Acceptance and Commitment Therapy for Inflammatory Bowel Disease

(RECLAIM Trial)

ML
Overseen ByMackenzie L Shanahan, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

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Mackenzie Lynmarie Shanahan, PhD

Principal Investigator

Michael E. DeBakey VA Medical Center, Houston, TX

Are You a Good Fit for This Trial?

This trial is for Veterans with inflammatory bowel disease (IBD) such as Crohn's or Ulcerative Colitis, who also struggle with mental health issues like depression, anxiety, or PTSD. It aims to help those whose conditions affect their quality of life and are not currently receiving psychotherapy.

Inclusion Criteria

My medical records confirm I have inflammatory bowel disease (IBD).
I have been diagnosed with depression, anxiety, or a trauma-related disorder.

Exclusion Criteria

Significant cognitive impairment
Active suicidality
I have not been hospitalized or had surgery for severe IBD symptoms in the last 30 days.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

One-day ACT group workshop tailored to the specific needs of Veterans with comorbid IBD and mental health conditions

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
Multiple follow-up assessments at 2 weeks, 3 months, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Acceptance and Commitment Therapy

Trial Overview

The study tests a one-day Acceptance and Commitment Therapy (ACT) session tailored for Veterans. ACT is a type of psychotherapy that helps patients accept what is out of their control and commit to actions that improve their lives.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: RECLAIMExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+