ACT for Veterans With IBD and Mental Health Challenges
RECLAIM
Using Acceptance and Commitment Training to Promote Rehabilitation and Engagement in Values-Centered Living in Veterans Adapting to Inflammatory Bowel Disease and Mental Health Challenges (RECLAIM)
2 other identifiers
interventional
50
1 country
1
Brief Summary
Many Veterans with gastrointestinal disorders, such as inflammatory bowel disease (IBD), also have mental health conditions. IBD and mental health conditions can worsen one another through the brain-gut axis, leading to dramatic deficits in psychosocial functioning and quality of life (QOL). Yet, few Veterans with comorbid IBD and mental health conditions receive psychotherapy and no evidence-based psychotherapies have been tested in Veterans with these comorbidities. Adapting brief acceptance and commitment therapy (ACT) to the specific to the needs of these patients and embedding treatment into routine gastroenterology care may increase Veterans' access to efficient and effective rehabilitative care. This study aims to adapt and test an integrated, 1-Day ACT intervention tailored to the specific needs of Veterans with IBD and mental health conditions to improve psychosocial functioning and QOL.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2028
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2026
CompletedFirst Posted
Study publicly available on registry
February 9, 2026
CompletedStudy Start
First participant enrolled
January 1, 2028
ExpectedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2030
Study Completion
Last participant's last visit for all outcomes
June 30, 2032
February 9, 2026
February 1, 2026
2.1 years
February 2, 2026
February 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
Feasibility of Intervention Measure (FIM)
Questionnaire evaluating patient perceptions of intervention feasibility
2 week follow up
Therapist Fidelity to Treatment
Standardized rating tool assessing therapist fidelity to treatment protocol
Immediate post-therapy assessment
Recruitment and Attrition Rates
Number of patients screened, approached, consented, completed treatment, and completed follow up assessment
Screening, baseline, Immediate post-therapy assessment, 2 week follow up, 3 month follow up, 6 month follow up
Single item assessing participant engagement in treatment as rated by therapist
Assessment of participant treatment engagement
Immediate post-therapy assessment
Percentage of treatment a patient completed
Assessment of participant treatment adherence
Immediate post-therapy assessment
Acceptability of Intervention Measure (AIM)
Questionnaire evaluating patient perceptions of the acceptability of treatment
2 week follow up
Intervention Appropriateness Measure (IAM)
Questionnaire evaluating patient perceptions of the appropriateness of treatment
2 week follow up
Inflammatory Bowel Disease Questionnaire (IBDQ)
Questionnaire evaluating IBD-specific quality of life
3 month follow up
PROMIS-SF Social Functioning Scales
Questionnaire evaluating participation in social roles, satisfaction with social roles, and social isolation
3 month follow up
PROMIS-SF Psychosocial Illness Impact
Questionnaire evaluating the psychosocial impact of chronic illness
3 month follow up
Secondary Outcomes (7)
Generalized Anxiety Disorder-7 (GAD-7)
3 month follow up
Patient Health Questionnaire- 9 (PHQ-9)
3 month follow up
PTSD Checklist for DSM-5 (PCL-5)
3 month follow up
Visceral Sensitivity Index (VSI)
3 month follow up
Patient Reported Outcomes 2 and 3 (PRO2, PRO3)
3 month follow up
- +2 more secondary outcomes
Study Arms (1)
RECLAIM
EXPERIMENTALOne-day ACT group workshop tailored to the specific needs of Veterans with comorbid IBD and mental health conditions. This workshop focuses on teaching behavioral tools to help Veterans engage in values-driven behaviors when navigating difficult internal and external experiences.
Interventions
Form of cognitive behavioral therapy that focuses on increasing psychological flexibility by fostering acceptance of difficult internal experiences, augmenting engagement in values-aligned behaviors, increasing contact with the present moment, and reducing reliance on avoidant coping.
Eligibility Criteria
You may qualify if:
- Diagnosis of IBD as confirmed by the medical record
- Current diagnosis of a depressive, anxiety, or trauma-related disorder
You may not qualify if:
- Severe IBD symptoms that would prevent full participation in the study (i.e., hospitalized in the past 30 days, surgery in the past 30 days)
- Significant cognitive impairment
- Active suicidality
- Uncontrolled psychosis or bipolar disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030-4211, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mackenzie Lynmarie Shanahan, PhD
Michael E. DeBakey VA Medical Center, Houston, TX
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2026
First Posted
February 9, 2026
Study Start (Estimated)
January 1, 2028
Primary Completion (Estimated)
January 31, 2030
Study Completion (Estimated)
June 30, 2032
Last Updated
February 9, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share