The Development of a Transdiagnostic Intervention to Improve Social Functioning and Intimate Relationships Among Veterans (ACT-SHARE)

November 18, 2025 updated by: VA Office of Research and Development
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Massachusetts
      • Bedford, Massachusetts, United States, 01730-1114
        • VA Bedford HealthCare System, Bedford, MA
        • Contact:
        • Principal Investigator:
          • Hannah Grigorian, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 PTSD and screening cutoffs for alcohol misuse (mild to severe AUD criteria met and/or above AUDIT cutoff).
  • Consents to audio recording.
  • Able to provide informed consent.
  • Consents to partner outreach if in a relationship.
  • Over 18 years of age

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Behavioral: Acceptance and Commitment Therapy for Social Health, Achievement, and Relationship Effectiveness (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).
Other Names:
  • ACT-SHARE

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Multidimensional Psychological Flexibility Inventory (MPFI)
Time Frame: Week 3, Week 12, 3-month Follow-up, 6-month Follow-up
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.
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
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.
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
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.
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
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.
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
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.
Week 3, Week 12, 3-month Follow-up, 6-month Follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hannah Grigorian, PhD, VA Bedford HealthCare System, Bedford, MA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 3, 2028

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 18, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 24, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D5027-W

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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