Inflammatory Bowel DiseasesRECLAIMNCT07397195
ACT for Veterans With IBD and Mental Health Challenges
A study testing Acceptance and Commitment Therapy in people with Inflammatory Bowel Diseases and Crohn's Disease, run by VA Office of Research and Development at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn's Disease, Ulcerative Colitis
- What is being tested?
- Acceptance and Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2028to 30 Jun 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of IBD as confirmed by the medical record
- Current diagnosis of a depressive, anxiety, or trauma-related disorder
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030-4211
Mackenzie L Shanahan, PhD, (713) 794-7939, mackenzie.shanahan2@va.gov
Mackenzie Lynmarie Shanahan, PhD
About this study
Official title: 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)
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.
Read the 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.
- Conditions
- Inflammatory Bowel Diseases, Crohn's Disease, Ulcerative Colitis, Depressive Disorder, Anxiety Disorder, Stress Disorders, Post-Traumatic
- Being tested
- Acceptance and Commitment Therapy
- Keywords
- Acceptance and Commitment Therapy, Veterans, Inflammatory Bowel Diseases, Anxiety Disorders, Depressive Disorder, Stress Disorders, Post-Traumatic
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative, Depressive Disorder, Anxiety Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyBehavioural
Also called ACT
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Acceptance and Commitment Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Intervention Measure (FIM)
Questionnaire evaluating patient perceptions of intervention feasibility
Measured: 2 week follow up
Therapist Fidelity to Treatment
Standardized rating tool assessing therapist fidelity to treatment protocol
Measured: Immediate post-therapy assessment
Recruitment and Attrition Rates
Number of patients screened, approached, consented, completed treatment, and completed follow up assessment
Measured: Screening, baseline, Immediate post-therapy assessment, 2 week follow up, 3 month follow up, 6 month follow up
Single item assessing participant engagement in treatment as rated by therapist
Assessment of participant treatment engagement
Measured: Immediate post-therapy assessment
Percentage of treatment a patient completed
Assessment of participant treatment adherence
Measured: Immediate post-therapy assessment
Acceptability of Intervention Measure (AIM)
Questionnaire evaluating patient perceptions of the acceptability of treatment
Measured: 2 week follow up
Intervention Appropriateness Measure (IAM)
Questionnaire evaluating patient perceptions of the appropriateness of treatment
Measured: 2 week follow up
Inflammatory Bowel Disease Questionnaire (IBDQ)
Questionnaire evaluating IBD-specific quality of life
Measured: 3 month follow up
PROMIS-SF Social Functioning Scales
Questionnaire evaluating participation in social roles, satisfaction with social roles, and social isolation
Measured: 3 month follow up
PROMIS-SF Psychosocial Illness Impact
Questionnaire evaluating the psychosocial impact of chronic illness
Measured: 3 month follow up
Secondary outcomes (7)
Generalized Anxiety Disorder-7 (GAD-7)
Questionnaire evaluating symptoms of anxiety
Measured: 3 month follow up
Patient Health Questionnaire- 9 (PHQ-9)
Questionnaire evaluating depressive symptoms
Measured: 3 month follow up
PTSD Checklist for DSM-5 (PCL-5)
Questionnaire evaluating symptoms of posttraumatic stress disorder
Measured: 3 month follow up
Visceral Sensitivity Index (VSI)
Questionnaire evaluating GI-specific anxiety
Measured: 3 month follow up
Patient Reported Outcomes 2 and 3 (PRO2, PRO3)
Questionnaire evaluating patient reported IBD symptoms
Measured: 3 month follow up
The Brief Pain Inventory-Short Form (BPI-SF)
Questionnaire evaluating pain intensity and interference
Measured: 3 month follow up
Acceptance and Action Questionnaire-II (AAQ-II)
Questionnaire evaluating psychological flexibility
Measured: 3 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start1 Jan 2028 (estimated)
- Primary completion31 Jan 2030 (estimated)
- Study completion30 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Mackenzie Lynmarie Shanahan, PhD, Principal investigator, Michael E. DeBakey VA Medical Center, Houston, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07397195
- Sponsor's protocol ID
- RRD9-007-25M
- Other IDs
- 1IK2RD000689-01A2
- Acronym
- RECLAIM
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07397195
- Acronym / sponsor ID
- RECLAIM / RRD9-007-25M
- Conditions
- Inflammatory Bowel Diseases, Crohn's Disease, Ulcerative Colitis, Depressive Disorder, Anxiety Disorder, Stress Disorders, Post-Traumatic
- Keywords
- Acceptance and Commitment Therapy, Veterans, Inflammatory Bowel Diseases, Anxiety Disorders, Depressive Disorder, Stress Disorders, Post-Traumatic
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jan 2028 (estimated)
- Primary completion
- 31 Jan 2030 (estimated)
- Study completion
- 30 Jun 2032 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RECLAIM | Experimental | Behavioral: Acceptance and Commitment TherapyOne-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of IBD as confirmed by the medical record
- Current diagnosis of a depressive, anxiety, or trauma-related disorder
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment TherapyAlso: ACTForm 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. | Behavioural | RECLAIM |
Primary outcome
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
7 secondary outcomes
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: 3 month follow up
Patient Health Questionnaire- 9 (PHQ-9)
Time frame: 3 month follow up
PTSD Checklist for DSM-5 (PCL-5)
Time frame: 3 month follow up
Visceral Sensitivity Index (VSI)
Time frame: 3 month follow up
Patient Reported Outcomes 2 and 3 (PRO2, PRO3)
Time frame: 3 month follow up
The Brief Pain Inventory-Short Form (BPI-SF)
Time frame: 3 month follow up
Acceptance and Action Questionnaire-II (AAQ-II)
Time frame: 3 month follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mackenzie Lynmarie Shanahan, PhD principal investigator
Michael E. DeBakey VA Medical Center, Houston, TX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy in people with Inflammatory Bowel Diseases and Crohn's Disease, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mackenzie L Shanahan, PhD ((713) 794-7939, mackenzie.shanahan2@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Intervention Measure (FIM) (time frame: 2 week follow up). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.