Evaluation of an Intervention to Promote Physical Activity in Outpatients With Mental Disorders

NCT ID: NCT02569619

Last Updated: 2016-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-03-31

Brief Summary

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The purpose of this study is to determine if a manualised intervention to promote physical activity (MoVo-LISA) is effective to help psychiatric outpatients to increase their level of everyday physical activity.

Detailed Description

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The Intervention program MoVo-LISA is a psychological intervention that should help participants to increase their level of physical activity for a healthy lifestyle.It contains three sessions (2 group,1 one on one) in the course of two weeks. The intervention focuses on planning and barrier management.

Participants develop activity ideas, goals and plans that enable them to integrate physical activity in their everyday routine and how to shield their motivation against barriers and difficulties.The intervention has proven to be effective with patients with pain disorders in rehabilitation.

This study examines if the intervention if effective for psychiatric outpatients as well. The intervention is compared to an active control group that receives a similar program that is focusing on a healthy diet.

Participants are recruited in the outpatient departements of three hospitals in Berlin and Brandenburg (Charité Universitätsmedizin Berlin - Departement of Psychiatry and Psychotherapy; St. Hewdig Hospital Berlin - Departement of Psychiatry; Oberhavel Hospital Brandenburg, Departement of Psychiatry) and at local psychiatrists in Berlin. Individuals are recruited by posters and flyers in the waiting areas areas or by information of their doctor. Patients can contact the researcher and are, after checked for eligibility, invited to an information event, where they get detailed information on the program and the study. After the information event, participants give written informed consent.

The intervention takes place in the outpatient departements of the three hospitals.

Clinical information about diagnoses, medication and functioning is obtained by their doctors by mail after the patients released them from confidentiality.

The study is an explorative approach to test if the program is suited for psychiatric patients. A sample size of 50 participants that complete the program is planned.

All data is collected pseudonymised to protect the identity of the patients.

Conditions

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Mental Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Activity Intervention

The activity intervention is MoVo-LISA (Göhner \& Fuchs, 2007). A psychological program with two group sessions of 90 minutes and one one-on-one session of about 15 minutes. The patients develop aims for their health, ideas, how to reach these aims through physical activity and make detailed plans, how to implement activity in their everyday routine. Difficulties and barriers are discussed.

Group Type EXPERIMENTAL

Activity Intervention

Intervention Type BEHAVIORAL

Healthy Diet Intervention

The healthy diet intervention is a modification of MoVo-LISA. A psychological program with two group sessions of 90 minutes and one one-on-one session of about 15 minutes. The patients develop aims for their health, ideas, how to reach these aims through a healthy diet and make detailed plans, how to implement a healthy diet in their everyday routine. Difficulties and barriers are discussed.

Group Type ACTIVE_COMPARATOR

Healthy Diet Intervention

Intervention Type BEHAVIORAL

Interventions

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Activity Intervention

Intervention Type BEHAVIORAL

Healthy Diet Intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Over 18 years of Age
* Patients in one of the psychiatric outpatients or at an local psychiatrist in Berlin
* Mental illness (ICD-10: F1-F4)
* No contraindications for physical activity
* Able to understand german language

Exclusion Criteria

* Contraindications to physical activity
* Acute suicidality
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Moritz Petzold

Dipl.Psych. Moritz Petzold

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreas Ströhle, Prof.

Role: STUDY_DIRECTOR

Charité Universitätsmedizin Berlin - Departement of Psychiatry and Psychotherapy

Moritz B Petzold, Dipl.Psych.

Role: PRINCIPAL_INVESTIGATOR

Charité Universitätsmedizin Berlin - Departement of Psychiatry and Psychotherapy

Locations

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Charité Universitätsmedizin Berlin - Departement of Psychiatry

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

References

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Hardt J, Gerbershagen HU. Cross-validation of the SCL-27: a short psychometric screening instrument for chronic pain patients. Eur J Pain. 2001;5(2):187-97. doi: 10.1053/eujp.2001.0231.

Reference Type BACKGROUND
PMID: 11465984 (View on PubMed)

Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

Reference Type BACKGROUND
PMID: 12900694 (View on PubMed)

Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.

Reference Type BACKGROUND
PMID: 8628042 (View on PubMed)

Winkler G, Doring A. Validation of a short qualitative food frequency list used in several German large scale surveys. Z Ernahrungswiss. 1998 Sep;37(3):234-41. doi: 10.1007/pl00007377.

Reference Type BACKGROUND
PMID: 9800314 (View on PubMed)

Related Links

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Other Identifiers

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GAF-1

Identifier Type: -

Identifier Source: org_study_id

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