Managing Stress With Inflammatory Bowel Disease
Managing Stress With Inflammatory Bowel Disease - an Open Trial of a Web-based Intervention
調査の概要
詳細な説明
Depression and anxiety are highly prevalent in IBD, with depression rates almost twice as high for those with IBD compared to the general community, and an estimated 30% overall with depression or anxiety. Perceived stress is a factor in the development of anxiety and depression. These comorbid conditions complicate management of IBD, adversely impacting patient outcomes and health, and increasing the resource burden to the health care system. However, comorbid depression and anxiety in IBD patients is undertreated, paralleling unmet mental health treatment needs in the general Canadian population. Development of alternate modes of effective treatment delivery is vital to enhance access, given limited mental health service availability. CBT has strong clinical evidence for its effectiveness in treating episodes of depression and anxiety as well as in preventing relapses. CBT may be successfully delivered as an internet-based intervention. While there are limited data on the efficacy of CBT tailored to the IBD population, studies targeting comorbid depression in IBD have resulted in significant mental health improvement. A recent study described an internet-based CBT for IBD reported modest outcomes (150), but participants were not selected to have psychiatric comorbidity and the primary outcomes were not improvement in mood or anxiety symptoms. The internet-based program used in this study will involve brief modules focused on areas important in managing stress, anxiety and depression including:
Core Topics: 1. About the Program, 2. IBD and Stress 3. Commitment to Living Life Fully, 4. The Brain-Gut Connection, 5. Understanding Anxiety, 6. Overcoming Avoidance, 7. Depression, 8. Behavioural Activation; Optional Topics: 9. Treatment Options, 10. IBD and the Workplace 11. Mindfulness
Procedures: Participants will be recruited with the use of a resources informing possible participants about the project. Patients expressing an interest in the program will receive a copy of the consent form for the study by email but asked not to sign it. They will be asked to schedule a time with the study coordinator to review with consent form, discuss any questions about the consent form or the program, and at the end to indicate verbally whether or not they provide consent. Those who provide consent will complete a brief psychiatric interview with the study coordinator to check for inclusion and exclusion criteria. The interview used will be the Mini International Neuropsychiatric Interview (MINI) for DSM5. Those who meet the inclusion criteria for the study will be sent a survey link to complete a the baseline measures for the program.Once participants are accepted into the study assessments will be completed at baseline, week 6, week 12, and during follow up at week 24.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Manitoba
-
Winnipeg、Manitoba、カナダ、R3E 0W2
- University of Manitoba - College of Medicine
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Diagnosed with inflammatory bowel disease - Crohn's disease or ulcerative colitis
- A score on a scale measuring perceived stress, anxiety or depression indicating the presence of a clinically significant problem
- Regular access to a personal computer and Internet to allow access to the program
- Ability to read and write English
Exclusion Criteria:
- Presence of significant suicidal ideation or suicidal intent within the last six months
- Presence of self-harming behavior in the last six months
- Currently active substance use disorder (last six months)
- Psychotic disorder (last six months)
- Eating disorder (last six months)
研究計画
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 |
---|---|
他の:Cognitive Behavioral Therapy
Online cognitive behavioral therapy intervention for 2 hours a week for 12 weeks.
|
cognitive behavioral therapy; focus on learning skills including acceptance and commitment
|
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 |
---|---|---|
Change in Hospital Anxiety and Depression Scale (HADS)
時間枠:Baseline, 6 weeks, 12 weeks, 24 weeks
|
scale measuring anxiety and depression (14 items); likert scale 0 (not at all) to 3 (most of the time); higher scores(summed) indicate presence of anxiety or depression
|
Baseline, 6 weeks, 12 weeks, 24 weeks
|
Change in Perceived Stress Scale 4 (PSS-4)
時間枠:Baseline, 6 weeks, 12 weeks, 24 weeks
|
scale measuring psychological stress (4 items); likert scale 0 (never) to 4 (very often); higher scores indicate higher levels of perceived stress
|
Baseline, 6 weeks, 12 weeks, 24 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Change in Patient-Reported Outcomes Measurement Information System - 29 (PROMIS-29)
時間枠:Baseline, 6 weeks, 12 weeks, 24 weeks
|
scale measuring health-related quality of life (29 items); likert scale 1 to 5, varying anchor points; in symptom oriented domains higher scores represent worse symptomology and in function oriented domains higher scores represent better functioning
|
Baseline, 6 weeks, 12 weeks, 24 weeks
|
Change in Clinical Global Impression - Improvement scale (CGI-I)
時間枠:Baseline, 6 weeks, 12 weeks, 24 weeks
|
scale measuring confidence in ability to manage stress (2 items); likert scale with varying anchor points; higher scores indicate higher stress and lower confidence
|
Baseline, 6 weeks, 12 weeks, 24 weeks
|
Change in the Work and Social Adjustment Scale (WSAS)
時間枠:Baseline, 6 weeks, 12 weeks, 24 weeks
|
scale measuring how inflammatory bowel disease impact daily functioning; likert scale 1(not at all) to 5 (very severely); higher scores indicate higher levels higher functional impairment
|
Baseline, 6 weeks, 12 weeks, 24 weeks
|
Change in Inflammatory Bowel Disease Symptom Inventory - Short Form (IBDSI)
時間枠:Baseline, 6 weeks, 12 weeks, 24 weeks
|
scale measuring symptoms of inflammatory bowel disease; likert scale with varying anchor points
|
Baseline, 6 weeks, 12 weeks, 24 weeks
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Patricia Furer, PhD、University of Manitoba
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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。
Cognitive Behavioral Therapyの臨床試験
-
University of MinnesotaNational Institute of Mental Health (NIMH)募集精神病性障害 | 統合失調症 | 統合失調症スペクトラムおよびその他の精神病性障害 | 統合失調感情障害 | 精神病 | 統合失調感情障害 | 統合失調症性障害 | 精神病、感情的 | 精神性気分障害 | 精神病患者番号/その他アメリカ
-
Douglas Mental Health University Institute募集
-
Universitätsklinikum Hamburg-EppendorfCytoSorbents, Inc募集
-
Universitätsklinikum Hamburg-Eppendorf完了