Effectiveness of trauma-focused cognitive behavioral therapy compared to psychosocial counseling in reducing HIV risk behaviors, substance use, and mental health problems among orphans and vulnerable children in Zambia: a community-based randomized controlled trial.

Orphans and vulnerable children (OVC) in sub-Saharan Africa are at high risk for HIV infection and transmission. HIV prevention and treatment efforts with OVC are hindered by mental health and substance use problems. This randomized controlled trial compared a mental health intervention, Trauma Focused Cognitive Behavioral Therapy (TF-CBT), to an enhanced version of an existing HIV Psychosocial Counseling (PC+) program among 610 adolescents who met PEPFAR criteria for OVC and had HIV risk behaviors in Lusaka, Zambia. Outcomes included HIV risk behaviors (e.g., risky sexual behaviors), mental health (internalizing symptoms, externalizing behaviors, PTSD) and substance use. At 12-month follow-up, there were significant within group reductions in both groups for all outcomes, with the only significant between group difference being for substance use, in which OVC who received TF-CBT had significantly greater reductions than OVC who received PC+. In a subgroup analysis of OVC with high levels of PTSD symptoms, TF-CBT was superior to PC + in reducing internalizing symptoms, functional impairment, and substance use. Findings support TF-CBT for reducing substance use among OVC. Subgroup analysis results suggest that a robust intervention such as TF-CBT is warranted for OVC with significant mental and behavioral health comorbidities. The similar performance of TF-CBT and PC + in the overall sample for risky sexual behavior and mild mental health problems indicates that enhancing existing psychosocial programs, such as PC, with standard implementation factors like having a defined training and supervision schedule (as was done to create PC+) may improve the efficacy of HIV risk reduction efforts.Clinical Trials Number: NCT02054780.

Intersection of alcohol use, HIV infection, and the HIV care continuum in Zambia: nationally representative survey.

Through a nationally-representative household survey, we measured the prevalence and correlates of unhealthy alcohol use (UAU) in Zambia and its association with the HIV care continuum. Adolescent and adult (ages 15-59 years) data, including the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C), from the 2016 Zambia Population-based HIV Impact Assessment, were analyzed. UAU was defined as AUDIT-C of 3 + points for women and 4 + for men. Among 20,923 participants, 15.3% had UAU; this was 21.6% among people living with HIV (PLWH). Male sex, increasing age, being employed, urban residence, and having HIV were independent correlates of UAU (all P < 0.05). Among PLWH, UAU was associated with reduced HIV diagnosis (adjusted odds ratio [AOR]: 0.66, 95% CI 0.50-0.88) and non-significant trends toward reduced ART use if diagnosed (AOR: 0.73, 95% CI 0.73-1.10) and reduced viral suppression (VS) if on ART (AOR: 0.91, 95% CI 0.57-1.44). Overall, UAU was linked to 25% lower odds of VS compared to abstinence. UAU in Zambia disproportionately affects certain groups including PLWH. Achieving and sustaining HIV epidemic control in Zambia will require evidence-based approaches to screen and treat UAU.

Mental health Narrative Community-Based Group Therapy in violence-displaced Afro-Colombians: a randomized controlled trial.

This study aims to evaluate the effect of a mental health Narrative Community-Based Group Therapy (NCGT) in Afro-Colombian violence survivors. A randomized controlled trial was conducted in Buenaventura and Quibdó, Colombia. Afro-Colombian adults (n=521) were randomly allocated to a NCGT (n1=175), a wait-control group (n2=171) or a Common Elements Treatment Approach (CETA, n3=175). The CETA was described separately given conceptual/methodological differences. Lay psychosocial community workers delivered the NCGT. Symptoms were assessed before and after intervention/wait with culturally adapted mental health symptoms and gender-specific functionality scales. Intent to treat analysis and mean difference of differences were used for comparisons. In Buenaventura, a significant reduction in functional impairment (mean difference: -0.30, 95% Confidence Interval [95% CI]: -0.55, -0.05) and depression (mean difference: -0.24, 95% CI: -0.42, -0.07) were found, with small and moderate effect size, respectively. In Quibdó, functionality improved significantly (mean difference: -0.29, 95% CI: -0.54, -0.04, small effect size). Even though differences in depression and anxiety were not significant, there were reductions in symptoms. The NCGT is effective in improving daily functioning among violence victims in the Colombian Pacific and has the potential to reduce symptoms of depression. Further exploration is required to understand the effects of a narrative group therapy for mental health in Afro-Colombian populations.Trial Registration: ClinicalTrials.gov number: NCT01856673 (https://clinicaltrials.gov/ct2/show/NCT01856673).

Efficacy of the Common Elements Treatment Approach (CETA) for Unhealthy Alcohol Use Among Adults with HIV in Zambia: Results from a Pilot Randomized Controlled Trial.

This randomized controlled trial tested the efficacy of a multi-session, evidence-based, lay counselor-delivered transdiagnostic therapy, the Common Elements Treatment Approach (CETA), in reducing unhealthy alcohol use and comorbidities among persons living with HIV (PLWH) in Zambia. Adult PLWH with (a) unhealthy alcohol use plus mental health or substance use comorbidities, or (b) severe unhealthy alcohol use were randomized to receive a single-session alcohol brief intervention (BI) alone or BI plus referral to CETA. Outcomes were measured at baseline and a 6-month follow-up and included Alcohol Use Disorders Identification Test (AUDIT) score (primary), depression and trauma symptoms, and other substance use (secondary). We enrolled 160 participants; 78 were randomized to BI alone and 82 to BI plus CETA. Due to COVID-19, the trial ended early before 36 participants completed. Statistically and clinically significant reductions in mean AUDIT score from baseline to 6-month follow-up were observed in both groups, however, participants assigned to BI plus CETA had significantly greater reductions compared to BI alone (- 3.2, 95% CI - 6.2 to - 0.1; Cohen's d: 0.48). The CETA effect size for AUDIT score increased in line with increasing mental health/substance use comorbidity (0 comorbidities d = 0.25; 1-2 comorbidities d = 0.36; 3+ comorbidities d = 1.6). Significant CETA treatment effects were observed for depression, trauma, and several other substances. BI plus referral to CETA was feasible and superior to BI alone for unhealthy alcohol use among adults with HIV, particularly among those with comorbidities. Findings support future effectiveness testing of CETA for HIV outcomes among PLWH with unhealthy alcohol use.Clinical Trials Number: NCT03966885.

Assessing trauma and related distress in refugee youth and their caregivers: should we be concerned about iatrogenic effects?

Assessment of potentially traumatic events and related psychological symptoms in refugee youth is common in epidemiological and intervention research. The objective of this study is to characterize reactions to assessments of trauma exposure and psychological symptoms, including traumatic stress, in refugee youth and their caregivers. Eighty-eight Somali youth and their caregivers participated in a screening and baseline interview for a psychological intervention in three refugee camps in Ethiopia. Participants were asked about their levels of distress prior to, immediately after, and approximately two weeks after completing the interview. Other quantitative and qualitative questions inquired about specific reactions to interview questions and procedures. Children and caregivers became increasingly relaxed over the course of the interview, on average. Few children (5.3%) or caregivers (6.5%) who reported being relaxed at the beginning of the interview became upset by the end of the interview. Some children and caregivers reported that certain assessment questions were upsetting and that feeling upset interfered with their activities. Despite some participants reporting persistent negative reactions, most reported liking and benefitting from the interview. While the majority of refugee youth and their caregivers reported positive experiences associated with completing trauma-related assessments, some reported negative reactions. Researchers and practitioners must consider the necessity, risks, and benefits of including questions about potentially traumatic events and related symptoms that are particularly upsetting in screening, survey research, and clinical assessment. When included, it is important that researchers and practitioners monitor negative reactions to these assessments and connect participants who become distressed with appropriate services.

Effectiveness of the Common Elements Treatment Approach (CETA) in reducing intimate partner violence and hazardous alcohol use in Zambia (VATU): A randomized controlled trial.

BACKGROUND: Both intimate partner violence (IPV) and alcohol misuse are highly prevalent, and partner alcohol misuse is a significant contributor to women's risk for IPV. There are few evidence-based interventions to address these problems in low- and middle-income countries (LMICs). We evaluated the effectiveness of an evidence-based, multi-problem, flexible, transdiagnostic intervention, the Common Elements Treatment Approach (CETA) in reducing (a) women's experience of IPV and (b) their male partner's alcohol misuse among couples in urban Zambia. METHODS AND FINDINGS: This was a single-blind, parallel-assignment randomized controlled trial in Lusaka, Zambia. Women who reported moderate or higher levels of IPV and their male partners with hazardous alcohol use were enrolled as a couple and randomized to CETA or treatment as usual plus safety checks (TAU-Plus). The primary outcome, IPV, was assessed by the Severity of Violence Against Women Scale (SVAWS) physical/sexual violence subscale, and the secondary outcome, male alcohol misuse, by the Alcohol Use Disorders Identification Test (AUDIT). Assessors were blinded. Analyses were intent-to-treat. Primary outcome assessments were planned at post-treatment, 12 months post-baseline, and 24 months post-baseline. Enrollment was conducted between May 23, 2016, and December 17, 2016. In total, 123 couples were randomized to CETA, 125 to TAU-Plus. The majority of female (66%) and a plurality of male (48%) participants were between 18 and 35 years of age. Mean reduction in IPV (via SVAWS subscale score) at 12 months post-baseline was statistically significantly greater among women who received CETA compared to women who received TAU-Plus (-8.2, 95% CI -14.9 to -1.5, p = 0.02, Cohen's d effect size = 0.49). Similarly, mean reduction in AUDIT score at 12 months post-baseline was statistically significantly greater among men who received CETA compared to men who received TAU (-4.5, 95% CI -6.9 to -2.2, p < 0.001, Cohen's d effect size = 0.43). The Data and Safety Monitoring Board recommended the trial be stopped early due to treatment effectiveness following the 12-month post-baseline assessment, and CETA was offered to control participants. Limitations of the trial included the lack of a true control condition (i.e., that received no intervention), self-reported outcomes that may be subject to social desirability bias, and low statistical power for secondary IPV outcomes. CONCLUSIONS: Results showed that CETA was more effective than TAU-Plus in reducing IPV and hazardous alcohol use among high-risk couples in Zambia. Future research and programming should include tertiary prevention approaches to IPV, such as CETA, rather than offering only community mobilization and primary prevention. TRIAL REGISTRATION: The trial was registered on ClinicalTrials.gov (NCT02790827).

Advancing successful implementation of task-shifted mental health care in low-resource settings (BASIC): protocol for a stepped wedge cluster randomized trial.

BACKGROUND: The mental health treatment gap-the difference between those with mental health need and those who receive treatment-is high in low- and middle-income countries. Task-shifting has been used to address the shortage of mental health professionals, with a growing body of research demonstrating the effectiveness of mental health interventions delivered through task-shifting. However, very little research has focused on how to embed, support, and sustain task-shifting in government-funded systems with potential for scale up. The goal of the Building and Sustaining Interventions for Children (BASIC) study is to examine implementation policies and practices that predict adoption, fidelity, and sustainment of a mental health intervention in the education sector via teacher delivery and the health sector via community health volunteer delivery. METHODS: BASIC is a Hybrid Type II Implementation-Effectiveness trial. The study design is a stepped wedge, cluster randomized trial involving 7 sequences of 40 schools and 40 communities surrounding the schools. Enrollment consists of 120 teachers, 120 community health volunteers, up to 80 site leaders, and up to 1280 youth and one of their primary guardians. The evidence-based mental health intervention is a locally adapted version of Trauma-focused Cognitive Behavioral Therapy, called Pamoja Tunaweza. Lay counselors are trained and supervised in Pamoja Tunaweza by local trainers who are experienced in delivering the intervention and who participated in a Train-the-Trainer model of skills transfer. After the first sequence completes implementation, in-depth interviews are conducted with initial implementing sites' counselors and leaders. Findings are used to inform delivery of implementation facilitation for subsequent sequences' sites. We use a mixed methods approach including qualitative comparative analysis to identify necessary and sufficient implementation policies and practices that predict 3 implementation outcomes of interest: adoption, fidelity, and sustainment. We also examine child mental health outcomes and cost of the intervention in both the education and health sectors. DISCUSSION: The BASIC study will provide knowledge about how implementation of task-shifted mental health care can be supported in government systems that already serve children and adolescents. Knowledge about implementation policies and practices from BASIC can advance the science of implementation in low-resource contexts. TRIAL REGISTRATION: Trial Registration: ClinicalTrials.gov Identifier: NCT03243396. Registered 9th August 2017, https://clinicaltrials.gov/ct2/show/NCT03243396.

Concordance of Self- and Partner-Reported Alcohol Consumption Among Couples Experiencing Intimate Partner Violence in Zambia.

BACKGROUND: Hazardous alcohol use is a predictor of intimate partner violence (IPV), and both are increasingly prevalent in sub-Saharan Africa. The accurate measurement of alcohol consumption is therefore critical in IPV intervention studies that target hazardous drinking. Collecting a collateral report in addition to self-report is one convergent validity approach to improve alcohol measurement. We investigated concordance between self- and partner-reported alcohol use among women who reported recent IPV and their male partners in Zambia. METHODS: Data were from the baseline of a randomized IPV intervention trial of 247 heterosexual couples in which a woman has reported recent IPV and her male partner has recent hazardous alcohol use. Both partners completed the Alcohol Use Disorders Identification Test (AUDIT) in reference to their own drinking and in reference to their partner's drinking. We calculated percent agreement across a range of outcomes: any use, quantity, frequency, and hazardous use. We also compared self- and partner-reported AUDIT scores using t-tests. RESULTS: Concordance was poor across most outcomes. Percent agreement with respect to the women's drinking ranged from 60% to 65% across outcomes and with respect to the men's drinking from 51% to 89%. Women's average partner-reported AUDIT score (20.7) was statistically significantly (p < 0.0001) higher than men's average self-reported score (15.8). CONCLUSIONS: In contrast to collateral report studies conducted in the United States, concordance between self- and partner-reported alcohol consumption was poor among families experiencing IPV in Zambia. Given the possible biases associated with self-reported alcohol use, findings suggest that a convergent validity approach is useful in this research context.

Psychometric evaluation of HIV risk behavior assessments using Audio Computer Assisted Self-Interviewing (ACASI) among orphans and vulnerable children in Zambia.

Social desirability bias and underreporting of HIV risk behaviors are significant challenges to the accurate evaluation of HIV prevention programs for orphans and vulnerable children (OVC) in sub-Saharan Africa. Valid and reliable HIV risk behavior instruments are critical to address these challenges. We assessed the psychometric properties of two risk behavior measures, the World Aids Foundation Survey (WAF) and the Peer HIV Risk Behavior Screener (PHRBS), administered to 210 OVC in Zambia using Audio Computer Assisted Self-Interviewing. All WAF subscales exhibited good internal reliability (α > .80); only the Sexual Behavior Practices subscale strongly distinguished (P < .01) adolescents who engaged in HIV risk behaviors ("cases") from those who did not ("non-cases"). An 8-item version of the PHRBS, refined using exploratory factor analysis, demonstrated good internal reliability (α = 87), differentiated "cases" from "non-cases" (P < .01), and correlated strongly with the Sexual Behavior Practices subcale (r = .34, P < .01). Results suggest that report of peers' sexual behaviors can serve as a proxy for OVCs' own behavior in contexts where social desirability bias affects reporting.

Psychological Treatments for the World: Lessons from Low- and Middle-Income Countries.

Common mental disorders, including depression, anxiety, and posttraumatic stress, are leading causes of disability worldwide. Treatment for these disorders is limited in low- and middle-income countries. This systematic review synthesizes the implementation processes and examines the effectiveness of psychological treatments for common mental disorders in adults delivered by nonspecialist providers in low- and middle-income countries. In total, 27 trials met the eligibility criteria; most treatments targeted depression or posttraumatic stress. Treatments were commonly delivered by community health workers or peers in primary care or community settings; they usually were delivered with fewer than 10 sessions over 2-3 months in an individual, face-to-face format. Treatments included common elements, such as nonspecific engagement and specific domains of behavioral, interpersonal, emotional, and cognitive elements. The pooled effect size was 0.49 (95% confidence interval = 0.36-0.62), favoring intervention conditions. Our review demonstrates that psychological treatments-comprising a parsimonious set of common elements and delivered by a low-cost, widely available human resource-have moderate to strong effects in reducing the burden of common mental disorders.

Controlled trial of psychotherapy for Congolese survivors of sexual violence.

BACKGROUND: Survivors of sexual violence have high rates of depression, anxiety, and post-traumatic stress disorder (PTSD). Although treatment for symptoms related to sexual violence has been shown to be effective in high-income countries, evidence is lacking in low-income, conflict-affected countries. METHODS: In this trial in the Democratic Republic of Congo, we randomly assigned 16 villages to provide cognitive processing therapy (1 individual session and 11 group sessions) or individual support to female sexual-violence survivors with high levels of PTSD symptoms and combined depression and anxiety symptoms. One village was excluded owing to concern about the competency of the psychosocial assistant, resulting in 7 villages that provided therapy (157 women) and 8 villages that provided individual support (248 women). Assessments of combined depression and anxiety symptoms (average score on the Hopkins Symptom Checklist [range, 0 to 3, with higher scores indicating worse symptoms]), PTSD symptoms (average score on the PTSD Checklist [range, 0 to 3, with higher scores indicating worse symptoms]), and functional impairment (average score across 20 tasks [range, 0 to 4, with higher scores indicating greater impairment]) were performed at baseline, at the end of treatment, and 6 months after treatment ended. RESULTS: A total of 65% of participants in the therapy group and 52% of participants in the individual-support group completed all three assessments. Mean scores for combined depression and anxiety improved in the individual-support group (2.2 at baseline, 1.7 at the end of treatment, and 1.5 at 6 months after treatment), but improvements were significantly greater in the therapy group (2.0 at baseline, 0.8 at the end of treatment, and 0.7 at 6 months after treatment) (P<0.001 for all comparisons). Similar patterns were observed for PTSD and functional impairment. At 6 months after treatment, 9% of participants in the therapy group and 42% of participants in the individual-support group met criteria for probable depression or anxiety (P<0.001), with similar results for PTSD. CONCLUSIONS: In this study of sexual-violence survivors in a low-income, conflict-affected country, group psychotherapy reduced PTSD symptoms and combined depression and anxiety symptoms and improved functioning. (Funded by the U.S. Agency for International Development Victims of Torture Fund and the World Bank; ClinicalTrials.gov number, NCT01385163.).

Moderators of treatment response to trauma-focused cognitive behavioral therapy among youth in Zambia.

BACKGROUND: The effectiveness of mental health interventions such as trauma-focused cognitive behavioral therapy (TF-CBT) may vary by client, caregiver, and intervention-level variables, but few randomized trials in low- and middle-income countries (LMIC) have conducted moderation analyses to investigate these characteristics. This study explores moderating factors to TF-CBT treatment response among a sample of orphans and vulnerable children (OVC) in Zambia. METHODS: Data were obtained from a completed randomized trial of TF-CBT among 257 OVC in Zambia. Trauma symptoms and functioning were measured at baseline and following the end of treatment. Mixed effects regression models were estimated for each moderator of interest: gender, age, number of trauma types experienced, history of sexual abuse, orphan status, primary caretaker, school status, and parental involvement in treatment. RESULTS: Treatment effectiveness was moderated by history of sexual abuse with greater reductions in both outcomes (trauma, p < .05; functioning, p < .01) for those that experienced sexual abuse. Primary caretaker was also a moderator with greater trauma reductions in those who identified their mother as the primary caretaker (p < .01), and better functioning in those that identified their father as the primary caretaker (p < .05). Nonorphans and single orphans (mother alive) showed greater reduction in functional impairment (p < .01) compared with double orphans. There was no significant moderator effect found by gender, age, number of trauma types, school status, or caregiver participation in treatment. CONCLUSIONS: This study suggests that TF-CBT was effective in reducing trauma symptoms and functional impairment among trauma-affected youth overall and that it may be particularly effective for survivors of child sexual abuse and children whose primary caretaker is a biological parent. Scale-up of TF-CBT is warranted given the wide range of effectiveness and prevalence of child sexual abuse. Future randomized trials of interventions in LMIC should power for moderation analyses in the study design phase when feasible.

Community-based mental health treatments for survivors of torture and militant attacks in Southern Iraq: a randomized control trial.

BACKGROUND: Systematic violence is a long-standing problem in Iraq. Research indicates that survivors often experience multiple mental health problems, and that there is a need for more rigorous research that targets symptoms beyond post-traumatic stress (PTS). Our objective was to test the effectiveness of two counseling therapies in Southern Iraq in addressing multiple mental health problems among survivors of systematic violence: (1) a transdiagnostic intervention (Common Elements Treatment Approach or CETA); and (2) cognitive processing therapy (CPT). The therapies were provided by non-specialized health workers since few MH professionals are available to provide therapy in Iraq. METHODS: This was a randomized, parallel, two site, two-arm (1:1 allocation), single-blinded, wait-list controlled (WLC) trial of CETA in one site (99 CETA, 50 WLC), and CPT in a second site (129 CPT, 64 WLC). Eligibility criteria were elevated trauma symptoms and experience of systematic violence. The primary and secondary outcomes were trauma symptoms and dysfunction, respectively, with additional assessment of depression and anxiety symptoms. Non-specialized health workers (community mental health worker, CMHW) provided the interventions in government-run primary health centers. Treatment effects were determined using longitudinal, multilevel models with CMHW and client as random effects, and a time by group interaction with robust variance estimation, to test for the net difference in mean score for each outcome between the baseline and follow up interview. Multiple imputation techniques were used to account for missingness at the item level and the participant level. All analyses were conducted using Stata 12. RESULTS: The CETA intervention showed large effect sizes for all outcomes. The CPT intervention showed moderate effects sizes for trauma and depression, with small to no effect for anxiety or dysfunction, respectively. CONCLUSIONS: Both CETA and CPT appear to benefit survivors of systematic violence in Southern Iraq by reducing multiple mental health symptoms, with CETA providing a very large benefit across a range of symptoms. Non-specialized health workers were able to treat comorbid symptoms of trauma, depression and anxiety, and dysfunction among survivors of systematic violence who have limited access to mental health professionals. The trial further supports the use of evidence-based therapies in lower-resource settings. TRIAL REGISTRATION AND PROTOCOL: This trial was registered at ClinicalTrials.gov on 16 July 2010 with an identifier of NCT01177072 as the Study of Effectiveness of Mental Health Interventions among Torture Survivors in Southern Iraq. The study protocol can be downloaded from the following website: http://tinyurl.com/CETA-Iraq-Protocol . In the protocol, the CETA intervention is given a different name: components-based intervention or CBI.

A randomized controlled trial of mental health interventions for survivors of systematic violence in Kurdistan, Northern Iraq.

BACKGROUND: Experiencing systematic violence and trauma increases the risk of poor mental health outcomes; few interventions for these types of exposures have been evaluated in low resource contexts. The objective of this randomized controlled trial was to assess the effectiveness of two psychotherapeutic interventions, Behavioral Activation Treatment for Depression (BATD) and Cognitive Processing Therapy (CPT), in reducing depression symptoms using a locally adapted and validated version of the Hopkins Symptom Checklist and dysfunction measured with a locally developed scale. Secondary outcomes included posttraumatic stress, anxiety, and traumatic grief symptoms. METHODS: Twenty community mental health workers, working in rural health clinics, were randomly assigned to training in one of the two interventions. The community mental health workers conducted baseline assessments, enrolled survivors of systematic violence based on severity of depression symptoms, and randomly assigned them to treatment or waitlist-control. Blinded community mental health workers conducted post-intervention assessments on average five months later. RESULTS: Adult survivors of systematic violence were screened (N = 732) with 281 enrolled in the trial; 215 randomized to an intervention (114 to BATD; 101 to CPT) and 66 to waitlist-control (33 to BATD; 33 to CPT). Nearly 70% (n = 149) of the intervention participants completed treatment and post-intervention assessments; 53 (80%) waitlist-controls completed post-intervention assessments. Estimated effect sizes for depression and dysfunction were 0.60 and 0.55 respectively, comparing BATD participants to all controls and 0.84 and 0.79 respectively, compared to BATD controls only. Estimated effect sizes for depression and dysfunction were 0.70 and 0.90 respectively comparing CPT participants to all controls and 0.44 and 0.63 respectively compared to CPT controls only. Using a permutation-based hypothesis test that is robust to the model assumptions implicit in regression models, BATD had significant effects on depression (p = .003) and dysfunction (p = .007), while CPT had a significant effect on dysfunction only (p = .004). CONCLUSIONS: Both interventions showed moderate to strong effects on most outcomes. This study demonstrates effectiveness of these interventions in low resource environments by mental health workers with limited prior experience. TRIAL REGISTRATION: ClinicalTrials.Gov NCT00925262 . Registered June 3, 2009.

Counselor and client perspectives of Trauma-focused Cognitive Behavioral Therapy for children in Zambia: a qualitative study.

This study examined Zambian counselors, children, and caregivers' perceptions of an evidence-based treatment (EBT) for trauma (Trauma-Focused Cognitive Behavioral Therapy [TF-CBT]) utilized in Zambia to address mental health problems in children. Semistructured interviews were conducted with local counselors trained in TF-CBT (N = 19; 90% of those trained; 12 female) and children/caregivers who had received TF-CBT in a small feasibility study (N = 18; 86% of the children and N = 16; 76% of the caregivers) who completed TF-CBT (total completed; N = 21). Each client was asked six open-ended questions, and domain analysis was used to explore the data. Counselors were positive about the program, liked the structure and flexibility, reported positive changes in their clients, and discussed the cultural adaptation around activities and language. Counselors stated the training was too short, and the supervision was necessary. Challenges included client engagement and attendance, availability of location, funding, and a lack of community understanding of "therapy." Children and caregivers stated multiple positive changes they attributed to TF-CBT, such as better family communication, reduction of problem behaviors, and ability to speak about the trauma. They recommended continuing the program. This study brings a critical examination of providers' and clients' perspectives of the implementation of an EBT for children in a low-resource setting. Clinical implications include changing implementation methods based on responses. Research implications include future study directions such as an effectiveness trial of TF-CBT and an examination of implementation factors.

Implementing Evidence-Based Mental Health Care in Low-Resource Settings: A Focus on Safety Planning Procedures.

Despite advances in global mental health evidence and policy recommendations, the uptake of evidence-based practices (EBP) in low- and middle-income countries has been slow. Lower resource settings have several challenges, such as limited trained personnel, lack of government resources set aside for mental health, poorly developed mental health systems, and inadequate child protection services. Given these inherent challenges, a possible barrier to implementation of EBP is how to handle safety risks such as suicide, intimate partner violence (IPV), and/or abuse. Safety issues are prevalent in populations with mental health problems and often over-looked and/or underreported. This article briefly reviews common safety issues such as suicide, IPV, and child abuse and proposes the use of certain implementation strategies which could be helpful in creating locally appropriate safety protocols. This article lays out steps and examples of how to create a safety protocol and describes and presents data on safety cases from three different studies. Discussion includes specific challenges and future directions, focusing on implementation.

A Common Elements Treatment Approach for Adult Mental Health Problems in Low- and Middle-Income Countries.

This paper describes the Common Elements Treatment Approach (CETA) for adults presenting with mood or anxiety problems developed specifically for use with lay counselors in low- and middle-income countries (LMIC). Details of the intervention development, training, supervision, and decision-making process are presented. Case vignettes are used as examples throughout. Preliminary findings are presented on counselor/supervisor performance and client outcomes from practice cases completed prior to randomized controlled trials (RCT) conducted at two sites for adult survivors of torture and/or systematic violence in (a) southern Iraq and (b) Thailand-Burma border. Data suggest that local supervisors and lay counselors with little prior mental health training or experience maintained fidelity to the model. The majority of pilot clients were retained in treatment, suggesting acceptability. Using the Reliable Change Index (RCI) for each individual we examined the number of clients above a minimal threshold (z > 1.96) for each outcome. In Iraq 100% of clients had RCIs above the threshold for depression and posttraumatic stress, and 81.8% for impaired function. In Thailand, 81.3% of clients had RCIs above minimum threshold for depression, 68.8% for posttraumatic stress, and 37.5% for impaired function. Implementation of CETA is discussed in relation to cultural issues within LMIC. These findings, combined with US-based evidence, suggest that a common elements approach warrants further development and testing as a means for addressing the treatment gap for mental health problems in LMIC.

Efficacy and moderators of efficacy of cognitive behavioural therapies with a trauma focus in children and adolescents: an individual participant data meta-analysis of randomised trials.

BACKGROUND: Existing clinical trials of cognitive behavioural therapies with a trauma focus (CBTs-TF) are underpowered to examine key variables that might moderate treatment effects. We aimed to determine the efficacy of CBTs-TF for young people, relative to passive and active control conditions, and elucidate putative individual-level and treatment-level moderators. METHODS: This was an individual participant data meta-analysis of published and unpublished randomised studies in young people aged 6-18 years exposed to trauma. We included studies identified by the latest UK National Institute of Health and Care Excellence guidelines (completed on Jan 29, 2018) and updated their search. The search strategy included database searches restricted to publications between Jan 1, 2018, and Nov 12, 2019; grey literature search of trial registries ClinicalTrials.gov and ISRCTN; preprint archives PsyArXiv and bioRxiv; and use of social media and emails to key authors to identify any unpublished datasets. The primary outcome was post-traumatic stress symptoms after treatment (<1 month after the final session). Predominantly, one-stage random-effects models were fitted. This study is registered with PROSPERO, CRD42019151954. FINDINGS: We identified 38 studies; 25 studies provided individual participant data, comprising 1686 young people (mean age 13·65 years [SD 3·01]), with 802 receiving CBTs-TF and 884 a control condition. The risk-of-bias assessment indicated five studies as low risk and 20 studies with some concerns. Participants who received CBTs-TF had lower mean post-traumatic stress symptoms after treatment than those who received the control conditions, after adjusting for post-traumatic stress symptoms before treatment (b=-13·17, 95% CI -17·84 to -8·50, p<0·001, τ2=103·72). Moderation analysis indicated that this effect of CBTs-TF on post-traumatic stress symptoms post-treatment increased by 0·15 units (b=-0·15, 95% CI -0·29 to -0·01, p=0·041, τ2=0·03) for each unit increase in pre-treatment post-traumatic stress symptoms. INTERPRETATION: This is the first individual participant data meta-analysis of young people exposed to trauma. Our findings support CBTs-TF as the first-line treatment, irrespective of age, gender, trauma characteristics, or carer involvement in treatment, with particular benefits for those with higher initial distress. FUNDING: Swiss National Science Foundation.

Implementation measurement in global mental health: Results from a modified Delphi panel and investigator survey.

Limited guidance exists to support investigators in the choice, adaptation, validation and use of implementation measures for global mental health implementation research. Our objectives were to develop consensus on best practices for implementation measurement and identify strengths and opportunities in current practice. We convened seven expert panelists. Participants rated approaches to measure adaptation and validation according to appropriateness and feasibility. Follow-up interviews were conducted and a group discussion was held. We then surveyed investigators who have used quantitative implementation measures in global mental health implementation research. Participants described their use of implementation measures, including approaches to adaptation and validation, alongside challenges and opportunities. Panelists agreed that investigators could rely on evidence of a measure's validity, reliability and dimensionality from similar contexts. Panelists did not reach consensus on whether to establish the pragmatic qualities of measures in novel settings. Survey respondents (n = 28) most commonly reported using the Consolidated Framework for Implementation Research Inner Setting Measures (n = 9) and the Program Assessment Sustainability Tool (n = 5). All reported adapting measures to their settings; only two reported validating their measures. These results will support guidance for implementation measurement in support of mental health services in diverse global settings.

Alcohol-focused and transdiagnostic treatments for unhealthy alcohol use among adults with HIV in Zambia: A 3-arm randomized controlled trial.

BACKGROUND: Clinical and quality of life outcomes in people living with human immunodeficiency virus (PLWH) are undermined by unhealthy alcohol use (UAU), which is highly prevalent in this population and is often complicated by mental health (MH) or other substance use (SU) comorbidity. In sub-Saharan Africa, evidence-based and implementable treatment options for people with HIV and UAU are needed. METHODS: We are conducting a hybrid clinical effectiveness-implementation trial at three public-sector HIV clinics in Lusaka, Zambia. Adults with HIV, who report UAU, and have suboptimal HIV clinical outcomes, will be randomized to one of three arms: an alcohol-focused brief intervention (BI), the BI with additional referral to a transdiagnostic cognitive behavioral therapy (Common Elements Treatment Approach [CETA]), or standard of care. The BI and CETA will be provided by HIV peer counselors, a common cadre of lay health worker in Zambia. Clinical outcomes will include HIV viral suppression, alcohol use, assessed by audio computer-assisted self-interview (ACASI) and direct alcohol biomarkers, Phophatidylethanol and Ethyl glucuronide, and comorbid MH and other SU. A range of implementation outcomes including cost effectiveness will also be analyzed. CONCLUSION: Hybrid and 3-arm trial design features facilitate the integrated evaluation of both brief, highly implementable, and more intensive, less implementable, treatment options for UAU among PLWH in sub-Saharan Africa. Use of ACASI and alcohol biomarkers will strengthen understanding of treatment effects.