An interventional study of Multi-professional CBT-rehabilitation in Exhaustion; Syndrome, Burnout, Professional and Burnout Syndrome, sponsored by Uppsala University. Completed at 2 sites in Sweden. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2023-02-21.
Sponsored by Uppsala University · Not applicable, Interventional, and Treatment
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.
This study is carried out at two specialized stress rehabilitation centers in Stockholm. All patients included in the clinics stress rehabilitation program are asked to participate in the study and are recruited consecutively from October 2017 throughout December 2018. An estimate of 400 patients will be included. The treatment program is a 24-week Multiprofessional standardized CBT-rehabilitation consisting of a nine-session CBT group treatment (stress management) followed by a seven-session group treatment in applied relaxation. Parallel to the group treatments patients receives nine sessions of individual CBT, three visits to an MD (for medication, follow-up, and sick-listing), two individual sessions to a physiotherapist and a three session-exercise group. Also, vocational measures are taken through rehabilitation meetings together with the patient's employer (if an employer exists). Primary treatment outcomes will be return-to-work (RTW) and symptoms of ED, anxiety, and depression. Secondary treatment outcomes will be quality of life, pathological worry, psychological flexibility, clinical perfectionism, insomnia, burnout, and symptoms. Predictors of symptom development and RTW will be explored. Also, comorbidity of chronic pain, negative effects of psychotherapy and treatment credibility will be investigated.
216 studies on the registry are indexed under Burnout, Professional; 33 are open to participants now.
This study's enrollment of 1,000 is above the median of 80 across 161 interventional studies indexed under Burnout, Professional.
Browse Burnout, Professional studies →Uppsala University is the lead sponsor of 390 studies on the registry; 86 are open to participants now.
Compared within Burnout, Professional, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Syndrome. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
24 weeks CBT-based multi-professional rehabilitation.
Behavioral: Multi-professional CBT-rehabilitation
See "Detailed description"
Change from baseline in exhaustion symptoms
Self-reported change in Karolinska Exhaustion Disorder Scale, 9 items
Time frame: Week 12 and 24
Change from baseline to follow-up in exhaustion symptoms
Self-reported change in Karolinska Exhaustion Disorder Scale, 9 items
Time frame: Week 12, 24 and 76
Change from baseline in depression
Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items
Time frame: Week 12 and 24
Change from baseline to follow-up in depression
Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items
Time frame: Week 12, 24 and 76
Change from baseline in anxiety
Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items
Time frame: Week 12 and 24
Change from baseline to follow-up in anxiety
Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items
Time frame: Week 12, 24 and 76
Change from baseline in employment rate
Sick-leave data collected from the Swedish Social Insurance Agency
Time frame: Week 24
Change from baseline to follow-up in employment rate
Sick-leave data collected from the Swedish Social Insurance Agency
Time frame: Week 24 and 76
Change from baseline in Quality of life
Self-reported change in EQ5D, 5 items
Time frame: Week 24
Change from baseline to follow-up in Quality of life
Self-reported change in EQ5D, 5 items
Time frame: Week 24 and 76
Change from baseline in insomnia symptoms
Self-reported change in Insomnia Severity Index (ISI), 7 items
Time frame: Week 12 and 24
Change from baseline to follow-up in insomnia symptoms
Self-reported change in Insomnia Severity Index (ISI), 7 items
Time frame: Week 12, 24 and 76
Change from baseline in Clinical Perfectionism
Self-reported change in Clinical Perfectionism Questionnaire (CPQ), 12 items
Time frame: Week 12 and 24
Change from baseline to follow-up in Clinical Perfectionism
Self-reported change in Clinical Perfectionism Questionnaire (CPQ), 12 items
Time frame: Week 12, 24 and 76
Change from baseline in Psychological Flexibility
Self-reported change in the Swedish Acceptance and Action Questionnaire (SAAQ), 6 items
Time frame: Week 12 and 24
Change from baseline to follow-up in Psychological Flexibility
Self-reported change in the Swedish Acceptance and Action Questionnaire (SAAQ), 6 items
Time frame: Week 12, 24 and 76
Change from baseline in pathological worry
Self reported change in Penn State Worry Questionnaire ultra-brief (PSWQ-brief), 3 items
Time frame: Week 12 and 24
Change from baseline to follow-up in pathological worry
Self reported change in Penn State Worry Questionnaire ultra-brief (PSWQ-brief), 3 items
Time frame: Week 12, 24 and 76
Change from baseline in perceived work ability
Self-rated work ability, 1 single item from Work Ability index (WAI)
Time frame: Week 12 and 24
Change from baseline to follow up in perceived work ability
Self-rated work ability, 1 single item from Work Ability index (WAI)
Time frame: Week 12, 24 and 76
Change from baseline in burnout
Self-rated burnout in Shirom Melamed Burnout Questionnaire (SMBQ), 22 items
Time frame: Week 12 and 24
Change from baseline to follow-up in burnout
Self-rated burnout in Shirom Melamed Burnout Questionnaire (SMBQ), 22 items
Time frame: Week 12, 24 and 76
Negative Effects of psychotherapy
Self-Reported negative effects in Negative Effects Questionnaire, 32 items
Time frame: at 24 week only
Treatment credibility rating
Self-reported treatment credibility, treatment Credibility Scale (TCS), 5 items
Time frame: Baseline and at 12 weeks
Plan to share: Undecided
Ran from Oct 2017 to primary completion in Dec 2020, 38 months.
Of 128 non-industry interventional studies with no phase under Burnout, Professional, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 22. This study's 38 months is above that.
Counting every sponsor, half of 132 studies reached it within 11 months; a quarter within 6 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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