ACT for Veterans With IBD and Mental Health Challenges

This study is testing a type of therapy called Acceptance and Commitment Therapy (ACT) for Veterans who have inflammatory bowel disease (IBD), which includes Crohn's disease and ulcerative colitis, and also experience mental health challenges like depression or anxiety. Many Veterans with IBD also have mental health conditions, and these can make each other worse. This study aims to see if ACT, a form of cognitive behavioral therapy, can help Veterans by increasing their ability to accept difficult feelings and engage in activities that align with their values. We want to see if this therapy can be successfully offered and if therapists can deliver it consistently. The study plans to enroll 50 participants. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 50 participants. It is not specified if it is randomized or blinded.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed up at 2 weeks, 3 months, and 6 months after therapy.

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NCT07397195

ACT for Veterans With IBD and Mental Health Challenges

Not Yet Recruiting
NAAges 18+InterventionalTreatment
VA Office of Research and Development
~50 participants
Updated 2026-02-09 on ClinicalTrials.gov
What's tested:Acceptance and Commitment Therapy

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of Intervention Measure (FIM)
Measured over 2 week follow up
+9 more outcomes measured
Inflammatory Bowel Diseases
Crohn's Disease
Ulcerative Colitis
Depressive Disorder
Anxiety Disorder
Stress Disorders, Post-Traumatic
1 sites across 1 states
Texas1
  • Mackenzie Lynmarie Shanahan, PhD · PRINCIPAL_INVESTIGATOR · Michael E. DeBakey VA Medical Center, Houston, TX

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Eligibility criteria

Inclusion

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

Exclusion

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
  • Feasibility of Intervention Measure (FIM)2 week follow up

    Questionnaire evaluating patient perceptions of intervention feasibility

  • Therapist Fidelity to TreatmentImmediate post-therapy assessment

    Standardized rating tool assessing therapist fidelity to treatment protocol

  • Recruitment and Attrition RatesScreening, 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

  • Single item assessing participant engagement in treatment as rated by therapistImmediate post-therapy assessment

    Assessment of participant treatment engagement

  • Percentage of treatment a patient completedImmediate post-therapy assessment

    Assessment of participant treatment adherence

  • Acceptability of Intervention Measure (AIM)2 week follow up

    Questionnaire evaluating patient perceptions of the acceptability of treatment

  • Intervention Appropriateness Measure (IAM)2 week follow up

    Questionnaire evaluating patient perceptions of the appropriateness of treatment

  • Inflammatory Bowel Disease Questionnaire (IBDQ)3 month follow up

    Questionnaire evaluating IBD-specific quality of life

  • PROMIS-SF Social Functioning Scales3 month follow up

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

  • PROMIS-SF Psychosocial Illness Impact3 month follow up

    Questionnaire evaluating the psychosocial impact of chronic illness