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

Mental Disorders Clinical Trial

— GAF  

Official title:

Evaluation of an Intervention to Promote Physical Activity in Outpatients With Mental Disorders: Motivational Determinants of Adherence, Effect on Cognitive Determinants of Physical Activity, Physical Activity, Sitting Time and Clinical Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02569619
• Other study ID #: GAF-1
• Status: Completed
• Phase: Phase 2
• First received: October 2, 2015
• Last updated: March 9, 2016
• Start date: April 2014
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders

Intervention

Behavioral:
• Activity Intervention

• Healthy Diet Intervention

Locations

Country	Name	City	State
Germany	Charité Universitätsmedizin Berlin - Departement of Psychiatry	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (4)

Craig CL, Marshall AL, Sjöström 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. — View Citation

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. — View Citation

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. — View Citation

Winkler G, Döring A. Validation of a short qualitative food frequency list used in several German large scale surveys. Z Ernahrungswiss. 1998 Sep;37(3):234-41. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in physical activity - objective	Physical activity is objectively measured using accelerometry (ActiGraph GT1M)	From baseline (T1) to 3 month after the intervention (T3)	No
Primary	Change in physical activity - subjective	Physical activity is subjectively measured with the International Physical Activity Questionaire (IPAQ)	From baseline (T1) to 3 month after the intervention (T3)	No
Secondary	Change in self-efficacy	Self-efficacy is measured using two likert scaled items	From baseline (T1) to 1 week after the intervention (T2)	No
Secondary	Change in intention for physical activity	Intention for physical activity is measured using two likert scaled items	From baseline (T1) to 1 week after the intervention (T2)	No
Secondary	Change in self concordance of the motivation for physical activity	Self concordance of the motivation for physical activity is measured using the "Sport- und bewegungsbezogene Selbstkonkordanz Skala", which consists of 12 likert scaled items	From baseline (T1) to 1 week after the intervention (T2)	No
Secondary	Change in outcome expectancies for physical activity	Outcome expectancies for physical activity are measured using 6 likert scaled items	From baseline (T1) to 1 week after the intervention (T2)	No
Secondary	Change in planning for physical activity	Planning for physical activity is measured using 4 likert scaled items	From baseline (T1) to 1 week after the intervention (T2)	No
Secondary	Change in barrier planning for physical activity	Barrier planning for physical activity is measured using 4 likert scaled items	From baseline (T1) to 1 week after the intervention (T2)	No
Secondary	Change in psychopathological symptoms	Psychopathological symptoms are measured by the Symptom Checklist 27 (SCL-27)	From baseline (T1) to 3 month after the intervention (T3)	No
Secondary	Change in health-related quality of life	Health-related quality of life is measured using the Sort-Form Health Questionnaire 12 (SF-12)	From baseline (T1) to 3 month after the intervention (T3)	No
Secondary	Change in dietary behavior	Dietary behavior is measured using the Food Frequency Questionnaire (FEL)	From baseline (T1) to 3 month after the intervention (T3)	No
Secondary	Change in consumption of portions of fruit and vegetable per day	Consumption of fruit and vegetable is measured using two items asking for the number of portions of fruit and vegetable that are consumed on a regular day (a portion is defined as a hand full). Consumption of fruit and vegetable is then added to check if the WHO recommendation of "5 a day" is met	From baseline (T1) to 3 month after the intervention (T3)	No

External Links

•   Information on the MoVo-model and intervention