Study of Effectiveness and Implementation of a Mental Health Intervention With Conflict-affected Communities in Ukraine

NCT03058302 | Completed

• 1 other identifier: 7293
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 3

Brief Summary

This project aims to contribute to the development of a community mental health care system while directly serving the conflict affected population in east Ukraine. This project is being supported by USAID's Victims of Torture Fund. In the Spring of 2015, the Johns Hopkins University (JHU) Applied Mental Health Research Group (AMHR) was invited to make a site visit to Ukraine with USAID to make an initial assessment of current mental health problems, service capacities, and treatment need. AMHR and USAID were requested by community-based partners to provide training and support in evidence based trauma treatment for people affected by war and displacement. Extensive conflict within the borders of Ukraine is a new experience for most Ukrainians, and local psychologists and psychotherapists were not prepared for wide-spread need or trained in appropriate methods of treatment for affected populations. JHU and USAID began activities in Ukraine in June 2015 and have identified the counseling intervention, Common Elements Treatment Approach (CETA), as appropriate and relevant for this context. Community providers from the three trial sites (Kyiv, Kharkiv, and Zaporizhia) have been trained in CETA as counselors and local supervisors. An ongoing training and supervision model (Apprenticeship Model) is being implemented in the three study sites. These three sites contain significant numbers of military veterans (demobilized soldiers from the ongoing conflict) and internally displaced persons (IDPs). Adult IDPs and Veterans from the three study sites will be recruited and screened to identify those with elevated depression and/or posttraumatic stress symptoms and impaired functioning. This study will be conducted as a 3-armed randomized controlled trial. This study will test to see if both the long and a short version of CETA are effective compared to a wait-control condition.

Conditions

Depression; PostTraumatic Stress Disorder

Outcome Measures

Primary Outcomes (2)

• Change in Mental health symptom levels from baseline (monthly for all groups)

  Change in Symptoms of depression and posttraumatic stress from baselines, measured monthly for all groups for 6 months post baseline

  Monthly for 6 months

• Change in Impaired functioning levels (monthly for all groups)

  Change in Impaired functioning levels from baseline, measured at the 6 month follow-up for all groups.

  6 months post-baseline

Secondary Outcomes (1)

• Change in Mental health symptom levels from baseline (Monthly for all groups)

  Monthly for 6 months

Study Arms (3)

Full CETA

EXPERIMENTAL

Full CETA participants will complete 12 CETA sessions. this is the same version of CETA that has been tested in other sites. They will be monitored weekly for clinical purposes (symptoms and safety) during treatment. they will also receive monthly research assessments (research outcomes) for 6 months after baseline assessment and commencement of treatment.

Behavioral: CETA (Common Elements Treatment Approach)

Brief CETA

EXPERIMENTAL

Brief CETA participants is a new shorter version of CETA that has the same content as Full CETA but provided in fewer sessions. Each participant will complete 5 CETA sessions and will be monitored weekly for clinical purposes (symptoms and safety) during treatment and thereafter monthly for research purposes (research outcomes) for 6 months after baseline assessment and commencement of treatment.

Behavioral: CETA (Common Elements Treatment Approach)

Wait-Control

NO INTERVENTION

Wait-control participants will undergo monthly monitoring after enrollment in the study for research purposes (research outcomes) for 6 months after baseline assessment.

Interventions

CETA (Common Elements Treatment Approach) BEHAVIORAL

The Common Elements Treatment Approach, or CETA, is a transdiagnostic psychotherapy based on cognitive behavioral elements for mood, anxiety and trauma related problems. CETA is based on the fact that most evidence-based mental health treatments (EBTs) consist of similar components. The objective of CETA is to provide a single training in a range of therapy components that are similar across EBTs and to then teach counselors how to design a specific course of treatment for each client based on the client's presenting problems.

Brief CETA; Full CETA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ukrainian adults (age 18 or older) who are either Internally Displaced Persons (IDPs) or military veterans of the conflict is East Ukraine, and their adult family members.
• A score of 7 or above on the locally validated depression scale AND a score of 4 or above on the locally validated function scale
• A score of 9 or above on the locally validated PTS scale AND a score of 4 or above on the locally validated function scale
• Living in or around the 3 study sites for the duration of the study (at least 6 months) and able to regularly attend at least one of the locations where CETA is available for duration of treatment.

You may not qualify if:

• Our definition of "veteran" excludes people who identify as veterans but are still active (i.e., active duty) in the Ukrainian military.
• Active thoughts and plans of suicidality or symptoms of psychosis requiring immediate referral to professional psychiatric services.
• Factors identified at baseline that preclude full participation, including: unstable and severe medical, psychiatric or drug use problem that currently necessitates inpatient treatment.

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• United States Agency for International Development (USAID): collaborator

Study Sites (3)

National University of Kyiv Mohyla Academy

Kharkiv, Ukraine

Location

National University of Kyiv Mohyla Academy

Kyiv, Ukraine

Location

National University of Kyiv Mohyla Academy

Zaporozh’ye, Ukraine

Location

Related Publications (5)

• Fairburn CG, Cooper Z, Doll HA, O'Connor ME, Bohn K, Hawker DM, Wales JA, Palmer RL. Transdiagnostic cognitive-behavioral therapy for patients with eating disorders: a two-site trial with 60-week follow-up. Am J Psychiatry. 2009 Mar;166(3):311-9. doi: 10.1176/appi.ajp.2008.08040608. Epub 2008 Dec 15.

  PMID: 19074978 BACKGROUND

• Farchione TJ, Fairholme CP, Ellard KK, Boisseau CL, Thompson-Hollands J, Carl JR, Gallagher MW, Barlow DH. Unified protocol for transdiagnostic treatment of emotional disorders: a randomized controlled trial. Behav Ther. 2012 Sep;43(3):666-78. doi: 10.1016/j.beth.2012.01.001. Epub 2012 Jan 18.

  PMID: 22697453 BACKGROUND

• McHugh RK, Murray HW, Barlow DH. Balancing fidelity and adaptation in the dissemination of empirically-supported treatments: The promise of transdiagnostic interventions. Behav Res Ther. 2009 Nov;47(11):946-53. doi: 10.1016/j.brat.2009.07.005. Epub 2009 Jul 29.

  PMID: 19643395 BACKGROUND

• Murray LK, Dorsey S, Haroz E, Lee C, Alsiary MM, Haydary A, Weiss WM, Bolton P. A Common Elements Treatment Approach for Adult Mental Health Problems in Low- and Middle-Income Countries. Cogn Behav Pract. 2014 May;21(2):111-123. doi: 10.1016/j.cbpra.2013.06.005.

  PMID: 25620867 BACKGROUND

• Murray LK, Haroz EE, Doty B, Singh NS, Bogdanov S, Bass J, Dorsey S, Bolton P. 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. Trials. 2018 Aug 3;19(1):418. doi: 10.1186/s13063-018-2752-y.

  PMID: 30075806 DERIVED

MeSH Terms

Conditions

Depression; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Paul Bolton, MBBS

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

• Laura Murray, PhD

  Johns Hopkins Bloomberg School of Public Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: until the 4th sessions participants receiving CETA and providers will be masked with respect to whether treatment is short or long CETA.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2017
• First Posted: February 20, 2017
• Study Start: January 1, 2017
• Primary Completion: November 30, 2018
• Study Completion: April 19, 2019
• Last Updated: October 7, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

UA (3)