CompletedNot Applicable

Evaluating Impacts of CSS for Veterans and Their Families in Ukraine

Ukraine1,193 participantsStarted 2020-02-28

Plain-language summary

This cluster-randomized controlled trial (c-RCT) evaluates the effectiveness of a brief, single-session psychosocial workshop, "CETA Short Session" (CSS), for reducing symptoms of distress and functional impairment and increasing treatment engagement among conflict veterans and their families in Ukraine. The CSS workshop includes psychoeducation, review of a self-assessment, safety screening, and training in cognitive coping. This will be evaluated against a single-session comparison workshop that includes all of the same workshop elements except for cognitive coping. Registration for both conditions includes completion of a self-assessment. Participants with safety concerns or very severe symptoms will be immediately referred to mental health treatment; others will be asked to wait for one month before being reassessed and, if indicated, referred to mental health treatment. Both conditions include an individual check-in phone call one week after the workshop. Distress and functional impairment outcomes will be assessed one month from baseline. Treatment engagement outcomes will be assessed three months from referral. The investigators hypothesize that individuals attending sessions randomized to CSS will show greater improvement in mental health outcomes and greater treatment engagement than those attending sessions randomized to the comparison condition. With the onset of the COVID-19 pandemic in Spring 2019, the RCT was paused to develop and pilot an online version of both the CSS and comparison workshop. The trial protocol has now been expanded to continue the effectiveness trial while allowing for both online and \[when/if feasible\] in-person intervention delivery.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Ukrainian adults (age 18 or older) who are Veterans of the Anti-Terrorist Operations (ATO) in Ukraine or an adult family member of a veteran * Meets a minimum total problem score on the locally validated screener indicative of at least moderate symptoms of distress Exclusion Criteria: * People who identify as ATO veterans but are still active (i.e., active duty) in the Ukrainian military. * Participants who arrive late to the workshop, operationalized as not having time to participate in the self-assessment review, will be excluded. In online workshops, late-arriving participants will be redirected to a waiting room, where they will be encouraged to attend a future session instead (and if so, could be included in the study). For in-person workshops, due to travel and other efforts required for attendance late arriving participants will be allowed to join the workshop, but excluded from the study due to lacking sufficient exposure. They can also choose to attend a future workshop, but if attending a portion of an initial workshop would remain study ineligible because they could potentially be exposed to both arms of the study. * Participants who are identified by service providers as needing higher-level care rather than outpatient psychotherapy will be immediately referred to that care and excluded from the study. This exclusion criteria refers to imminent danger to self or others that requires urgent safety procedures and institution-based mental hea…

What they're measuring

Change in mental health symptom scores

Timeframe: Baseline, 1-month follow-up

Mental health treatment engagement

Timeframe: 3 months following referral to mental health treatment

Change in functional impairment

Timeframe: Baseline, 1-month follow-up

Trial details

NCT IDNCT04234815

SponsorJohns Hopkins Bloomberg School of Public Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-02-23