Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:50 AM
Study NCT ID:
NCT07397195
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-09
First Post:
2026-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ACT for Veterans With IBD and Mental Health Challenges
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064869', 'term': 'Acceptance and Commitment Therapy'}], 'ancestors': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2028-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2032-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-02', 'studyFirstSubmitDate': '2026-02-02', 'studyFirstSubmitQcDate': '2026-02-02', 'lastUpdatePostDateStruct': {'date': '2026-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of Intervention Measure (FIM)', 'timeFrame': '2 week follow up', 'description': 'Questionnaire evaluating patient perceptions of intervention feasibility'}, {'measure': 'Therapist Fidelity to Treatment', 'timeFrame': 'Immediate post-therapy assessment', 'description': 'Standardized rating tool assessing therapist fidelity to treatment protocol'}, {'measure': 'Recruitment and Attrition Rates', 'timeFrame': 'Screening, baseline, Immediate post-therapy assessment, 2 week follow up, 3 month follow up, 6 month follow up', 'description': 'Number of patients screened, approached, consented, completed treatment, and completed follow up assessment'}, {'measure': 'Single item assessing participant engagement in treatment as rated by therapist', 'timeFrame': 'Immediate post-therapy assessment', 'description': 'Assessment of participant treatment engagement'}, {'measure': 'Percentage of treatment a patient completed', 'timeFrame': 'Immediate post-therapy assessment', 'description': 'Assessment of participant treatment adherence'}, {'measure': 'Acceptability of Intervention Measure (AIM)', 'timeFrame': '2 week follow up', 'description': 'Questionnaire evaluating patient perceptions of the acceptability of treatment'}, {'measure': 'Intervention Appropriateness Measure (IAM)', 'timeFrame': '2 week follow up', 'description': 'Questionnaire evaluating patient perceptions of the appropriateness of treatment'}, {'measure': 'Inflammatory Bowel Disease Questionnaire (IBDQ)', 'timeFrame': '3 month follow up', 'description': 'Questionnaire evaluating IBD-specific quality of life'}, {'measure': 'PROMIS-SF Social Functioning Scales', 'timeFrame': '3 month follow up', 'description': 'Questionnaire evaluating participation in social roles, satisfaction with social roles, and social isolation'}, {'measure': 'PROMIS-SF Psychosocial Illness Impact', 'timeFrame': '3 month follow up', 'description': 'Questionnaire evaluating the psychosocial impact of chronic illness'}], 'secondaryOutcomes': [{'measure': 'Generalized Anxiety Disorder-7 (GAD-7)', 'timeFrame': '3 month follow up', 'description': 'Questionnaire evaluating symptoms of anxiety'}, {'measure': 'Patient Health Questionnaire- 9 (PHQ-9)', 'timeFrame': '3 month follow up', 'description': 'Questionnaire evaluating depressive symptoms'}, {'measure': 'PTSD Checklist for DSM-5 (PCL-5)', 'timeFrame': '3 month follow up', 'description': 'Questionnaire evaluating symptoms of posttraumatic stress disorder'}, {'measure': 'Visceral Sensitivity Index (VSI)', 'timeFrame': '3 month follow up', 'description': 'Questionnaire evaluating GI-specific anxiety'}, {'measure': 'Patient Reported Outcomes 2 and 3 (PRO2, PRO3)', 'timeFrame': '3 month follow up', 'description': 'Questionnaire evaluating patient reported IBD symptoms'}, {'measure': 'The Brief Pain Inventory-Short Form (BPI-SF)', 'timeFrame': '3 month follow up', 'description': 'Questionnaire evaluating pain intensity and interference'}, {'measure': 'Acceptance and Action Questionnaire-II (AAQ-II)', 'timeFrame': '3 month follow up', 'description': 'Questionnaire evaluating psychological flexibility'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acceptance and Commitment Therapy', 'Veterans', 'Inflammatory Bowel Diseases', 'Anxiety Disorders', 'Depressive Disorder', 'Stress Disorders, Post-Traumatic'], 'conditions': ['Inflammatory Bowel Diseases', "Crohn's Disease", 'Ulcerative Colitis', 'Depressive Disorder', 'Anxiety Disorder', 'Stress Disorders, Post-Traumatic']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of IBD as confirmed by the medical record\n* Current diagnosis of a depressive, anxiety, or trauma-related disorder\n\nExclusion Criteria:\n\n* 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)\n* Significant cognitive impairment\n* Active suicidality\n* Uncontrolled psychosis or bipolar disorder'}, 'identificationModule': {'nctId': 'NCT07397195', 'acronym': 'RECLAIM', 'briefTitle': 'ACT for Veterans With IBD and Mental Health Challenges', 'organization': {'class': 'FED', 'fullName': 'VA Office of Research and Development'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'RRD9-007-25M'}, 'secondaryIdInfos': [{'id': '1IK2RD000689-01A2', 'type': 'OTHER_GRANT', 'domain': 'VA Office of Research and Development'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RECLAIM', 'description': '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.', 'interventionNames': ['Behavioral: Acceptance and Commitment Therapy']}], 'interventions': [{'name': 'Acceptance and Commitment Therapy', 'type': 'BEHAVIORAL', 'otherNames': ['ACT'], 'description': '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.', 'armGroupLabels': ['RECLAIM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030-4211', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Mackenzie L Shanahan, PhD', 'role': 'CONTACT', 'email': 'mackenzie.shanahan2@va.gov', 'phone': '(713) 794-7939'}, {'name': 'Mackenzie Lynmarie Shanahan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Michael E. DeBakey VA Medical Center, Houston, TX', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Mackenzie L Shanahan, PhD', 'role': 'CONTACT', 'email': 'mackenzie.shanahan2@va.gov', 'phone': '(713) 794-7939'}], 'overallOfficials': [{'name': 'Mackenzie Lynmarie Shanahan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Michael E. DeBakey VA Medical Center, Houston, TX'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Office of Research and Development', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}