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

Study Overview
=================
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.

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

Conditions
-----------------
Mental Disorders

Intervention / Treatment
-----------------
* Behavioral: Activity Intervention
* Behavioral: Healthy Diet Intervention


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Activity Intervention<br>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. | Behavioral: Activity Intervention<br> <br> |
| Active Comparator: Healthy Diet Intervention<br>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. | Behavioral: Healthy Diet Intervention<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical activity - objective | Physical activity is objectively measured using accelerometry (ActiGraph GT1M) | From baseline (T1) to 3 month after the intervention (T3) | 
| 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in self-efficacy | Self-efficacy is measured using two likert scaled items | From baseline (T1) to 1 week after the intervention (T2) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| Change in dietary behavior | Dietary behavior is measured using the Food Frequency Questionnaire (FEL) | From baseline (T1) to 3 month after the intervention (T3) | 
| 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Promotion, Physical Activity, Mental Health, Physical Exercise, Mental disorder