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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Depressive Disorder; Inflammatory Bowel Diseases; Stress Disorders, Post-Traumatic; Crohn's Disease; Ulcerative Colitis; Anxiety Disorder
• Intervention / Treatment: Behavioral: Acceptance and Commitment Therapy

Detailed Description

Nearly 80,000 Veterans have inflammatory bowel disease (Crohn's disease and ulcerative colitis; IBD). IBD is characterized by chronic inflammation of the gastrointestinal tract leading to significant pain, elimination difficulties, and functional impairment. Compounding these difficulties, nearly 50% of Veterans with IBD have comorbid depression, anxiety, and/or posttraumatic stress disorder. These comorbid conditions worsen IBD symptoms through the brain-gut axis, and lead to dramatic deficits in quality of life (QOL) and psychosocial functioning. Yet, less than 20% of patients with IBD and mental health conditions receive psychotherapy and 25-50% of psychotherapy patients drop out before clinically indicated. VA's integrated behavioral healthcare in primary and specialty care clinics increases therapy engagement and adherence, improving Veteran health and functioning. Despite this, psychogastroenterology services are underdeveloped in VA gastroenterology (GI) clinics. Moreover, no evidence-based psychotherapies have been tested in Veterans with comorbid IBD and mental health problems. It is essential to develop evidence-based psychotherapies for integrated use in GI clinics to practically increase access to care and improve the functioning and QOL of Veterans with GI conditions. Acceptance and commitment therapy (ACT) is a transdiagnostic psychotherapy that improves psychosocial functioning and QOL in patients with a variety of chronic and mental health conditions. ACT is flexibly delivered in various treatment formats, allowing providers to utilize methods that match the needs of specific populations and clinical settings. One-day ACT workshops improve access and retention while effectively and efficiently improving the psychosocial functioning of Veterans with various chronic health conditions. A pilot study of 1-day ACT for patients with IBD suggested preliminary feasibility, acceptability, and effectiveness in improving QOL. However, this pilot did not target Veterans or those with mental health conditions and was not delivered as an integrated part of GI care. This is a concern, as 1-day ACT is efficient and effective, yet is rarely used in routine clinical practice. Adapting 1-day ACT for integrated use in VA GI clinics will increase Veteran access to brief, evidence-based, rehabilitative treatment. This study aims to improve the psychosocial functioning and QOL of Veterans with comorbid IBD and mental health conditions by adapting and testing a 1-day, integrated ACT intervention, coined RECLAIM. The aims of this study are to: 1) Characterize the ACT-specific coping factors associated with psychosocial functioning and QOL in Veterans with IBD using survey and interview data to inform intervention adaptation; 2) Adapt a 1-day ACT intervention for Veterans with IBD and comorbid depressive, anxiety, and trauma disorders for integrated use in GI clinics. Pilot intervention (RECLAIM) with 10 Veterans and refine; 3) Test the feasibility and acceptability of RECLAIM with 40 Veterans with IBD and comorbid depressive, anxiety, and trauma disorders using a convergent mixed-methods design.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mackenzie L Shanahan, PhD; Phone Number: (713) 794-7939; Email: mackenzie.shanahan2@va.gov

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030-4211
      • Michael E. DeBakey VA Medical Center, Houston, TX
      • Contact: Mackenzie L Shanahan, PhD; Phone Number: (713) 794-7939; Email: mackenzie.shanahan2@va.gov
      • Principal Investigator: Mackenzie Lynmarie Shanahan, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of IBD as confirmed by the medical record
• Current diagnosis of a depressive, anxiety, or trauma-related disorder

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RECLAIM; One-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.	Behavioral: Acceptance and Commitment Therapy; 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.; Other Names: ACT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Generalized Anxiety Disorder-7 (GAD-7)	Questionnaire evaluating symptoms of anxiety	3 month follow up
Patient Health Questionnaire- 9 (PHQ-9)	Questionnaire evaluating depressive symptoms	3 month follow up
PTSD Checklist for DSM-5 (PCL-5)	Questionnaire evaluating symptoms of posttraumatic stress disorder	3 month follow up
Visceral Sensitivity Index (VSI)	Questionnaire evaluating GI-specific anxiety	3 month follow up
Patient Reported Outcomes 2 and 3 (PRO2, PRO3)	Questionnaire evaluating patient reported IBD symptoms	3 month follow up
The Brief Pain Inventory-Short Form (BPI-SF)	Questionnaire evaluating pain intensity and interference	3 month follow up
Acceptance and Action Questionnaire-II (AAQ-II)	Questionnaire evaluating psychological flexibility	3 month follow up

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Mackenzie Lynmarie Shanahan, PhD, Michael E. DeBakey VA Medical Center, Houston, TX

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2028
• Primary Completion (Estimated): January 31, 2030
• Study Completion (Estimated): June 30, 2032

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: February 2, 2026
• First Posted (Actual): February 9, 2026

Study Record Updates

• Last Update Posted (Actual): February 9, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Acceptance and Commitment Therapy; Veterans; Depressive Disorder; Stress Disorders, Post-Traumatic; Inflammatory Bowel Diseases; Anxiety Disorders
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Mood Disorders; Gastroenteritis; Colitis; Stress Disorders, Traumatic; Anxiety Disorders; Depressive Disorder; Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases; Stress Disorders, Post-Traumatic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Acceptance and Commitment Therapy
• Other Study ID Numbers: RRD9-007-25M; 1IK2RD000689-01A2 (Other Grant/Funding Number: VA Office of Research and Development)

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