- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01547026
Self-regulation Strategies to Improve Exercise Behavior Among Schizophrenic Patients
Self-regulation Strategies to Improve Exercise Behavior: A Randomized Clinical Trial in Persons With Schizophrenia Spectrum Disorders
Patients who suffer from diseases of the schizophrenia spectrum are frequently burdened by weight gain. Sport programs have been shown to improve somatic and psychological health. However, the motivation to participate in sports therapy is usually impaired due to illness-related factors such as anhedonia and negative symptoms. Previous attempts to increase participation in sports therapy have used psycho-educational and behavioral attempts that require a lot of resources. In this study the investigators will use a brief method developed in experimental social psychology to build up implementation intentions. This method has been shown to improve psychological test performance in schizophrenia patients but has never been used in a clinical context.
In two psychiatric hospitals, in-patients with schizophrenia who have been examined by a medical doctor, for whom any medical concerns for sports therapy participation have been excluded and who declared their motivation to participate in an existing standard sports exercise program will be recruited for the study. After information on the study and signing of an informed consent patients will be randomly assigned to two treatment conditions. In the control condition, the main therapist will individually deliver a 10-minute psycho-education on the helpfulness of sports to improve the health; this will be repeated in a shorter form in the regular individual treatment sessions over the following weeks. The intervention condition will use a structured procedure of the same duration to build up implementation intentions to participate in the sports therapy. The implementation intentions will briefly be repeated and updated in the following session.
Primary outcome variables will be percentage of attended sport therapy sessions, persistence and compliance. Secondary outcome variables will be Body Mass Index. As confounding variables the investigators will assess amount of anti-psychotic medication in Chlorpromazine equivalents, negative and depressive symptoms, usual sport activities and cognitive impairments.
The investigators expect that building up implementation intentions will increase participation, persistence and compliance of the patients in the sports and exercise therapy program compared to the patients who just have received psycho-education.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Reichenau, 독일, 78479
- Center for Psychiatry Reichenau
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- schizophrenia or schizo-affective disorder
Exclusion Criteria:
- manic episode
- florid positive psychotic symptoms
- catatonic symptoms
- medical concerns for possible damage to patients health by participation in sports therapy
- patient is aggressive
- patient is suicidal
- epilepsia
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Psycho-education
Patients receive a 10 min.
psycho-education on positive health effects of sports
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In a 10 minute structured therapy session patients are assisted to build up implementation intentions to participate in the sports program.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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percentage of sports therapy sessions attended
기간: max. 8 weeks
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During a single patient's in-patient treatment, we count the number of sport therapy sessions that were attended and compute a ratio attended/offered sessions
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max. 8 weeks
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Persistence
기간: max. 8 weeks
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We assess whether a patient has persisted to participate in successive sports therapy session
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max. 8 weeks
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Compliance
기간: max. 8 weeks
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We assess how long the individual patient participates in each therapy session (standard duration 30 min.)
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max. 8 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Body Mass Index (BMI)
기간: max. 8 weeks
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We use the routine weekly weight measurements of clinic staff to calculate changes of the BMI over the period of participation into the study.
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max. 8 weeks
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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .