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

9 maart 2016 bijgewerkt door: Moritz Petzold, Charite University, Berlin, Germany

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

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

86

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Duitsland
      • Berlin, Duitsland, 10117
        • Charité Universitätsmedizin Berlin - Departement of Psychiatry

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Activity Intervention
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.
Gedragsmatig: Activity Intervention
Actieve vergelijker: Healthy Diet Intervention
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.
Gedragsmatig: Healthy Diet Intervention

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in physical activity - objective
Tijdsspanne: From baseline (T1) to 3 month after the intervention (T3)
Physical activity is objectively measured using accelerometry (ActiGraph GT1M)
From baseline (T1) to 3 month after the intervention (T3)
Change in physical activity - subjective
Tijdsspanne: From baseline (T1) to 3 month after the intervention (T3)
Physical activity is subjectively measured with the International Physical Activity Questionaire (IPAQ)
From baseline (T1) to 3 month after the intervention (T3)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in self-efficacy
Tijdsspanne: From baseline (T1) to 1 week after the intervention (T2)
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
Tijdsspanne: From baseline (T1) to 1 week after the intervention (T2)
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
Tijdsspanne: 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
From baseline (T1) to 1 week after the intervention (T2)
Change in outcome expectancies for physical activity
Tijdsspanne: From baseline (T1) to 1 week after the intervention (T2)
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
Tijdsspanne: From baseline (T1) to 1 week after the intervention (T2)
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
Tijdsspanne: From baseline (T1) to 1 week after the intervention (T2)
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
Tijdsspanne: From baseline (T1) to 3 month after the intervention (T3)
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
Tijdsspanne: 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)
From baseline (T1) to 3 month after the intervention (T3)
Change in dietary behavior
Tijdsspanne: From baseline (T1) to 3 month after the intervention (T3)
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
Tijdsspanne: 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
From baseline (T1) to 3 month after the intervention (T3)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Charite University, Berlin, Germany

Onderzoekers

  • Studie directeur: Andreas Ströhle, Prof., Charité Universitätsmedizin Berlin - Departement of Psychiatry and Psychotherapy
  • Hoofdonderzoeker: Moritz B Petzold, Dipl.Psych., Charité Universitätsmedizin Berlin - Departement of Psychiatry and Psychotherapy

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 april 2014

Primaire voltooiing (Werkelijk)

1 maart 2016

Studie voltooiing (Werkelijk)

1 maart 2016

Studieregistratiedata

Eerst ingediend

2 oktober 2015

Eerst ingediend dat voldeed aan de QC-criteria

5 oktober 2015

Eerst geplaatst (Schatting)

7 oktober 2015

Updates van studierecords

Laatste update geplaatst (Schatting)

10 maart 2016

Laatste update ingediend die voldeed aan QC-criteria

9 maart 2016

Laatst geverifieerd

1 maart 2016

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • GAF-1

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