Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030-4211, United States
Location contact
Mackenzie L Shanahan, PhD
CONTACT
Mackenzie Lynmarie Shanahan, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07397195
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Houston, Texas, 77030-4211, United States
Mackenzie L Shanahan, PhD
CONTACT
Mackenzie Lynmarie Shanahan, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 2 week follow up
Questionnaire evaluating patient perceptions of intervention feasibility
Time frame: Immediate post-therapy assessment
Standardized rating tool assessing therapist fidelity to treatment protocol
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
Time frame: Immediate post-therapy assessment
Assessment of participant treatment engagement
Time frame: Immediate post-therapy assessment
Assessment of participant treatment adherence
Time frame: 2 week follow up
Questionnaire evaluating patient perceptions of the acceptability of treatment
Time frame: 2 week follow up
Questionnaire evaluating patient perceptions of the appropriateness of treatment
Time frame: 3 month follow up
Questionnaire evaluating IBD-specific quality of life
Time frame: 3 month follow up
Questionnaire evaluating participation in social roles, satisfaction with social roles, and social isolation
Time frame: 3 month follow up
Questionnaire evaluating the psychosocial impact of chronic illness
Time frame: 3 month follow up
Questionnaire evaluating symptoms of anxiety
Time frame: 3 month follow up
Questionnaire evaluating depressive symptoms
Time frame: 3 month follow up
Questionnaire evaluating symptoms of posttraumatic stress disorder
Time frame: 3 month follow up
Questionnaire evaluating GI-specific anxiety
Time frame: 3 month follow up
Questionnaire evaluating patient reported IBD symptoms
Time frame: 3 month follow up
Questionnaire evaluating pain intensity and interference
Time frame: 3 month follow up
Questionnaire evaluating psychological flexibility
Contact information is provided by the study sponsor or research team.
VA Office of Research and Development
Fed
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
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.
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