Acceptance and Commitment Therapy for Inflammatory Bowel Disease

(RECLAIM Trial)

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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?

This trial aims to help Veterans with both inflammatory bowel disease (IBD) and mental health issues such as depression or anxiety. It tests a one-day therapy called Acceptance and Commitment Therapy (ACT), which teaches skills to better manage difficult thoughts and feelings. The goal is to improve daily life and emotional well-being. Veterans with IBD and a mental health diagnosis, who have not been hospitalized or undergone surgery recently, might be suitable candidates. As an unphased trial, this study offers Veterans a unique opportunity to potentially enhance their quality of life through innovative therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this therapy is safe for Veterans with IBD and mental health conditions?

Research shows that Acceptance and Commitment Therapy (ACT) is a safe and well-tolerated treatment for people with inflammatory bowel disease (IBD). Studies have found that ACT can help reduce stress, depression, and anxiety in those with IBD. In some trials, participants reported feeling better after attending ACT sessions.

An online version of ACT proved easy to use and helpful for people with IBD. This suggests that ACT is a promising option for improving mental health in people with IBD without causing harm.

Overall, ACT has shown safety for people with IBD, with no significant negative effects reported in studies. This makes it a good choice for those looking to improve their mental health along with their digestive health.12345

Why are researchers excited about this trial?

Researchers are excited about Acceptance and Commitment Therapy (ACT) for Inflammatory Bowel Disease (IBD) because it offers a fresh approach to managing the condition. Unlike traditional treatments focusing on medication to control inflammation, ACT is a psychological intervention that helps patients handle stress and emotional challenges related to IBD. This therapy empowers individuals by teaching them behavioral tools to pursue meaningful activities even when faced with difficult internal and external experiences. This method is particularly promising for Veterans with IBD and mental health issues, as it addresses the mental health challenges that often accompany chronic physical conditions.

What evidence suggests that Acceptance and Commitment Therapy might be an effective treatment for inflammatory bowel disease?

Research has shown that Acceptance and Commitment Therapy (ACT), which participants in this trial will receive, can lower stress and improve the quality of life for individuals with long-term conditions like inflammatory bowel disease (IBD). Studies have found that ACT reduces stress symptoms and helps patients manage their perception of IBD symptoms. For those with Crohn's disease, ACT has been linked to better health-related quality of life and less self-reported disease activity. One study found that a smartphone-based ACT program consistently lowered stress levels in IBD patients. Overall, ACT has demonstrated benefits in reducing mental distress and improving well-being in people with chronic diseases.46789

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+

Citations

Poster Session II - PMC - PMC - NIH

Acceptance and commitment therapy (ACT) has been shown to be beneficial in chronic disease-related psychological distress.

Acceptance and Commitment Therapy for Adults Living ...

However, ACT offers a significant added benefit for health-related quality of life and self-reported Crohn's disease activity and may be a useful adjuvant ...

The effect of Acceptance and Commitment Therapy (ACT) ...

A smartphone-based ACT intervention reduced stress in IBD patients. · Single-Case Experimental Design showed consistent stress reduction (median −2). · Findings ...

P0379 Group-Based Acceptance and Commitment Therapy in ...

This prospective effectiveness study consecutively enrolled adult outpatients with Crohn's disease (CD) and ulcerative colitis (UC).

Randomized controlled trial of an Acceptance and ...

Both groups experienced a significant decrease in stress symptoms and IBD symptom perception at T1. No significant differences were observed at follow-up for ...

Acceptance and commitment therapy for the treatment ... - PMC

Within IBD, three randomized controlled trials (RCTs) tested the impact of ACT, two of which found reductions in stress, depression, and anxiety ...

Inflammatory Bowel Diseases | Oxford Academic

This trial shows that an online ACT intervention for individuals with IBD is feasible and acceptable. Moreover, the intervention had an effect ...

Acceptance and Commitment Therapy (ACT) in ...

IBD patients are also at increased risk of illness-related psychological difficulties including body image concerns, sexual problems and reduced self-esteem.

protocol for a feasibility trial of the ACTforIBD programme

This study aims to evaluate the feasibility and preliminary efficacy of ACTforIBD to reduce psychological distress in patients with IBD.