Clinical trial NCT04234815: Evaluating Impacts of CSS for Veterans and Their Families in Ukraine
Official title: Evaluating Impacts of a Brief Psychosocial Workshop for Veterans and Their Families in Ukraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychosocial Problem
Psychological Distress
Engagement, Patient
Keywords: Mental health
Psychosocial support
Intervention
Depression
Post-traumatic stress
Functioning
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: United States Agency for International Development (USAID)
First posted: 2020-01-21
Enrollment: 1193
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: Community-based organizations in Ukraine that are currently providing social services to veterans or their families and are interested in receiving training to provide CSS will be engaged as implementing partners. Individuals selected to be providers at these organizations will complete a 2-day Provider Training and will additionally receive ongoing supervision over the course of the study to ensure intervention fidelity and appropriate response and support to individuals needing referral to mental health treatment.

Cluster-level randomization to CSS or eTAU will be carried out at the workshop level within provider, such that all Providers will deliver both the CSS and eTAU workshops to groups that have been randomly allocated to either receive CSS or eTAU. In this way, all organizations will offer both CSS and eTAU, integrated into each organization's regular program offerings and advertised through organizations' regular communication channels.

As part of the registration and triage procedures included as regular programming in both arms of the trial, participants will self-complete a short, locally validated Self-Assessment Form that assesses symptoms of distress (depression, post-traumatic stress), functional impairment, and safety risk (two safety-related questions assessing recent thoughts of harm to self or others). This assessment will be completed in advance and reviewed by an M\&E staff member prior to the workshop, but assessment scores will not determine workshop eligibility (e.g., people with low scores can still participate). One exception to this is that any individuals who respond positively to either of the safety questions will be contacted by the CSS/eTAU provider within 24-hours for further safety assessment. If no safety issues are identified, they will be registered for the workshop as normal; however, identified safety issues will trigger an appropriate safety planning or referral response as described below, which may include bypassing the workshop in lieu of direct enrollment in treatment services. At the end of the workshop, participants will be informed of the study and invited to participate; those who agree will provide informed consent.

After the workshop, as part of regular programming the provider will follow up individually with participants to discuss recommended next steps. Evaluation of level of need, and therefore choice of follow-up response, will be made by the provider using the self-assessment results as well as any information reported to the provider during the workshop (such as new safety concerns, or changes in problem scores). Follow-up contacts will be ordered by priority.

1. Individuals who indicate any new safety concerns at the workshop will be contacted within 24 hours for further assessment to determine the appropriate referrals and/or safety plan.
2. Individuals with high symptom scores, but no safety concerns, will be contacted within 72 hours and offered a referral to outpatient mental health care.
3. Individuals with moderate symptom scores will be contacted within 1 week for triage and encouraged to use the newly learned skills over the next month. On that triage phone call, participants will be told they will be re-assessed in one month to determine if they still require mental health treatment (at which time they would be referred if indicated). For those who attended CSS (rather than eTAU), providers will also ask about participant use of the cognitive coping skill over the past week, including asking them how often they've used it, whether it has been helpful, and soliciting an example through a series of questions that walk them through the skill.

At one month, all study participants who were not immediately referred to outpatient mental health services at baseline will be sent an individual link to re-administer the self-assessment, the CSS skill check, and complete an implementation feedback questionnaire.

For all study participants who receive an outpatient mental health referral, either immediate or delayed, engagement outcomes will be assessed three months following referral.

Eligibility criteria: 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 health care.

Primary outcomes:
measure: Change in mental health symptom scores
timeFrame: Baseline, 1-month follow-up
measure: Mental health treatment engagement
timeFrame: 3 months following referral to mental health treatment
measure: Change in functional impairment
timeFrame: Baseline, 1-month follow-up
Secondary outcomes:
measure: Aggression
timeFrame: Baseline, 1-month follow-up
measure: Social Connectedness
timeFrame: Baseline, 1-month follow-up
measure: Alcohol consumption
timeFrame: Baseline, 1-month follow-up
Other outcomes:
measure: Implementation outcomes
timeFrame: 1-month follow-up
Locations:
city: Kyiv
country: Ukraine
facility: NaUKMA
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Judy Bass, PhD
role: PRINCIPAL_INVESTIGATOR
References: