Alcohol ProblemsACT-SHARENCT06746727
The Development of a Transdiagnostic Intervention to Improve Social Functioning and Intimate Relationships Among Veterans
A study testing Acceptance and Commitment Therapy for Social Health, Achievement, and Relationship Effectiveness (ACT-SHARE) in people with Alcohol Problems and Post-Traumatic Stress Disorder, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Veterans seeking to improve their romantic relationships when high conflict and unhealthy dynamics (e.g., aggression) are present remain underserved within the VHA with few treatment options. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Problems, Post-Traumatic Stress Disorder
- What is being tested?
- Acceptance and Commitment Therapy for Social Health, Achievement, and Relationship Effectiveness (ACT-SHARE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2028to 30 Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Endorses at least one act of IPV in the past 3 months
- Endorses treatment goals related to improving romantic relationship functioning
- Meets DSM 5 Criteria for post-traumatic stress disorder (PTSD) and screening cutoffs for alcohol misuse (mild to severe alcohol use disorder criteria met and/or above Alcohol Use Disorders Identification Test cutoff)
- Consents to audio recording
- Able to provide informed consent
- Consents to partner outreach if in a relationship
Who cannot join
- Evidence of active psychosis or mania
- Suicidality requiring inpatient hospitalization
- Severity of active substance use requiring detoxification
- Cognitive impairment that would interfere with study participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
VA Bedford HealthCare System, Bedford, MA
Bedford, Massachusetts, 01730-1114
Paula Mroz, PhD, (781) 687-3299, paula.mroz@va.gov
Hannah Grigorian, PhD
About this study
Veterans seeking to improve their romantic relationships when high conflict and unhealthy dynamics (e.g., aggression) are present remain underserved within the VHA with few treatment options. Veterans with PTSD and alcohol misuse face compounding and overlapping barriers to intimate relationship functioning warranting tailored interventions. These Veterans may be best served through individual, Acceptance and Commitment Therapy (ACT) interventions which can both 1) improve the ability to manage challenging, internal experiences (e.g., physiological reactivity, cravings, beliefs about worth and trust) and 2) encourage participation in valued actions to improve relationship functioning. Following development and refinement, this clinical trial will pilot an evidence-based, integrated ACT intervention (ACT for Social Health, Achievement, and Relationship Effectiveness [ACT-SHARE]) to improve relationship health and safety for Veterans with PTSD alcohol misuse.
Read the detailed description
Romantic partnerships greatly impact mental and physical wellness. However, these vital relationships are frequently put at risk by behaviors which put the health and safety of relationships at risk such as high interpersonal conflict or aggression (intimate partner violence [IPV]). Veterans endorse high rates of relationship conflict which frequently include the use of physical or psychological aggression toward a partner. As a prevalent and detrimental problem, interventions are gravely needed that consider primary drivers of relationship conflict and aggression: internal emotional processes and intimate relationship functioning (e.g., intimacy, communication, conflict resolution). Intervention development holds particular importance for Veterans who have few treatment options and present with distinct risk factors. For instance, co-occurring PTSD and alcohol misuse (i.e., hazardous alcohol use or alcohol use disorder; AUD) exacerbate risk for intimate relationship dysfunction and IPV use among Veterans through overlapping processes (e.g., emotional numbing, social erosion, increased threat perception). Despite high prevalence of co-occurrence and well-defined impact on relationship functioning and IPV use risk, Veterans with PTSD and alcohol misuse are not well served by couple's interventions, IPV use treatments, or evidence-based practices for co-occurring disorders. Veterans endorsing high relationship conflict, particularly when reaching the point of IPV use, are frequently excluded from services or sent to several, distinct interventions to treat intersecting problems such as alcohol misuse and PTSD. While evidenced based interventions for PTSD and alcohol misuse show distinct promise in symptom reduction, they do not necessarily improve psychosocial functioning. Relationship health and safety interventions do not yet exist which provide tailored, individual programming. With these limitations, existing referral lines for increase likelihood for dropout and evidence higher rates of poor relationship functioning and IPV following treatment. A new intervention is needed which can provide individualized treatment for Veterans with PTSD and alcohol misuse targeting intimate relationship functioning and IPV reduction. Acceptance and Commitment Therapy (ACT) is a promising avenue for intervention development. Increasing "psychological flexibility" via ACT, or value-driven functioning in the presence of challenging internal experiences, addresses a transdiagnostic process spanning across PTSD, alcohol misuse, intimate relationship functioning, and IPV use. This five year Rehabilitation Research Development and Translation (RRDT) career development award aims to develop, refine, and pilot this individual, manualized treatment called: ACT for Social Health, Achievement, and Relationship Effectiveness (ACT-SHARE). Following Phase 1 which will develop the intervention and Phase 2 which will refine the intervention through iterative feedback, Phase 3 will pilot the adapted intervention, full trial procedures including 12-month follow-up, and training and rating procedures. Primary aims include feasibility and acceptability with exploratory aims examining change scores (relationship functioning, IPV use, PTSD symptoms, alcohol use) and candidate processes (psychological flexibility).
- Conditions
- Alcohol Problems, Post-Traumatic Stress Disorder
- Being tested
- Acceptance and Commitment Therapy for Social Health, Achievement, and Relationship Effectiveness (ACT-SHARE)
- Keywords
- Social Functioning, Intimate Partner Abuse, Post-Traumatic Stress Disorder, Alcohol Problems, Acceptance and Commitment Therapy
- Medical subject headings
- Alcohol-Related Disorders, Stress Disorders, Post-Traumatic, Social Adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment Therapy for Social Health, Achievement, and Relationship Effectiveness (ACT-SHARE)Behavioural
Also called ACT-SHARE
This single-arm intervention will pilot a new, manualized intervention adapted from existing interventions using Acceptance and Commitment Therapy (ACT) to address alcohol use, PTSD, social functioning, and IPV use. ACT for Social Health, Achievement, and Relationship Effectiveness (ACT-SHARE) aims to assist Veterans in developing skills central to psychological flexibility (e.g., acceptance, mindfulness, commitment to values-based action) to improve their relationship functioning and decrease IPV use in the presence of PTSD symptoms (e.g., anger, irritability, detachment from others) and alcohol use issues (e.g., cravings, triggers, disconnection from valued roles).
| Study group | Role | What they receive |
|---|---|---|
| ACT-SHARE | Experimental | This is a single-arm intervention with all participants assigned to receive Acceptance and Commitment Therapy for Social Health, Achievement, and Relationship Effectiveness (ACT-SHARE). ACT-SHARE has been adapted for this study from existing interventions using Acceptance and Commitment Therapy (ACT) to address alcohol use, PTSD, social functioning, and IPV use. Receives: Behavioral: Acceptance and Commitment Therapy for Social Health, Achievement, and Relationship Effectiveness (ACT-SHARE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Client Satisfaction Questionnaire (CSQ-8)
The CSQ-8 is a commonly used, 8-item measure to assess treatment satisfaction (administered at post-treatment and follow ups).
Measured: Week 12
Secondary outcomes (5)
Multidimensional Psychological Flexibility Inventory (MPFI)
The MPFI, a 30-item self-report measure, assesses psychological flexibility across 6 dimensions: present moment awareness, self as context, acceptance, contact with values, committed action, cognitive defusion; and psychological inflexibility across 6 dimensions: cognitive fusion, self as context, inaction, lack of contact with values, lack of contact with the present moment, experiential avoidance, and 2 global composite scores. The MFPI is sensitive to clinical change within interventions.
Measured: Week 3, Week 12, 3-month Follow-up, 6-month Follow-up
Interpersonal Confidence Questionnaire (ICQ)
The ICQ, a 40-item self-report measure, assesses intimate relationship functioning across 5 domains: relationship initiation, asserting displeasure, emotional disclosure, providing emotional support, and conflict management. The ICQ is a comprehensive measure of intimate relationship functioning and has demonstrated sensitivity to change in randomized controlled trials for IPV use consistent with the proposed study's follow-up points.
Measured: Week 3, Week 12, 3-month Follow-up, 6-month Follow-up
Revised Conflict Tactics Scales 2 Revised Short Form (CTS-2 SF)
20 items will assess IPV use and experience in the following domains: physical assault, sexual coercion, psychological aggression, injury, and negotiation. The CTS-2 therefore assesses both the use of violence and adaptive use of non-violent conflict resolution strategies. The CTS-2 is the gold standard for IPV assessment with well-established psychometric properties including construct, convergent, and discriminant validity. The CTS-2 was developed to assess annual and lifetime IPV rates and will be adapted to the current study to assess the past 3 months.
Measured: 3-month Follow-up, 6-month Follow-up
Alcohol Use Disorders Identification Test (AUDIT)
The AUDIT (10 items)assesses drinking frequency, quantity, intensity, dependence, tolerance, and consequences. Items are summed to receive a total score from 0-40. Higher scores indicate greater alcohol use and associated problems. Good reliability and validity have been demonstrated in empirical studies.5 The World Health Organization (WHO) defines scores 8-14 as "hazardous drinking" while scores 15 or above signal probable dependence.
Measured: Week 3, Week 12, 3-month Follow-up, 6-month Follow-up
PTSD Checklist (PCL-5)
The PCL-5 is a 20-item self-report measure of PTSD symptoms. The PCL-5 is sensitive across diagnostic dimensions of PTSD with higher scores reflecting greater severity.
Measured: Week 3, Week 12, 3-month Follow-up, 6-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 posted24 Dec 2024
- Study start3 Jul 2028 (estimated)
- Primary completion1 Apr 2030 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol ProblemsStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This single-arm intervention will pilot a new, manualized intervention adapted from existing interventions using Acceptance and Commitment Therapy (ACT) to address alcohol use, PTSD, social functioning, and IPV use. ACT for Social Health, Achievement, and Relationship Effectiveness (ACT-SHARE) aims to assist Veterans in developing skills central to psychological flexibility (e.g., acceptance, mindfulness, commitment to values-based action) to improve their relationship functioning and decrease IPV use in the presence of PTSD symptoms (e.g., anger, irritability, detachment from others) and alcohol use issues (e.g., cravings, triggers, disconnection from valued roles).
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Hannah Grigorian, PhD, Principal investigator, VA Bedford HealthCare System, Bedford, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746727
- Sponsor's protocol ID
- D5027-W
- Other IDs
- 1IK2RX005027-01A2
- Acronym
- ACT-SHARE
- Status last verified
- Oct 2026
- First submitted
- 18 Dec 2024
- Last updated
- 2 Nov 2026
- 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 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of a Transdiagnostic Intervention to Improve Social Functioning and Intimate Relationships Among Veterans
- ClinicalTrials.gov ID
- NCT06746727
- Acronym / sponsor ID
- ACT-SHARE / D5027-W
- Conditions
- Alcohol Problems, Post-Traumatic Stress Disorder
- Keywords
- Social Functioning, Intimate Partner Abuse, Post-Traumatic Stress Disorder, Alcohol Problems, Acceptance and Commitment Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 3 Jul 2028 (estimated)
- Primary completion
- 1 Apr 2030 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 24 Dec 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.
Veterans seeking to improve their romantic relationships when high conflict and unhealthy dynamics (e.g., aggression) are present remain underserved within the VHA with few treatment options. Veterans with PTSD and alcohol misuse face compounding and overlapping barriers to intimate relationship functioning warranting tailored interventions. These Veterans may be best served through individual, Acceptance and Commitment Therapy (ACT) interventions which can both 1) improve the ability to manage challenging, internal experiences (e.g., physiological reactivity, cravings, beliefs about worth and trust) and 2) encourage participation in valued actions to improve relationship functioning. Following development and refinement, this clinical trial will pilot an evidence-based, integrated ACT intervention (ACT for Social Health, Achievement, and Relationship Effectiveness [ACT-SHARE]) to improve relationship health and safety for Veterans with PTSD alcohol misuse.
Detailed description
Romantic partnerships greatly impact mental and physical wellness. However, these vital relationships are frequently put at risk by behaviors which put the health and safety of relationships at risk such as high interpersonal conflict or aggression (intimate partner violence [IPV]). Veterans endorse high rates of relationship conflict which frequently include the use of physical or psychological aggression toward a partner. As a prevalent and detrimental problem, interventions are gravely needed that consider primary drivers of relationship conflict and aggression: internal emotional processes and intimate relationship functioning (e.g., intimacy, communication, conflict resolution). Intervention development holds particular importance for Veterans who have few treatment options and present with distinct risk factors. For instance, co-occurring PTSD and alcohol misuse (i.e., hazardous alcohol use or alcohol use disorder; AUD) exacerbate risk for intimate relationship dysfunction and IPV use among Veterans through overlapping processes (e.g., emotional numbing, social erosion, increased threat perception). Despite high prevalence of co-occurrence and well-defined impact on relationship functioning and IPV use risk, Veterans with PTSD and alcohol misuse are not well served by couple's interventions, IPV use treatments, or evidence-based practices for co-occurring disorders. Veterans endorsing high relationship conflict, particularly when reaching the point of IPV use, are frequently excluded from services or sent to several, distinct interventions to treat intersecting problems such as alcohol misuse and PTSD. While evidenced based interventions for PTSD and alcohol misuse show distinct promise in symptom reduction, they do not necessarily improve psychosocial functioning. Relationship health and safety interventions do not yet exist which provide tailored, individual programming. With these limitations, existing referral lines for increase likelihood for dropout and evidence higher rates of poor relationship functioning and IPV following treatment. A new intervention is needed which can provide individualized treatment for Veterans with PTSD and alcohol misuse targeting intimate relationship functioning and IPV reduction. Acceptance and Commitment Therapy (ACT) is a promising avenue for intervention development. Increasing "psychological flexibility" via ACT, or value-driven functioning in the presence of challenging internal experiences, addresses a transdiagnostic process spanning across PTSD, alcohol misuse, intimate relationship functioning, and IPV use. This five year Rehabilitation Research Development and Translation (RRDT) career development award aims to develop, refine, and pilot this individual, manualized treatment called: ACT for Social Health, Achievement, and Relationship Effectiveness (ACT-SHARE). Following Phase 1 which will develop the intervention and Phase 2 which will refine the intervention through iterative feedback, Phase 3 will pilot the adapted intervention, full trial procedures including 12-month follow-up, and training and rating procedures. Primary aims include feasibility and acceptability with exploratory aims examining change scores (relationship functioning, IPV use, PTSD symptoms, alcohol use) and candidate processes (psychological flexibility).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This single-arm intervention will pilot a new, manualized intervention adapted from existing interventions using Acceptance and Commitment Therapy (ACT) to address alcohol use, PTSD, social functioning, and IPV use. ACT for Social Health, Achievement, and Relationship Effectiveness (ACT-SHARE) aims to assist Veterans in developing skills central to psychological flexibility (e.g., acceptance, mindfulness, commitment to values-based action) to improve their relationship functioning and decrease IPV use in the presence of PTSD symptoms (e.g., anger, irritability, detachment from others) and alcohol use issues (e.g., cravings, triggers, disconnection from valued roles).
| Arm | Type | Receives |
|---|---|---|
| ACT-SHARE | Experimental | Behavioral: Acceptance and Commitment Therapy for Social Health, Achievement, and Relationship Effectiveness (ACT-SHARE)This is a single-arm intervention with all participants assigned to receive Acceptance and Commitment Therapy for Social Health, Achievement, and Relationship Effectiveness (ACT-SHARE). ACT-SHARE has been adapted for this study from existing interventions using Acceptance and Commitment Therapy (ACT) to address alcohol use, PTSD, social functioning, and IPV use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Endorses at least one act of IPV in the past 3 months
- Endorses treatment goals related to improving romantic relationship functioning
- Meets DSM 5 Criteria for post-traumatic stress disorder (PTSD) and screening cutoffs for alcohol misuse (mild to severe alcohol use disorder criteria met and/or above Alcohol Use Disorders Identification Test cutoff)
- Consents to audio recording
- Able to provide informed consent
Key exclusion criteria (4 listed)
- Evidence of active psychosis or mania
- Suicidality requiring inpatient hospitalization
- Severity of active substance use requiring detoxification
- Cognitive impairment that would interfere with study participation
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 Therapy for Social Health, Achievement, and Relationship Effectiveness (ACT-SHARE)Also: ACT-SHAREThis single-arm intervention will pilot a new, manualized intervention adapted from existing interventions using Acceptance and Commitment Therapy (ACT) to address alcohol use, PTSD, social functioning, and IPV use. ACT for Social Health, Achievement, and Relationship Effectiveness (ACT-SHARE) aims to assist Veterans in developing skills central to psychological flexibility (e.g., acceptance, mindfulness, commitment to values-based action) to improve their relationship functioning and decrease IPV use in the presence of PTSD symptoms (e.g., anger, irritability, detachment from others) and alcohol use issues (e.g., cravings, triggers, disconnection from valued roles). | Behavioural | ACT-SHARE |
Primary outcome
Client Satisfaction Questionnaire (CSQ-8)
Time frame: Week 12
The CSQ-8 is a commonly used, 8-item measure to assess treatment satisfaction (administered at post-treatment and follow ups).
5 secondary outcomes
Multidimensional Psychological Flexibility Inventory (MPFI)
Time frame: Week 3, Week 12, 3-month Follow-up, 6-month Follow-up
Interpersonal Confidence Questionnaire (ICQ)
Time frame: Week 3, Week 12, 3-month Follow-up, 6-month Follow-up
Revised Conflict Tactics Scales 2 Revised Short Form (CTS-2 SF)
Time frame: 3-month Follow-up, 6-month Follow-up
Alcohol Use Disorders Identification Test (AUDIT)
Time frame: Week 3, Week 12, 3-month Follow-up, 6-month Follow-up
PTSD Checklist (PCL-5)
Time frame: Week 3, Week 12, 3-month Follow-up, 6-month Follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- 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.
Hannah Grigorian, PhD principal investigator
VA Bedford HealthCare System, Bedford, MA
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 for Social Health, Achievement, and Relationship Effectiveness (ACT-SHARE) in people with Alcohol Problems and Post-Traumatic Stress Disorder, run by VA Office of Research and Development at 1 site in United States.
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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 2 Nov 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hannah Grigorian, PhD ((781) 888-6962, hannah.grigorian@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Client Satisfaction Questionnaire (CSQ-8) (time frame: Week 12). 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 2 Nov 2026.