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CompletedNCT01547026Updated Feb 13, 2013

Self-regulation Strategies to Improve Exercise Behavior Among Schizophrenic Patients

An interventional study of Implementation Intentions in Schizophrenia and Schizo-affective Disorder, sponsored by University of Konstanz. Completed at 1 site in Germany. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2013-02-13.

Sponsored by University of Konstanz · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Schizophrenia
  • Schizo-affective Disorder

Keywords

  • schizophrenia
  • exercise
  • sport
  • weight control
  • fitness
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 42 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

University of Konstanz is the lead sponsor of 48 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • schizophrenia or schizo-affective disorder

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
42 participants (actual)

Study arms

  • Active comparator
    Psycho-education

    Patients receive a 10 min. psycho-education on positive health effects of sports

    Behavioral: Implementation Intentions

Interventions

  • BehavioralImplementation Intentions

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: max. 8 weeks

  2. Persistence

    We assess whether a patient has persisted to participate in successive sports therapy session

    Time frame: max. 8 weeks

  3. Compliance

    We assess how long the individual patient participates in each therapy session (standard duration 30 min.)

    Time frame: max. 8 weeks

Secondary outcomes

  1. 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.

    Time frame: max. 8 weeks

07

Study locations

1 site
  • Center for Psychiatry Reichenau
    Reichenau, 78479, Germany
08

References and documents

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. PubMed 26335438 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01547026
Lead sponsor
University of Konstanz
Collaborators
Center for Psychiatry, Reichenau, Germany, Thurgau Psychiatric Services, Switzerland
Responsible party
Michael Odenwald (Chief Psychologist of the Schizophrenia Research Ward, University of Konstanz) — Principal investigator
First posted
Mar 7, 2012
Start date
Apr 2012
Primary completion
Oct 2012
Completion
Dec 2012
Last update
Feb 13, 2013

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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