Virtual Group Therapy for IBD Patients With Anxiety and Depression
2026년 8월 28일 업데이트: University of Chicago
Group-based Virtual Psychotherapy Intervention for Anxiety and Depression in Patients With Inflammatory Bowel Disease
This study is being done to better understand the complex relationship between mental health and Inflammatory Bowel Disease (IBD), with a particular focus on symptoms of depression and anxiety. While depression and anxiety have traditionally been viewed as reactions to the burden of living with IBD, new research suggests that the biological factors involved in IBD may also contribute directly to these mental health challenges. This study aims to evaluate whether a virtual, group-based psychological treatment is both acceptable and feasible for patients with IBD who experience significant depression and/or anxiety. Researchers will also evaluate participants' depression, generalized anxiety, and associated psychosocial factors (poor sleep quality, GI-specific anxiety, fatigue) before, during, and after treatment. Finally, researchers will evaluate disease severity as it relates to mental health status by comparing it to symptoms, biochemical disease and tryptophan metabolites from blood and stool samples.
People who agree to join the study will be asked to attend three in-person visits and 10 virtual group psychotherapy sessions over 11 weeks. Participants will be asked to complete questionnaires, give stool and blood samples, and the research team will collect information about participations from medical records.
연구 개요
상태
상태
아직 모집하지 않음
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
중재적
등록 (추정된)
등록
16
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Lead Study Coordinator
- 전화번호: 872-303-7886
- 이메일: Ela.Chintagunta@bsd.uchicago.edu
연구 장소
-
-
Illinois
-
Chicago, Illinois, 미국, 60637
- University of Chicago
-
연락하다:
- Lead Study Coordinator
- 전화번호: 872-303-7886
- 이메일: Ela.Chintagunta@bsd.uchicago.edu
-
수석 연구원:
- Alyse Bedell, PhD, CST
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- 18+ years of age
- Patients with Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis)
- English-speaking
- Patients with score ≥10 on General Anxiety Disorder-7 (GAD-7) questionnaire (considered moderate or higher anxiety symptoms) or ≥10 on the Patient Health Questionnaire-9 (PHQ-9) (considered moderate or higher depressive symptoms) within 3 months
- Able to provide written consent
Exclusion Criteria:
- Unwilling and/or unable to participate
- Non-English speakers
- Unable to understand the instructions or to consent to participation in the study, including patients with a diagnosed cognitive impairment
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
1
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Patients with IBD who self-report moderate or higher anxiety or depression symptoms
|
Participants will engage in a course of ten, 120-minute sessions of group psychotherapy.
The intervention will be guided by the Mind Over Mood treatment manual.
Mind Over Mood is a manual that is published and commonly used to treat depression and anxiety as guided by a therapist and for self-help.
For this study, the manual will be adapted for patients with IBD.
Session content will include interventions such as psychoeducation on the brain-gut connection and the CBT model, behavioral activation and activity scheduling, cognitive monitoring and restructuring, development of behavioral experiments to test underlying assumptions, building acceptance and gratitude, and maintenance of gains and relapse prevention.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Determine acceptability of a 10-session, group-based, virtual treatment guided by the Mind over Mood treatment manual in patients with IBD with clinically significant depression and/or anxiety
기간: End of intervention at week 10
|
Acceptability will be assessed using the Client Satisfaction Questionnaire-4 (CSQ-4), which is used to measure overall satisfaction and client self-efficacy in healthcare, mental health, and social programs.
Scores range from 4-16, with higher scores indicating higher satisfaction with the treatment.
CSQ-4 scores are commonly classified as "low satisfaction/dissatisfaction" (4-8), "moderate/neutral satisfaction" (9-12), and "high satisfaction" (13-16).
|
End of intervention at week 10
|
|
Determine feasibility of a 10-session, group-based, virtual treatment guided by the Mind over Mood treatment manual in patients with IBD with clinically significant depression and/or anxiety
기간: End of treatment at 10 weeks
|
Feasibility will be assessed by analyzing recruitment and retention (i.e., number of patients who are referred that enroll in the study and complete treatment)
|
End of treatment at 10 weeks
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in depression
기간: Before, during, and after treatment (weeks 0, 5, and 10).
|
Measured via Patient Health Questionnaire-9 (PHQ-9), a 9-item self-report tool used to screen, diagnose, and measure the severity of depression in clinical settings.
It scores depressive symptoms experienced over the past two weeks on a scale from 0 to 27, with higher scores indicating more severe symptoms.
Scores are commonly classified as "minimal or no depression" (0-4), "mild depression" (5-9), "moderate depression" (10-14), "moderately severe depression" (15-19), and "severe depression" (20-27).
|
Before, during, and after treatment (weeks 0, 5, and 10).
|
|
Change in anxiety
기간: Before, during, and after treatment (weeks 0, 5, and 10).
|
Measured via Generalized Anxiety Disorder-7 (GAD-7), a 7-item self-report tool used to screen for anxiety and measure its severity over the past two weeks.
Scores range from 0-21, with higher numbers indicating more severe symptoms.
GAD-7 scores are commonly classified as "minimal anxiety" (0-4), "mild anxiety" (5-9), "moderate anxiety" (10-14), and "severe anxiety" (15-21).
|
Before, during, and after treatment (weeks 0, 5, and 10).
|
|
Change in fatigue
기간: Before, during, and after treatment (weeks 0, 5, and 10).
|
Measured via Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), 13-item tool that measures tiredness and how it affects daily life over the past 7 days.
Scores range from 0-52, with higher numbers indicating less fatigue.
FACIT-Fatigue scores are commonly classified as "severe fatigue" (0-21), "moderate fatigue" (22-30), "mild fatigue" (31-40), and "little to no fatigue" (40-52).
|
Before, during, and after treatment (weeks 0, 5, and 10).
|
|
Change in sleep quality
기간: Before, during, and after treatment (weeks 0, 5, and 10).
|
Measured via Pittsburgh Sleep Quality Index (PSQI), 19-item self-report questionnaire that evaluates subjective sleep quality and disturbances over a one-month time period.
Scores range from 0-21, with higher numbers indicating worse sleep quality.
PSQI scores are commonly classified as "good sleep quality" (0-5) and "poor sleep quality" (6-21).
|
Before, during, and after treatment (weeks 0, 5, and 10).
|
|
Change in gastrointestinal symptom-specific anxiety (GSA)
기간: Before, during, and after treatment (weeks 0, 5, and 10).
|
Measured via Visceral Sensitivity Index (VSI), a 15-item self-report questionnaire that evaluates GSA, including fear, hypervigilance, and avoidance of belly sensations.
Scores range from 0-75, with higher numbers indicating worse GSA.
|
Before, during, and after treatment (weeks 0, 5, and 10).
|
|
Change in clinical IBD outcomes (CD)
기간: Before, during, and after treatment (weeks 0, 5, and 10).
|
Measured for patients with CD via change in scores on the Harvey Bradshaw Index (HBI), a clinical tool used to measure the severity of CD based on five patient symptoms from the previous day.
Scores range from 0-16 and up, with higher numbers indicating more severe disease activity.
HBI scores are commonly classified as "clinical remission" (0-4), "mild disease activity" (5-7), "moderate disease activity" (8-16), and "severe disease activity" (16 or more).
|
Before, during, and after treatment (weeks 0, 5, and 10).
|
|
Change in clinical IBD outcomes (UC)
기간: Before, during, and after treatment (weeks 0, 5, and 10).
|
Measured for patients with UC via change in scores on the Simple Clinical Colitis Activity Index (SCCAI), a clinical tool used to measure the severity of UC.
Scores range from 0-5 and up, with higher numbers indicating more severe disease activity.
UC scores are commonly classified as "clinical remission" (0-2), "mild disease activity" (3-4), and "active flare or relapse" (5 or more).
|
Before, during, and after treatment (weeks 0, 5, and 10).
|
|
Change in biomedical IBD outcomes
기간: Before, during, and after treatment (weeks 0, 5, and 10).
|
Change in biochemical inflammation measured by fecal calprotectin and c-reactive protein levels.
|
Before, during, and after treatment (weeks 0, 5, and 10).
|
|
Change in targeted metabolites including compounds from tryptophan metabolism
기간: Before, during, and after treatment (weeks 0, 5, and 10).
|
Change in untargeted metabolite levels
|
Before, during, and after treatment (weeks 0, 5, and 10).
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
협력자
수사관
수사관
- 수석 연구원: Alyse Bedell, PhD, CST, University of Chicago
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
연구 시작
2026년 9월 1일
기본 완료 (추정된)
기본 완료
2027년 6월 1일
연구 완료 (추정된)
연구 완료
2027년 6월 1일
연구 등록 날짜
최초 제출
최초 제출
2026년 8월 24일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 8월 28일
처음 게시됨 (실제)
처음 게시됨
2026년 9월 1일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 9월 1일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 28일
마지막으로 확인됨
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- IRB26-0657
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .