Virtual Group Therapy for IBD Patients With Anxiety and Depression
2026年8月28日 更新者：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.
調査の概要
研究の種類
介入
入学 (推定)
16
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Lead Study Coordinator
- 電話番号：872-303-7886
- メール：Ela.Chintagunta@bsd.uchicago.edu
研究場所
-
-
Illinois
-
Chicago、Illinois、アメリカ、60637
- University of Chicago
-
コンタクト：
- Lead Study Coordinator
- 電話番号：872-303-7886
- メール：Ela.Chintagunta@bsd.uchicago.edu
-
主任研究者：
- Alyse Bedell, PhD, CST
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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
時間枠：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
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in depression
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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).
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Alyse Bedell, PhD, CST、University of Chicago
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月1日
一次修了 (推定)
2027年6月1日
研究の完了 (推定)
2027年6月1日
試験登録日
最初に提出
2026年8月24日
QC基準を満たした最初の提出物
2026年8月28日
最初の投稿 (実際)
2026年9月1日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月1日
QC基準を満たした最後の更新が送信されました
2026年8月28日
最終確認日
2026年8月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。