Clinical trial NCT02569619: Evaluation of an Intervention to Promote Physical Activity in Outpatients With Mental Disorders
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mental Disorders
Keywords: Physical Activity
Mental Health
Physical Exercise
Mental disorder
Promotion
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2015-10-07
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in physical activity - objective
timeFrame: From baseline (T1) to 3 month after the intervention (T3)
measure: Change in physical activity - subjective
timeFrame: From baseline (T1) to 3 month after the intervention (T3)
Secondary outcomes:
measure: Change in self-efficacy
timeFrame: From baseline (T1) to 1 week after the intervention (T2)
measure: Change in intention for physical activity
timeFrame: From baseline (T1) to 1 week after the intervention (T2)
measure: Change in self concordance of the motivation for physical activity
timeFrame: From baseline (T1) to 1 week after the intervention (T2)
measure: Change in outcome expectancies for physical activity
timeFrame: From baseline (T1) to 1 week after the intervention (T2)
measure: Change in planning for physical activity
timeFrame: From baseline (T1) to 1 week after the intervention (T2)
measure: Change in barrier planning for physical activity
timeFrame: From baseline (T1) to 1 week after the intervention (T2)
measure: Change in psychopathological symptoms
timeFrame: From baseline (T1) to 3 month after the intervention (T3)
measure: Change in health-related quality of life
timeFrame: From baseline (T1) to 3 month after the intervention (T3)
measure: Change in dietary behavior
timeFrame: From baseline (T1) to 3 month after the intervention (T3)
measure: Change in consumption of portions of fruit and vegetable per day
timeFrame: From baseline (T1) to 3 month after the intervention (T3)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin - Departement of Psychiatry
Study officials:
affiliation: Charité Universitätsmedizin Berlin - Departement of Psychiatry and Psychotherapy
name: Andreas Ströhle, Prof.
role: STUDY_DIRECTOR
affiliation: Charité Universitätsmedizin Berlin - Departement of Psychiatry and Psychotherapy
name: Moritz B Petzold, Dipl.Psych.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.