Self-regulation Strategies to Improve Exercise Behavior Among Schizophrenic Patients
Primary Purpose
Schizophrenia, Schizo-affective Disorder
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Implementation Intentions
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, exercise, sport, weight control, fitness
Eligibility Criteria
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
Sites / Locations
- Center for Psychiatry Reichenau
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
Psycho-education
Arm Description
Patients receive a 10 min. psycho-education on positive health effects of sports
Outcomes
Primary Outcome Measures
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
Persistence
We assess whether a patient has persisted to participate in successive sports therapy session
Compliance
We assess how long the individual patient participates in each therapy session (standard duration 30 min.)
Secondary Outcome Measures
Body Mass Index (BMI)
We use the routine weekly weight measurements of clinic staff to calculate changes of the BMI over the period of participation into the study.
Full Information
NCT ID
NCT01547026
First Posted
March 3, 2012
Last Updated
February 12, 2013
Sponsor
University of Konstanz
Collaborators
Center for Psychiatry, Reichenau, Germany, Thurgau Psychiatric Services, Switzerland
1. Study Identification
Unique Protocol Identification Number
NCT01547026
Brief Title
Self-regulation Strategies to Improve Exercise Behavior Among Schizophrenic Patients
Official Title
Self-regulation Strategies to Improve Exercise Behavior: A Randomized Clinical Trial in Persons With Schizophrenia Spectrum Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Konstanz
Collaborators
Center for Psychiatry, Reichenau, Germany, Thurgau Psychiatric Services, Switzerland
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizo-affective Disorder
Keywords
schizophrenia, exercise, sport, weight control, fitness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Psycho-education
Arm Type
Active Comparator
Arm Description
Patients receive a 10 min. psycho-education on positive health effects of sports
Intervention Type
Behavioral
Intervention Name(s)
Implementation Intentions
Intervention Description
In a 10 minute structured therapy session patients are assisted to build up implementation intentions to participate in the sports program.
Primary Outcome Measure Information:
Title
percentage of sports therapy sessions attended
Description
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
Time Frame
max. 8 weeks
Title
Persistence
Description
We assess whether a patient has persisted to participate in successive sports therapy session
Time Frame
max. 8 weeks
Title
Compliance
Description
We assess how long the individual patient participates in each therapy session (standard duration 30 min.)
Time Frame
max. 8 weeks
Secondary Outcome Measure Information:
Title
Body Mass Index (BMI)
Description
We use the routine weekly weight measurements of clinic staff to calculate changes of the BMI over the period of participation into the study.
Time Frame
max. 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Center for Psychiatry Reichenau
City
Reichenau
ZIP/Postal Code
78479
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
26335438
Citation
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.
Results Reference
derived
Learn more about this trial
Self-regulation Strategies to Improve Exercise Behavior Among Schizophrenic Patients
We'll reach out to this number within 24 hrs