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Testing the effectiveness and implementation of a brief version of the Common Elements Treatment Approach (CETA) in Ukraine: a study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Mental illness is a major public health concern. Despite progress understanding which treatments work, a significant treatment gap remains. An ongoing concern is treatment length. Modular, flexible, transdiagnostic approaches have been offered as one solution to scalability challenges. The Common Elements Treatment Approach (CETA) is one such approach and offers the ability to treat a wide range of common mental health problems. CETA is supported by two randomized trials from low- and middle-income countries showing strong effectiveness and implementation outcomes. METHODS/DESIGN:This trial evaluates the effectiveness and implementation of two versions of CETA using a non-inferiority design to test two primary hypotheses: (1) a brief five-session version of CETA (Brief CETA) will provide similar effectiveness for reducing the severity of common mental health problems such as depression, post-traumatic stress, impaired functioning, anxiety, and substance use problems compared with the standard 8-12-session version of CETA (Standard CETA); and (2) both Brief and Standard CETA will have superior impact on the outcomes compared to a wait-list control condition. For both hypotheses, the main effect will be assessed using longitudinal data and mixed-effects regression models over a 6-month period post baseline. A secondary aim includes exploration of implementation factors. Additional planned analyses will include exploration of: moderators of treatment impact by disorder severity and comorbidity; the impact of individual therapeutic components; and trends in symptom change between end of treatment and 6-month assessment for all participants. DISCUSSION:This trial is the first rigorous study comparing a standard-length (8-12 sessions) modular, flexible, transdiagnostic, cognitive-behavioral approach to a shortened version of the approach (five sessions). Brief CETA entails "front-loading" with elements that research suggests are strong mechanisms of change. The study design will allow us to draw conclusions about the effects of both Brief and Standard CETA as well as which elements are integral to their mechanisms of action, informing future implementation and fidelity efforts. The results from this trial will inform future dissemination, implementation and scale-up of CETA in Ukraine and contribute to our understanding of the effects of modular, flexible, transdiagnostic approaches in similar contexts. TRIAL REGISTRATION:ClinicalTrials.gov, ID: NCT03058302 (U.S. National Library of Medicine). Registered on 20 February 2017.

SUBMITTER: Murray LK

PROVIDER: S-EPMC6090833 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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Testing the effectiveness and implementation of a brief version of the Common Elements Treatment Approach (CETA) in Ukraine: a study protocol for a randomized controlled trial.

Murray Laura K LK Haroz Emily E EE Doty Benjamin B Singh Namrita S NS Bogdanov Sergey S Bass Judith J Dorsey Shannon S Bolton Paul P

Trials 20180803 1

<h4>Background</h4>Mental illness is a major public health concern. Despite progress understanding which treatments work, a significant treatment gap remains. An ongoing concern is treatment length. Modular, flexible, transdiagnostic approaches have been offered as one solution to scalability challenges. The Common Elements Treatment Approach (CETA) is one such approach and offers the ability to treat a wide range of common mental health problems. CETA is supported by two randomized trials from ...[more]

PMID: 30075806

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Project description:IntroductionIntimate partner violence (IPV) is a barrier to consistent HIV treatment in South Africa. Previous trials have established that the Common Elements Treatment Approach (CETA), a cognitive-behavioural-based intervention, is effective in reducing mental and behavioural health problems but has not been trialled for effectiveness in improving HIV outcomes. This paper describes the protocol for a randomised trial that is testing the effectiveness of CETA in improving HIV treatment outcomes among women experiencing IPV in South Africa.Methods and analysisWe are conducting a randomised trial among HIV-infected women on antiretroviral therapy, who have experienced sexual and/or physical IPV, to test the effect of CETA on increasing retention and viral suppression and reducing IPV. Women living with HIV who have an unsuppressed viral load or are at high risk for poor adherence and report experiencing recent IPV, defined as at least once within in the last 12 months, will be recruited from HIV clinics and randomised 1:1 to receive CETA or an active attention control (text message reminders). All participants will be followed for 24 months. Follow-up HIV data will be collected passively using routinely collected medical records. HIV outcomes will be assessed at 12 and 24 months post-baseline. Questionnaires on violence, substance use and mental health will be administered at baseline, post-CETA completion and at 12 months post-baseline. Our primary outcome is retention and viral suppression (<50 copies/mL) by 12 months post-baseline. We will include 400 women which will give us 80% power to detect an absolute 21% difference between arms. Our primary analysis will be an intention-to-treat comparison of intervention and control by risk differences with 95% CIs.Ethics and disseminationEthics approval provided by University of the Witwatersrand Human Research Ethics Committee (Medical), Boston University Institutional Review Board and Johns Hopkins School Institutional Review Board. Results will be published in peer-reviewed journals.Trial registration numberNCT04242992.

Project description: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).

Project description:BackgroundMotivational interviewing (MI) has been shown to effectively improve self-management for youth living with HIV (YLH) and has demonstrated success across the youth HIV care cascade-currently, the only behavioral intervention to do so. Substantial barriers prevent the effective implementation of MI in real-world settings. Thus, there is a critical need to understand how to implement evidence-based practices (EBPs), such as MI, and promote behavior change in youth HIV treatment settings as risk-taking behaviors peak during adolescence and young adulthood.ObjectiveThis study aims to describe the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) protocol of a tailored MI (TMI) implementation-effectiveness trial (ATN 146 TMI) to scale up an EBP in multidisciplinary adolescent HIV settings while balancing flexibility and fidelity. This protocol is part of the Scale It Up program described in this issue.MethodsThis study is a type 3, hybrid implementation-effectiveness trial that tests the effect of TMI on fidelity (MI competency and adherence to program requirements) while integrating findings from two other ATN protocols described in this issue-ATN 153 Exploration, Preparations, Implementation, Sustainment and ATN 154 Cascade Monitoring. ATN 153 guides the mixed methods investigation of barriers and facilitators of implementation, while ATN 154 provides effectiveness outcomes. The TMI study population consists of providers at 10 adolescent HIV care sites around the United States. These 10 clinics are randomly assigned to 5 blocks to receive the TMI implementation intervention (workshop and trigger-based coaching guided by local implementation teams) utilizing the dynamic wait-listed controlled design. After 12 months of implementation, a second randomization compares a combination of internal facilitator coaching with the encouragement of communities of practice (CoPs) to CoPs alone. Participants receive MI competency assessments on a quarterly basis during preimplementation, during the 12 months of implementation and during the sustainment period for a total of 36 months. We hypothesize that MI competency ratings will be higher among providers during the TMI implementation phase compared with the standard care phase, and successful implementation will be associated with improved cascade-related outcomes, namely undetectable viral load and a greater number of clinic visits among YLH.ResultsParticipant recruitment began in August 2017 and is ongoing. As of mid-May 2018, TMI has 150 active participants.ConclusionsThis protocol describes the underlying theoretical framework, study design, measures, and lessons learned for TMI, a type 3, hybrid implementation-effectiveness trial, which has the potential to scale up MI and improve patient outcomes in adolescent HIV settings.Trial registrationClinicalTrials.gov NCT03681912; https://clinicaltrials.gov/ct2/show/NCT03681912 (Archived by WebCite at http://www.webcitation.org/754oT7Khx).International registered report identifier (irrid)DERR1-10.2196/11200.

Project description:BackgroundPhysical inactivity is a leading risk factor for chronic disease. Brief physical activity counselling delivered within healthcare systems has been shown to increase physical activity levels; however, implementation efforts have mostly targeted primary healthcare and uptake has been sub-optimal. The Brief Physical Activity Counselling by Physiotherapists (BEHAVIOUR) trial aims to address this evidence-practice gap by evaluating (i) the effectiveness of a multi-faceted implementation strategy, relative to usual practice for improving the proportion of patients receiving brief physical activity counselling as part of their routine hospital-based physiotherapy care and (ii) effectiveness of brief physical activity counselling embedded in routine physiotherapy care, relative to routine physiotherapy care, at improving physical activity levels among patients receiving physiotherapy care.MethodsEffectiveness-implementation hybrid type II cluster randomised controlled trial with embedded economic evaluation, qualitative study and culturally adapted patient-level outcome measures. The trial will be conducted across five hospitals in a local health district in Sydney, Australia, with a lower socioeconomic and culturally diverse population. The evidence-based intervention is brief physical activity counselling informed by the 5As counselling model and behavioural theory, embedded into routine physiotherapy care. The multi-faceted strategy to support the implementation of the counselling intervention was developed with key stakeholders guided by the Consolidated Framework for Implementation Research and the Capabilities, Opportunities, Motivation-Behaviour (COM-B) theoretical model, and consists of clinician education and training, creating a learning collaborative, tailored strategies to address community referral barriers, team facilitation, and audit and feedback. Thirty teams of physiotherapists will be randomised to receive the multi-faceted implementation strategy immediately or after a 9-month delay. Each physiotherapy team will recruit an average of 10 patients (n=300) to collect effectiveness outcomes at baseline and 6 months. The primary effectiveness outcome is self-reported planned physical activity using the Incidental and Planned Exercise Questionnaire, and the primary implementation outcome is reach (proportion of eligible new physiotherapy patients who receive brief physical activity counselling). Secondary effectiveness and implementation outcomes will also be collected.DiscussionThis project focuses on physiotherapists as health professionals with the requisite skills and patterns of practice to tackle the increasing burden of chronic disease in a high-risk population.Trial registrationANZCTR, ACTRN12621000194864 . Registered on 23 February 2021.

Project description:BackgroundYoung men who have sex with men (YMSM), particularly those who are partnered, are at unique risk for HIV. YMSM are among those at highest risk for HIV. Meanwhile, despite the fact that primary partners account for many-possibly most-new HIV infections, partnered men who have sex with men perceive themselves to be at much lower risk for HIV infection and therefore test less often than single men. In response to the risk of primary partner HIV transmission, couples HIV testing and counseling (CHTC) procedures have been developed for use in adult populations. Although promising, YMSM couples may require additional support to complete CHTC given their developmental context in which sexual and romantic relationships are relatively new, and communication skills are emergent.ObjectiveThe aim of this study was to test the additive benefit of adjunct treatment components tailored for YMSM, which enhance communication skills before the completion of CHTC. The intervention tests a continuum of prevention packages including assertive communication training videos and motivational interviewing focused on assisting with identification and development (MI-AID) before entering into the dyadic intervention components. This protocol is part of the Adolescent Medicine Trials Network (ATN) Scale It Up program described in this issue.MethodsThis is a comparative effectiveness trial that will be executed in 3 phases. Phase 1 will gather qualitative data related to intervention development and implementation from partnered YMSM at 4 subject recruitment venues (SRVs). Phase 2 will compare a continuum of these interventions in a pilot randomized controlled trial (RCT) at 2 SRVs. Phase 3 will compare the most successful adapted intervention package from phase 2 to CHTC as usual in a larger RCT at 4 SRVs. This phase is focused on implementation and sustainment phases of the Exploration, Preparation, Implementation, and Sustainment framework.ResultsPhase 1 data will be drawn from qualitative interviews with partnered YMSM (n=24) and staff from ATN sites (n=20). Baseline enrollment for phase 2 is expected to begin across 2 SRVs in June 2018 (ncouples=36). In phase 2, survey data collection along with HIV and sexually transmitted infection (STI) testing will occur at baseline, and 1- and 3-month (postintervention) follow-ups. Phase 3 will begin enrollment across 4 SRVs in September 2019 (ncouples=144) and follow-ups will occur at 1, 3, 6, and 9 months postintervention.ConclusionsAlthough MI-AID, video-based assertive communication training, and CHTC have established efficacy when administered on their own, this study will be the first to evaluate the strongest adjunctive version of these interventions to address the specific developmental needs of partnered YMSM.Trial registrationClinicalTrials.gov NCT03386110; http://clinicaltrials.gov/ct2/show/NCT03386110 (Archived by WebCite at http://www.webcitation.org/75mlO7GCx).International registered report identifier (irrid)DERR1-10.2196/11186.

Dataset Information

Testing the effectiveness and implementation of a brief version of the Common Elements Treatment Approach (CETA) in Ukraine: a study protocol for a randomized controlled trial.

Publications

Testing the effectiveness and implementation of a brief version of the Common Elements Treatment Approach (CETA) in Ukraine: a study protocol for a randomized controlled trial.

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