"If there is a tension about something, I can solve it": A qualitative investigation of change processes in a trial of brief problem-solving interventions for common adolescent mental health problems in India.

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.

Pilot randomised controlled trial of a remotely delivered online intervention for adolescent mental health problems in India: lessons learned about low acceptability and feasibility during the COVID-19 pandemic.

BACKGROUND: 'POD Adventures' is a gamified problem-solving intervention delivered via smartphone app, and supported by non-specialist counsellors for a target population of secondary school students in India during the COVID-19 pandemic. AIMS: To evaluate the feasibility and acceptability of undertaking a randomised controlled trial of POD Adventures when delivered online with telephone support from counsellors. METHOD: We conducted a parallel, two-arm, individually randomised pilot-controlled trial with 11 secondary schools in Goa, India. Participants received either the POD Adventures intervention delivered over 4 weeks or usual care comprising information about local mental health services and national helplines. Outcomes were assessed at two timepoints: baseline and 6 weeks post-randomisation. RESULTS: Seventy-nine classroom sensitisation sessions reaching a total of 1575 students were conducted. Ninety-two self-initiated study referrals (5.8%) were received, but only 11 participants enrolled in the study. No intervention arm participants completed the intervention. Outcomes at 6 weeks were not available for intervention arm participants (n = 5), and only four control arm participants completed outcomes. No qualitative interviews or participant satisfaction measures were completed because participants could not be reached by the study team. CONCLUSIONS: Despite modifications to address barriers arising from COVID-19 restrictions, online delivery was not feasible in the study context. Low recruitment and missing feasibility and acceptability data make it difficult to draw conclusions about intervention engagement and indicative clinical outcomes. Prior findings showing high uptake, adherence and engagement with POD Adventures when delivered in a school-based context suggest that an online study and delivery posed the biggest barriers to study participation and engagement.

EMPOWER: Toward the Global Dissemination of Psychosocial Interventions.

Even before the COVID-19 pandemic, the needs for care of persons with mental illness remained largely unmet worldwide, testifying to the inadequacy of current approaches to mental health care and their unsuitability for the rising demand. One hurdle to improved access to quality care is the reliance on expensive specialist providers, particularly for the delivery of psychosocial interventions. This article describes EMPOWER, a not-for-profit program that builds on the clinical science demonstrating the effectiveness of brief psychosocial interventions for a range of psychiatric conditions; implementation science demonstrating the effectiveness of delivery of these interventions by non-specialist providers (NSPs); and pedagogical science demonstrating the effectiveness of digital approaches for training and quality assurance. The EMPOWER program leverages digital tools for training and supervising NSPs, designing competency-based curricula, assessing treatment-specific competencies, implementing measurement-based peer supervision for support and quality assurance, and evaluating impacts to enhance the effectiveness of the delivery system.

Effectiveness and costs associated with a lay counselor-delivered, brief problem-solving mental health intervention for adolescents in urban, low-income schools in India: 12-month outcomes of a randomized controlled trial.

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.

A Guided Internet-Based Problem-Solving Intervention Delivered Through Smartphones for Secondary School Pupils During the COVID-19 Pandemic in India: Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: "POD Adventures" is a gamified mental health intervention delivered via a smartphone app and supported by counsellors for a target population of secondary school students in India. This paper describes the protocol for a pilot randomized controlled trial of a remotely delivered version of the intervention in the context of COVID-19 restrictions. OBJECTIVE: Our objectives are to assess the feasibility of research procedures and intervention delivery and to generate preliminary estimates of the effectiveness of the intervention to inform the sample size calculation of a full-scale trial. METHODS: We will conduct a parallel, 2-arm, individually randomized pilot controlled trial in 11 secondary schools in Goa, India. This pilot trial aims to recruit 70 participants with a felt need for psychological support. Participants will receive either the POD Adventures intervention delivered over 4 weeks or usual care comprising information about local mental health services and national helplines. Outcomes will be assessed at two timepoints: baseline and 6 weeks post randomization. RESULTS: The first participant was enrolled on January 28, 2021, and 6-week assessment completed on April 4, 2021. Owing to a second wave of the COVID-19 pandemic in India, schools in Goa were closed on April 22, 2021. Trial participants are currently receiving the intervention or completing follow-up assessments. CONCLUSIONS: This pilot trial will help understand the feasibility of implementing and evaluating a remotely delivered digital mental health intervention in a low-resource setting. Our findings will be used to design future trials that can address difficulties of accessing psychosocial support in-person and support wider efforts to scale up evidence-based mental health interventions for young people. TRIAL REGISTRATION: ClinicalTrials.gov NCT04672486; https://clinicaltrials.gov/ct2/show/NCT04672486. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/30339.

Clinical and cost-effectiveness of two ways of delivering guided self-help for people with an eating disorder: A multi-arm randomized controlled trial.

OBJECTIVE: Increasing the availability and accessibility of evidence-based treatments for eating disorders is an important goal. This study investigated the effectiveness and cost-effectiveness of guided self-help via face-to-face meetings (fGSH) and a more scalable method, providing support via email (eGSH). METHOD: A pragmatic, randomized controlled trial was conducted at three sites. Adults with binge-eating disorders were randomized to fGSH, eGSH, or a waiting list condition, each lasting 12 weeks. The primary outcome variable for clinical effectiveness was overall severity of eating psychopathology and, for cost-effectiveness, binge-free days, with explorative analyses using symptom abstinence. Costs were estimated from both a partial societal and healthcare provider perspective. RESULTS: Sixty participants were included in each condition. Both forms of GSH were superior to the control condition in reducing eating psychopathology (IRR = -1.32 [95% CI -1.77, -0.87], p < .0001; IRR = -1.62 [95% CI -2.25, -1.00], p < .0001) and binge eating. Attrition was higher in eGSH. Probabilities that fGSH and eGSH were cost-effective compared with WL were 93% (99%) and 51% (79%), respectively, for a willingness to pay of £100 (£150) per additional binge-free day. DISCUSSION: Both forms of GSH were associated with clinical improvement and were likely to be cost-effective compared with a waiting list condition. Provision of support via email is likely to be more convenient for many patients although the risk of non-completion is greater.

Digital training for non-specialist health workers to deliver a brief psychological treatment for depression in India: Protocol for a three-arm randomized controlled trial.

BACKGROUND: Training non-specialist health workers (NSHWs) at scale is a major barrier to increasing the coverage of depression care in India. This trial will test the effectiveness of two forms of digital training compared to conventional face-to-face training in changing the competence of NSHWs to deliver a brief evidence-based psychological treatment for depression. METHODS: This protocol is for a three-arm, parallel group randomized controlled trial comparing three ways of training NSHWs to deliver the Healthy Activity Program (HAP), a brief manualized psychotherapy for depression, in primary care. The arms are: digital training (DGT); digital training combined with individualized coaching support (DGT+); and conventional face-to-face training (F2F). The target sample comprises N = 336 government contracted NSHWs in Madhya Pradesh, India. The primary outcome is change of competence to deliver HAP; secondary outcomes include cost-effectiveness of the training programs, change in participants' mental health knowledge, attitudes and behavior, and satisfaction with the training. Assessors blind to participant allocation status will collect outcomes pre- (baseline) and post- (endpoint) training to ascertain differences in outcomes between arms. Training program costs will be collected to calculate incremental costs of achieving one additional unit on the competency measure in the digital compared to face-to-face training programs. Health worker motivation, job satisfaction, and burnout will be collected as exploratory outcome variables. DISCUSSION: This trial will determine whether digital training is an effective, cost-effective, and scalable approach for building workforce capacity to deliver a brief evidence-based psychological treatment for depression in primary care in a low-resource setting. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04157816.

Risk factors for anorexia nervosa and bulimia nervosa in Japan and compared to a U.S. sample.

OBJECTIVE: This study provides the first systematic investigation of environmental exposure to putative psychosocial risk factors for eating disorders in individuals with AN and BN in Japan. It also provides a comparison of risk factors for the development of AN and BN in Japan versus the United States. METHOD: Participants in Japan were 96 women with a current DSM-IV AN or BN primary diagnosis (AN, n = 60; BN, n = 36) and 57 women with no current psychiatric diagnosis (NC group). Participants in the United States were 137 women with a current DSM-IV AN or BN primary diagnosis (AN-U.S., n = 71; BN-U.S., n = 66). A standardized semi-structured interview retrospectively assessed exposure to risk factors prior to first symptom onset, which were analyzed using General Linear Model analyses. RESULTS: Perfectionism and negative affectivity, family relationship issues, and, to a lesser degree, parental psychopathology predicted the emergence of AN and BN in Japan. Physical and sexual abuse and family eating and weight concerns were not significant risk factors in Japan. Compared to their respective diagnostic U.S. groups, the Japanese AN group reported higher levels of individual mental health factors and lower levels of family dieting and family overweight, and the Japanese BN group reported higher levels on individual mental health factors, lower exposure to problems with their parents, and lower exposure to family weight and eating concerns. DISCUSSION: These country-specific data from Japan contribute to an increasingly nuanced and global understanding of risk factors for eating disorders.

Mediators of change in cognitive behavior therapy and interpersonal psychotherapy for eating disorders: A secondary analysis of a transdiagnostic randomized controlled trial.

OBJECTIVE: Understanding the mechanisms of action of psychological treatments is a key first step in refining and developing more effective treatments. The present study examined hypothesized mediators of change of enhanced cognitive behavior therapy (CBT-E) and interpersonal psychotherapy for eating disorders (IPT-ED). METHOD: A series of mediation studies were embedded in a randomized controlled trial (RCT) comparing 20 weeks of CBT-E and IPT-ED in a transdiagnostic, non-underweight sample of patients with eating disorders (N = 130) consecutively referred to the service. Three hypothesized mediators of change in CBT-E (regular eating, weighing frequency, and shape checking) and the key hypothesized mediator of IPT-ED (interpersonal problem severity) were studied. RESULTS: The data supported regular eating as being a mediator of the effect of CBT-E on binge-eating frequency. The findings were inconclusive regarding the role of the other putative mediators of the effects of CBT-E; and were similarly inconclusive for interpersonal problem severity as a mediator of the effect of IPT-ED. DISCUSSION: This research highlights the potential benefits of embedding mediation studies within RCTs to better understand how treatments work. The findings supported the role of regular eating in reducing patients' binge-eating frequency. Other key hypothesized mediators of CBT-E and IPT-ED were not supported, although the data were not inconsistent with them. Key methodological issues to address in future work include the need to capture both behavioral and cognitive processes of change in CBT-E, and identifying key time points for change in IPT-ED.

Effectiveness of a brief lay counsellor-delivered, problem-solving intervention for adolescent mental health problems in urban, low-income schools in India: a randomised controlled trial.

BACKGROUND: Mental health problems are a leading cause of disability in adolescents worldwide. Problem solving is a well-tested mental health intervention in many populations. We aimed to investigate the effectiveness of a brief, transdiagnostic problem-solving intervention for common adolescent mental health problems when delivered by non-specialist school counsellors in New Delhi, India. METHODS: This randomised trial was done in six government-run schools (three all-boys schools, two all-girls schools, and one co-educational school) that serve low-income communities. We recruited participants from grades 9 to 12 (ages 12-20 years) by selecting students with persistently elevated mental health symptoms accompanied by distress or functional impairment. Clinical eligibility criteria were assessed by research assistants using the Hindi-language version of the Strengths and Difficulties Questionnaire (SDQ), with reference to locally validated borderline cutoff scores of 19 or greater for boys and 20 or greater for girls on the SDQ Total Difficulties scale, an abnormal score of 2 or more on the SDQ Impact scale, and persistence of more than 1 month on the SDQ Chronicity index. Participants were randomly allocated (1:1) to problem solving delivered through a brief (2-3 week) counsellor-led intervention with supporting printed materials (intervention group), or problem solving delivered via printed booklets alone (control group). Primary outcomes were adolescent-reported mental health symptoms (SDQ Total Difficulties scale) and idiographic psychosocial problems (Youth Top Problems [YTP]) at 6 weeks. Primary analyses were done on an intention-to-treat basis at the 6-week endpoint. The trial is registered with ClinicalTrials.gov, NCT03630471. FINDINGS: Participants were enrolled between Aug 20, and Dec 4, 2018. 283 eligible adolescents were referred to the trial, and 251 (89%) of these were enrolled (mean age 15·61 years; 174 [69%] boys). 125 participants were allocated to each group (after accounting for one participant in the intervention group who withdrew consent after randomisation). Primary outcome data were available for 245 (98%) participants. At 6 weeks, the mean YTP scores were 3·52 (SD 2·66) in the intervention group and 4·60 (2·75) in the control group (adjusted mean difference -1·01, 95% CI -1·63 to -0·38; adjusted effect size 0·36, 95% CI 0·11 to 0·61; p=0·0015). The mean SDQ Total Difficulties scores were 17·48 (5·45) in the intervention group and 18·33 (5·45) in the control group (-0·86, -2·14 to 0·41; 0·16, -0·09 to 0·41; p=0·18). We observed no adverse events. INTERPRETATION: A brief lay counsellor-delivered problem-solving intervention combined with printed booklets seemed to have a modest effect on psychosocial outcomes among adolescents with diverse mental health problems compared with problem-solving booklets alone. This counsellor-delivered intervention might be a suitable first-line intervention in a stepped care approach, which is being evaluated in ongoing studies. FUNDING: Wellcome Trust.

Development of a transdiagnostic, low-intensity, psychological intervention for common adolescent mental health problems in Indian secondary schools.

BACKGROUND: The 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. METHOD: Contextual 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. RESULTS: The 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. DISCUSSION: Findings 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.

Temporal pathways of change in two randomized controlled trials for depression and harmful drinking in Goa, India.

BACKGROUND: The current study explored the temporal pathways of change within two treatments, the Healthy Activity Program (HAP) for depression and the Counselling for Alcohol Problems (CAP) Program for harmful drinking. METHODS: The study took place in the context of two parallel randomized controlled trials in Goa, India. N = 50 random participants who met a priori criteria were selected from each treatment trial and examined for potential direct and mediational pathways. In HAP, we examined the predictive roles of therapy quality and patient-reported activation, assessing whether activation mediated the effects of therapy quality on depression (Patient Health Questionnaire-9) outcomes. In CAP, we examined the predictive roles of therapy quality and patient change- and counter-change-talk, assessing whether change- or counter-change-talk mediated the effects of therapy quality on daily alcohol consumption. RESULTS: In HAP, therapy quality (both general and treatment-specific skills) was associated with patient activation; patient activation but not therapy quality significantly predicted depression outcomes, and patient activation mediated the effects of higher general skills on subsequent clinical outcomes [a × b = -2.555, 95% confidence interval (CI) -5.811 to -0.142]. In CAP, higher treatment-specific skills, but not general skills, were directly associated with drinking outcomes, and reduced levels of counter-change talk both independently predicted, and mediated the effects of higher general skills on, reduced alcohol consumption (a × b = -24.515, 95% CI -41.190 to -11.060). Change talk did not predict alcohol consumption and was not correlated with counter-change talk. CONCLUSION: These findings suggest that therapy quality in early sessions operated through increased patient activation and reduced counter-change talk to reduce depression and harmful drinking respectively.

The effectiveness of a low-intensity problem-solving intervention for common adolescent mental health problems in New Delhi, India: protocol for a school-based, individually randomized controlled trial with an embedded stepped-wedge, cluster randomized controlled recruitment trial.

BACKGROUND: Conduct, 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/DESIGN: We 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. DISCUSSION: Both 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 REGISTRATION: Both 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).

The Roles of Early Response and Sudden Gains on Depression Outcomes: Findings From a Randomized Controlled Trial of Behavioral Activation in Goa, India.

The Healthy Activity Program (HAP), a brief, lay-counselor-delivered, behavioral activation psychological treatment, was found to be effective in reducing depressive symptoms among primary care attendees in India. We now examine whether early response predicts depression (PHQ-9) outcomes at the primary endpoint of 3 months and sustained recovery at 12 months after enrollment and the extent to which this effect is influenced by sudden gains in the context of the larger randomized controlled trial. HAP participants (N = 245) who exhibited an early response (150 of 245 or 61.2%), as defined by a 50% reduction in depressive symptoms from baseline to Session 3, had lower depressive symptom scores than those who did not at 3 months (5.29 vs. 10.75, F = 33.21, p < .001) and at 12 months (6.56 vs. 11.02, F = 21.84, p < .001). Further exploratory analyses suggested that this advantage was largely confined to the subset of early responders who also showed sudden gains (87 of 150).

Imagery-Focused Cognitive Therapy (ImCT) for Mood Instability and Anxiety in a Small Sample of Patients with Bipolar Disorder: a Pilot Clinical Audit.

BACKGROUND: Despite the global impact of bipolar disorder (BD), treatment success is limited. Challenges include syndromal and subsyndromal mood instability, comorbid anxiety, and uncertainty around mechanisms to target. The Oxford Mood Action Psychology Programme (OxMAPP) offered a novel approach within a cognitive behavioural framework, via mental imagery-focused cognitive therapy (ImCT). AIMS: This clinical audit evaluated referral rates, clinical outcomes and patient satisfaction with the OxMAPP service. METHOD: Eleven outpatients with BD received ImCT in addition to standard psychiatric care. Mood data were collected weekly from 6 months pre-treatment to 6 months post-treatment via routine mood monitoring. Anxiety was measured weekly from start of treatment until 1 month post-treatment. Patient feedback was provided via questionnaire. RESULTS: Referral and treatment uptake rates indicated acceptability to referrers and patients. From pre- to post-treatment, there was (i) a significant reduction in the duration of depressive episode relapses, and (ii) a non-significant trend towards a reduction in the number of episodes, with small to medium effect size. There was a large effect size for the reduction in weekly anxiety symptoms from assessment to 1 month follow-up. Patient feedback indicated high levels of satisfaction with ImCT, and underscored the importance of the mental imagery focus. CONCLUSIONS: This clinical audit provides preliminary evidence that ImCT can help improve depressive and anxiety symptoms in BD as part of integrated clinical care, with high patient satisfaction and acceptability. Formal assessment designs are needed to further test the feasibility and efficacy of the new ImCT treatment on anxiety and mood instability.

Increasing the Availability of Psychological Treatments: A Multinational Study of a Scalable Method for Training Therapists.

BACKGROUND: One of the major barriers to the dissemination and implementation of psychological treatments is the scarcity of suitably trained therapists. A highly scalable form of Web-centered therapist training, undertaken without external support, has recently been shown to have promise in promoting therapist competence. OBJECTIVE: The aim of this study was to conduct an evaluation of the acceptability and effectiveness of a scalable independent form of Web-centered training in a multinational sample of therapists and investigate the characteristics of those most likely to benefit. METHODS: A cohort of eligible therapists was recruited internationally and offered access to Web-centered training in enhanced cognitive behavioral therapy, a multicomponent, evidence-based, psychological treatment for any form of eating disorder. No external support was provided during training. Therapist competence was assessed using a validated competence measure before training and after 20 weeks. RESULTS: A total of 806 therapists from 33 different countries expressed interest in the study, and 765 (94.9%) completed a pretraining assessment. The median number of training modules completed was 15 out of a possible 18 (interquartile range, IQR: 4-18), and 87.9% (531/604) reported that they treated at least one patient during training as recommended. Median pretraining competence score was 7 (IQR: 5-10, range: 0-19; N=765), and following training, it was 12 (IQR: 9-15, range: 0-20; N=577). The expected change in competence scores from pretraining to posttraining was 3.5 (95% CI 3.1-3.8; P<.001). After training, 52% (300/574) of therapists with complete competence data met or exceeded the competence threshold, and 45% (95% CI 41-50) of those who had not met this threshold before training did so after training. Compliance with training predicted both an increase in competence scores and meeting or exceeding the competence threshold. Expected change in competence score increased for each extra training module completed (0.19, 95% CI 0.13-0.25), and those who treated a suitable patient during training had an expected change in competence score 1.2 (95% CI 0.4-2.1) points higher than those who did not. Similarly, there was an association between meeting the competence threshold after training and the number of modules completed (odds ratio, OR=1.11, 95% CI 1.07-1.15), and treating at least one patient during training was associated with competence after training (OR=2.2, 95% CI 1.2-4.1). CONCLUSIONS: Independent Web-centered training can successfully train large numbers of therapists dispersed across a wide geographical area. This finding is of importance because the availability of a highly scalable method of training potentially increases the number of people who might receive effective psychological treatments.

Treatments for bulimia nervosa: a network meta-analysis.

BACKGROUND: Bulimia nervosa (BN) is a severe eating disorder that can be managed using a variety of treatments including pharmacological, psychological, and combination treatments. We aimed to compare their effectiveness and to identify the most effective for the treatment of BN in adults. METHODS: A search was conducted in Embase, Medline, PsycINFO, and Central from their inception to July 2016. Studies were included if they reported on treatments for adults who fulfilled diagnostic criteria for BN. Only randomised controlled trials (RCTs) that examined available psychological, pharmacological, or combination therapies licensed in the UK were included. We conducted a network meta-analysis (NMA) of RCTs. The outcome analysed was full remission at the end of treatment. RESULTS: We identified 21 eligible trials with 1828 participants involving 12 treatments, including wait list. The results of the NMA suggested that individual cognitive behavioural therapy (CBT) (specific to eating disorders) was most effective in achieving remission at the end of treatment compared with wait list (OR 3.89, 95% CrI 1.19-14.02), followed by guided cognitive behavioural self-help (OR 3.81, 95% CrI 1.51-10.90). Inconsistency checks did not identify any significant inconsistency between the direct and indirect evidence. CONCLUSIONS: The analysis suggested that the treatments that are most likely to achieve full remission are individual CBT (specific to eating disorders) and guided cognitive behavioural self-help, although no firm conclusions could be drawn due to the limited evidence base. There is a need for further research on the maintenance of treatment effects and the mediators of treatment outcome.

The Impact of Digital Technology on Psychological Treatments and Their Dissemination.

(Reprinted with permission from Behaviour Research and Therapy 88 (2017) 19-25).

The empirical status of the third-wave behaviour therapies for the treatment of eating disorders: A systematic review.

Although third-wave behaviour therapies are being increasingly used for the treatment of eating disorders, their efficacy is largely unknown. This systematic review and meta-analysis aimed to examine the empirical status of these therapies. Twenty-seven studies met full inclusion criteria. Only 13 randomized controlled trials (RCT) were identified, most on binge eating disorder (BED). Pooled within- (pre-post change) and between-groups effect sizes were calculated for the meta-analysis. Large pre-post symptom improvements were observed for all third-wave treatments, including dialectical behaviour therapy (DBT), schema therapy (ST), acceptance and commitment therapy (ACT), mindfulness-based interventions (MBI), and compassion-focused therapy (CFT). Third-wave therapies were not superior to active comparisons generally, or to cognitive-behaviour therapy (CBT) in RCTs. Based on our qualitative synthesis, none of the third-wave therapies meet established criteria for an empirically supported treatment for particular eating disorder subgroups. Until further RCTs demonstrate the efficacy of third-wave therapies for particular eating disorder subgroups, the available data suggest that CBT should retain its status as the recommended treatment approach for bulimia nervosa (BN) and BED, and the front running treatment for anorexia nervosa (AN) in adults, with interpersonal psychotherapy (IPT) considered a strong empirically-supported alternative.

Assessing Therapist Competence: Development of a Performance-Based Measure and Its Comparison With a Web-Based Measure.

BACKGROUND: Recent research interest in how best to train therapists to deliver psychological treatments has highlighted the need for rigorous, but scalable, means of measuring therapist competence. There are at least two components involved in assessing therapist competence: the assessment of their knowledge of the treatment concerned, including how and when to use its strategies and procedures, and an evaluation of their ability to apply such knowledge skillfully in practice. While the assessment of therapists' knowledge has the potential to be completed efficiently on the Web, the assessment of skill has generally involved a labor-intensive process carried out by clinicians, and as such, may not be suitable for assessing training outcome in certain circumstances. OBJECTIVES: The aims of this study were to develop and evaluate a role-play-based measure of skill suitable for assessing training outcome and to compare its performance with a highly scalable Web-based measure of applied knowledge. METHODS: Using enhanced cognitive behavioral therapy (CBT-E) for eating disorders as an exemplar, clinical scenarios for role-play assessment were developed and piloted together with a rating scheme for assessing trainee therapists' performance. These scenarios were evaluated by examining the performance of 93 therapists from different professional backgrounds and at different levels of training in implementing CBT-E. These therapists also completed a previously developed Web-based measure of applied knowledge, and the ability of the Web-based measure to efficiently predict competence on the role-play measure was investigated. RESULTS: The role-play measure assessed performance at implementing a range of CBT-E procedures. The majority of the therapists rated their performance as moderately or closely resembling their usual clinical performance. Trained raters were able to achieve good-to-excellent reliability for averaged competence, with intraclass correlation coefficients ranging from .653 to 909. The measure was also sensitive to change, with scores being significantly higher after training than before as might be expected (mean difference 0.758, P<.001) even when taking account of repeated data (mean difference 0.667, P<.001). The major shortcoming of the role-play measure was that it required considerable time and resources. This shortcoming is inherent in the method. Given this, of most interest for assessing training outcome, scores on the Web-based measure efficiently predicted therapist competence, as judged by the role-play measure (with the Web-based measure having a positive predictive value of 77% and specificity of 78%). CONCLUSIONS: The results of this study suggest that while it was feasible and acceptable to assess performance using the newly developed role-play measure, the highly scalable Web-based measure could be used in certain circumstances as a substitute for the more labor-intensive, and hence, more costly role-play method.