Self-regulation Strategies to Improve Exercise Behavior Among Schizophrenic Patients
1 other identifier
interventional
42
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable schizophrenia
Started Apr 2012
Shorter than P25 for not_applicable schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2012
CompletedFirst Posted
Study publicly available on registry
March 7, 2012
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFebruary 13, 2013
February 1, 2013
6 months
March 3, 2012
February 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
percentage of sports therapy sessions attended
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
max. 8 weeks
Persistence
We assess whether a patient has persisted to participate in successive sports therapy session
max. 8 weeks
Compliance
We assess how long the individual patient participates in each therapy session (standard duration 30 min.)
max. 8 weeks
Secondary Outcomes (1)
Body Mass Index (BMI)
max. 8 weeks
Study Arms (1)
Psycho-education
ACTIVE COMPARATORPatients receive a 10 min. psycho-education on positive health effects of sports
Interventions
In a 10 minute structured therapy session patients are assisted to build up implementation intentions to participate in the sports program.
Eligibility Criteria
You may qualify if:
- schizophrenia or schizo-affective disorder
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Konstanzlead
- Center for Psychiatry, Reichenau, Germanycollaborator
- Thurgau Psychiatric Services, Switzerlandcollaborator
Study Sites (1)
Center for Psychiatry Reichenau
Reichenau, 78479, Germany
Related Publications (1)
Sailer P, Wieber F, Propster K, Stoewer S, Nischk D, Volk F, Odenwald M. A brief intervention to improve exercising in patients with schizophrenia: a controlled pilot study with mental contrasting and implementation intentions (MCII). BMC Psychiatry. 2015 Sep 3;15:211. doi: 10.1186/s12888-015-0513-y.
PMID: 26335438DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Psychologist of the Schizophrenia Research Ward
Study Record Dates
First Submitted
March 3, 2012
First Posted
March 7, 2012
Study Start
April 1, 2012
Primary Completion
October 1, 2012
Study Completion
December 1, 2012
Last Updated
February 13, 2013
Record last verified: 2013-02