AnxietySHAWLNCT06679114
Preventing Mental Disorders Among Women Internally Displaced by War in Ukraine: The SHAWL Trial
A study testing Acceptance and Commitment Therapy in people with Anxiety and Mental Health Disorder, run by Boston Medical Center at 1 site in Ukraine.
Trial summary
This study is a randomized controlled trial among 120 recently displaced women to determine the effectiveness of a single-session Acceptance and Commitment Therapy (ACT) group therapy on prevention of development of mental health disorders or worsened mental health symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anxiety, Mental Health Disorder, War-Related Trauma
- What is being tested?
- Acceptance and Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUkraine
- Study dates
- 27 Mar 2025to 10 Jan 2026
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or over
- Identify as a displaced woman within one year of migration
- Endorsing mild to moderate depressive symptoms (subscale score between 3 and 7) and/or anxiety symptoms (subscale score between 2 and 6) on the Mental Health Assessment Inventory (MHAI) but not exceeding the maximum score for either subscale (i.e., not exceeding 7 on the depressive symptoms subscale and not exceeding 6 on the anxiety symptoms subscale)
- Ability to provide informed consent
- Speak Ukrainian or Russian
Who cannot join
- Diagnosis of a depressive or anxiety disorder, or symptoms necessitating urgent referral for evaluation of suicidal or homicidal ideation
- Receipt of psychiatric care for depression or anxiety in the past 5 years
- A severe medical problem that inhibits ability to participate in the trial
Trial locations and contacts
1 site in 1 country.
About this study
This study is a randomized controlled trial among 120 recently displaced women to determine the effectiveness of a single-session Acceptance and Commitment Therapy (ACT) group therapy on prevention of development of mental health disorders or worsened mental health symptoms.
Read the detailed description
The war in Ukraine has provoked the world's current largest humanitarian displacement: since February 2022, one-third of Ukrainians have been forced to leave their homes, resulting in upwards of 7 million internally displaced persons. Estimates suggest that 60% of Ukraine's displaced persons are women, who face stressors including difficulty accessing necessary primary health and psychological care, restricted access to food and stable housing, and increased strain from separation from their social networks and additional family care responsibilities.
Early reports from Ukraine consistently describe the psychological distress that displaced women are presently experiencing. It is anticipated that nearly one in five people exposed to conflict will develop mental disorders, notably depressive and anxiety disorders. Thus, improving access to mental health prevention programs that mitigate development of mental disorders for women in Ukraine is critical.
This study will adapt a community-based Acceptance and Commitment Therapy (ACT) intervention to prevent the development symptoms of depression and anxiety among women displaced by war in Ukraine. ACT is an evidence-based approach that uses acceptance, mindfulness and behavioral change processes to improve psychological flexibility. Recently displaced women who screen positive for symptoms of depression and anxiety will be recruited. The investigators plan to adapt and evaluate a single-session ACT group intervention to limit effects of mental health distress among these displaced women.
The central hypothesis of this research is that an ACT-based intervention delivered in a humanitarian context will help displaced women in Ukraine learn skills to improve psychological flexibility, thereby decreasing symptoms of depression and anxiety and ultimately mitigating onset of mental disorders.
- Conditions
- Anxiety, Mental Health Disorder, War-Related Trauma, Acceptance and Commitment Therapy, Depressive Symptoms Mild to Moderate in Severity, Refugee Health
- Being tested
- Acceptance and Commitment Therapy, Attention control
- Keywords
- Displacement, Women's health, Ukraine
- Medical subject headings
- Anxiety Disorders, Mental Disorders, War-Related Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyBehavioural
The single-session ACT group intervention will involve a mixture of didactic instruction, discussion, metaphors, and experiential activities. ACT activities will help women notice and accept that negative thoughts, emotions, and experiences while being displaced by war are part of migratory and post-migratory life. ACT activities will also help them identify, reorient towards, and commit to values-consistent behaviors through effective goal-setting. The single-session will be approximately 3 hours long.
Attention controlBehavioural
Usual care will be minimally enhanced by providing participants with an educational information session that provides information on health promotion.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral: ACT Therapy | Experimental | Participants randomized to this group will receive a single-session ACT intervention Receives: Behavioral: Acceptance and Commitment Therapy |
| Attention control | Active comparator | Participants in the control group will receive minimally enhanced usual care to receive treatment as usual enhanced by a health information group session. Receives: Behavioral: Attention control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety symptoms
Anxiety symptoms will be assessed using the Mental Health Assessment Inventory (MHAI) anxiety subscore which has 4 items, and each item is rated on a 3-point Likert scale where "0" means "none of the time" and "3" means "almost all of the time." Total score on the subscale ranges from 0-12 with higher scores indicating greater symptoms of anxiety.
Measured: Baseline, 3 months
Depressive symptoms
Depressive symptoms will be assessed using the Mental Health Assessment Inventory (MHAI) depression subscore which has 6 items, and each item is rated on a 3-point Likert scale where "0" means "none of the time" and "3" means "almost all of the time." Total score on the subscale ranges from 0-36 with higher scores indicating greater symptoms of depression.
Measured: Baseline, 3 months
Secondary outcomes (2)
Experiential avoidance
Experiential avoidance will be assessed with the Multidimensional Experiential Avoidance Questionnaire (MEAQ) which is scored by summing up responses across its 62 items. Each item is rated on a 6-point Likert scale ranging from "strongly disagree" to "strongly agree". Higher scores indicate greater levels of experiential avoidance.
Measured: Baseline, 3-months
Psychological flexibility
Psychological flexibility will be assessed using the Acceptance and Actions Questionnaire (AAQ-2) which has 7 items, and each item is rated on a 7-point Likert scale where "1" means "never true" and "7" means "always true". Scores can range from 7 to 49. The higher the score, the more someone tends to avoid unwanted thoughts and feelings, signifying less psychological flexibility.
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start27 Mar 2025
- Primary completion10 Jan 2026
- Study completion10 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Karsten Lunze, MD DrPH MPH, Principal investigator, CABUSchool of Medicine, General Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06679114
- Sponsor's protocol ID
- H-45281
- Other IDs
- R34MH134077
- Acronym
- SHAWL
- Status last verified
- Jan 2026
- First submitted
- 6 Nov 2024
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Mental Disorders Among Women Internally Displaced by War in Ukraine: The SHAWL Trial
- ClinicalTrials.gov ID
- NCT06679114
- Acronym / sponsor ID
- SHAWL / H-45281
- Conditions
- Anxiety, Mental Health Disorder, War-Related Trauma, Acceptance and Commitment Therapy, Depressive Symptoms Mild to Moderate in Severity, Refugee Health
- Keywords
- Displacement, Women's health, Ukraine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 27 Mar 2025 (actual)
- Primary completion
- 10 Jan 2026 (actual)
- Study completion
- 10 Jan 2026 (actual)
- First posted
- 7 Nov 2024 (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 study is a randomized controlled trial among 120 recently displaced women to determine the effectiveness of a single-session Acceptance and Commitment Therapy (ACT) group therapy on prevention of development of mental health disorders or worsened mental health symptoms.
Detailed description
The war in Ukraine has provoked the world's current largest humanitarian displacement: since February 2022, one-third of Ukrainians have been forced to leave their homes, resulting in upwards of 7 million internally displaced persons. Estimates suggest that 60% of Ukraine's displaced persons are women, who face stressors including difficulty accessing necessary primary health and psychological care, restricted access to food and stable housing, and increased strain from separation from their social networks and additional family care responsibilities.
Early reports from Ukraine consistently describe the psychological distress that displaced women are presently experiencing. It is anticipated that nearly one in five people exposed to conflict will develop mental disorders, notably depressive and anxiety disorders. Thus, improving access to mental health prevention programs that mitigate development of mental disorders for women in Ukraine is critical.
This study will adapt a community-based Acceptance and Commitment Therapy (ACT) intervention to prevent the development symptoms of depression and anxiety among women displaced by war in Ukraine. ACT is an evidence-based approach that uses acceptance, mindfulness and behavioral change processes to improve psychological flexibility. Recently displaced women who screen positive for symptoms of depression and anxiety will be recruited. The investigators plan to adapt and evaluate a single-session ACT group intervention to limit effects of mental health distress among these displaced women.
The central hypothesis of this research is that an ACT-based intervention delivered in a humanitarian context will help displaced women in Ukraine learn skills to improve psychological flexibility, thereby decreasing symptoms of depression and anxiety and ultimately mitigating onset of mental disorders.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral: ACT Therapy | Experimental | Behavioral: Acceptance and Commitment TherapyParticipants randomized to this group will receive a single-session ACT intervention |
| Attention control | Active comparator | Behavioral: Attention controlParticipants in the control group will receive minimally enhanced usual care to receive treatment as usual enhanced by a health information group session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 or over
- Identify as a displaced woman within one year of migration
- Endorsing mild to moderate depressive symptoms (subscale score between 3 and 7) and/or anxiety symptoms (subscale score between 2 and 6) on the Mental Health Assessment Inventory (MHAI) but not exceeding the maximum score for either subscale (i.e., not exceeding 7 on the depressive symptoms subscale and not exceeding 6 on the anxiety symptoms subscale)
- Ability to provide informed consent
- Speak Ukrainian or Russian
Key exclusion criteria (3 listed)
- Diagnosis of a depressive or anxiety disorder, or symptoms necessitating urgent referral for evaluation of suicidal or homicidal ideation
- Receipt of psychiatric care for depression or anxiety in the past 5 years
- A severe medical problem that inhibits ability to participate in the trial
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 |
|---|---|---|
| Acceptance and Commitment TherapyThe single-session ACT group intervention will involve a mixture of didactic instruction, discussion, metaphors, and experiential activities. ACT activities will help women notice and accept that negative thoughts, emotions, and experiences while being displaced by war are part of migratory and post-migratory life. ACT activities will also help them identify, reorient towards, and commit to values-consistent behaviors through effective goal-setting. The single-session will be approximately 3 hours long. | Behavioural | Behavioral: ACT Therapy |
| Attention controlUsual care will be minimally enhanced by providing participants with an educational information session that provides information on health promotion. | Behavioural | Attention control |
Primary outcome
Anxiety symptoms
Time frame: Baseline, 3 months
Anxiety symptoms will be assessed using the Mental Health Assessment Inventory (MHAI) anxiety subscore which has 4 items, and each item is rated on a 3-point Likert scale where "0" means "none of the time" and "3" means "almost all of the time." Total score on the subscale ranges from 0-12 with higher scores indicating greater symptoms of anxiety.
Depressive symptoms
Time frame: Baseline, 3 months
Depressive symptoms will be assessed using the Mental Health Assessment Inventory (MHAI) depression subscore which has 6 items, and each item is rated on a 3-point Likert scale where "0" means "none of the time" and "3" means "almost all of the time." Total score on the subscale ranges from 0-36 with higher scores indicating greater symptoms of depression.
2 secondary outcomes
Experiential avoidance
Time frame: Baseline, 3-months
Psychological flexibility
Time frame: Baseline, 3 months
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 16 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
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.
Karsten Lunze, MD DrPH MPH principal investigator
CABUSchool of Medicine, General Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy in people with Anxiety and Mental Health Disorder, run by Boston Medical Center 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 5 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 16 Jan 2026. 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?
Anxiety symptoms (time frame: Baseline, 3 months). The study lists 2 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 16 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.