Self-regulation Strategies to Improve Exercise Behavior Among Schizophrenic Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Schizo-affective Disorder
• Intervention / Treatment: Behavioral: Implementation Intentions

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Reichenau, Germany, 78479
    • Center for Psychiatry Reichenau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Konstanz
• Collaborators: Center for Psychiatry, Reichenau, Germany; Thurgau Psychiatric Services, Switzerland

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: March 3, 2012
• First Submitted That Met QC Criteria: March 6, 2012
• First Posted (Estimate): March 7, 2012

Study Record Updates

• Last Update Posted (Estimate): February 13, 2013
• Last Update Submitted That Met QC Criteria: February 12, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: exercise; schizophrenia; sport; fitness; weight control
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Psychotic Disorders; Mood Disorders
• Other Study ID Numbers: UKonstanzMichaelOdenwald2012-1