Abstract
BackgroundMental 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/designThis 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.DiscussionThis 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 registrationClinicalTrials.gov, ID: NCT03058302 (U.S. National Library of Medicine). Registered on 20 February 2017.
Highlights
Anxiety management strategiesBehavioral Activation Cognitive coping/RestructuringImaginal Gradual Exposure Suicide/homicide/danger assessment and planningCognitive-behavioral therapy (CBT) for substance use and relapse prevention RelaxationGetting Active (GA) Thinking in a Different Way (TDW) – Part I and Part II TDW1 and TDW2 Talking about trauma memories (TDM) SafetySubstance use element (SU) Description Focus on obstacles to engagement Linking program to assisting with client’s problems Includes family when appropriate.Program information Normalization/validation of current symptoms/problems Strategies to improve physiological stress
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
The study design will allow us to draw conclusions about the effects of both Brief and Standard Common Elements Treatment Approach (CETA) as well as which elements are integral to their mechanisms of action, informing future implementation and fidelity efforts
Summary
This trial uses a robust design that allows us to compare the effectiveness of two interventions using a non-inferiority design. Counselors are able to choose a primary problem of substance use, anxiety, depression or trauma whereas in the two completed trials all started with a trauma flow based on more restricted inclusion criteria For those participants who are randomized to Standard CETA, providers have full flexibility in choosing the elements, order, and dosing that they provide after the first five sessions. A brief modular, flexible, transdiagnostic approach is useful when working in settings with displaced and trauma-affected populations, given the high rates of comorbidity and high mobility in some settings The results from this trial will inform future dissemination, implementation and scale-up of CETA in Ukraine as well as contribute to our understanding of these approaches in similar LMIC contexts.
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
