A Pilot Randomized Controlled Trial of an Intervention for Adults With Depression: the eMotion Study.
2018年4月18日 更新者：University of Exeter
A Pilot Randomized Controlled Trial of a Web-based Intervention Using Behavioral Activation and Physical Activity for Adults With Depression: the eMotion Study.
Physical activity has many potential mood enhancing benefits, and may be as effective as anti-depressants and psychological therapies for treating depression and low mood.
However, getting people with depression to become more active is challenging.
Behavioural Activation (BA) is an evidenced based psychotherapeutic treatment that focuses on increasing exposure to positive environmental stimuli which could provide an effective delivery mechanism for increasing physical activity for people who are more sedentary than the general population.
The purpose of this study is to examine the feasibility of delivering a theory informed online intervention combining physical activity and BA (eMotion) to people with depression, and to examine its effects on depressive symptoms and physical activity.
調査の概要
詳細な説明
A randomised controlled trial (RCT) design will be used in this study. 120 participants experiencing depressive symptoms (>10 on the PHQ-8) over the age of 18 will be recruited from the community. Participants will be eligible to participate if the over 18, score over 10 on the PHQ-8 and, are able to walk unaided for at least 5 minutes and have access to the internet. Following baseline measures, participants will be randomised in a 1:1 ratio to the intervention or waiting list control arm and be followed up at 2 and 5 months. Those randomised to the intervention arm will receive eMotion which is comprised of a series of weekly audio visual modules designed to increase exposure to positive activities and physical activity. Main outcomes of interest include recruitment, retention, fidelity and acceptability. Baseline and follow up measures will also include the PHQ-8, and objective (GENEActvie accelerometers) and subjective (IPAQ) measures of physical activity. A parallel process evaluation will run alongside the RCT.
If effective, this intervention has the potential to improve depressive symptoms in a wide range of hard to reach people in the community and increase their physical activity. Further evaluation in a full scale RCT is planned pending results of this trial.
研究の種類
介入
入学 (実際)
62
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Devon
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Exeter、Devon、イギリス、EX1 2LU
- University of Exeter
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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年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- Adults (aged ≥18 years).
- Adults with possible mild to moderately severe depression reflected by a score of between 10 and 23 (i.e. moderate to moderately severe depressive symptoms) on the Patient Health Questionnaire (PHQ-8) as has been done in previous studies looking at low mood and depressive symptoms.
- Adults living in the UK.
- Having access to the internet.
- Able to walk continuously and unaided for a minimum of 5 minutes.
- Provision of informed consent to participate.
Exclusion Criteria:
- Adults (aged <18 years).
- Adults without possible mild to moderately severe depression reflected by a score of between 10 and 23 (i.e. moderate to moderately severe depressive symptoms) on the Patient Health Questionnaire (PHQ-8) as has been done in previous studies looking at low mood and depressive symptoms.
- Adults not living in the UK.
- No access to the internet.
- Not able to walk continuously and unaided for a minimum of 5 minutes.
- Lacking capacity to give informed consent to participate.
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：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 |
|---|---|
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実験的：eMotion intervention
Subjects randomised to the intervention arm will receive eMotion for two months.
eMotion is comprised of a series of weekly audio visual modules designed to increase exposure to positive activities and physical activity.
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eMotion is comprised of a series of weekly audio visual modules designed to increase exposure to positive activities and physical activity
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介入なし：Waiting list control
Subjects in the waiting list control group will be given no intervention for two months; the control group will then be able to access eMotion if they wish but this will not form part of the research project
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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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Depression
時間枠：Two months
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Depression will be measured using tThe Personal Health Questionnaire (PHQ-8).
The PHQ-8 is an 8 item measure used to measure the frequency of depressive symptoms.
This is a freely available brief self-report questionnaire which assesses depressive symptoms based on the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV).
Each item is rated on a scale of 0 to 3 with a maximum score of 24.
It has been shown to have good validity, reliability, sensitivity and specificity.
It has also been shown to discriminate between levels of major and major severe depression being 10-19, and 20-23 respectively (Kroenke et al., 2009)
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Two months
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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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Objective Physical Activity
時間枠：Two months
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Objective physical activity will be assessed using GeneACTIVE wrist worn accelerometers.
The accelerometer is a small wrist worn device that measures and records acceleration.
1 minute epochs will be used to measure movement, with higher counts per minute reflecting higher levels of physical activity as recommended in previous studies (Helgadóttir, Forsell, & Ekblom, 2015; Mailey et al., 2010).
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Two months
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Anxiety
時間枠：Two months
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General Anxiety Disorder (GAD-7) is a 7 item scale which measures symptoms and severity of anxiety based on the DSM-IV criteria and included in the minimum IAPT data set (Spitzer, Kroenke, Williams, & Lowe, 2006).
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Two months
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Affective Mood State
時間枠：Two months
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Ecological Momentary Assessment of Mood (EMA) will be taken using a one item 10 point scale asking the participant to rate their mood where 1 = sad and 10 = happy.
This will be taken twice per day randomly over five days during baseline data collection and at two months follow up using 'Text local', a text messaging service which allows participants to respond with a number response indicating their current mood at that point in time.
This approach is adapted from previous research (van Rijsbergen, Bockting, Berking, Koeter, & Schene, 2012).
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Two months
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Self-reported physical activity
時間枠：Two months
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Self-reported physical activity will be measured using the short-form IPAQ which measures Minutes per week of moderate to vigorous physical activity will be assessed by using the International Physical Activity Questionnaire (IPAQ).
The IPAQ is a valid cross national measure of self-reported physical activity (Craig et al., 2003).
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Two months
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Fidelity of receipt
時間枠：Two months
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The website will be assessed by asking questions understanding, perceived understanding the key learning goals for participants in all groups.
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Two months
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Fidelity of enactment
時間枠：Two months
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Fidelity of enactment will be measured by asking participants in all groups if they have carried out specific behaviour change techniques relating to physical activity, and behavioural activation along with rating confidence.
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Two months
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Participant satisfaction
時間枠：Two months
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The Client Satisfaction Questionnaire - Short Form (CSQ-SF).
This is a 4 item measure which will be used to assess participant satisfaction in eMotion 2 months post randomization.
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Two months
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Participant views of intervention
時間枠：Two months
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Qualitative interviews after the final intervention session, all participants who receive eMotion will be invited to participate in a semi structured interview over the phone.
The purpose of this is to further examine the acceptability of the intervention and any suggestions for improvement which can be absorbed into a next trial.
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Two months
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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
捜査官
- 主任研究者：Jeffrey D Lambert, MSc、University of Exeter
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。
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 (実際)
2016年5月1日
一次修了 (実際)
2017年4月15日
研究の完了 (実際)
2017年4月15日
試験登録日
最初に提出
2016年6月15日
QC基準を満たした最初の提出物
2017年3月13日
最初の投稿 (実際)
2017年3月20日
学習記録の更新
投稿された最後の更新 (実際)
2018年4月20日
QC基準を満たした最後の更新が送信されました
2018年4月18日
最終確認日
2018年4月1日
詳しくは
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