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Clinical Trials/NCT02569619
NCT02569619
Completed
Phase 2

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

Charite University, Berlin, Germany1 site in 1 country86 target enrollmentApril 2014

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Mental Disorders
Sponsor
Charite University, Berlin, Germany
Enrollment
86
Locations
1
Primary Endpoint
Change in physical activity - objective
Status
Completed
Last Updated
10 years ago

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.

Registry
clinicaltrials.gov
Start Date
April 2014
End Date
March 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Moritz Petzold

Dipl.Psych. Moritz Petzold

Charite University, Berlin, Germany

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

Outcomes

Primary Outcomes

Change in physical activity - objective

Time Frame: From baseline (T1) to 3 month after the intervention (T3)

Physical activity is objectively measured using accelerometry (ActiGraph GT1M)

Change in physical activity - subjective

Time Frame: From baseline (T1) to 3 month after the intervention (T3)

Physical activity is subjectively measured with the International Physical Activity Questionaire (IPAQ)

Secondary Outcomes

  • Change in planning for physical activity(From baseline (T1) to 1 week after the intervention (T2))
  • Change in health-related quality of life(From baseline (T1) to 3 month after the intervention (T3))
  • Change in consumption of portions of fruit and vegetable per day(From baseline (T1) to 3 month after the intervention (T3))
  • Change in self-efficacy(From baseline (T1) to 1 week after the intervention (T2))
  • Change in barrier planning for physical activity(From baseline (T1) to 1 week after the intervention (T2))
  • Change in dietary behavior(From baseline (T1) to 3 month after the intervention (T3))
  • Change in intention for physical activity(From baseline (T1) to 1 week after the intervention (T2))
  • Change in self concordance of the motivation for physical activity(From baseline (T1) to 1 week after the intervention (T2))
  • Change in outcome expectancies for physical activity(From baseline (T1) to 1 week after the intervention (T2))
  • Change in psychopathological symptoms(From baseline (T1) to 3 month after the intervention (T3))

Study Sites (1)

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