Self-regulation Strategies to Improve Exercise Behavior Among Schizophrenic Patients

Schizophrenia Clinical Trial

Official title:

Self-regulation Strategies to Improve Exercise Behavior: A Randomized Clinical Trial in Persons With Schizophrenia Spectrum Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01547026
• Other study ID #: UKonstanzMichaelOdenwald2012-1
• Status: Completed
• Phase: N/A
• First received: March 3, 2012
• Last updated: February 12, 2013
• Start date: April 2012
• Est. completion date: December 2012

Study information

• Verified date: February 2013
• Source: University of Konstanz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: University of Konstanz
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mood Disorders
• Psychotic Disorders
• Schizo-affective Disorder
• Schizophrenia

Intervention

Behavioral:
• Implementation Intentions
In a 10 minute structured therapy session patients are assisted to build up implementation intentions to participate in the sports program.

Locations

Country	Name	City	State
Germany	Center for Psychiatry Reichenau	Reichenau

Sponsors (3)

Lead Sponsor	Collaborator
University of Konstanz	Center for Psychiatry, Reichenau, Germany, Thurgau Psychiatric Services, Switzerland

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Persistence	We assess whether a patient has persisted to participate in successive sports therapy session	max. 8 weeks	No
Primary	Compliance	We assess how long the individual patient participates in each therapy session (standard duration 30 min.)	max. 8 weeks	No
Secondary	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.	max. 8 weeks	No