Clinical trial NCT01928264: Physical Activity in Insurance Medicine: Effects on Patients With Psychiatric Disorders
Official title: Physical Activity in Insurance Medicine: Effects on Psycho(-Physio-)Logical Functions, Capacity / Participation Skills, and the Ability to Work in Psychiatric Disorders
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Depressive Disorder
Somatoform Disorder
Anxiety Disorder
Personality Disorder
Keywords: Mental disorders
Physical activity
Disability pension
Disability pension due to mental illness
Ability to work
Mental toughness
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Psychiatric Hospital of the University of Basel
name: Institute for Exercise and Health Sciences, University of Basle, Switzerland
First posted: 2013-08-23
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in the ability to work (h/d / %)
timeFrame: baseline and 15 months
Secondary outcomes:
measure: Change in the ability to work (h/d / %)
timeFrame: baseline and 6 months
measure: Change in the ability to work (h/d / %)
timeFrame: baseline and 12 weeks
measure: Change in participation skills (sum score)
timeFrame: baseline and 15 months
measure: Change in participation skills (sum score)
timeFrame: baseline and 6 months
measure: Change in participation skills (sum score)
timeFrame: baseline and 12 weeks
measure: Change in psychological functioning (sum scores)
timeFrame: baseline and 15 months
measure: Change in psychological functioning (sum scores)
timeFrame: baseline and 6 months
measure: Change in psychological functioning (sum scores)
timeFrame: baseline and 12 weeks
measure: Change in subjective sleep quality (sum score)
timeFrame: baseline and 15 months
measure: Change in subjective sleep quality (sum score)
timeFrame: baseline and 6 months
measure: Change in subjective sleep quality (sum score)
timeFrame: baseline and 12 weeks
measure: Change in subjective sleep quality (sum score)
timeFrame: baseline and 8 weeks
measure: Change in subjective sleep quality (sum score)
timeFrame: baseline and 4 weeks
measure: Change in subjectively perceived stress (sum score)
timeFrame: baseline and 15 months
measure: Change in subjectively perceived stress (sum score)
timeFrame: baseline and 6 months
measure: Change in subjectively perceived stress (sum score)
timeFrame: baseline and 12 weeks
measure: Change in subjectively perceived stress (sum score)
timeFrame: baseline and 8 weeks
measure: Change in subjectively perceived stress (sum score)
timeFrame: baseline and 4 weeks
measure: Change in Clinical Global Impression (sum score)
timeFrame: baseline and 15 months
measure: Change in Clinical Global Impression (sum score)
timeFrame: baseline and 6 months
measure: Change in Clinical Global Impression (sum score)
timeFrame: baseline and 12 weeks
measure: Change in Leisure-time physical activity (sum score)
timeFrame: baseline and 15 months
measure: Change in Leisure-time physical activity (sum score)
timeFrame: baseline and 6 months
measure: Change in Leisure-time physical activity (sum score)
timeFrame: baseline and 12 weeks
measure: Change in self-efficacy (sum score)
timeFrame: baseline and 15 months
measure: Change in self-efficacy (sum score)
timeFrame: baseline and 6 months
measure: Change in self-efficacy (sum score)
timeFrame: baseline and 12 weeks
measure: Change in self-efficacy (sum score)
timeFrame: baseline and 8 weeks
measure: Change in self-efficacy (sum score)
timeFrame: baseline and 4 weeks
Other outcomes:
measure: Change in physical fitness (VO2max = ml/kg/min)
timeFrame: baseline and 15 months
measure: Change in physical fitness (VO2max = ml/kg/min)
timeFrame: baseline and 6 months
measure: Change in physical fitness (VO2max = ml/kg/min)
timeFrame: baseline and 12 weeks
measure: Change in physical fitness (VO2max = ml/kg/min)
timeFrame: baseline and 8 weeks
measure: Change in physical fitness (VO2max = ml/kg/min)
timeFrame: baseline and 4 weeks
measure: Change in perceived fitness (sum score)
timeFrame: baseline and 15 months
measure: Change in perceived fitness (sum score)
timeFrame: baseline and 6 months
measure: Change in perceived fitness (sum score)
timeFrame: baseline and 12 weeks
measure: Change in perceived fitness (sum score)
timeFrame: baseline and 8 weeks
measure: Change in perceived fitness (sum score)
timeFrame: baseline and 4 weeks
Locations:
city: Basel
country: Switzerland
facility: Psychiatric Hospital of the University of Basel
Study officials:
affiliation: Psychiatric Hospital of the University of Basel
name: Kristin Rabovsky, MD
role: PRINCIPAL_INVESTIGATOR
References: