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

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, 202

Delivering Psychological Treatment to Children via Phone: A Set of Guiding Principles Based on Recent Research with Syrian Refugee Children

This guidance sets out basic principles for the safe delivery of psychological therapy to children via telephone, based on the adaptation of an existing therapy for phone delivery among Syrian refugee children in Lebanon. The project was a collaboration between Queen Mary University of London, American University of Beirut, Médecins du Monde, Johns Hopkins University, and Medical School Hamburg

Treatment of an HIV-affected adolescent with heroin dependence in a low-income country: A clinical case study from Zambia

Introduction: Although the World Health Organization (WHO) has recommended guidelines for the treatment of opioid dependence, there are myriad challenges to successfully implementing such guidelines in resource constrained settings, such as in low and middle-income countries (LMICs). To highlight these challenges, this paper presents a clinical case study of an adolescent study participant in a randomized controlled trial comparing two counseling programs in Lusaka, Zambia. Case description: This 15 year-old male reported smoking marijuana and heroin daily, and injecting heroin monthly (while needle sharing). The patient was linked to the only physician capable of treating heroin addiction in Zambia. The patient was placed on a 30-day detox regimen of Tramadol administered from home, as in-patient detox services are unavailable in Zambia. The patient experienced complications with out-patient detox, including a relapse that led to violent behavior and temporary incarceration. The patient's treatment regimen was altered to include Lorazepam, a mild sedative, and psychosocial counseling. After completing detox the client was prescribed Naltrexone for maintenance as Methadone is listed as a banned substance in Zambia, and Buprenorphine is not available and is cost prohibitive. Conclusions: Despite a considerable amount of time and resources expended to successfully treat the patient, the majority of WHO guidelines for opioid dependence treatment were not attainable within the Zambian context. Additional research into the effectiveness and implementation of evidence-based interventions for substance use in LMICs is warranted. Keywords: HIV, Orphans and vulnerable children, Substance abuse, Heroin, Low- and middle-income countr

Integration of Common Elements Treatment Approach (CETA) into public sector HIV clinics for unhealthy alcohol use in urban Zambia: Qualitative evaluation on acceptability and feasibility

Background: In Sub-Saharan Africa, unhealthy alcohol use (UAU) is a growing threat to achieving ‘the last mile’ towards ending AIDS by 2030. Common Elements Treatment Approach (CETA) is a multisession transdiagnostic cognitive behavioral therapy protocol that can treat a range of common co-morbid mental and behavioral mental health problems, including UAU. In a randomized controlled trial (RCT), we previously reported that CETA was clinically effective in reducing UAU and mental health comorbidities among PWH in Zambia. In this qualitative evaluation we sought to explore health worker, key policymaker and patient perspectives on the acceptability and feasibility of integrating CETA within existing HIV services. Methodology: We conducted focus group discussions (FGDs) with PWH who reported alcohol use, lay and profession HIV clinic staff, and key informant interviews with policy-makers. Following trial completion, we conducted in-depth interviews (IDIs) among people with HIV and UAU who received CETA, and HIV peer counsellors that provided CETA. Data were transcribed verbatim and analyzed in NVivo 12 using thematic analysis. Emerging themes were organized according to acceptability and feasibility. Results: All participant types reported CETA to be acceptable due to the perceived need and relevance to HIV-related behavioral health issues. HIV peer counselors, successfully provided CETA with a rigorous supervision structure using an apprenticeship model. Participants receiving CETA also remained motivated throughout the sessions as they learned new problem-solving skills, which they continued to use following the close of the study. Implementation factors related to limited behavioral health infrastructure, workloads, and human resources were seen as challenges to the scale-up and sustainability of CETA within HIV care. Conclusion: CETA was feasible and acceptable at 2 urban sites in Zambia. Future studies integrating of CETA into HIV care should consider implementation factors such as infrastructure, workloads, and human resources to support integration into HIV care

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

Delivering Therapy over Telephone in a Humanitarian Setting: A Pilot Randomized Controlled Trial of Common Elements Treatment Approach (CETA) with Syrian Refugee Children in Lebanon

Background: In recent years, the number of forcibly displaced persons has risen worldwide, with approximately 40% being children and adolescents. Most of them are hosted in low- and middle-income countries (LMICs). Many individuals meet the criteria for mental health issues, which can also be exacerbated by a number of risk factors, including low socioeconomic status, displacement, and stressors linked to conflicts in their country or region of origin. However, the vast majority never receive treatment for their psychological problems due to multiple reasons, including a shortage of mental health professionals in LIMCs, transportation challenges in accessing clinics, and clinic hours conflicting with family commitments. In the current study we investigated whether individual psychotherapy delivered by trained lay counsellors over telephone to Syrian refugee children living in Lebanon is effective and overcomes barriers to treatment access. Methods: After adaptation of Common Elements Treatment Approach (CETA) to remote delivery over telephone (t-CETA), preliminary effectiveness of the treatment modality was assessed with a pilot single blind randomised controlled trial including a total sample of 20 refugee children with diagnosed mental health problems. Data was analysis applying a Bayesian approach. Results: Findings provide first evidence that t-CETA is effective in reducing mental health symptoms compared to standard in-person treatment-as-usual, though no significant changes were found for impairment. In addition, there was a significant session-by-session decrease in self-reported mental health symptoms over the course of treatment. Importantly, the majority of children allocated to t-CETA completed treatment whilst all children in the treatment-as-usual condition were unable to do so. Conclusion: The study provides first evidence that telephone-delivered psychotherapy in a humanitarian setting, delivered by lay counsellors under supervision, works and significantly increases access to treatment compared to traditional in-person treatment. However, findings remain to be replicated in larger trials

Testing the validity and reliability of the shame questionnaire among sexually abused girls in Zambia.

PURPOSE:The aim of the current study is to test the validity and reliability of the Shame Questionnaire among traumatized girls in Lusaka, Zambia. METHODS:The Shame Questionnaire was validated through both classical test and item response theory methods. Internal reliability, criterion validity and construct validity were examined among a sample of 325 female children living in Zambia. Sub-analyses were conducted to examine differences in construct validity among girls who reported sexual abuse and girls who did not. RESULTS:All girls in the sample were sexually abused, but only 61.5% endorsed or reported that sexual abuse had occurred. Internal consistency was very good among the sample with alpha = .87. Criterion validity was demonstrated through a significant difference of mean Shame Questionnaire scores between girls who experienced 0-1 trauma events and more than one traumatic event, with higher mean Shame Questionnaire scores among girls who had more than one traumatic event (p = .004 for 0-1 compared to 2 and 3 events and p = .016 for 0-1 compared to 4+ events). Girls who reported a history of witnessing or experiencing physical abuse had a significantly higher mean Shame Questionnaire score than girls who did not report a history of witnessing or experiencing physical abuse (p<.0001). There was no significant difference in mean Shame Questionnaire score between girls who reported a sexual abuse history and girls who did not. Exploratory factor analysis indicated a two-factor model of the Shame Questionnaire, with an experience of shame dimension and an active outcomes of shame dimension. Item response theory analysis indicated adequate overall item fit. Results also indicate potential differences in construct validity between girls who did and did not endorse sexual abuse. CONCLUSIONS:This study suggests the general utility of the Shame Questionnaire among Zambian girls and demonstrates the need for more psychometric studies in low and middle income countries

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)