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

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

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.

Study Overview

• Status: Terminated
• Conditions: Depressive Disorder; Anxiety Disorder; Personality Disorder; Somatoform Disorder
• Intervention / Treatment: Behavioral: Physical activity

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4012
    • Psychiatric Hospital of the University of Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physical activity; Physical activity group program over 12 weeks; 1 hour sessions, 2 times a week	Behavioral: Physical activity
No Intervention: Leisure time activities; 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?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Time Frame
Change in physical fitness (VO2max = ml/kg/min)	baseline and 15 months
Change in physical fitness (VO2max = ml/kg/min)	baseline and 6 months
Change in physical fitness (VO2max = ml/kg/min)	baseline and 12 weeks
Change in physical fitness (VO2max = ml/kg/min)	baseline and 8 weeks
Change in physical fitness (VO2max = ml/kg/min)	baseline and 4 weeks
Change in perceived fitness (sum score)	baseline and 15 months
Change in perceived fitness (sum score)	baseline and 6 months
Change in perceived fitness (sum score)	baseline and 12 weeks
Change in perceived fitness (sum score)	baseline and 8 weeks
Change in perceived fitness (sum score)	baseline and 4 weeks

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: Psychiatric Hospital of the University of Basel; Institute for Exercise and Health Sciences, University of Basle, Switzerland
• Investigators: Principal Investigator: Kristin Rabovsky, MD, Psychiatric Hospital of the University of Basel

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: August 5, 2013
• First Submitted That Met QC Criteria: August 20, 2013
• First Posted (Estimate): August 23, 2013

Study Record Updates

• Last Update Posted (Estimate): October 16, 2015
• Last Update Submitted That Met QC Criteria: October 14, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Physical activity; Mental disorders; Disability pension; Disability pension due to mental illness; Ability to work; Mental toughness
• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Mood Disorders; Personality Disorders; Depressive Disorder; Disease; Problem Behavior; Anxiety Disorders; Mental Disorders; Somatoform Disorders
• Other Study ID Numbers: 114/13