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

Primary Purpose

Depressive Disorder, Somatoform Disorder, Anxiety Disorder

Status
Terminated
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Physical activity
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder focused on measuring Mental disorders, Physical activity, Disability pension, Disability pension due to mental illness, Ability to work, Mental toughness

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Psychiatric Hospital of the University of Basel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Physical activity

Leisure time activities

Arm Description

Physical activity group program over 12 weeks; 1 hour sessions, 2 times a week

Predominantly sedentary leisure time group activities, like playing board games, doing handicrafts, etc.; 12 weeks, 1 hour sessions, 2 times a week

Outcomes

Primary Outcome Measures

Change in the ability to work (h/d / %)

Secondary Outcome Measures

Change in the ability to work (h/d / %)
Change in the ability to work (h/d / %)
Change in participation skills (sum score)
Change in participation skills (sum score)
Change in participation skills (sum score)
Change in psychological functioning (sum scores)
Change in psychological functioning (sum scores)
Change in psychological functioning (sum scores)
Change in subjective sleep quality (sum score)
Change in subjective sleep quality (sum score)
Change in subjective sleep quality (sum score)
Change in subjective sleep quality (sum score)
Change in subjective sleep quality (sum score)
Change in subjectively perceived stress (sum score)
Change in subjectively perceived stress (sum score)
Change in subjectively perceived stress (sum score)
Change in subjectively perceived stress (sum score)
Change in subjectively perceived stress (sum score)
Change in Clinical Global Impression (sum score)
Change in Clinical Global Impression (sum score)
Change in Clinical Global Impression (sum score)
Change in Leisure-time physical activity (sum score)
Change in Leisure-time physical activity (sum score)
Change in Leisure-time physical activity (sum score)
Change in self-efficacy (sum score)
Change in self-efficacy (sum score)
Change in self-efficacy (sum score)
Change in self-efficacy (sum score)
Change in self-efficacy (sum score)

Full Information

First Posted
August 5, 2013
Last Updated
October 14, 2015
Sponsor
University Hospital, Basel, Switzerland
Collaborators
Psychiatric Hospital of the University of Basel, Institute for Exercise and Health Sciences, University of Basle, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT01928264
Brief Title
Physical Activity in Insurance Medicine: Effects on Patients With Psychiatric Disorders
Acronym
PhysActIV
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

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Terminated
Study Start Date
August 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland
Collaborators
Psychiatric Hospital of the University of Basel, Institute for Exercise and Health Sciences, University of Basle, Switzerland

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physical activity
Arm Type
Experimental
Arm Description
Physical activity group program over 12 weeks; 1 hour sessions, 2 times a week
Arm Title
Leisure time activities
Arm Type
No Intervention
Arm Description
Predominantly sedentary leisure time group activities, like playing board games, doing handicrafts, etc.; 12 weeks, 1 hour sessions, 2 times a week
Intervention Type
Behavioral
Intervention Name(s)
Physical activity
Primary Outcome Measure Information:
Title
Change in the ability to work (h/d / %)
Time Frame
baseline and 15 months
Secondary Outcome Measure Information:
Title
Change in the ability to work (h/d / %)
Time Frame
baseline and 6 months
Title
Change in the ability to work (h/d / %)
Time Frame
baseline and 12 weeks
Title
Change in participation skills (sum score)
Time Frame
baseline and 15 months
Title
Change in participation skills (sum score)
Time Frame
baseline and 6 months
Title
Change in participation skills (sum score)
Time Frame
baseline and 12 weeks
Title
Change in psychological functioning (sum scores)
Time Frame
baseline and 15 months
Title
Change in psychological functioning (sum scores)
Time Frame
baseline and 6 months
Title
Change in psychological functioning (sum scores)
Time Frame
baseline and 12 weeks
Title
Change in subjective sleep quality (sum score)
Time Frame
baseline and 15 months
Title
Change in subjective sleep quality (sum score)
Time Frame
baseline and 6 months
Title
Change in subjective sleep quality (sum score)
Time Frame
baseline and 12 weeks
Title
Change in subjective sleep quality (sum score)
Time Frame
baseline and 8 weeks
Title
Change in subjective sleep quality (sum score)
Time Frame
baseline and 4 weeks
Title
Change in subjectively perceived stress (sum score)
Time Frame
baseline and 15 months
Title
Change in subjectively perceived stress (sum score)
Time Frame
baseline and 6 months
Title
Change in subjectively perceived stress (sum score)
Time Frame
baseline and 12 weeks
Title
Change in subjectively perceived stress (sum score)
Time Frame
baseline and 8 weeks
Title
Change in subjectively perceived stress (sum score)
Time Frame
baseline and 4 weeks
Title
Change in Clinical Global Impression (sum score)
Time Frame
baseline and 15 months
Title
Change in Clinical Global Impression (sum score)
Time Frame
baseline and 6 months
Title
Change in Clinical Global Impression (sum score)
Time Frame
baseline and 12 weeks
Title
Change in Leisure-time physical activity (sum score)
Time Frame
baseline and 15 months
Title
Change in Leisure-time physical activity (sum score)
Time Frame
baseline and 6 months
Title
Change in Leisure-time physical activity (sum score)
Time Frame
baseline and 12 weeks
Title
Change in self-efficacy (sum score)
Time Frame
baseline and 15 months
Title
Change in self-efficacy (sum score)
Time Frame
baseline and 6 months
Title
Change in self-efficacy (sum score)
Time Frame
baseline and 12 weeks
Title
Change in self-efficacy (sum score)
Time Frame
baseline and 8 weeks
Title
Change in self-efficacy (sum score)
Time Frame
baseline and 4 weeks
Other Pre-specified Outcome Measures:
Title
Change in physical fitness (VO2max = ml/kg/min)
Time Frame
baseline and 15 months
Title
Change in physical fitness (VO2max = ml/kg/min)
Time Frame
baseline and 6 months
Title
Change in physical fitness (VO2max = ml/kg/min)
Time Frame
baseline and 12 weeks
Title
Change in physical fitness (VO2max = ml/kg/min)
Time Frame
baseline and 8 weeks
Title
Change in physical fitness (VO2max = ml/kg/min)
Time Frame
baseline and 4 weeks
Title
Change in perceived fitness (sum score)
Time Frame
baseline and 15 months
Title
Change in perceived fitness (sum score)
Time Frame
baseline and 6 months
Title
Change in perceived fitness (sum score)
Time Frame
baseline and 12 weeks
Title
Change in perceived fitness (sum score)
Time Frame
baseline and 8 weeks
Title
Change in perceived fitness (sum score)
Time Frame
baseline and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin Rabovsky, MD
Organizational Affiliation
Psychiatric Hospital of the University of Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychiatric Hospital of the University of Basel
City
Basel
ZIP/Postal Code
4012
Country
Switzerland

12. IPD Sharing Statement

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

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