Psychosocial ProblemNCT04234815
Evaluating Impacts of CSS for Veterans and Their Families in Ukraine
A study testing CETA Short Session (CSS) and Psychoeducation and Safety in people with Psychosocial Problem and Psychological Distress, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Ukraine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychosocial Problem, Psychological Distress, Engagement, Patient
- What is being tested?
- CETA Short Session (CSS) and Psychoeducation and Safety
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,193 participants
- Where
- 1 siteUkraine
- Study dates
- 28 Feb 2020to 23 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating Impacts of a Brief Psychosocial Workshop for Veterans and Their Families in Ukraine
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.
Read the 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.
- 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.
- Individuals with high symptom scores, but no safety concerns, will be contacted within 72 hours and offered a referral to outpatient mental health care.
- 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.
- Being tested
- CETA Short Session (CSS), Psychoeducation and Safety
- Keywords
- Mental health, Psychosocial support, Intervention, Depression, Post-traumatic stress, Functioning
- Medical subject headings
- Patient Participation, Psychological Well-Being, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CETA Short Session (CSS)Behavioural
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.
Psychoeducation and SafetyBehavioural
This intervention is the same as CSS with the exception that the cognitive coping skill training is removed.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: CETA Short Session (CSS) |
| 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. Receives: Behavioral: Psychoeducation and Safety |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: Baseline, 1-month follow-up
Secondary outcomes (3)
Aggression
Items adapted (based on qualitative data) from the Conflict Tactics Scale - Revised (range: 0-18, higher scores indicate more aggression)
Measured: Baseline, 1-month follow-up
Social Connectedness
Items adapted (based on qualitative data) from the Social Connectedness Scale - Revised (range: 0-24, higher scores indicate greater disconnection)
Measured: Baseline, 1-month follow-up
Alcohol consumption
AUDIT-C scores (range: 0-12, higher scores indicate greater substance use)
Measured: Baseline, 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start28 Feb 2020
- Primary completion23 Feb 2022
- Study completion23 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychosocial ProblemStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Responsible party
- Sponsor
- Investigators
- Judy Bass, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234815
- Sponsor's protocol ID
- 9782
- Status last verified
- Sep 2022
- First submitted
- 16 Jan 2020
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Impacts of a Brief Psychosocial Workshop for Veterans and Their Families in Ukraine
- ClinicalTrials.gov ID
- NCT04234815
- Acronym / sponsor ID
- 9782
- Keywords
- Mental health, Psychosocial support, Intervention, Depression, Post-traumatic stress, Functioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,193 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID)
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- 23 Feb 2022 (actual)
- Study completion
- 23 Feb 2022 (actual)
- First posted
- 21 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- Individuals with high symptom scores, but no safety concerns, will be contacted within 72 hours and offered a referral to outpatient mental health care.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CETA Short Session (CSS) | Experimental | Behavioral: CETA Short Session (CSS)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 | Behavioral: Psychoeducation and SafetyA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CETA Short Session (CSS)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. | Behavioural | CETA Short Session (CSS) |
| Psychoeducation and SafetyThis intervention is the same as CSS with the exception that the cognitive coping skill training is removed. | Behavioural | Enhanced Treatment as Usual (eTAU) |
Primary outcome
Change in mental health symptom scores
Time frame: Baseline, 1-month follow-up
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)
Mental health treatment engagement
Time frame: 3 months following referral to mental health treatment
Follow-up on referral to mental health treatment, derived from client monitoring records (indicated as yes/no)
Change in functional impairment
Time frame: Baseline, 1-month follow-up
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)
3 secondary outcomes
Aggression
Time frame: Baseline, 1-month follow-up
Social Connectedness
Time frame: Baseline, 1-month follow-up
Alcohol consumption
Time frame: Baseline, 1-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judy Bass, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CETA Short Session (CSS) and Psychoeducation and Safety in people with Psychosocial Problem and Psychological Distress, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mental health symptom scores (time frame: Baseline, 1-month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2022.