Physical Activity in Insurance Medicine: Effects on Patients With Psychiatric Disorders

Study Overview
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Brief Summary
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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.

Official Title
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Physical Activity in Insurance Medicine: Effects on Psycho(-Physio-)Logical Functions, Capacity / Participation Skills, and the Ability to Work in Psychiatric Disorders

Conditions
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Depressive Disorder, Somatoform Disorder, Anxiety Disorder, Personality Disorder

Intervention / Treatment
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* Behavioral: Physical activity


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical activity<br>Physical activity group program over 12 weeks; 1 hour sessions, 2 times a week | Behavioral: Physical activity<br> <br> |
| No Intervention: Leisure time activities<br>Predominantly sedentary leisure time group activities, like playing board games, doing handicrafts, etc.; 12 weeks, 1 hour sessions, 2 times a week | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the ability to work (h/d / %) |  | baseline and 15 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the ability to work (h/d / %) |  | baseline and 6 months | 
| Change in the ability to work (h/d / %) |  | baseline and 12 weeks | 
| Change in participation skills (sum score) |  | baseline and 15 months | 
| Change in participation skills (sum score) |  | baseline and 6 months | 
| Change in participation skills (sum score) |  | baseline and 12 weeks | 
| Change in psychological functioning (sum scores) |  | baseline and 15 months | 
| Change in psychological functioning (sum scores) |  | baseline and 6 months | 
| Change in psychological functioning (sum scores) |  | baseline and 12 weeks | 
| Change in subjective sleep quality (sum score) |  | baseline and 15 months | 
| Change in subjective sleep quality (sum score) |  | baseline and 6 months | 
| Change in subjective sleep quality (sum score) |  | baseline and 12 weeks | 
| Change in subjective sleep quality (sum score) |  | baseline and 8 weeks | 
| Change in subjective sleep quality (sum score) |  | baseline and 4 weeks | 
| Change in subjectively perceived stress (sum score) |  | baseline and 15 months | 
| Change in subjectively perceived stress (sum score) |  | baseline and 6 months | 
| Change in subjectively perceived stress (sum score) |  | baseline and 12 weeks | 
| Change in subjectively perceived stress (sum score) |  | baseline and 8 weeks | 
| Change in subjectively perceived stress (sum score) |  | baseline and 4 weeks | 
| Change in Clinical Global Impression (sum score) |  | baseline and 15 months | 
| Change in Clinical Global Impression (sum score) |  | baseline and 6 months | 
| Change in Clinical Global Impression (sum score) |  | baseline and 12 weeks | 
| Change in Leisure-time physical activity (sum score) |  | baseline and 15 months | 
| Change in Leisure-time physical activity (sum score) |  | baseline and 6 months | 
| Change in Leisure-time physical activity (sum score) |  | baseline and 12 weeks | 
| Change in self-efficacy (sum score) |  | baseline and 15 months | 
| Change in self-efficacy (sum score) |  | baseline and 6 months | 
| Change in self-efficacy (sum score) |  | baseline and 12 weeks | 
| Change in self-efficacy (sum score) |  | baseline and 8 weeks | 
| Change in self-efficacy (sum score) |  | baseline and 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mental disorders, Physical activity, Disability pension, Disability pension due to mental illness, Ability to work, Mental toughness