‐based randomized controlled trial in New Delhi, India, which compared two problem‐solving intervention formats: a lay counsellor‐led format supported by printed materials (intervention arm) and printed problem‐solving materials alone ("bibliotherapy" control arm). A total of 32 participants, ranging in age from 14 to 20 years (mean = 16.4 years, SD = 1.9) and comprising 21 males and 11 females, were interviewed across both trial arms at 12‐month follow‐up. Results: Five themes were derived using thematic framework analysis. The "impacts on symptoms and functioning" theme described symptomatic improvements and functional gains. "Processes underlying problem solving" reflected changes in positive beliefs, attitudes and emotions when confronted with problems, and the use of a more effective problem‐solving coping style. "Experiences of problem‐solving materials" covered benefits (e.g. access to relatable stories and readymade solutions) and limitations (e.g. diminishing use over time) of printed problem‐solving handouts. "Role of supporting figures" accounted for the facilitating roles played by counsellors and trusted others. There were also accounts of researchers functioning as de facto counsellors in the bibliotherapy arm. "Recommended modifications for intervention delivery" included more flexible and private ways to access the interventions, greater personalization of the counselling process, more engaging and relevant supporting materials, and suggestions for widening access to the interventions in schools and community settings. Conclusions: We infer from our qualitative analysis that changes in problem‐solving style and problem orientation underpinned long‐term symptomatic and functional improvements. Participants in the counsellor‐led intervention appeared better able to sustain the use of problem‐solving skills and generalize this approach beyond the original presenting problems. We attribute the differences between arms to the influence of direct advice and supportive interactions with counsellors. Practice implications are discussed. [ABSTRACT FROM AUTHOR]

Young women (n=102) with bulimia nervosa were compared with 204 control subjects without an eating disorder and with 102 subjects with other psychiatric disorders. Results suggest that sexual and physical abuse are both risk factors for psychiatric disorders in general, including bulimia nervosa, but are not specific risk factors for bulimia. (DB)

To link to full-text access for this article, visit this link: http://dx.doi.org/10.1016/j.brat.2009.06.019 Byline: Jackie A. Wales (a), Robert L. Palmer (a), Christopher G. Fairburn (b) Abstract: A catchment area-based sample of patients recruited for an eating disorder treatment trial was compared with patients from the same geographical area seen in the 12 months before and after the trial. The three samples were very similar. The research sample was representative of the usual clinic sample from which it had been selected and thus the results could be extrapolated with some confidence to other similar clinical settings. It is concluded that whilst treatment trials, by their very nature, have explicit and implicit inclusion and exclusion criteria with appropriate designs they can be usefully representative. Author Affiliation: (a) University Department of Health Sciences, Brandon Unit, Leicester General Hospital, Leicester LE5 4PW, UK (b) Department of Psychiatry, Oxford University, Warneford Hospital, Oxford OX3 7JX, UK Article History: Received 12 May 2009; Revised 26 June 2009; Accepted 30 June 2009

Background Counselling for Alcohol Problems (CAP), a brief intervention delivered by lay counsellors, enhanced remission and abstinence over 3 months among male primary care attendees with harmful drinking in a setting in India. We evaluated the sustainability of the effects after treatment termination, the cost-effectiveness of CAP over 12 months, and the effects of the hypothesized mediator 'readiness to change' on clinical outcomes. Methods and findings Male primary care attendees aged 18-65 years screening with harmful drinking on the Alcohol Use Disorders Identification Test (AUDIT) were randomised to either CAP plus enhanced usual care (EUC) (n = 188) or EUC alone (n = 189), of whom 89% completed assessments at 3 months, and 84% at 12 months. Primary outcomes were remission and mean standard ethanol consumed in the past 14 days, and the proposed mediating variable was readiness to change at 3 months. CAP participants maintained the gains they showed at the end of treatment through the 12-month follow-up, with the proportion with remission (AUDIT score < 8: 54.3% versus 31.9%; adjusted prevalence ratio [aPR] 1.71 [95% CI 1.32, 2.22]; p < 0.001) and abstinence in the past 14 days (45.1% versus 26.4%; adjusted odds ratio 1.92 [95% CI 1.19, 3.10]; p = 0.008) being significantly higher in the CAP plus EUC arm than in the EUC alone arm. CAP participants also fared better on secondary outcomes including recovery (AUDIT score < 8 at 3 and 12 months: 27.4% versus 15.1%; aPR 1.90 [95% CI 1.21, 3.00]; p = 0.006) and percent of days abstinent (mean percent [SD] 71.0% [38.2] versus 55.0% [39.8]; adjusted mean difference 16.1 [95% CI 7.1, 25.0]; p = 0.001). The intervention effect for remission was higher at 12 months than at 3 months (aPR 1.50 [95% CI 1.09, 2.07]). There was no evidence of an intervention effect on Patient Health Questionnaire 9 score, suicidal behaviour, percentage of days of heavy drinking, Short Inventory of Problems score, WHO Disability Assessment Schedule 2.0 score, days unable to work, or perpetration of intimate partner violence. Economic analyses indicated that CAP plus EUC was dominant over EUC alone, with lower costs and better outcomes; uncertainty analysis showed a 99% chance of CAP being cost-effective per remission achieved from a health system perspective, using a willingness to pay threshold equivalent to 1 month's wages for an unskilled manual worker in Goa. Readiness to change level at 3 months mediated the effect of CAP on mean standard ethanol consumption at 12 months (indirect effect -6.014 [95% CI -13.99, -0.046]). Serious adverse events were infrequent, and prevalence was similar by arm. The methodological limitations of this trial are the susceptibility of self-reported drinking to social desirability bias, the modest participation rates of eligible patients, and the examination of mediation effects of only 1 mediator and in only half of our sample. Conclusions CAP's superiority over EUC at the end of treatment was largely stable over time and was mediated by readiness to change. CAP provides better outcomes at lower costs from a societal perspective. Trial registration ISRCTN registry ISRCTN76465238, Author(s): Abhijit Nadkarni 1,2, Helen A. Weiss 2, Benedict Weobong 1,2, David McDaid 3, Daisy R. Singla 4, A-La Park 3, Bhargav Bhat 1, Basavaraj Katti 1, Jim McCambridge 5, [...]

Background The Healthy Activity Programme (HAP), a brief behavioural intervention delivered by lay counsellors, enhanced remission over 3 months among primary care attendees with depression in peri-urban and rural settings in India. We evaluated the sustainability of the effects after treatment termination, the cost-effectiveness of HAP over 12 months, and the effects of the hypothesized mediator of activation on clinical outcomes. Methods and findings Primary care attendees aged 18-65 years screened with moderately severe to severe depression on the Patient Health Questionnaire 9 (PHQ-9) were randomised to either HAP plus enhanced usual care (EUC) (n = 247) or EUC alone (n = 248), of whom 95% completed assessments at 3 months, and 91% at 12 months. Primary outcomes were severity on the Beck Depression Inventory-II (BDI-II) and remission on the PHQ-9. HAP participants maintained the gains they showed at the end of treatment through the 12-month follow-up (difference in mean BDI-II score between 3 and 12 months = -0.34; 95% CI -2.37, 1.69; p = 0.74), with lower symptom severity scores than participants who received EUC alone (adjusted mean difference in BDI-II score = -4.45; 95% CI -7.26, -1.63; p = 0.002) and higher rates of remission (adjusted prevalence ratio [aPR] = 1.36; 95% CI 1.15, 1.61; p < 0.009). They also fared better on most secondary outcomes, including recovery (aPR = 1.98; 95% CI 1.29, 3.03; p = 0.002), any response over time (aPR = 1.45; 95% CI 1.27, 1.66; p < 0.001), higher likelihood of reporting a minimal clinically important difference (aPR = 1.42; 95% CI 1.17, 1.71; p < 0.001), and lower likelihood of reporting suicidal behaviour (aPR = 0.71; 95% CI 0.51, 1.01; p = 0.06). HAP plus EUC also had a marginal effect on WHO Disability Assessment Schedule score at 12 months (aPR = -1.58; 95% CI -3.33, 0.17; p = 0.08); other outcomes (days unable to work, intimate partner violence toward females) did not statistically significantly differ between the two arms. Economic analyses indicated that HAP plus EUC was dominant over EUC alone, with lower costs and better outcomes; uncertainty analysis showed that from this health system perspective there was a 95% chance of HAP being cost-effective, given a willingness to pay threshold of Intl$16,060-equivalent to GDP per capita in Goa-per quality-adjusted life year gained. Patient-reported behavioural activation level at 3 months mediated the effect of the HAP intervention on the 12-month depression score ([beta] = -2.62; 95% CI -3.28, -1.97; p < 0.001). Serious adverse events were infrequent, and prevalence was similar by arm. We were unable to assess possible episodes of remission and relapse that may have occurred between our outcome assessment time points of 3 and 12 months after randomisation. We did not account for or evaluate the effect of mediators other than behavioural activation. Conclusions HAP's superiority over EUC at the end of treatment was largely stable over time and was mediated by patient activation. HAP provides better outcomes at lower costs from a perspective covering publicly funded healthcare services and productivity impacts on patients and their families. Trial registration ISRCTN registry ISRCTN95149997, Author(s): Benedict Weobong 1,6, Helen A. Weiss 2, David McDaid 3, Daisy R. Singla 4, Steven D. Hollon 5, Abhijit Nadkarni 1,6, A-La Park 3, Bhargav Bhat 6, Basavraj Katti [...]

Perfectionism can be a problem in its own right and it can impede the progress of treatment of Axis I disorders. This study reports on a preliminary randomised controlled trial of cognitive- behaviour therapy (CBT) for 'clinical perfectionism'. Twenty participants were randomly assigned to either immediate treatment (IT) (n = 10) or a waitlist (NL) (n = 10). Treatment consisted often sessions of CBT over eight weeks. Two participants did not complete the follow-up assessments (10%). Fifteen of the original 20 participants (75%) were clinically significantly improved after treatment and the effect size was large (1.8). Treatment gains were maintained at 8-week and 16-week follow-up. [c] 2006 Elsevier Ltd. All rights reserved. Keywords: Cognitive-behaviour therapy; Clinical perfectionism; Randomised controlled trial

The relationship between the eating disorders and attentional biases is studied in two samples of female patients with clinical eating disorders and anxiety along with a control group of normal females. The negative eating biases were observed in women with eating disorders than in anxious and normal controls.

To link to full-text access for this article, visit this link: http://dx.doi.org/10.1016/j.brat.2006.01.015 Byline: Roz Shafran, Michelle Lee, Elizabeth Payne, Christopher G. Fairburn Keywords: Body checking; Eating disorders; Experiment; Body dissatisfaction; Body size estimation Abstract: The relationship between repeated body checking and its impact on body size estimation and body dissatisfaction is of interest for two reasons. First, it has importance in theoretical accounts of the maintenance of eating disorders and, second, body checking is targeted in cognitive-behavioural treatment. The aim of this study was to determine the impact of manipulating body checking on body size estimation and body dissatisfaction. Sixty women were randomly assigned either to repeatedly scrutinize their bodies in a critical way in the mirror ('high body checking') or to refrain from body checking but to examine the whole of their bodies in a neutral way ('low body checking'). Body dissatisfaction, feelings of fatness and the strength of a particular self-critical thought increased immediately after the manipulation among those in the high body checking condition. Feelings of fatness decreased among those in the low body checking condition. These changes were short-lived. The manipulation did not effect estimations of body size or the discrepancy between estimations of body size and desired body size. The implications of these findings for understanding the influence of body checking on the maintenance of body dissatisfaction are considered. Author Affiliation: Department of Psychiatry, Warneford Hospital, Oxford University, Oxford OX3 7JX, UK Article History: Received 17 November 2005; Revised 25 January 2006; Accepted 31 January 2006

To link to full-text access for this article, visit this link: http://dx.doi.org/10.1016/j.brat.2005.08.009 Byline: Roz Shafran, Michelle Lee, Elizabeth Payne, Christopher G. Fairburn Keywords: Eating disorders; Theory; Experiment; Perfectionism Abstract: The relationship between perfectionism and eating disorders is well established and is of theoretical interest. This study used an experimental design to test the hypothesis that manipulating personal standards, a central feature of perfectionism, would influence eating attitudes and behaviour. Forty-one healthy women were randomly assigned either to a high personal standards condition (n=18) or to a low personal standards condition for 24h (n=23). Measures of personal standards, perfectionism, and eating attitudes and behaviour were taken before and after the experimental manipulation. The manipulation was successful. After the manipulation, participants in the high personal standards condition ate fewer high calorie foods, made more attempts to restrict the overall amount of food eaten, and had significantly more regret after eating than those in the low personal standards condition. Other variables remained unchanged. It is concluded that experimental analyses can be of value in elucidating causal connections between perfectionism and eating attitudes and behaviour. Author Affiliation: Oxford University Department of Psychiatry, Warneford Hospital, Oxford OX3 7JX, UK Article History: Received 11 February 2005; Revised 2 August 2005; Accepted 18 August 2005

The relationship between therapeutic alliance, therapist adherence to treatment protocol, and outcome was analyzed in a randomized trial of cognitive-behavioral therapy (CBT) and interpersonal psychotherapy for bulimia nervosa. Independent observers rated audiotapes of full-length therapy sessions. Purging frequency was the primary outcome variable. There were no significant therapist or Therapist X Treatment effects on outcome. Although results showed high levels of alliance and adherence across treatments, CBT was associated with greater adherence. Across treatments and time points, better adherence was associated with enhanced alliance. Treatment condition and baseline purging frequency, but not adherence, predicted outcome. Early alliance predicted posttreatment purging frequency. In temporal analyses, prior symptom change assessed early in treatment was significantly related to subsequent adherence at midtreatment. Keywords: therapeutic alliance, treatment adherence, bulimia nervosa, cognitive-behavioral therapy, interpersonal psychotherapy

The 'Not Otherwise Specified' (NOS) category within DSM-IV is designed for disorders of clinical severity that are not specified within broad diagnostic classes. 'NOS' diagnoses are intended to be residual categories and they tend to be neglected by researchers. This can be inappropriate. The problems associated with certain NOS diagnoses are well illustrated by 'Eating Disorder NOS' (sometimes termed EDNOS), which is the most common category of eating disorder encountered in routine clinical practice yet it has barely been studied. Indeed, there has been no research on its treatment. Interim and longer-term conceptual and practical solutions to the anomalous status of eating disorder NOS are proposed including the creation of a new diagnosis termed 'mixed eating disorder'. Several of these solutions are of relevance to NOS categories in general. All the solutions should fulfil criteria for clinical utility. Keywords: DSM-IV; NOS; Eating disorder; Diagnosis; Classification; Clinical utility