About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of IBD as confirmed by the medical record
Current diagnosis of a depressive, anxiety, or trauma-related disorder
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Acceptance and Commitment Therapy
BehavioralForm 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.
Treatment groups
Trial outcomes
Primary outcomes
Feasibility of Intervention Measure (FIM)
Questionnaire evaluating patient perceptions of intervention feasibility
Therapist Fidelity to Treatment
Standardized rating tool assessing therapist fidelity to treatment protocol
Recruitment and Attrition Rates
Number of patients screened, approached, consented, completed treatment, and completed follow up assessment
Single item assessing participant engagement in treatment as rated by therapist
Assessment of participant treatment engagement
Secondary outcomes
Generalized Anxiety Disorder-7 (GAD-7)
Questionnaire evaluating symptoms of anxiety
Patient Health Questionnaire- 9 (PHQ-9)
Questionnaire evaluating depressive symptoms
PTSD Checklist for DSM-5 (PCL-5)
Questionnaire evaluating symptoms of posttraumatic stress disorder
Visceral Sensitivity Index (VSI)
Questionnaire evaluating GI-specific anxiety
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: