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Clinical Trials/NCT07397195
NCT07397195Not yet recruitingNot Applicable

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)

VA Office of Research and Development1 site in 1 country50 target enrollmentStarted: January 1, 2028Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
50
Locations
1
Primary Endpoint
Feasibility of Intervention Measure (FIM)

Study Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

RECLAIM

Experimental

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.

Intervention: Acceptance and Commitment Therapy (Behavioral)

Outcomes

Primary Outcomes

Feasibility of Intervention Measure (FIM)

Time Frame: 2 week follow up

Questionnaire evaluating patient perceptions of intervention feasibility

Therapist Fidelity to Treatment

Time Frame: Immediate post-therapy assessment

Standardized rating tool assessing therapist fidelity to treatment protocol

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

Single item assessing participant engagement in treatment as rated by therapist

Time Frame: Immediate post-therapy assessment

Assessment of participant treatment engagement

Percentage of treatment a patient completed

Time Frame: Immediate post-therapy assessment

Assessment of participant treatment adherence

Acceptability of Intervention Measure (AIM)

Time Frame: 2 week follow up

Questionnaire evaluating patient perceptions of the acceptability of treatment

Intervention Appropriateness Measure (IAM)

Time Frame: 2 week follow up

Questionnaire evaluating patient perceptions of the appropriateness of treatment

Inflammatory Bowel Disease Questionnaire (IBDQ)

Time Frame: 3 month follow up

Questionnaire evaluating IBD-specific quality of life

PROMIS-SF Social Functioning Scales

Time Frame: 3 month follow up

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

PROMIS-SF Psychosocial Illness Impact

Time Frame: 3 month follow up

Questionnaire evaluating the psychosocial impact of chronic illness

Secondary Outcomes

  • Generalized Anxiety Disorder-7 (GAD-7)(3 month follow up)
  • Patient Health Questionnaire- 9 (PHQ-9)(3 month follow up)
  • PTSD Checklist for DSM-5 (PCL-5)(3 month follow up)
  • Visceral Sensitivity Index (VSI)(3 month follow up)
  • Patient Reported Outcomes 2 and 3 (PRO2, PRO3)(3 month follow up)
  • The Brief Pain Inventory-Short Form (BPI-SF)(3 month follow up)
  • Acceptance and Action Questionnaire-II (AAQ-II)(3 month follow up)

Investigators

Sponsor Class
Fed
Responsible Party
Sponsor

Study Sites (1)

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