ACT for Veterans With IBD and Mental Health Challenges

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Acceptance and Commitment Therapy

    Behavioral

    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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: RECLAIMExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility of Intervention Measure (FIM)

Questionnaire evaluating patient perceptions of intervention feasibility

Time frame
2 week follow up
2

Therapist Fidelity to Treatment

Standardized rating tool assessing therapist fidelity to treatment protocol

Time frame
Immediate post-therapy assessment
3

Recruitment and Attrition Rates

Number of patients screened, approached, consented, completed treatment, and completed follow up assessment

Time frame
Screening, baseline, Immediate post-therapy assessment, 2 week follow up, 3 month follow up, 6 month follow up
4

Single item assessing participant engagement in treatment as rated by therapist

Assessment of participant treatment engagement

Time frame
Immediate post-therapy assessment

Secondary outcomes

1

Generalized Anxiety Disorder-7 (GAD-7)

Questionnaire evaluating symptoms of anxiety

Time frame
3 month follow up
2

Patient Health Questionnaire- 9 (PHQ-9)

Questionnaire evaluating depressive symptoms

Time frame
3 month follow up
3

PTSD Checklist for DSM-5 (PCL-5)

Questionnaire evaluating symptoms of posttraumatic stress disorder

Time frame
3 month follow up
4

Visceral Sensitivity Index (VSI)

Questionnaire evaluating GI-specific anxiety

Time frame
3 month follow up

Other outcomes

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: