NCT01547026

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable schizophrenia

Timeline
Completed

Started Apr 2012

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 7, 2012

Completed
25 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

February 13, 2013

Status Verified

February 1, 2013

Enrollment Period

6 months

First QC Date

March 3, 2012

Last Update Submit

February 12, 2013

Conditions

Keywords

schizophreniaexercisesportweight controlfitness

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Body Mass Index (BMI)

    max. 8 weeks

Study Arms (1)

Psycho-education

ACTIVE COMPARATOR

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

Behavioral: Implementation Intentions

Interventions

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

Psycho-education

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • schizophrenia or schizo-affective disorder

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Psychiatry Reichenau

Reichenau, 78479, Germany

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersMotor Activity

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Psychologist of the Schizophrenia Research Ward

Study Record Dates

First Submitted

March 3, 2012

First Posted

March 7, 2012

Study Start

April 1, 2012

Primary Completion

October 1, 2012

Study Completion

December 1, 2012

Last Updated

February 13, 2013

Record last verified: 2013-02

Locations