Depressive DisorderPhysActIVNCT01928264
Physical Activity in Insurance Medicine: Effects on Patients With Psychiatric Disorders
A study testing Physical activity in people with Depressive Disorder and Somatoform Disorder, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Depressive Disorder, Somatoform Disorder, Anxiety Disorder
- What is being tested?
- Physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2013to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- Physical Activity Readiness Questionnaire without evidence for reduction
- or: Physical activity readiness certificated by the general practitioner
- Informed consent
Who cannot join
- Comorbidity with a somatic disorder that limits the ability for physical exercises
- Pregnancy
- Ongoing disturbance of the study
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Psychiatric Hospital of the University of Basel
Basel, 4012
About this study
Official title: 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.
- Being tested
- Physical activity
- Keywords
- Mental disorders, Physical activity, Disability pension, Disability pension due to mental illness, Ability to work, Mental toughness
- Medical subject headings
- Depressive Disorder, Somatoform Disorders, Anxiety Disorders, Personality Disorders, Mental Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Physical activity | Experimental | Physical activity group program over 12 weeks; 1 hour sessions, 2 times a week Receives: Behavioral: Physical activity |
| Leisure time activities | No intervention | Predominantly sedentary leisure time group activities, like playing board games, doing handicrafts, etc.; 12 weeks, 1 hour sessions, 2 times a week |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the ability to work (h/d / %)
Measured: baseline and 15 months
Secondary outcomes (29)
Change in the ability to work (h/d / %)
Measured: baseline and 6 months
Change in the ability to work (h/d / %)
Measured: baseline and 12 weeks
Change in participation skills (sum score)
Measured: baseline and 15 months
Change in participation skills (sum score)
Measured: baseline and 6 months
Change in participation skills (sum score)
Measured: baseline and 12 weeks
Change in psychological functioning (sum scores)
Measured: baseline and 15 months
Change in psychological functioning (sum scores)
Measured: baseline and 6 months
Change in psychological functioning (sum scores)
Measured: baseline and 12 weeks
Change in subjective sleep quality (sum score)
Measured: baseline and 15 months
Change in subjective sleep quality (sum score)
Measured: baseline and 6 months
Change in subjective sleep quality (sum score)
Measured: baseline and 12 weeks
Change in subjective sleep quality (sum score)
Measured: baseline and 8 weeks
Change in subjective sleep quality (sum score)
Measured: baseline and 4 weeks
Change in subjectively perceived stress (sum score)
Measured: baseline and 15 months
Change in subjectively perceived stress (sum score)
Measured: baseline and 6 months
Change in subjectively perceived stress (sum score)
Measured: baseline and 12 weeks
Change in subjectively perceived stress (sum score)
Measured: baseline and 8 weeks
Change in subjectively perceived stress (sum score)
Measured: baseline and 4 weeks
Change in Clinical Global Impression (sum score)
Measured: baseline and 15 months
Change in Clinical Global Impression (sum score)
Measured: baseline and 6 months
Change in Clinical Global Impression (sum score)
Measured: baseline and 12 weeks
Change in Leisure-time physical activity (sum score)
Measured: baseline and 15 months
Change in Leisure-time physical activity (sum score)
Measured: baseline and 6 months
Change in Leisure-time physical activity (sum score)
Measured: baseline and 12 weeks
Change in self-efficacy (sum score)
Measured: baseline and 15 months
Change in self-efficacy (sum score)
Measured: baseline and 6 months
Change in self-efficacy (sum score)
Measured: baseline and 12 weeks
Change in self-efficacy (sum score)
Measured: baseline and 8 weeks
Change in self-efficacy (sum score)
Measured: baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Psychiatric Hospital of the University of Basel, Institute for Exercise and Health Sciences, University of Basle, Switzerland
- Responsible party
- Sponsor
- Investigators
- Kristin Rabovsky, MD, Principal investigator, Psychiatric Hospital of the University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01928264
- Sponsor's protocol ID
- 114/13
- Acronym
- PhysActIV
- Status last verified
- Oct 2015
- First submitted
- 5 Aug 2013
- Last updated
- 16 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity in Insurance Medicine: Effects on Psycho(-Physio-)Logical Functions, Capacity / Participation Skills, and the Ability to Work in Psychiatric Disorders
- ClinicalTrials.gov ID
- NCT01928264
- Acronym / sponsor ID
- PhysActIV / 114/13
- Keywords
- Mental disorders, Physical activity, Disability pension, Disability pension due to mental illness, Ability to work, Mental toughness
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Psychiatric Hospital of the University of Basel, Institute for Exercise and Health Sciences, University of Basle, Switzerland
- Study start
- Aug 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 23 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical activity | Experimental | Behavioral: Physical activityPhysical activity group program over 12 weeks; 1 hour sessions, 2 times a week |
| Leisure time activities | No intervention | –Predominantly sedentary leisure time group activities, like playing board games, doing handicrafts, etc.; 12 weeks, 1 hour sessions, 2 times a week |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- Comorbidity with a somatic disorder that limits the ability for physical exercises
- Pregnancy
- Ongoing disturbance of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity | Behavioural | Physical activity |
Primary outcome
Change in the ability to work (h/d / %)
Time frame: baseline and 15 months
29 secondary outcomes
Change in the ability to work (h/d / %)
Time frame: baseline and 6 months
Change in the ability to work (h/d / %)
Time frame: baseline and 12 weeks
Change in participation skills (sum score)
Time frame: baseline and 15 months
Change in participation skills (sum score)
Time frame: baseline and 6 months
Change in participation skills (sum score)
Time frame: baseline and 12 weeks
Change in psychological functioning (sum scores)
Time frame: baseline and 15 months
Change in psychological functioning (sum scores)
Time frame: baseline and 6 months
Change in psychological functioning (sum scores)
Time frame: baseline and 12 weeks
Change in subjective sleep quality (sum score)
Time frame: baseline and 15 months
Change in subjective sleep quality (sum score)
Time frame: baseline and 6 months
Change in subjective sleep quality (sum score)
Time frame: baseline and 12 weeks
Change in subjective sleep quality (sum score)
Time frame: baseline and 8 weeks
Change in subjective sleep quality (sum score)
Time frame: baseline and 4 weeks
Change in subjectively perceived stress (sum score)
Time frame: baseline and 15 months
Change in subjectively perceived stress (sum score)
Time frame: baseline and 6 months
Change in subjectively perceived stress (sum score)
Time frame: baseline and 12 weeks
Change in subjectively perceived stress (sum score)
Time frame: baseline and 8 weeks
Change in subjectively perceived stress (sum score)
Time frame: baseline and 4 weeks
Change in Clinical Global Impression (sum score)
Time frame: baseline and 15 months
Change in Clinical Global Impression (sum score)
Time frame: baseline and 6 months
Change in Clinical Global Impression (sum score)
Time frame: baseline and 12 weeks
Change in Leisure-time physical activity (sum score)
Time frame: baseline and 15 months
Change in Leisure-time physical activity (sum score)
Time frame: baseline and 6 months
Change in Leisure-time physical activity (sum score)
Time frame: baseline and 12 weeks
Change in self-efficacy (sum score)
Time frame: baseline and 15 months
Change in self-efficacy (sum score)
Time frame: baseline and 6 months
Change in self-efficacy (sum score)
Time frame: baseline and 12 weeks
Change in self-efficacy (sum score)
Time frame: baseline and 8 weeks
Change in self-efficacy (sum score)
Time frame: baseline and 4 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin Rabovsky, MD principal investigator
Psychiatric Hospital of the University of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in people with Depressive Disorder and Somatoform Disorder, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the ability to work (h/d / %) (time frame: baseline and 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2015.