Self-regulation Strategies to Improve Exercise Behavior Among Schizophrenic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01547026
Recruitment Status : Completed
First Posted : March 7, 2012
Last Update Posted : February 13, 2013
Center for Psychiatry, Reichenau, Germany
Thurgau Psychiatric Services, Switzerland
Information provided by (Responsible Party):
Michael Odenwald, University of Konstanz

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizo-affective Disorder Behavioral: Implementation Intentions Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Self-regulation Strategies to Improve Exercise Behavior: A Randomized Clinical Trial in Persons With Schizophrenia Spectrum Disorders
Study Start Date : April 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Psycho-education
Patients receive a 10 min. psycho-education on positive health effects of sports
Behavioral: Implementation Intentions
In a 10 minute structured therapy session patients are assisted to build up implementation intentions to participate in the sports program.

Primary Outcome Measures :
  1. percentage of sports therapy sessions attended [ Time Frame: max. 8 weeks ]
    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

  2. Persistence [ Time Frame: max. 8 weeks ]
    We assess whether a patient has persisted to participate in successive sports therapy session

  3. Compliance [ Time Frame: max. 8 weeks ]
    We assess how long the individual patient participates in each therapy session (standard duration 30 min.)

Secondary Outcome Measures :
  1. Body Mass Index (BMI) [ Time Frame: max. 8 weeks ]
    We use the routine weekly weight measurements of clinic staff to calculate changes of the BMI over the period of participation into the study.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01547026

Center for Psychiatry Reichenau
Reichenau, Germany, 78479
Sponsors and Collaborators
University of Konstanz
Center for Psychiatry, Reichenau, Germany
Thurgau Psychiatric Services, Switzerland

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Michael Odenwald, Chief Psychologist of the Schizophrenia Research Ward, University of Konstanz Identifier: NCT01547026     History of Changes
Other Study ID Numbers: UKonstanzMichaelOdenwald2012-1
First Posted: March 7, 2012    Key Record Dates
Last Update Posted: February 13, 2013
Last Verified: February 2013

Keywords provided by Michael Odenwald, University of Konstanz:
weight control

Additional relevant MeSH terms:
Mood Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders