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| Name | Class |
|---|---|
| United States Agency for International Development (USAID) | FED |
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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CETA Short Session (CSS) | Experimental | A single-session, 1.5-2 hour group workshop that includes psychoeducation, self-assessment, safety screening, and training in cognitive coping. Participants with at least moderate symptoms of distress will also receive a follow-up phone call to discuss next steps occurring within one week after workshop attendance. On this phone call they will also be asked about their use of the cognitive coping skill over the last week, and provided feedback if using it incorrectly. |
|
| Enhanced Treatment as Usual (eTAU) | Active Comparator | A single-session, approximately 1-hour group workshop that includes the same psychoeducation, self-assessment, and safety screening as the experimental condition, but no training in cognitive coping. Participants with at least moderate symptoms of distress will also receive a follow-up phone call to discuss next steps occurring within one week after workshop attendance. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CETA Short Session (CSS) | Behavioral | CETA Short Session (CSS) is a brief, low-intensity psychosocial intervention incorporating foundational components of the Common Elements Treatment Approach (CETA). CETA is an 8-12 session, transdiagnostic psychotherapy for common mental disorders. CSS was designed to serve as both a prevention/support approach for a broader range of needs, as well as an engagement/outreach strategy to identify and refer individuals to treatment. CSS is delivered in a group format over approximately two hours and consists of: 1) Psychoeducation: instruction about the brain and brain functioning, including normalization of psychological responses to stress and a brief self-assessment; 2) Safety: screening and referral for individuals identified as at risk of harm to self or others; and 3) Cognitive coping: based on the cognitive triangle, participants practice identifying an unhelpful thought changing it to a more helpful alternative, and examining how these thoughts impact feelings and behaviors. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mental health symptom scores | International Depression Symptom Scale (IDSS): a locally-validated self-report instrument that produces total and syndrome-specific scores. (range: 0-54, higher indicates more symptomatic) | Baseline, 1-month follow-up |
| Mental health treatment engagement | Follow-up on referral to mental health treatment, derived from client monitoring records (indicated as yes/no) | 3 months following referral to mental health treatment |
| Change in functional impairment | a locally developed (based on qualitative data) and validated self-report instrument that produces a functional impairment score (range: 0-56, higher scores indicate greater functional impairment) | Baseline, 1-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Aggression | Items adapted (based on qualitative data) from the Conflict Tactics Scale - Revised (range: 0-18, higher scores indicate more aggression) | Baseline, 1-month follow-up |
| Social Connectedness |
| Measure | Description | Time Frame |
|---|---|---|
| Implementation outcomes | JHU Implementation Measure for LMIC (JHUIM): A validated implementation questionnaire assessing adoption, acceptability, appropriateness, and feasibility of the intervention. | 1-month follow-up |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judy Bass, PhD | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NaUKMA | Kyiv | Ukraine |
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| ID | Term |
|---|---|
| D010358 | Patient Participation |
| D000092862 | Psychological Well-Being |
| D003863 | Depression |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D012449 | Safety |
| ID | Term |
|---|---|
| D000056 | Accident Prevention |
| D000059 | Accidents |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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Participants are not informed of their condition, but may reasonably deduce it.
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| Psychoeducation and Safety | Behavioral | This intervention is the same as CSS with the exception that the cognitive coping skill training is removed. |
|
Items adapted (based on qualitative data) from the Social Connectedness Scale - Revised (range: 0-24, higher scores indicate greater disconnection)
| Baseline, 1-month follow-up |
| Alcohol consumption | AUDIT-C scores (range: 0-12, higher scores indicate greater substance use) | Baseline, 1-month follow-up |
| D010549 | Personal Satisfaction |
| D001526 | Behavioral Symptoms |