E-Compared-CH: Comparative Effectiveness Research on Internet-based Depression Treatment - Swiss Trial (E-COMPARED_CH)
European Comparative Effectiveness Research on Internet-based Depression Treatment - Swiss Trial
調査の概要
詳細な説明
Background
Depression is a common mental disorder with a negative impact on mental well-being, quality of life, and social and work-related functioning both in the short and longer term. Additionally, depression is associated with increased morbidity, mortality, health care utilization and health care costs. On a population level, depression is one of the most costly diseases. The economic costs of depression were estimated at €136.3 billion (EU25) in 2010 in the EU and are still rising. European health care systems face the challenge of improving access to cost-effective treatments while simultaneously working to sustain budgetary stability in times of economic austerity.
Internet-based depression treatment appears a very promising alternative to current routine depression treatment strategies. Meta-analyses have demonstrated the clinical effectiveness and potential cost-effectiveness of Internet-based treatment for depression in controlled research setting. Internet-based treatment thus has the potential to keep depression treatment affordable, as it enables mental health care providers to reach out to large populations needing depression treatment at a better cost-effectiveness than those of standard treatment as usual (TAU), but with similar levels of clinical efficacy and quality of care. The trials will be conducted in 8 European countries.
Objective
To compare the clinical and cost-effectiveness of blended CBT and TAU in secondary care
Methods
In Switzerland, a randomized-controlled trial will be carried out in secondary care, comparing the clinical and cost-effectiveness of CBT and TAU for adults with major depressive disorder (MDD). Respondents will be followed until 12 months after baseline (measures will be taken at BL, 12 weeks, 18 weeks, 6 months and 12 months).
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Bern、スイス、3014
- Department of Clinical Psychology and Psychotherapy
-
-
Zurich
-
Kilchberg、Zurich、スイス、8802
- Sanatorium Kilchberg
-
-
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:
- Being 18 years of age or older
- Meet DSM-IV diagnostic criteria for MDD confirmed by MINI International Neuropsychiatric Interview version 5.0
- Informed Consent
- Having access to a PC and Internet connection
- Having a Smartphone that is compatible with the mobile component of the intervention
- Understanding of the German language spoken and written
Exclusion Criteria
- Current high risk for suicide according to the MINI Interview section C
- Serious psychiatric co-morbidity: substance dependence, bipolar affective disorder, psychotic illness, obsessive compulsive disorder, as established at the MINI interview
- Currently receiving psychological treatment for depression
- Being unable to comprehend the spoken and written language (German)
- Not having access to a PC and fast Internet connection (i.e. broadband or comparable).
- Not having a Smartphone that is compatible with the mobile component of the intervention that is offered or not willing to carry a Smartphone during the duration of treatment
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：ランダム化
- 介入モデル：並列代入
- 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：Blended CBT
Internet based blended CBT depression treatment combines individual face-to-face cognitive behavioural therapy (CBT) with CBT delivered through an Internet based treatment platform with mobile phone components.
The core components of the CBT treatment are: (1) psychoeducation, (2) behavioural activation, (3) cognitive restructuring, and (4) relapse prevention.
|
Internet based blended CBT depression treatment combines individual face-to-face cognitive behavioural therapy (CBT) with CBT delivered through an Internet based treatment platform with mobile phone components.
The core components of the CBT treatment are: (1) psychoeducation, (2) behavioural activation, (3) cognitive restructuring, and (4) relapse prevention.
|
|
アクティブコンパレータ：Treatment as usual
Treatment as usual (TAU) is defined as the routine care that subjects receive when they are diagnosed with depression in the secondary care system.
The investigators will not interfere with treatment as usual but they will monitor carefully which health care services are utilized by usual care patients using patient records and through self-report.
|
Treatment as usual (TAU) is defined as the routine care that subjects receive when they are diagnosed with depression in the secondary care system.
The investigators will not interfere with treatment as usual but they will monitor carefully which health care services are utilized by usual care patients using patient records and through self-report.
|
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 |
時間枠 |
|---|---|
|
Patient Health Questionnaire-9 (PHQ-9)
時間枠：18 weeks
|
18 weeks
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Assessment of Quality of Life (AQoL-6D)
時間枠：Baseline, 12 weeks, 18 weeks, 6 months, and 12 months
|
Baseline, 12 weeks, 18 weeks, 6 months, and 12 months
|
|
Quick Inventory of Depressive Symptomatology Self-Report (QIDS-16-SR)
時間枠：Baseline, 12 weeks, 18 weeks, 6 months, and 12 months
|
Baseline, 12 weeks, 18 weeks, 6 months, and 12 months
|
|
MINI International Neuropsychiatric Interview (M.I.N.I; Ackenheil et al., 1999)
時間枠：Baseline, 18 weeks, and 12 months
|
Baseline, 18 weeks, and 12 months
|
|
EuroQoL (EQ-5D-5L; Herdman et al., 2011)
時間枠：Baseline, 12 weeks, 18 weeks, 6 months, and 12 months
|
Baseline, 12 weeks, 18 weeks, 6 months, and 12 months
|
|
Questionnaires on Costs Associated with Psychiatric Illness (TiC-P; Hakkaart-van Rooijen, van Straten, Donker, Tiemens, 2002)
時間枠：Baseline, 12 weeks, 18 weeks, 6 months, and 12 months
|
Baseline, 12 weeks, 18 weeks, 6 months, and 12 months
|
|
Client Satisfaction Questionnaire (CSQ-8; Nguyen, Attkinson, & Stegner, 1983)
時間枠：12 weeks, and 18 weeks
|
12 weeks, and 18 weeks
|
|
System Usability Scale (SUS; Brooke, 1996)
時間枠：12 weeks, and 18 weeks
|
12 weeks, and 18 weeks
|
|
Patient Health Questionnaire-9 (PHQ-9)
時間枠：Baseline, 12 weeks, 6 months, and 12 months
|
Baseline, 12 weeks, 6 months, and 12 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Thomas Berger, PhD、University of Bern
出版物と役立つリンク
一般刊行物
- van Genugten CR, Schuurmans J, Hoogendoorn AW, Araya R, Andersson G, Banos R, Botella C, Cerga Pashoja A, Cieslak R, Ebert DD, Garcia-Palacios A, Hazo JB, Herrero R, Holtzmann J, Kemmeren L, Kleiboer A, Krieger T, Smoktunowicz E, Titzler I, Topooco N, Urech A, Smit JH, Riper H. Examining the Theoretical Framework of Behavioral Activation for Major Depressive Disorder: Smartphone-Based Ecological Momentary Assessment Study. JMIR Ment Health. 2021 Dec 6;8(12):e32007. doi: 10.2196/32007.
- Kleiboer A, Smit J, Bosmans J, Ruwaard J, Andersson G, Topooco N, Berger T, Krieger T, Botella C, Banos R, Chevreul K, Araya R, Cerga-Pashoja A, Cieslak R, Rogala A, Vis C, Draisma S, van Schaik A, Kemmeren L, Ebert D, Berking M, Funk B, Cuijpers P, Riper H. European COMPARative Effectiveness research on blended Depression treatment versus treatment-as-usual (E-COMPARED): study protocol for a randomized controlled, non-inferiority trial in eight European countries. Trials. 2016 Aug 3;17(1):387. doi: 10.1186/s13063-016-1511-1.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
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。
うつ病性障害、メジャーの臨床試験
Blended CBTの臨床試験
-
University of Sao Paulo General HospitalLuiz Aparecido Bortolotto; Chao Lung Wen; Margarida Vieira; Miriam Harume Tsunemi; Isabela Ribeiro... と他の協力者完了高血圧、従来の治療に抵抗性 | 服薬不遵守
-
VA Office of Research and DevelopmentCorporal Michael J. Crescenz VA Medical Center募集
-
NMP Medical Research InstituteWarwick Research Services完了
-
Psychiatric Research Unit, Region Zealand, DenmarkAarhus University Hospital; University of Copenhagen; Mental Health Centre Copenhagen完了パニック障害 | うつ病、単極性 | 不安障害 社会デンマーク
-
Stony Brook UniversityNational Institute for Occupational Safety and Health (NIOSH/CDC)完了