Evaluation of an Intervention to Promote Physical Activity in Outpatients With Mental Disorders (GAF)
Evaluation of an Intervention to Promote Physical Activity in Outpatients With Mental Disorders: Motivational Determinants of Adherence, Effect on Cognitive Determinants of Physical Activity, Physical Activity, Sitting Time and Clinical Symptoms
調査の概要
詳細な説明
The Intervention program MoVo-LISA is a psychological intervention that should help participants to increase their level of physical activity for a healthy lifestyle.It contains three sessions (2 group,1 one on one) in the course of two weeks. The intervention focuses on planning and barrier management.
Participants develop activity ideas, goals and plans that enable them to integrate physical activity in their everyday routine and how to shield their motivation against barriers and difficulties.The intervention has proven to be effective with patients with pain disorders in rehabilitation.
This study examines if the intervention if effective for psychiatric outpatients as well. The intervention is compared to an active control group that receives a similar program that is focusing on a healthy diet.
Participants are recruited in the outpatient departements of three hospitals in Berlin and Brandenburg (Charité Universitätsmedizin Berlin - Departement of Psychiatry and Psychotherapy; St. Hewdig Hospital Berlin - Departement of Psychiatry; Oberhavel Hospital Brandenburg, Departement of Psychiatry) and at local psychiatrists in Berlin. Individuals are recruited by posters and flyers in the waiting areas areas or by information of their doctor. Patients can contact the researcher and are, after checked for eligibility, invited to an information event, where they get detailed information on the program and the study. After the information event, participants give written informed consent.
The intervention takes place in the outpatient departements of the three hospitals.
Clinical information about diagnoses, medication and functioning is obtained by their doctors by mail after the patients released them from confidentiality.
The study is an explorative approach to test if the program is suited for psychiatric patients. A sample size of 50 participants that complete the program is planned.
All data is collected pseudonymised to protect the identity of the patients.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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Berlin、ドイツ、10117
- Charité Universitätsmedizin Berlin - Departement of Psychiatry
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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:
- Over 18 years of Age
- Patients in one of the psychiatric outpatients or at an local psychiatrist in Berlin
- Mental illness (ICD-10: F1-F4)
- No contraindications for physical activity
- Able to understand german language
Exclusion Criteria:
- Contraindications to physical activity
- Acute suicidality
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 |
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実験的：Activity Intervention
The activity intervention is MoVo-LISA (Göhner & Fuchs, 2007).
A psychological program with two group sessions of 90 minutes and one one-on-one session of about 15 minutes.
The patients develop aims for their health, ideas, how to reach these aims through physical activity and make detailed plans, how to implement activity in their everyday routine.
Difficulties and barriers are discussed.
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アクティブコンパレータ：Healthy Diet Intervention
The healthy diet intervention is a modification of MoVo-LISA.
A psychological program with two group sessions of 90 minutes and one one-on-one session of about 15 minutes.
The patients develop aims for their health, ideas, how to reach these aims through a healthy diet and make detailed plans, how to implement a healthy diet in their everyday routine.
Difficulties and barriers are discussed.
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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 in physical activity - objective
時間枠：From baseline (T1) to 3 month after the intervention (T3)
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Physical activity is objectively measured using accelerometry (ActiGraph GT1M)
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From baseline (T1) to 3 month after the intervention (T3)
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Change in physical activity - subjective
時間枠：From baseline (T1) to 3 month after the intervention (T3)
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Physical activity is subjectively measured with the International Physical Activity Questionaire (IPAQ)
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From baseline (T1) to 3 month after the intervention (T3)
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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 in self-efficacy
時間枠：From baseline (T1) to 1 week after the intervention (T2)
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Self-efficacy is measured using two likert scaled items
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From baseline (T1) to 1 week after the intervention (T2)
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Change in intention for physical activity
時間枠：From baseline (T1) to 1 week after the intervention (T2)
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Intention for physical activity is measured using two likert scaled items
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From baseline (T1) to 1 week after the intervention (T2)
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Change in self concordance of the motivation for physical activity
時間枠：From baseline (T1) to 1 week after the intervention (T2)
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Self concordance of the motivation for physical activity is measured using the "Sport- und bewegungsbezogene Selbstkonkordanz Skala", which consists of 12 likert scaled items
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From baseline (T1) to 1 week after the intervention (T2)
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Change in outcome expectancies for physical activity
時間枠：From baseline (T1) to 1 week after the intervention (T2)
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Outcome expectancies for physical activity are measured using 6 likert scaled items
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From baseline (T1) to 1 week after the intervention (T2)
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Change in planning for physical activity
時間枠：From baseline (T1) to 1 week after the intervention (T2)
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Planning for physical activity is measured using 4 likert scaled items
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From baseline (T1) to 1 week after the intervention (T2)
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Change in barrier planning for physical activity
時間枠：From baseline (T1) to 1 week after the intervention (T2)
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Barrier planning for physical activity is measured using 4 likert scaled items
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From baseline (T1) to 1 week after the intervention (T2)
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Change in psychopathological symptoms
時間枠：From baseline (T1) to 3 month after the intervention (T3)
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Psychopathological symptoms are measured by the Symptom Checklist 27 (SCL-27)
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From baseline (T1) to 3 month after the intervention (T3)
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Change in health-related quality of life
時間枠：From baseline (T1) to 3 month after the intervention (T3)
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Health-related quality of life is measured using the Sort-Form Health Questionnaire 12 (SF-12)
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From baseline (T1) to 3 month after the intervention (T3)
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Change in dietary behavior
時間枠：From baseline (T1) to 3 month after the intervention (T3)
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Dietary behavior is measured using the Food Frequency Questionnaire (FEL)
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From baseline (T1) to 3 month after the intervention (T3)
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Change in consumption of portions of fruit and vegetable per day
時間枠：From baseline (T1) to 3 month after the intervention (T3)
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Consumption of fruit and vegetable is measured using two items asking for the number of portions of fruit and vegetable that are consumed on a regular day (a portion is defined as a hand full).
Consumption of fruit and vegetable is then added to check if the WHO recommendation of "5 a day" is met
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From baseline (T1) to 3 month after the intervention (T3)
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協力者と研究者
捜査官
- スタディディレクター：Andreas Ströhle, Prof.、Charité Universitätsmedizin Berlin - Departement of Psychiatry and Psychotherapy
- 主任研究者：Moritz B Petzold, Dipl.Psych.、Charité Universitätsmedizin Berlin - Departement of Psychiatry and Psychotherapy
出版物と役立つリンク
一般刊行物
- Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
- Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
- Hardt J, Gerbershagen HU. Cross-validation of the SCL-27: a short psychometric screening instrument for chronic pain patients. Eur J Pain. 2001;5(2):187-97. doi: 10.1053/eujp.2001.0231.
- Winkler G, Doring A. Validation of a short qualitative food frequency list used in several German large scale surveys. Z Ernahrungswiss. 1998 Sep;37(3):234-41. doi: 10.1007/pl00007377.
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
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最初の投稿 (見積もり)
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最終確認日
詳しくは
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