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.

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.

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.

Posttraumatic stress symptoms and structure among orphan and vulnerable children and adolescents in Zambia.

BACKGROUND: Scant information exists on posttraumatic stress disorder (PTSD) symptoms and structure in youth from developing countries. METHODS: We describe the symptom profile and exposure to trauma experiences among 343 orphan and vulnerable children and adolescents from Zambia. We distinguished profiles of posttraumatic stress symptoms using latent class analysis. RESULTS: Average number of trauma-related symptoms (21.6; range 0-38) was similar across sex and age. Latent class model suggested three classes varying by level of severity: low (31% of the sample), medium (45% of the sample), and high (24% of the sample) symptomatology. CONCLUSIONS: Results suggest that PTSD is a continuously distributed latent trait.

Feasibility and acceptability of phone-delivered psychological therapy for refugee children and adolescents in a humanitarian setting.

BACKGROUND: Refugee children are at high risk of mental health problems but face barriers to accessing mental health services, a problem exacerbated by a shortage of mental health professionals. Having trained lay counsellors deliver therapy via telephone could overcome these barriers. This is the first study to explore feasibility and acceptability of telephone-delivered therapy with refugee children in a humanitarian setting. METHODS: An evidence-based intervention, Common Elements Treatment Approach, was adapted for telephone-delivery (t-CETA) and delivered by lay counsellors to Syrian refugee children in informal tented settlements in the Beqaa region of Lebanon. Following delivery of t-CETA, semi-structured interviews were conducted with counsellors (N = 3) and with children who received t-CETA (N = 11, 45% female, age 8-17 years) and their caregivers (N = 11, 100% female, age 29-56 years) (N = 25 interviews). Thematic content analysis was conducted separately for interviews with counsellors and interviews with families and results were synthesized. RESULTS: Three themes emerged from interviews with counsellors and four themes from interviews with families, with substantial overlap between them. Synthesized themes were: counselling over the phone both solves and creates practical and logistical challenges; t-CETA is adapted to potential cultural blocks; the relationship between the counsellor and the child and caregiver is extremely important; the family's attitude to mental health influences their understanding of and engagement with counselling; and t-CETA works and is needed. Counselling over the phone overcame logistical barriers, such as poor transportation, and cultural barriers, such as stigma associated with attending mental health services. It provided a more flexible and accessible service and resulted in reductions in symptoms for many children. Challenges included access to phones and poor network coverage, finding an appropriate space, and communication challenges over the phone. CONCLUSIONS: Despite some challenges, telephone-delivered therapy for children shows promising evidence of feasibility and acceptability in a humanitarian context and has the potential to increase access to mental health services by hard-to-reach populations. Approaches to addressing challenges of telephone-delivered therapy are discussed. Trial Registration ClinicalTrials.gov ID: NCT03887312; registered 22nd March 2019.

Effectiveness of abbreviated trauma-focused cognitive behavioural therapy for South African adolescents: a randomized controlled trial.

Background: In low- and middle- income countries (LMICs) trauma exposure among youth is high, but mental health services are critically under-resourced. In such contexts, abbreviated trauma treatments are needed.Objective: To evaluate the efficacy of an abbreviated eight-session version of Trauma-Focused Cognitive Behavioural Therapy (TF-CBT) for improving posttraumatic stress disorder (PTSD) and depression symptoms in a sample of South African adolescents.Method: 75 trauma-exposed adolescents (21 males, 54 females; mean age = 14.92, range = 11-19) with posttraumatic stress disorder (PTSD) symptoms were randomly assigned to eight sessions of TF-CBT or to usual services. At baseline, post-treatment and three-month follow-up, participants completed the Child PTSD Symptom Scale for DSM 5 (CPSS-5) and the Beck Depression Inventory II (BDI-II). The trial is registered on the Pan African Trial Registry (PACTR202011506380839).6.Results: 95% of TF-CBT participants completed treatment while only 47% of TAU participants accessed treatment. Intention-to-treat analyses found that the TF-CBT group had a significantly greater reduction in CPSS-5 PTSD symptom severity at post-treatment (Cohen's d = 0. 60, p < .01) and three-month follow-up (Cohen's d = 0.62, p < . 01), and a greater reduction in the proportion of participants meeting the CPSS-5 clinical cut-off for PTSD at both time points (p = .02 and p = .03, respectively). There was also a significantly greater reduction in depression symptom severity in the TF-CBT group at post-treatment (Cohen's d = 0.51, p = .03) and three-month follow-up (Cohen's d = 0.41, p = .05), and a greater reduction in the proportion of TF-CBT participants meeting the BDI clinical cut-off for depression at both time points (p = .02 and p = .03, respectively).Conclusion: The findings provide preliminary evidence of the efficacy of an abbreviated eight-session version of TF-CBT for reducing PTSD and depression symptoms in a LMIC sample of adolescents with multiple trauma exposure.

Trauma-Focused Cognitive Behavioural Therapy (TF-CBT) is one of the leading evidence-based treatments for child and adolescent posttraumatic stress, but an abbreviated version has not been evaluated in low- and middle-income countries (LMICs).At post-treatment and three-month follow-up, eight sessions of TF-CBT were more effective than treatment-as-usual in reducing posttraumatic stress and depression symptoms in an LMIC sample of South African adolescents exposed to multiple traumas.Effect sizes were similar to those reported for standard length TF-CBT, indicating that abbreviated TF-CBT may be a suitable option for resource-constrained child and adolescent mental health services in LMICs.

What drives change in children receiving telephone-delivered Common Elements Treatment Approach (t-CETA)? A multiple n = 1 study with Syrian refugee children and adolescents in Lebanon.

BACKGROUND: Although the evidence-base for mental health and psychosocial support (MHPSS) interventions in humanitarian settings is growing rapidly, their mechanisms of change remain poorly understood despite the potential to improve the effectiveness and reach of interventions. OBJECTIVE: This study aimed to explore the mechanisms or factors that drive change in a modular transdiagnostic telephone-delivered mental health intervention, Common Elements Treatment Approach (t-CETA). PARTICIPANTS AND SETTING: Participants were Syrian refugee children and adolescents living in tented settlements in Lebanon. METHODS: We used a multiple n = 1 design, drawing on secondary data from 9 children who completed t-CETA during a pilot randomized controlled trial. RESULTS: Children with historical war-related trauma were more likely to show significant improvement across symptom clusters by the end of treatment compared to children presenting with depression related to daily living conditions. Children also showed fluctuating symptoms during the early stages of treatment (engagement and cognitive restructuring) but significant decline in symptoms after the trauma module (prolonged imaginal exposure) and depression module (behavioral activation). Salient external life events identified were starting or dropping out of school, working, change in living conditions, family conflict and the October Revolution; and interpersonal factors of parental engagement (with or without full attendance) and counsellor skills in building rapport were also identified as having an impact on treatment success. CONCLUSIONS: Implications of our findings are discussed in terms of integrating active ingredients into MHPSS programming, and building on parental and multi-sector involvement in child and adolescent mental health care in humanitarian settings.

Development and Piloting of a Mental Health Prevention and Referral Program for Veterans and Their Families in Ukraine.

BACKGROUND: While growing evidence exists for the effectiveness of mental health interventions in global mental health, the evidence base for psychosocial supports is lacking despite the need for a broader range of supports that span the prevention-treatment continuum and can be integrated into other service systems. Following rigorous evaluation of the Common Elements Treatment Approach (CETA) in Ukraine, this article describes the development and feasibility testing of CETA Psychosocial Support (CPSS), a brief psychosocial prevention and referral program for Ukrainian veterans and their families. CPSS DEVELOPMENT: CPSS development used evidence-based CETA intervention components and was informed by a stakeholder needs analysis incorporating feedback from veterans and their families, literature review, and expert consultations. The program includes psychoeducation, cognitive coping skill development, and a self-assessment tool that identifies participants for potential referral. After initial development of the program, the intervention underwent: (1) initial implementation by skilled providers focused on iterative refinement; (2) additional field-testing of the refined intervention by newly trained providers in real-world conditions; and (3) a formal pilot evaluation with collection of pre-post mental health assessments and implementation ratings using locally validated instruments. RESULTS: Fifteen CPSS providers delivered 14 group sessions to 109 participants (55 veterans, 39 family members, and 15 providers from veterans' service organizations). After incorporating changes related to content, process, and group dynamics, data from the pilot evaluation suggest the refined CPSS program is an acceptable and potentially effective brief psychosocial prevention and promotion program that can be implemented by trained veteran providers. Forty percent of participants required safety or referral follow-ups. CONCLUSION: The iterative, inclusive development process resulted in an appropriate program with content and implementation strategies tailored to Ukrainian veterans and their families. Brief psychosocial programs can fit within a larger multitiered mental health and psychosocial continuum of care that supports further referral.

Testing a Screening, Brief Intervention, and Referral to Treatment Intervention Approach for Addressing Unhealthy Alcohol and Other Drug Use in Humanitarian Settings: Protocol of the Ukuundapwa Chapamo Randomised Controlled Trial.

Refugees and other displaced persons are exposed to many risk factors for unhealthy alcohol and other drug (AOD) use and concomitant mental health problems. Evidence-based services for AOD use and mental health comorbidities are rarely available in humanitarian settings. In high income countries, screening, brief intervention and referral to treatment (SBIRT) systems can provide appropriate care for AOD use but have rarely been used in low- and middle-income countries and to our knowledge never tested in a humanitarian setting. This paper describes the protocol for a randomised controlled trial to compare the effectiveness of an SBIRT system featuring the Common Elements Treatment Approach (CETA) to treatment as usual in reducing unhealthy AOD use and mental health comorbidities among refugees from the Democratic Republic of the Congo and host community members in an integrated settlement in northern Zambia. The trial is an individually randomised, single-blind, parallel design with outcomes assessed at 6-months (primary) and 12-months post-baseline. Participants are Congolese refugees and Zambians in the host community, 15 years of age or older with unhealthy alcohol use. Outcomes are: unhealthy alcohol use (primary), other drug use, depression, anxiety and traumatic stress. The trial will explore SBIRT acceptability, appropriateness, cost-effectiveness, feasibility, and reach.

Experiences and Perceptions of Telephone-delivery of the Common Elements Treatment Approach for Mental Health Needs Among Young People in Zambia During the COVID-19 Pandemic.

Background: Mental and behavioral health needs are immense in low-to-middle income countries (LMIC), particularly for adolescents and young adults (AYA). However, access to mental health services is limited in LMIC due to barriers such as distance to a health care site, low number of providers, and other structural and logistical challenges. During the COVID-19 pandemic, these barriers were significantly exacerbated and, thus, mental health services were severely disrupted. A potential solution to some of these barriers is remote delivery of such services via technology. Exploration of AYA experiences is needed to understand the benefits and challenges when shifting to remotely delivered services. Methods: Participants included 16 AYA (15-29 years) residing in Lusaka, Zambia who met criteria for a mental or behavioral health concern and received telehealth delivery of the Common Elements Treatment Approach (CETA). AYA participated in semi-structured qualitative interviews to explore feasibility, acceptability, and barriers to telephone-delivered treatment in this context. Thematic coding analysis was conducted to identify key themes. Findings: Three major response themes emerged: 1) Advantages of telehealth delivery of CETA, Disadvantages or barriers to telehealth delivery of CETA, 3) AYA recommendations for optimizing telehealth (ways to improve telehealth delivery in Zambia. Results indicate that logistical and sociocultural barriers i.e., providing AYA with phones to use for sessions, facilitating one face-to-face meeting with providers) need to be addressed for success of remotely delivered services. Conclusion: AYA in this sample reported telehealth delivery reduces some access barriers to engaging in mental health care provision in Zambia. Addressing logistical and sociocultural challenges identified in this study will optimize feasibility of telehealth delivery and will support the integration of virtual mental health services in the Zambian health system.

Comparative effectiveness of in-person vs. remote delivery of the Common Elements Treatment Approach for addressing mental and behavioral health problems among adolescents and young adults in Zambia: protocol of a three-arm randomized controlled trial.

BACKGROUND: In low- and middle-income countries (LMIC), there is a substantial gap in the treatment of mental and behavioral health problems, which is particularly detrimental to adolescents and young adults (AYA). The Common Elements Treatment Approach (CETA) is an evidence-based, flexible, transdiagnostic intervention delivered by lay counselors to address comorbid mental and behavioral health conditions, though its effectiveness has not yet been tested among AYA. This paper describes the protocol for a randomized controlled trial that will test the effectiveness of traditional in-person delivered CETA and a telehealth-adapted version of CETA (T-CETA) in reducing mental and behavioral health problems among AYA in Zambia. Non-inferiority of T-CETA will also be assessed. METHODS: This study is a hybrid type 1 three-arm randomized trial to be conducted in Lusaka, Zambia. Following an apprenticeship model, experienced non-professional counselors in Zambia will be trained as CETA trainers using a remote, technology-delivered training method. The new CETA trainers will subsequently facilitate technology-delivered trainings for a new cohort of counselors recruited from community-based partner organizations throughout Lusaka. AYA with mental and behavioral health problems seeking services at these same organizations will then be identified and randomized to (1) in-person CETA delivery, (2) telehealth-delivered CETA (T-CETA), or (3) treatment as usual (TAU). In the superiority design, CETA and T-CETA will be compared to TAU, and using a non-inferiority design, T-CETA will be compared to CETA, which is already evidence-based in other populations. At baseline, post-treatment (approximately 3-4 months post-baseline), and 6 months post-treatment (approximately 9 months post-baseline), we will assess the primary outcomes such as client trauma symptoms, internalizing symptoms, and externalizing behaviors and secondary outcomes such as client substance use, aggression, violence, and health utility. CETA trainer and counselor competency and cost-effectiveness will also be measured as secondary outcomes. Mixed methods interviews will be conducted with trainers, counselors, and AYA participants to explore the feasibility, acceptability, and sustainability of technology-delivered training and T-CETA provision in the Zambian context. DISCUSSION: Adolescents and young adults in LMIC are a priority population for the treatment of mental and behavioral health problems. Technology-delivered approaches to training and intervention delivery can expand the reach of evidence-based interventions. If found effective, CETA and T-CETA would help address a major barrier to the scale-up and sustainability of mental and behavioral treatments among AYA in LMIC. TRIAL REGISTRATION: ClinicalTrials.gov NCT03458039 . Prospectively registered on May 10, 2021.

The Role of Violence Acceptance and Inequitable Gender Norms in Intimate Partner Violence Severity Among Couples in Zambia.

Inequitable gender norms, including the acceptance of violence in intimate relationships, have been found to be associated with the occurrence of intimate partner violence (IPV) perpetration and victimization. Despite these findings, few studies have considered whether inequitable gender norms are related to IPV severity. This study uses baseline data from a psychotherapeutic intervention targeting heterosexual couples (n = 247) in Lusaka, Zambia, who reported moderate to severe male-perpetrated IPV and male hazardous alcohol use to consider: (a) prevailing gender norms, including those related to IPV; (b) the relationship between IPV acceptance and IPV severity; and (c) the relationship between inequitable gender norms and IPV severity. Multiple linear regression analyses were used to model the relationships between IPV acceptance and inequitable gender norms, and female-reported IPV severity (including threats of violence, physical violence, sexual violence, and total violence), separately among male and female participants. In general, men and women were similar in their patterns of agreement with gender norms, with both highly endorsing items related to household roles. More than three-quarters of men (78.1%) and women (78.5%) indicated overall acceptance of violence in intimate relationships, with no significant differences between men and women in their endorsement of any IPV-related gender norms. Among men, IPV acceptance was associated with a statistically significant increase in IPV perpetration severity in terms of threatening violence (B = 5.86, 95% confidence interval [CI] = [1.84, 9.89]), physical violence (B = 4.54, 95% CI = [0.10, 8.98]), and total violence (B = 11.65, 95% CI = [3.14, 20.16]). There was no association between IPV acceptance and IPV victimization severity among women. Unlike IPV acceptance, there was no evidence for a relationship between inequitable gender norms and IPV severity for either men or women. These findings have implications for the appropriateness of gender transformative interventions in targeting men and women in relationships in which there is ongoing IPV.

Moderator effects in a randomized controlled trial of the Common Elements Treatment Approach (CETA) for intimate partner violence and hazardous alcohol use in Zambia.

BACKGROUND: Intimate partner violence (IPV) and hazardous alcohol use are prevalent and co-occurring problems in low- and middle-income countries (LMICs). While limited evidence suggests that cognitive behavioral therapy (CBT) interventions can help address these problems, few randomized trials in LMICs have investigated moderators of treatment effectiveness. This study explores moderating factors impacting responsiveness to a CBT-based intervention for IPV and hazardous alcohol use among couples in Zambia. METHODS: Data were obtained from a completed randomized trial of a CBT-based intervention, the Common Elements Treatment Approach (CETA), among 248 couples in Lusaka. Female experiences of IPV and male alcohol use were measured at baseline and 12 months post-baseline. Mixed effects regression models were used to evaluate each moderator: age, educational attainment, employment status, marital status, physical disability, HIV status, trauma exposure, depression, post-traumatic stress disorder, alcohol use disorder, and substance use. RESULTS: Treatment effectiveness for male alcohol use was moderated by female substance use, with greater reductions among men whose partners reported using non-alcohol substances (e.g., cannabis) (p < 0.01). Other marginally significant moderators (p < 0.15) of change in male alcohol use included female education and male depression, substance use, and moderate-to-severe alcohol use at baseline. Female HIV status and depression were marginally significant moderators of change in IPV. CONCLUSIONS: This study suggests that CETA may be especially effective for highly symptomatic individuals with comorbid mental and behavioral health problems, a promising finding given that such comorbidity is widespread in LMICs. Psychotherapeutic treatments that can flexibly and simultaneously address co-occurring problems are needed.

A randomized-controlled trial of community-based transdiagnostic psychotherapy for veterans and internally displaced persons in Ukraine.

BACKGROUND: There is limited research on community-based mental health interventions in former Soviet countries despite different contextual factors from where most research has been conducted. Ongoing military conflict has resulted in many displaced persons and veterans and their families with high burdens of mental health problems. Lack of community-based services and poor uptake of existing psychiatric services led to the current trial to determine the effectiveness of the common elements treatment approach (CETA) on anxiety, depression, and posttraumatic stress symptoms (PTS) among conflict affected adults in Ukraine. METHODS: We conducted a three-armed randomized-controlled trial of CETA delivered in its standard form (8-12 sessions), a brief form (five-sessions), and a wait-control condition. Eligible participants were displaced adults, army veterans and their adult family members with elevated depression and/or PTS and impaired functioning. Treatment was delivered by community-based providers trained in both standard and brief CETA. Outcome data were collected monthly. RESULTS: There were 302 trial participants (n = 117 brief CETA, n = 129 standard CETA, n = 56 wait-controls). Compared with wait-controls, participants in standard and brief CETA experienced clinically and statistically significant reductions in depression, anxiety, and PTS and dysfunction (effect sizes d = 0.46-1.0-6). Comparing those who received standard CETA with brief CETA, the former reported fewer symptoms and less dysfunction with small-to-medium effect sized (d = 0.20-0.55). CONCLUSIONS: Standard CETA is more effective than brief CETA, but brief CETA also had significant effects compared with wait-controls. Given demonstrated effectiveness, CETA could be scaled up as an effective community-based approach.

Common Elements Treatment Approach (CETA) for unhealthy alcohol use among persons with HIV in Zambia: Study protocol of the ZCAP randomized controlled trial.

AIMS: Prevalence of unhealthy alcohol use and co-occurring mental health problems is high among persons living with HIV (PLWH) in sub-Saharan Africa (SSA). Yet, there is a dearth of evidence-based treatment options that can address both unhealthy alcohol use and comorbidities in SSA HIV care settings. Recent studies testing single-session alcohol brief interventions (BIs) among PLWH in SSA have suggested that more robust treatments are needed. This paper describes the protocol of a pilot randomized controlled superiority trial that will test the effectiveness of an evidence-based transdiagnostic multi-session psychotherapy, the Common Elements Treatment Approach (CETA), compared to a control condition consisting of a single session brief alcohol intervention (BI) based on CETA, at reducing unhealthy alcohol use, mental health problems, and other substance use among PLWH in urban Zambia. METHODS: The study is a single-blind, parallel, individually randomized trial conducted in HIV treatment centers in Lusaka. 160 PLWH who meet criteria for unhealthy alcohol use + mental health or substance use comorbidities and/or have a more severe alcohol use disorder are eligible. Participants are randomized 1:1 to receive the single-session BI or CETA. Outcomes are assessed at baseline and a six-month follow-up and include unhealthy alcohol use, depression, trauma symptoms, and other substance use. CONCLUSIONS: The trial is a first step in establishing the effectiveness of CETA at reducing unhealthy alcohol use and comorbidities among PLWH in SSA. If effectiveness is demonstrated, a larger trial featuring long-term follow-ups and HIV treatment outcomes will be undertaken.

Effectiveness of Trauma-Focused Cognitive Behavioral Therapy Among Trauma-Affected Children in Lusaka, Zambia: A Randomized Clinical Trial.

IMPORTANCE: Orphans and vulnerable children (OVC) are at high risk for experiencing trauma and related psychosocial problems. Despite this, no randomized clinical trials have studied evidence-based treatments for OVC in low-resource settings. OBJECTIVE: To evaluate the effectiveness of lay counselor-provided trauma-focused cognitive behavioral therapy (TF-CBT) to address trauma and stress-related symptoms among OVC in Lusaka, Zambia. DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial compared TF-CBT and treatment as usual (TAU) (varying by site) for children recruited from August 1, 2012, through July 31, 2013, and treated until December 31, 2013, for trauma-related symptoms from 5 community sites within Lusaka, Zambia. Children were aged 5 through 18 years and had experienced at least one traumatic event and reported significant trauma-related symptoms. Analysis was with intent to treat. INTERVENTIONS: The intervention group received 10 to 16 sessions of TF-CBT (n = 131). The TAU group (n = 126) received usual community services offered to OVC. MAIN OUTCOMES AND MEASURES: The primary outcome was mean item change in trauma and stress-related symptoms using a locally validated version of the UCLA Posttraumatic Stress Disorder Reaction Index (range, 0-4) and functional impairment using a locally developed measure (range, 0-4). Outcomes were measured at baseline and within 1 month after treatment completion or after a waiting period of approximately 4.5 months after baseline for TAU. RESULTS: At follow-up, the mean item change in trauma symptom score was -1.54 (95% CI, -1.81 to -1.27), a reduction of 81.9%, for the TF-CBT group and -0.37 (95% CI, -0.57 to -0.17), a reduction of 21.1%, for the TAU group. The mean item change for functioning was -0.76 (95% CI, -0.98 to -0.54), a reduction of 89.4%, and -0.54 (95% CI, -0.80 to -0.29), a reduction of 68.3%, for the TF-CBT and TAU groups, respectively. The difference in change between groups was statistically significant for both outcomes (P < .001). The effect size (Cohen d) was 2.39 for trauma symptoms and 0.34 for functioning. Lay counselors participated in supervision and assessed whether the intervention was provided with fidelity in all 5 community settings. CONCLUSIONS AND RELEVANCE: The TF-CBT adapted for Zambia substantially decreased trauma and stress-related symptoms and produced a smaller improvement in functional impairment among OVC having experienced high levels of trauma. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01624298.

Identification, modification, and implementation of an evidence-based psychotherapy for children in a low-income country: the use of TF-CBT in Zambia.

BACKGROUND: The need to address the treatment gap in mental health services in low- and middle-income countries (LMIC) is well recognized and particularly neglected among children and adolescents. Recent literature with adult populations suggests that evidence-based mental health treatments are effective, feasible, and cross-culturally modifiable for use in LMIC. This paper addresses a gap in the literature documenting pre-trial processes. We describe the process of selecting an intervention to meet the needs of a particular population and the process of cross-cultural adaptation. METHODS: Community-based participatory research principles were implemented for intervention selection, including joint meetings with stakeholders, review of qualitative research, and review of the literature. Trauma-focused Cognitive Behavioral Therapy (TF-CBT) was chosen as the evidence-based practice for modification and feasibility testing. The TF-CBT adaptation process, rooted within an apprenticeship model of training and supervision, is presented. Clinical case notes were reviewed to document modifications. RESULTS: Choosing an intervention can work as a collaborative process with community involvement. Results also show that modifications were focused primarily on implementation techniques rather than changes in TF-CBT core elements. CONCLUSIONS: Studies documenting implementation processes are critical to understanding why intervention choices are made and how the adaptations are generated in global mental health. More articles are needed on how to implement evidence-based treatments in LMIC.

An evaluation of trauma focused cognitive behavioral therapy for children in Zambia.

To monitor and evaluate the feasibility of implementing Trauma Focused-Cognitive Behavioral Therapy (TF-CBT) to address trauma and stress-related symptoms in orphans and vulnerable children (OVC) in Zambia as part of ongoing programming within a non-governmental organization (NGO). As part of ongoing programming, voluntary care-workers administered locally validated assessments to identify children who met criteria for moderate to severe trauma symptomatology. Local lay counselors implemented TF-CBT with identified families, while participating in ongoing supervision. Fifty-eight children and adolescents aged 5-18 completed the TF-CBT treatment, with pre- and post-assessments. The mean number of traumas reported by the treatment completers (N=58) was 4.11. Post assessments showed significant reductions in severity of trauma symptoms (p<0.0001), and severity of shame symptoms (p<0.0001). Our results suggest that TF-CBT is a feasible treatment option in Zambia for OVC. A decrease in symptoms suggests that a controlled trial is warranted. Implementation factors monitored suggest that it is feasible to integrate and evaluate evidence-based mental health assessments and intervention into programmatic services run by an NGO in low/middle resource countries. Results also support the effectiveness of implementation strategies such as task shifting, and the Apprenticeship Model of training and supervision.