Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07397195

ACT for Veterans With IBD and Mental Health Challenges

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030-4211, United States

Location contact

Mackenzie L Shanahan, PhD

CONTACT

[email protected]

(713) 794-7939

Mackenzie Lynmarie Shanahan, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acceptance and Commitment Therapy

Behavioral

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

Primary outcomes

  1. Feasibility of Intervention Measure (FIM)

    Time frame: 2 week follow up

    Questionnaire evaluating patient perceptions of intervention feasibility

  2. Therapist Fidelity to Treatment

    Time frame: Immediate post-therapy assessment

    Standardized rating tool assessing therapist fidelity to treatment protocol

  3. Recruitment and Attrition Rates

    Time frame: Screening, baseline, Immediate post-therapy assessment, 2 week follow up, 3 month follow up, 6 month follow up

    Number of patients screened, approached, consented, completed treatment, and completed follow up assessment

  4. Single item assessing participant engagement in treatment as rated by therapist

    Time frame: Immediate post-therapy assessment

    Assessment of participant treatment engagement

  5. Percentage of treatment a patient completed

    Time frame: Immediate post-therapy assessment

    Assessment of participant treatment adherence

  6. Acceptability of Intervention Measure (AIM)

    Time frame: 2 week follow up

    Questionnaire evaluating patient perceptions of the acceptability of treatment

  7. Intervention Appropriateness Measure (IAM)

    Time frame: 2 week follow up

    Questionnaire evaluating patient perceptions of the appropriateness of treatment

  8. Inflammatory Bowel Disease Questionnaire (IBDQ)

    Time frame: 3 month follow up

    Questionnaire evaluating IBD-specific quality of life

  9. PROMIS-SF Social Functioning Scales

    Time frame: 3 month follow up

    Questionnaire evaluating participation in social roles, satisfaction with social roles, and social isolation

  10. PROMIS-SF Psychosocial Illness Impact

    Time frame: 3 month follow up

    Questionnaire evaluating the psychosocial impact of chronic illness

Secondary outcomes

  1. Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: 3 month follow up

    Questionnaire evaluating symptoms of anxiety

  2. Patient Health Questionnaire- 9 (PHQ-9)

    Time frame: 3 month follow up

    Questionnaire evaluating depressive symptoms

  3. PTSD Checklist for DSM-5 (PCL-5)

    Time frame: 3 month follow up

    Questionnaire evaluating symptoms of posttraumatic stress disorder

  4. Visceral Sensitivity Index (VSI)

    Time frame: 3 month follow up

    Questionnaire evaluating GI-specific anxiety

  5. Patient Reported Outcomes 2 and 3 (PRO2, PRO3)

    Time frame: 3 month follow up

    Questionnaire evaluating patient reported IBD symptoms

  6. The Brief Pain Inventory-Short Form (BPI-SF)

    Time frame: 3 month follow up

    Questionnaire evaluating pain intensity and interference

  7. Acceptance and Action Questionnaire-II (AAQ-II)

    Time frame: 3 month follow up

    Questionnaire evaluating psychological flexibility

Study contacts

Contact information is provided by the study sponsor or research team.

Mackenzie L Shanahan, PhD

CONTACT

[email protected]

(713) 794-7939

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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)

Acronym: RECLAIM

Important dates

Study start
2028
Primary completion
2030
Study completion
2032
First posted
Feb 9, 2026
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.