Adjustment Disorders, Burnout, Professional, Burnout Syndrome, Exhaustion; Syndrome
Conditions
Keywords
Exhaustion Disorder, Burnout, Clinical Burnout
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMulti-professional CBT-rehabilitation
See Detailed description
Sponsors
PBM Sweden AB
Uppsala University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open Clinical Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in employment rate | Week 24 | Sick-leave data collected from the Swedish Social Insurance Agency |
| Change from baseline to follow-up in employment rate | Week 24 and 76 | Sick-leave data collected from the Swedish Social Insurance Agency |
| Change from baseline in exhaustion symptoms | Week 12 and 24 | Self-reported change in Karolinska Exhaustion Disorder Scale, 9 items |
| Change from baseline to follow-up in exhaustion symptoms | Week 12, 24 and 76 | Self-reported change in Karolinska Exhaustion Disorder Scale, 9 items |
| Change from baseline in depression | Week 12 and 24 | Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items |
| Change from baseline to follow-up in depression | Week 12, 24 and 76 | Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items |
| Change from baseline in anxiety | Week 12 and 24 | Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items |
| Change from baseline to follow-up in anxiety | Week 12, 24 and 76 | Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline to follow-up in Psychological Flexibility | Week 12, 24 and 76 | Self-reported change in the Swedish Acceptance and Action Questionnaire (SAAQ), 6 items |
| Change from baseline in pathological worry | Week 12 and 24 | Self reported change in Penn State Worry Questionnaire ultra-brief (PSWQ-brief), 3 items |
| Change from baseline to follow-up in pathological worry | Week 12, 24 and 76 | Self reported change in Penn State Worry Questionnaire ultra-brief (PSWQ-brief), 3 items |
| Change from baseline to follow up in perceived work ability | Week 12, 24 and 76 | Self-rated work ability, 1 single item from Work Ability index (WAI) |
| Change from baseline in burnout | Week 12 and 24 | Self-rated burnout in Shirom Melamed Burnout Questionnaire (SMBQ), 22 items |
| Change from baseline to follow-up in burnout | Week 12, 24 and 76 | Self-rated burnout in Shirom Melamed Burnout Questionnaire (SMBQ), 22 items |
| Change from baseline in perceived work ability | Week 12 and 24 | Self-rated work ability, 1 single item from Work Ability index (WAI) |
| Change from baseline in Quality of life | Week 24 | Self-reported change in EQ5D, 5 items |
| Change from baseline to follow-up in Quality of life | Week 24 and 76 | Self-reported change in EQ5D, 5 items |
| Change from baseline in insomnia symptoms | Week 12 and 24 | Self-reported change in Insomnia Severity Index (ISI), 7 items |
| Change from baseline to follow-up in insomnia symptoms | Week 12, 24 and 76 | Self-reported change in Insomnia Severity Index (ISI), 7 items |
| Change from baseline in Clinical Perfectionism | Week 12 and 24 | Self-reported change in Clinical Perfectionism Questionnaire (CPQ), 12 items |
| Change from baseline to follow-up in Clinical Perfectionism | Week 12, 24 and 76 | Self-reported change in Clinical Perfectionism Questionnaire (CPQ), 12 items |
| Change from baseline in Psychological Flexibility | Week 12 and 24 | Self-reported change in the Swedish Acceptance and Action Questionnaire (SAAQ), 6 items |
Other
| Measure | Time frame | Description |
|---|---|---|
| Negative Effects of psychotherapy | at 24 week only | Self-Reported negative effects in Negative Effects Questionnaire, 32 items |
| Treatment credibility rating | Baseline and at 12 weeks | Self-reported treatment credibility, treatment Credibility Scale (TCS), 5 items |
Countries
Sweden
Outcome results
None listed