Internet-based Cognitive Behavior Therapy for Stress Disorders: a Randomized Trial
2019年12月13日 更新者：Erik Hedman、Karolinska Institutet
Stress disorders in form of adjustment disorder and burnout syndrom are highly prevalent and cause substantial suffering.
Prior evidence suggest that these disorders may be effectively treated with cognitive behavior therapy (CBT), but access to psychological treatment is limited.
One possible solution is to provide therapy via the Internet, which has been shown to be effective for anxiety disorders and depression.
In the present study, we will investigate the efficacy of Internet-based CBT (ICBT) for adjustment disorders and burnout syndrom in a randomized controlled trial (N=100).
Participants will be randomized to active treatment (n=50) or a control condition on waiting list.
調査の概要
詳細な説明
Stress disorders in form of adjustment disorder and burnout syndrom are highly prevalent and cause substantial suffering.
Prior evidence suggest that these disorders may be effectively treated with cognitive behavior therapy (CBT), but access to psychological treatment is limited.
One possible solution is to provide therapy via the Internet, which has been shown to be effective for anxiety disorders and depression.
Internet-based CBT can be described as online bibliotherapy with therapist support via a secure messaging system.
In this study psychologists will deliver the treatment.
We will investigate the efficacy of Internet-based CBT (ICBT) for adjustment disorder and burnout syndrom in a randomized controlled trial (N=100).
Participants will be randomized to active treatment (n=50) or a control condition on waiting list.
We expect that participants who receive ICBT will make superior improvements compared to the control condition on measures of stress, burnout, depressive symptoms, general anxiety and general functioning.
研究の種類
介入
入学 (実際)
100
段階
- 適用できない
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
18年～65年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
To be included in the study participants must be between 18 and 65 years of age and suffer from primary stress-related disorders by meeting diagnostic criteria for adjustment disorder or burnout syndrome. Participants must have access to a computer and to the Internet, as well as being able to write and write in Swedish.
Exclusion Criteria:
Exclusion criteria include (a) meeting the criteria for another axis-1 diagnosis that is assessed to be the primary area of difficulty, (b) suffering from substance abuse/dependence in the past 6 months, (c) suffering from current or past psychosis or bipolar disorder, (d) moderate to high suicide risk, (e) initiated or changed pharmachological treatment for depression or anxiety in the past month and (f) other on-going psychological treatment for stress-related difficulties, and (g) not having received CBT for stress-related ill-health in the past year.
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：ランダム化
- 介入モデル：並列代入
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Active treatment, Internet-based CBT
Internet-based treatment with therapist support using an asynchronous messaging system.
The treatment is comprised of 12 modules (similar to chapters) and the treatment is 12 weeks long.
The treatment is based on cognitive behavior therapy.
Participants will be stratified based on diagnosis, i.e. adjustment disorder and burnout.
|
Internet-based treatment with therapist support using an asynchronous messaging system.
The treatment is comprised of 12 modules (similar to chapters) and the treatment is 12 weeks long.
The treatment is based on cognitive behavior therapy
|
|
介入なし：Waiting list control
The control condition is a waiting list.
Participants in this arm receive no active treatment.
After 12 weeks on waiting list, participants are crossed over to treatment.
|
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 Perceived stress scale (PSS)
時間枠：baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
|
Change in PSS at post-treatment and follow-up compared to baseline
|
baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Shirlom Melamed Burnout Questionnaire (SMBQ)
時間枠：baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
|
Change in SMBQ at post-treatment and follow-up compared to baseline
|
baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
|
|
Insomnia Severity Index (IS)
時間枠：baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
|
Change in ISI at post-treatment and follow-up compared to baseline
|
baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
|
|
Generalized AnxietyDisorder-7 (GAD-7)
時間枠：baseline, post-treatment (12 weeks), 6 month follow-up
|
Change in GAD-7 at post-treatment and follow-up compared to baseline
|
baseline, post-treatment (12 weeks), 6 month follow-up
|
|
Physical Health Questionnaire-15 (PHQ-15)
時間枠：baseline, post-treatment (12 weeks), 6 month follow-up
|
Change in PHQ-15 at post-treatment and follow-up compared to baseline
|
baseline, post-treatment (12 weeks), 6 month follow-up
|
|
Montgomery Åsberg Depression Rating Scale - self-rated (MADRS-S)
時間枠：baseline, post-treatment (12 weeks), 6 month follow-up
|
Change in MADRS-S at post-treatment and follow-up compared to baseline
|
baseline, post-treatment (12 weeks), 6 month follow-up
|
|
Self-rated health (SRH)
時間枠：baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
|
Change in SRH at post-treatment and follow-up compared to baseline
|
baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
|
|
Work Ability Index (WAI)
時間枠：baseline, post-treatment (12 weeks), 6 month follow-up
|
Change in WAI at post-treatment and follow-up compared to baseline
|
baseline, post-treatment (12 weeks), 6 month follow-up
|
|
Euroqol 5 dimensions (EQ5D)
時間枠：baseline, post-treatment (12 weeks), 6 month follow-up
|
Change in EQ5D at post-treatment and follow-up compared to baseline
|
baseline, post-treatment (12 weeks), 6 month follow-up
|
|
Brunnsviken Brief Quality of life inventory (BBQ)
時間枠：baseline, post-treatment (12 weeks), 6 month follow-up
|
Change in BBQ at post-treatment and follow-up compared to baseline
|
baseline, post-treatment (12 weeks), 6 month follow-up
|
|
World Health Organization Disability Assessment Schedule (WHODAS)
時間枠：baseline, post-treatment (12 weeks), 6 month follow-up
|
Change in WHODAS at post-treatment and follow-up compared to baseline.
|
baseline, post-treatment (12 weeks), 6 month follow-up
|
|
Alcohol Disorders Identification Test (AUDIT)
時間枠：Baseline
|
This instrument will be used for screening purpose only
|
Baseline
|
|
Sickness questionnaire state (SQ)
時間枠：baseline, post-treatment (12 weeks), 6 month follow-up
|
Change in SQ at post-treatment and follow-up compared to baseline
|
baseline, post-treatment (12 weeks), 6 month follow-up
|
|
Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P) Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)
時間枠：baseline, post-treatment (12 weeks), 6 month follow-up
|
Change in TIC-P at post-treatment and follow-up compared to baseline
|
baseline, post-treatment (12 weeks), 6 month follow-up
|
|
Karolinska Sleep Questionnaire (KSQ)
時間枠：baseline, post-treatment (12 weeks), 6 month follow-up
|
Change in KSQ at post-treatment and follow-up compared to baseline
|
baseline, post-treatment (12 weeks), 6 month follow-up
|
|
Client Satisfaction Questionnaire (CSQ)
時間枠：Post-treatment (12 weeks)
|
Mean and standard deviations will be presented
|
Post-treatment (12 weeks)
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Credibility Scale (C-scale)
時間枠：Week 2 and week 8
|
Measures treatment credibility.
Mean scores and standard deviations will be presented
|
Week 2 and week 8
|
|
Change in Putative mediators
時間枠：week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
|
week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
|
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
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Lindsater E, Axelsson E, Salomonsson S, Santoft F, Ljotsson B, Akerstedt T, Lekander M, Hedman-Lagerlof E. Cost-Effectiveness of Therapist-Guided Internet-Based Cognitive Behavioral Therapy for Stress-Related Disorders: Secondary Analysis of a Randomized Controlled Trial. J Med Internet Res. 2019 Sep 13;21(9):e14675. doi: 10.2196/14675.
- Lindsater E, Axelsson E, Salomonsson S, Santoft F, Ejeby K, Ljotsson B, Akerstedt T, Lekander M, Hedman-Lagerlof E. Internet-Based Cognitive Behavioral Therapy for Chronic Stress: A Randomized Controlled Trial. Psychother Psychosom. 2018;87(5):296-305. doi: 10.1159/000490742. Epub 2018 Jul 24.
- Axelsson E, Lindsater E, Ljotsson B, Andersson E, Hedman-Lagerlof E. The 12-item Self-Report World Health Organization Disability Assessment Schedule (WHODAS) 2.0 Administered Via the Internet to Individuals With Anxiety and Stress Disorders: A Psychometric Investigation Based on Data From Two Clinical Trials. JMIR Ment Health. 2017 Dec 8;4(4):e58. doi: 10.2196/mental.7497.
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
2015年10月1日
一次修了 (実際)
2017年10月1日
研究の完了 (実際)
2017年10月1日
試験登録日
最初に提出
2015年9月1日
QC基準を満たした最初の提出物
2015年9月2日
最初の投稿 (見積もり)
2015年9月3日
学習記録の更新
投稿された最後の更新 (実際)
2019年12月16日
QC基準を満たした最後の更新が送信されました
2019年12月13日
最終確認日
2019年12月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- ICBT for stress
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。
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