Depressive Disorder Clinical Trial
— PhysActIVOfficial title:
Physical Activity in Insurance Medicine: Effects on Psycho(-Physio-)Logical Functions, Capacity / Participation Skills, and the Ability to Work in Psychiatric Disorders
Verified date | October 2015 |
Source | University Hospital, Basel, Switzerland |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Ethikkommission |
Study type | Interventional |
We will conduct a randomized control trial to investigate whether and to what extent regular and guided group physical activity over 12 weeks (2 sessions à 1 hour/week) improves physical fitness and (physio-)psychological functions (like subjective sleep, mental toughness, perceived stress, self-efficacy, etc.), as well as participation skills and the ability to work, in claimants for a disability pension due to psychiatric disorders, whose ability to work had recently been assessed by means of a psychiatric expert opinion. The control group is designed very similar and implies predominantly sedentary leisure time group activities (e.g. playing board games, doing handicrafts). Measures will be performed at baseline, post-test, and at follow ups three and twelve months after post-test, some variables will additionally be assessed 4-weekly during the intervention. We expect that intervention group participants will report and show, respectively, more improved physical fitness, (physio-)psychological functioning and participations skills, as well as increased ability to work, compared to the control group.
Status | Terminated |
Enrollment | 13 |
Est. completion date | April 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Claimants for a disability pension due to a mental disorder, whose ability to work has been recently assessed by means of a psychiatric expert opinion - Both genders - 18-55 years old - Clinical diagnosis of depressive disorder, somatoform disorder, anxiety disorder, personality disorder - Sufficient competence in understanding, speaking and reading German - Sufficient cognitive, emotional and social level of functioning to be able to participate in a group - Physical Activity Readiness Questionnaire without evidence for reduction - or: Physical activity readiness certificated by the general practitioner - Informed consent Exclusion Criteria: - Comorbidity with a somatic disorder that limits the ability for physical exercises - Pregnancy - Ongoing disturbance of the study |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Switzerland | Psychiatric Hospital of the University of Basel | Basel |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Basel, Switzerland | Institute for Exercise and Health Sciences, University of Basle, Switzerland, Psychiatric Hospital of the University of Basel |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in physical fitness (VO2max = ml/kg/min) | baseline and 15 months | No | |
Other | Change in physical fitness (VO2max = ml/kg/min) | baseline and 6 months | No | |
Other | Change in physical fitness (VO2max = ml/kg/min) | baseline and 12 weeks | No | |
Other | Change in physical fitness (VO2max = ml/kg/min) | baseline and 8 weeks | No | |
Other | Change in physical fitness (VO2max = ml/kg/min) | baseline and 4 weeks | No | |
Other | Change in perceived fitness (sum score) | baseline and 15 months | No | |
Other | Change in perceived fitness (sum score) | baseline and 6 months | No | |
Other | Change in perceived fitness (sum score) | baseline and 12 weeks | No | |
Other | Change in perceived fitness (sum score) | baseline and 8 weeks | No | |
Other | Change in perceived fitness (sum score) | baseline and 4 weeks | No | |
Primary | Change in the ability to work (h/d / %) | baseline and 15 months | No | |
Secondary | Change in the ability to work (h/d / %) | baseline and 6 months | No | |
Secondary | Change in the ability to work (h/d / %) | baseline and 12 weeks | No | |
Secondary | Change in participation skills (sum score) | baseline and 15 months | No | |
Secondary | Change in participation skills (sum score) | baseline and 6 months | No | |
Secondary | Change in participation skills (sum score) | baseline and 12 weeks | No | |
Secondary | Change in psychological functioning (sum scores) | baseline and 15 months | No | |
Secondary | Change in psychological functioning (sum scores) | baseline and 6 months | No | |
Secondary | Change in psychological functioning (sum scores) | baseline and 12 weeks | No | |
Secondary | Change in subjective sleep quality (sum score) | baseline and 15 months | No | |
Secondary | Change in subjective sleep quality (sum score) | baseline and 6 months | No | |
Secondary | Change in subjective sleep quality (sum score) | baseline and 12 weeks | No | |
Secondary | Change in subjective sleep quality (sum score) | baseline and 8 weeks | No | |
Secondary | Change in subjective sleep quality (sum score) | baseline and 4 weeks | No | |
Secondary | Change in subjectively perceived stress (sum score) | baseline and 15 months | No | |
Secondary | Change in subjectively perceived stress (sum score) | baseline and 6 months | No | |
Secondary | Change in subjectively perceived stress (sum score) | baseline and 12 weeks | No | |
Secondary | Change in subjectively perceived stress (sum score) | baseline and 8 weeks | No | |
Secondary | Change in subjectively perceived stress (sum score) | baseline and 4 weeks | No | |
Secondary | Change in Clinical Global Impression (sum score) | baseline and 15 months | No | |
Secondary | Change in Clinical Global Impression (sum score) | baseline and 6 months | No | |
Secondary | Change in Clinical Global Impression (sum score) | baseline and 12 weeks | No | |
Secondary | Change in Leisure-time physical activity (sum score) | baseline and 15 months | No | |
Secondary | Change in Leisure-time physical activity (sum score) | baseline and 6 months | No | |
Secondary | Change in Leisure-time physical activity (sum score) | baseline and 12 weeks | No | |
Secondary | Change in self-efficacy (sum score) | baseline and 15 months | No | |
Secondary | Change in self-efficacy (sum score) | baseline and 6 months | No | |
Secondary | Change in self-efficacy (sum score) | baseline and 12 weeks | No | |
Secondary | Change in self-efficacy (sum score) | baseline and 8 weeks | No | |
Secondary | Change in self-efficacy (sum score) | baseline and 4 weeks | No |
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