An ACT Manual-based, Guided Self-help Intervention Pilot (ACT)
Evaluating Acceptance and Commitment Therapy as a Low-intensity, Manual-based, Guided Self-help Intervention for Anxiety and Depression: A Pilot Study
調査の概要
詳細な説明
Many patients are offered written self-help material as a stage 1 (low intensity) intervention for anxiety and/or depression, as recommended by the United Kingdom's National Institute for Clinical Excellence's pathways framework (http://pathways.nice.org.uk/).
Acceptance and Commitment Therapy (ACT) is an emerging therapy that has been shown to help patients with mild to moderate anxiety and/or depression in therapist-led individual and group treatments. However, few studies have shown how effective ACT is in the form of a low-intensity, guided self-help intervention.
This study seeks to find out whether an ACT-based manual, sent to patients with anxiety and/or depression, increases their ability to effectively manage their difficulties and improve their quality of life. Participants on a primary care mental health waiting list will be invited to take part in this study.
Eligible participants will be randomly allocated to one of two groups: the ACT intervention or waiting list as usual. Participants receiving the ACT intervention will be posted a manual and will be asked to read a chapter each week for six weeks. A member of the research team will also phone them on two occasions to support their use of the manual, trouble shoot any difficulties and provide encouragement. All participants will be asked to complete nine, short questionnaires sent through the post prior to and after six weeks of self-help.
By comparing the results the study will demonstrate whether the ACT intervention is effective compared to wait list as usual.
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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Stirlingshire
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Falkirk、Stirlingshire、イギリス、FK1 5QE
- Adult Psychology Department
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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:
- On the primary care waiting list for individual therapy
- Anxiety or depression/low mood assessed using the Depression, Anxiety and Stress Scales (DASS21). Those with mild to moderate (≥ 4 and ≤ 7) mixed anxiety (including panic, agoraphobia, obsessive compulsive disorder, generalised anxiety disorder and phobias) or depressive/low mood (including dysthymia; ≥ 5 and ≤ 10) will be included.
- For those participants presenting with both anxiety and depression, at least one must reach the minimum cut off score and neither should exceed the maximum cut-off score.
- Adequate English ability
- Able to give informed consent
Exclusion Criteria:
- High suicide risk (as indicated with a risk score of >0.3 on the Clinical Outcomes in Routine Evaluation questionnaire; CORE-34
- Participants that have been flagged at the referral meeting to receive specialised individual therapy (e.g. schema-focussed therapy)
- Medication change within the last three months*
- Currently receiving or received psychological help within the last 6 months using a Cognitive Behavioural Therapy or ACT modality (e.g. Beating the Blues, Anxiety Management Groups, Mindfulness, Individual therapy)
- Currently taking part in another research study
- Intellectual impairment (e.g. a learning disability)
Referral for a primary diagnosis, other than anxiety/depression, that would significantly over arch any work focusing on anxiety/depression even if the above criteria is met for anxiety/depression (e.g. an eating disorder whereby the stated symptoms: cognitions, physical sensations, emotions and behaviours, are orientated solely around food).
- Those individuals who have started or changed medication within the last 3 months will still be eligible to participate, but will be put on hold until this time period has elapsed. They will be informed of this and told that they may not be entered into the trial if recruitment targets are met or individual treatment becomes available (the waiting list will be reviewed at the time).
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:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:ACT Intervention Group
This group will receive an ACT self-help manual to be completed over the course of 6 weeks.
They will also receive two brief telephone calls during the reading of the manual by a member of the research team.
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A six chapter, 58 page self-help manual based on the principles of Acceptance and Commitment Therapy
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介入なし:Control Group
This group will receive no intervention
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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 |
|---|---|---|
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Change is being assessed using the Quality of Life BREF (WHOQOLBREF; Skevington et al., 2004) questionnaire
時間枠:Baseline and 6 weeks
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26-item self-report questionnaire
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Baseline and 6 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Change is being assessed using the Acceptance and Action Questionnaire II (AAQII; Bond, Hayes & Baer et. al, 2011).
時間枠:Baseline and 6 weeks
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A 7-item, unidimensional, self-report questionnaire which measures the construct of experiential avoidance/psychological inflexibility
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Baseline and 6 weeks
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Shane A Ford、National Health Service, United Kingdom
出版物と役立つリンク
一般刊行物
- Skevington SM, Lotfy M, O'Connell KA; WHOQOL Group. The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004 Mar;13(2):299-310. doi: 10.1023/B:QURE.0000018486.91360.00.
- Bond FW, Hayes SC, Baer RA, Carpenter KM, Guenole N, Orcutt HK, Waltz T, Zettle RD. Preliminary psychometric properties of the Acceptance and Action Questionnaire-II: a revised measure of psychological inflexibility and experiential avoidance. Behav Ther. 2011 Dec;42(4):676-88. doi: 10.1016/j.beth.2011.03.007. Epub 2011 May 25.
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。
ACT Intervention Groupの臨床試験
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Riphah International Universityまだ募集していません
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Riphah International Universityまだ募集していません
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University of MichiganNational Institute on Drug Abuse (NIDA)完了
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University of Southern CaliforniaNational Institutes of Health (NIH)積極的、募集していない
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Mansoura Universityまだ募集していません