Therapy Labs: To Improve Adherence in Internet Based Psychotherapy
調査の概要
状態
条件
詳細な説明
This study centers on people with mild symptoms of stress or worry. Participants are recruited by advertisement and the web. Potential participants are contacted by phone and informed about the study. Written informed consent is collected through mail from those who are interested in participating. They are asked to answer all the instruments of the study via a secure internet portal used for delivering the intervention. If they do not fulfill the exclusion criteria they are randomized to one of four conditions. When the intervention has ended participants are asked to fill out all the instruments and again at four week follow up. To find significant (p<.05) results on the primary outcome variables with estimated medium effect sizes, pair-wise comparisons, a power of .80 and allowing for 10% attrition, forty participants are needed in each condition.
The intervention used in this project will be a standard program of applied relaxation that has been used and empirically tested in previous clinical studies. Since the aim of the present project is to investigate factors that affect adherence rather than the intervention effect, the investigators will use a well tested intervention with known effects on symptoms of stress and anxiety. Previous studies have shown that self help with applied relaxation can have a positive effect on for example stress, anxiety and sleep. By providing an intervention that is beneficial, credible and relevant for people with mild symptoms of stress and anxiety it would be possible to investigate how manipulating different factors of the intervention affects the adherence. Applied relaxation will in this intervention consist of a four-week program provided via the Internet. The exact composition of the intervention will be slightly different in each condition depending on the research question, see below. The program includes four steps; tension sensitivity training, long relaxation, short relaxation and applied relaxation. Each week includes information, assignments and support via the secure internet portal.
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
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-
-
Uppsala、スウェーデン、75105
- Uppsala University
-
-
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:
- Self-reported mild to moderate symptoms of stress or worry
Exclusion Criteria:
- insufficient mastery of Swedish language
- elevated symptoms of anxiety or depression that warrant clinical care
- other medical or mental illness that need immediate clinical attention
- no daily access to computer, internet and cell phone
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
- 割り当て:ランダム化
- 介入モデル:階乗代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ:Normal presentation
Standard internet based CBT presentation.
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All the material will be presented as plain text.
|
|
実験的:Enhanced presentation
Enhanced internet CBT presentation.
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The material of the intervention is designed to be as appealing as possible with clear organization, animated presentations, ample illustrations, etc.
|
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アクティブコンパレータ:Normal support
Standard internet based CBT support.
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Participants receive semi-standardized support once a week and there will be no formal training or competence.
|
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実験的:Enhanced support
Enhanced internet CBT support.
|
Participants are offered daily support through the internet from trained therapists.
|
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 |
|---|---|
|
Number of treatment components completed
時間枠:Four weeks after treatment start
|
Four weeks after treatment start
|
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Number of behavioral prescriptions completed
時間枠:Four weeks after treatment start
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Four weeks after treatment start
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Perceived Stress Scale
時間枠:Baseline and four weeks after treatment start
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Baseline and four weeks after treatment start
|
その他の成果指標
結果測定 |
時間枠 |
|---|---|
|
Perceived Stress Scale
時間枠:Baseline and eight weeks after treatment start
|
Baseline and eight weeks after treatment start
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター:Timo Hursti, PhD、Uppsala University
出版物と役立つリンク
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 (見積もり)
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
本研究に関する用語
その他の研究ID番号
- sveal1031
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。