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

Primary Purpose

Mental Disorders

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Activity Intervention
Healthy Diet Intervention
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Disorders focused on measuring Physical Activity, Mental Health, Physical Exercise, Mental disorder, Promotion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charité Universitätsmedizin Berlin - Departement of Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Activity Intervention

Healthy Diet Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in physical activity - objective
Physical activity is objectively measured using accelerometry (ActiGraph GT1M)
Change in physical activity - subjective
Physical activity is subjectively measured with the International Physical Activity Questionaire (IPAQ)

Secondary Outcome Measures

Change in self-efficacy
Self-efficacy is measured using two likert scaled items
Change in intention for physical activity
Intention for physical activity is measured using two likert scaled items
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
Change in outcome expectancies for physical activity
Outcome expectancies for physical activity are measured using 6 likert scaled items
Change in planning for physical activity
Planning for physical activity is measured using 4 likert scaled items
Change in barrier planning for physical activity
Barrier planning for physical activity is measured using 4 likert scaled items
Change in psychopathological symptoms
Psychopathological symptoms are measured by the Symptom Checklist 27 (SCL-27)
Change in health-related quality of life
Health-related quality of life is measured using the Sort-Form Health Questionnaire 12 (SF-12)
Change in dietary behavior
Dietary behavior is measured using the Food Frequency Questionnaire (FEL)
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

Full Information

First Posted
October 2, 2015
Last Updated
March 9, 2016
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT02569619
Brief Title
Evaluation of an Intervention to Promote Physical Activity in Outpatients With Mental Disorders
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorders
Keywords
Physical Activity, Mental Health, Physical Exercise, Mental disorder, Promotion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Activity Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy Diet Intervention
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Activity Intervention
Intervention Type
Behavioral
Intervention Name(s)
Healthy Diet Intervention
Primary Outcome Measure Information:
Title
Change in physical activity - objective
Description
Physical activity is objectively measured using accelerometry (ActiGraph GT1M)
Time Frame
From baseline (T1) to 3 month after the intervention (T3)
Title
Change in physical activity - subjective
Description
Physical activity is subjectively measured with the International Physical Activity Questionaire (IPAQ)
Time Frame
From baseline (T1) to 3 month after the intervention (T3)
Secondary Outcome Measure Information:
Title
Change in self-efficacy
Description
Self-efficacy is measured using two likert scaled items
Time Frame
From baseline (T1) to 1 week after the intervention (T2)
Title
Change in intention for physical activity
Description
Intention for physical activity is measured using two likert scaled items
Time Frame
From baseline (T1) to 1 week after the intervention (T2)
Title
Change in self concordance of the motivation for physical activity
Description
Self concordance of the motivation for physical activity is measured using the "Sport- und bewegungsbezogene Selbstkonkordanz Skala", which consists of 12 likert scaled items
Time Frame
From baseline (T1) to 1 week after the intervention (T2)
Title
Change in outcome expectancies for physical activity
Description
Outcome expectancies for physical activity are measured using 6 likert scaled items
Time Frame
From baseline (T1) to 1 week after the intervention (T2)
Title
Change in planning for physical activity
Description
Planning for physical activity is measured using 4 likert scaled items
Time Frame
From baseline (T1) to 1 week after the intervention (T2)
Title
Change in barrier planning for physical activity
Description
Barrier planning for physical activity is measured using 4 likert scaled items
Time Frame
From baseline (T1) to 1 week after the intervention (T2)
Title
Change in psychopathological symptoms
Description
Psychopathological symptoms are measured by the Symptom Checklist 27 (SCL-27)
Time Frame
From baseline (T1) to 3 month after the intervention (T3)
Title
Change in health-related quality of life
Description
Health-related quality of life is measured using the Sort-Form Health Questionnaire 12 (SF-12)
Time Frame
From baseline (T1) to 3 month after the intervention (T3)
Title
Change in dietary behavior
Description
Dietary behavior is measured using the Food Frequency Questionnaire (FEL)
Time Frame
From baseline (T1) to 3 month after the intervention (T3)
Title
Change in consumption of portions of fruit and vegetable per day
Description
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
Time Frame
From baseline (T1) to 3 month after the intervention (T3)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Ströhle, Prof.
Organizational Affiliation
Charité Universitätsmedizin Berlin - Departement of Psychiatry and Psychotherapy
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Moritz B Petzold, Dipl.Psych.
Organizational Affiliation
Charité Universitätsmedizin Berlin - Departement of Psychiatry and Psychotherapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité Universitätsmedizin Berlin - Departement of Psychiatry
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
11465984
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. doi: 10.1053/eujp.2001.0231.
Results Reference
background
PubMed Identifier
12900694
Citation
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.
Results Reference
background
PubMed Identifier
8628042
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. doi: 10.1097/00005650-199603000-00003.
Results Reference
background
PubMed Identifier
9800314
Citation
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.
Results Reference
background
Links:
URL
http://www.sport.uni-freiburg.de/institut/Arbeitsbereiche/psychologie/psych_proj/konz
Description
Information on the MoVo-model and intervention

Learn more about this trial

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

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