Self-regulation Strategies to Improve Exercise Behavior Among Schizophrenic Patients

This study has been completed.
Sponsor:
Collaborators:
Center for Psychiatry, Reichenau, Germany
Thurgau Psychiatric Services, Switzerland
Information provided by (Responsible Party):
Michael Odenwald, University of Konstanz
ClinicalTrials.gov Identifier:
NCT01547026
First received: March 3, 2012
Last updated: February 12, 2013
Last verified: February 2013
  Purpose

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 Intervention
Schizophrenia
Schizo-affective Disorder
Behavioral: Implementation Intentions

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Self-regulation Strategies to Improve Exercise Behavior: A Randomized Clinical Trial in Persons With Schizophrenia Spectrum Disorders

Resource links provided by NLM:


Further study details as provided by University of Konstanz:

Primary Outcome Measures:
  • percentage of sports therapy sessions attended [ Time Frame: max. 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: max. 8 weeks ] [ Designated as safety issue: No ]
    We assess whether a patient has persisted to participate in successive sports therapy session

  • Compliance [ Time Frame: max. 8 weeks ] [ Designated as safety issue: No ]
    We assess how long the individual patient participates in each therapy session (standard duration 30 min.)


Secondary Outcome Measures:
  • Body Mass Index (BMI) [ Time Frame: max. 8 weeks ] [ Designated as safety issue: No ]
    We use the routine weekly weight measurements of clinic staff to calculate changes of the BMI over the period of participation into the study.


Enrollment: 42
Study Start Date: April 2012
Study Completion Date: December 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01547026

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

No publications provided

Responsible Party: Michael Odenwald, Chief Psychologist of the Schizophrenia Research Ward, University of Konstanz
ClinicalTrials.gov Identifier: NCT01547026     History of Changes
Other Study ID Numbers: UKonstanzMichaelOdenwald2012-1
Study First Received: March 3, 2012
Last Updated: February 12, 2013
Health Authority: Germany: University of Konstanz

Keywords provided by University of Konstanz:
schizophrenia
exercise
sport
weight control
fitness

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Mood Disorders
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on August 19, 2014