Evaluating Impacts of CSS for Veterans and Their Families in Ukraine (NCT04234815) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in mental health symptom scores
Timeframe: Baseline, 1-month follow-up
2
Mental health treatment engagement
Timeframe: 3 months following referral to mental health treatment
3
Change in functional impairment
Timeframe: Baseline, 1-month follow-up
Trial details
NCT IDNCT04234815
SponsorJohns Hopkins Bloomberg School of Public Health