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Completed

NCT Number: NCT02569619

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

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.

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Key information

Conditions

Mental Disorders Behavior Motor Activity Personal Satisfaction Psychological Well-Being

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Charité Universitätsmedizin Berlin - Departement of Psychiatry

Berlin, State of Berlin, 10117, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Activity Intervention

Behavioral

Healthy Diet Intervention

Behavioral

Primary outcomes

  1. 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)

  2. 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

  1. Change in self-efficacy

    Time frame: From baseline (T1) to 1 week after the intervention (T2)

    Self-efficacy is measured using two likert scaled items

  2. Change in intention for physical activity

    Time frame: From baseline (T1) to 1 week after the intervention (T2)

    Intention for physical activity is measured using two likert scaled items

  3. Change in self concordance of the motivation for physical activity

    Time frame: From baseline (T1) to 1 week after the intervention (T2)

    Self concordance of the motivation for physical activity is measured using the "Sport- und bewegungsbezogene Selbstkonkordanz Skala", which consists of 12 likert scaled items

  4. Change in outcome expectancies for physical activity

    Time frame: From baseline (T1) to 1 week after the intervention (T2)

    Outcome expectancies for physical activity are measured using 6 likert scaled items

  5. Change in planning for physical activity

    Time frame: From baseline (T1) to 1 week after the intervention (T2)

    Planning for physical activity is measured using 4 likert scaled items

  6. Change in barrier planning for physical activity

    Time frame: From baseline (T1) to 1 week after the intervention (T2)

    Barrier planning for physical activity is measured using 4 likert scaled items

  7. Change in psychopathological symptoms

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

    Psychopathological symptoms are measured by the Symptom Checklist 27 (SCL-27)

  8. Change in health-related quality of life

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

    Health-related quality of life is measured using the Sort-Form Health Questionnaire 12 (SF-12)

  9. Change in dietary behavior

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

    Dietary behavior is measured using the Food Frequency Questionnaire (FEL)

  10. Change in consumption of portions of fruit and vegetable per day

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

    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

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study 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

Acronym: GAF

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 7, 2015
Registry last updated
Mar 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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