Burnout, Professional Clinical Trial
Official title:
Multiprofessional Rehabilitation for Exhaustion Disorder
Verified date | February 2023 |
Source | Uppsala University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Stress-related mental disorders are today the leading cause of long-term sick leave in Sweden, and a large part of this increase is due to Clinical burnout, in Sweden called "Exhaustion disorder" (ED). Even though clinical guidelines recommend multi-professional rehabilitation (MPR) for ED, few studies have evaluated the effects of these treatment programs in clinical practice. This large-scale open clinical trial investigates whether MPR for ED seems to alleviate symptoms of ED and if it results in return-to-work.
Status | Completed |
Enrollment | 1000 |
Est. completion date | December 29, 2020 |
Est. primary completion date | December 29, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility | Inclusion Criteria: - Confirmed exhaustion disorder according to criteria established by the Swedish National Board of Health and Welfare - 18 - 64 years of age - Considered suitable for multimodal rehabilitation in group - Self-rating of > 4,5 på SMBQ Exclusion Criteria: - Abuse of alcohol or drugs - Moderate-high suicidal risk - Severe psychiatric illness (severe depression, bipolar, schizophrenia etc.) - Untreated PTSD |
Country | Name | City | State |
---|---|---|---|
Sweden | PBM Sweden AB Globen | Stockholm | Södermanland |
Sweden | PBM Sweden City | Stockholm | Uppland |
Lead Sponsor | Collaborator |
---|---|
Uppsala University | PBM Sweden AB |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Negative Effects of psychotherapy | Self-Reported negative effects in Negative Effects Questionnaire, 32 items | at 24 week only | |
Other | Treatment credibility rating | Self-reported treatment credibility, treatment Credibility Scale (TCS), 5 items | Baseline and at 12 weeks | |
Primary | Change from baseline in exhaustion symptoms | Self-reported change in Karolinska Exhaustion Disorder Scale, 9 items | Week 12 and 24 | |
Primary | Change from baseline to follow-up in exhaustion symptoms | Self-reported change in Karolinska Exhaustion Disorder Scale, 9 items | Week 12, 24 and 76 | |
Primary | Change from baseline in depression | Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items | Week 12 and 24 | |
Primary | Change from baseline to follow-up in depression | Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items | Week 12, 24 and 76 | |
Primary | Change from baseline in anxiety | Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items | Week 12 and 24 | |
Primary | Change from baseline to follow-up in anxiety | Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items | Week 12, 24 and 76 | |
Primary | Change from baseline in employment rate | Sick-leave data collected from the Swedish Social Insurance Agency | Week 24 | |
Primary | Change from baseline to follow-up in employment rate | Sick-leave data collected from the Swedish Social Insurance Agency | Week 24 and 76 | |
Secondary | Change from baseline in Quality of life | Self-reported change in EQ5D, 5 items | Week 24 | |
Secondary | Change from baseline to follow-up in Quality of life | Self-reported change in EQ5D, 5 items | Week 24 and 76 | |
Secondary | Change from baseline in insomnia symptoms | Self-reported change in Insomnia Severity Index (ISI), 7 items | Week 12 and 24 | |
Secondary | Change from baseline to follow-up in insomnia symptoms | Self-reported change in Insomnia Severity Index (ISI), 7 items | Week 12, 24 and 76 | |
Secondary | Change from baseline in Clinical Perfectionism | Self-reported change in Clinical Perfectionism Questionnaire (CPQ), 12 items | Week 12 and 24 | |
Secondary | Change from baseline to follow-up in Clinical Perfectionism | Self-reported change in Clinical Perfectionism Questionnaire (CPQ), 12 items | Week 12, 24 and 76 | |
Secondary | Change from baseline in Psychological Flexibility | Self-reported change in the Swedish Acceptance and Action Questionnaire (SAAQ), 6 items | Week 12 and 24 | |
Secondary | Change from baseline to follow-up in Psychological Flexibility | Self-reported change in the Swedish Acceptance and Action Questionnaire (SAAQ), 6 items | Week 12, 24 and 76 | |
Secondary | Change from baseline in pathological worry | Self reported change in Penn State Worry Questionnaire ultra-brief (PSWQ-brief), 3 items | Week 12 and 24 | |
Secondary | Change from baseline to follow-up in pathological worry | Self reported change in Penn State Worry Questionnaire ultra-brief (PSWQ-brief), 3 items | Week 12, 24 and 76 | |
Secondary | Change from baseline in perceived work ability | Self-rated work ability, 1 single item from Work Ability index (WAI) | Week 12 and 24 | |
Secondary | Change from baseline to follow up in perceived work ability | Self-rated work ability, 1 single item from Work Ability index (WAI) | Week 12, 24 and 76 | |
Secondary | Change from baseline in burnout | Self-rated burnout in Shirom Melamed Burnout Questionnaire (SMBQ), 22 items | Week 12 and 24 | |
Secondary | Change from baseline to follow-up in burnout | Self-rated burnout in Shirom Melamed Burnout Questionnaire (SMBQ), 22 items | Week 12, 24 and 76 |
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