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Trial record 25 of 293 for:    "Somatoform Disorder"

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

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ClinicalTrials.gov Identifier: NCT01928264
Recruitment Status : Terminated
First Posted : August 23, 2013
Last Update Posted : October 16, 2015
Sponsor:
Collaborators:
Psychiatric Hospital of the University of Basel
Institute for Exercise and Health Sciences, University of Basle, Switzerland
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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.

Condition or disease Intervention/treatment Phase
Depressive Disorder Somatoform Disorder Anxiety Disorder Personality Disorder Behavioral: Physical activity Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : August 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Change in the ability to work (h/d / %) [ Time Frame: baseline and 15 months ]

Secondary Outcome Measures :
  1. Change in the ability to work (h/d / %) [ Time Frame: baseline and 6 months ]
  2. Change in the ability to work (h/d / %) [ Time Frame: baseline and 12 weeks ]
  3. Change in participation skills (sum score) [ Time Frame: baseline and 15 months ]
  4. Change in participation skills (sum score) [ Time Frame: baseline and 6 months ]
  5. Change in participation skills (sum score) [ Time Frame: baseline and 12 weeks ]
  6. Change in psychological functioning (sum scores) [ Time Frame: baseline and 15 months ]
  7. Change in psychological functioning (sum scores) [ Time Frame: baseline and 6 months ]
  8. Change in psychological functioning (sum scores) [ Time Frame: baseline and 12 weeks ]
  9. Change in subjective sleep quality (sum score) [ Time Frame: baseline and 15 months ]
  10. Change in subjective sleep quality (sum score) [ Time Frame: baseline and 6 months ]
  11. Change in subjective sleep quality (sum score) [ Time Frame: baseline and 12 weeks ]
  12. Change in subjective sleep quality (sum score) [ Time Frame: baseline and 8 weeks ]
  13. Change in subjective sleep quality (sum score) [ Time Frame: baseline and 4 weeks ]
  14. Change in subjectively perceived stress (sum score) [ Time Frame: baseline and 15 months ]
  15. Change in subjectively perceived stress (sum score) [ Time Frame: baseline and 6 months ]
  16. Change in subjectively perceived stress (sum score) [ Time Frame: baseline and 12 weeks ]
  17. Change in subjectively perceived stress (sum score) [ Time Frame: baseline and 8 weeks ]
  18. Change in subjectively perceived stress (sum score) [ Time Frame: baseline and 4 weeks ]
  19. Change in Clinical Global Impression (sum score) [ Time Frame: baseline and 15 months ]
  20. Change in Clinical Global Impression (sum score) [ Time Frame: baseline and 6 months ]
  21. Change in Clinical Global Impression (sum score) [ Time Frame: baseline and 12 weeks ]
  22. Change in Leisure-time physical activity (sum score) [ Time Frame: baseline and 15 months ]
  23. Change in Leisure-time physical activity (sum score) [ Time Frame: baseline and 6 months ]
  24. Change in Leisure-time physical activity (sum score) [ Time Frame: baseline and 12 weeks ]
  25. Change in self-efficacy (sum score) [ Time Frame: baseline and 15 months ]
  26. Change in self-efficacy (sum score) [ Time Frame: baseline and 6 months ]
  27. Change in self-efficacy (sum score) [ Time Frame: baseline and 12 weeks ]
  28. Change in self-efficacy (sum score) [ Time Frame: baseline and 8 weeks ]
  29. Change in self-efficacy (sum score) [ Time Frame: baseline and 4 weeks ]

Other Outcome Measures:
  1. Change in physical fitness (VO2max = ml/kg/min) [ Time Frame: baseline and 15 months ]
  2. Change in physical fitness (VO2max = ml/kg/min) [ Time Frame: baseline and 6 months ]
  3. Change in physical fitness (VO2max = ml/kg/min) [ Time Frame: baseline and 12 weeks ]
  4. Change in physical fitness (VO2max = ml/kg/min) [ Time Frame: baseline and 8 weeks ]
  5. Change in physical fitness (VO2max = ml/kg/min) [ Time Frame: baseline and 4 weeks ]
  6. Change in perceived fitness (sum score) [ Time Frame: baseline and 15 months ]
  7. Change in perceived fitness (sum score) [ Time Frame: baseline and 6 months ]
  8. Change in perceived fitness (sum score) [ Time Frame: baseline and 12 weeks ]
  9. Change in perceived fitness (sum score) [ Time Frame: baseline and 8 weeks ]
  10. Change in perceived fitness (sum score) [ Time Frame: baseline and 4 weeks ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01928264


Locations
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Switzerland
Psychiatric Hospital of the University of Basel
Basel, Switzerland, 4012
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Psychiatric Hospital of the University of Basel
Institute for Exercise and Health Sciences, University of Basle, Switzerland
Investigators
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Principal Investigator: Kristin Rabovsky, MD Psychiatric Hospital of the University of Basel

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01928264     History of Changes
Other Study ID Numbers: 114/13
First Posted: August 23, 2013    Key Record Dates
Last Update Posted: October 16, 2015
Last Verified: October 2015

Keywords provided by University Hospital, Basel, Switzerland:
Mental disorders
Physical activity
Disability pension
Disability pension due to mental illness
Ability to work
Mental toughness

Additional relevant MeSH terms:
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Somatoform Disorders
Disease
Depressive Disorder
Depression
Anxiety Disorders
Personality Disorders
Mental Disorders
Problem Behavior
Pathologic Processes
Mood Disorders
Behavioral Symptoms