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| Name | Class |
|---|---|
| PBM Sweden AB | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multi-professional CBT-rehabilitation | Other | 24 weeks CBT-based multi-professional rehabilitation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-professional CBT-rehabilitation | Behavioral | See "Detailed description" |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in exhaustion symptoms | Self-reported change in Karolinska Exhaustion Disorder Scale, 9 items | Week 12 and 24 |
| Change from baseline to follow-up in exhaustion symptoms | Self-reported change in Karolinska Exhaustion Disorder Scale, 9 items | Week 12, 24 and 76 |
| Change from baseline in depression | Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items | Week 12 and 24 |
| Change from baseline to follow-up in depression | Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items | Week 12, 24 and 76 |
| Change from baseline in anxiety | Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items | Week 12 and 24 |
| Change from baseline to follow-up in anxiety | Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items | Week 12, 24 and 76 |
| Change from baseline in employment rate | Sick-leave data collected from the Swedish Social Insurance Agency | Week 24 |
| Change from baseline to follow-up in employment rate |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Quality of life | Self-reported change in EQ5D, 5 items | Week 24 |
| Change from baseline to follow-up in Quality of life | Self-reported change in EQ5D, 5 items |
| Measure | Description | Time Frame |
|---|---|---|
| Negative Effects of psychotherapy | Self-Reported negative effects in Negative Effects Questionnaire, 32 items | at 24 week only |
| Treatment credibility rating | Self-reported treatment credibility, treatment Credibility Scale (TCS), 5 items |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gunilla Brodda Jansen, Assoc. Proff. | Karolinska University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PBM Sweden AB Globen | Stockholm | Södermanland County | 12177 | Sweden | ||
| PBM Sweden City |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38783205 | Derived | Martensson G, Johansson F, Buhrman M, Ahs F, Clason van de Leur J. A network analysis of exhaustion disorder symptoms throughout treatment. BMC Psychiatry. 2024 May 23;24(1):389. doi: 10.1186/s12888-024-05842-9. | |
| 37821913 | Derived | van de Leur JC, Buhrman M, Wallby K, Karlstrom A, Johansson F. Associations between improvements in psychological variables and subsequent sick leave among persons receiving a multimodal intervention for exhaustion disorder. BMC Public Health. 2023 Oct 11;23(1):1976. doi: 10.1186/s12889-023-16799-x. |
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| ID | Term |
|---|---|
| D013577 | Syndrome |
| D002055 | Burnout, Professional |
| D000077062 | Burnout, Psychological |
| D000275 | Adjustment Disorders |
| ID | Term |
|---|---|
| D004194 | Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000073397 | Occupational Stress |
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Open Clinical Trial
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Sick-leave data collected from the Swedish Social Insurance Agency
| Week 24 and 76 |
| Week 24 and 76 |
| Change from baseline in insomnia symptoms | Self-reported change in Insomnia Severity Index (ISI), 7 items | Week 12 and 24 |
| Change from baseline to follow-up in insomnia symptoms | Self-reported change in Insomnia Severity Index (ISI), 7 items | Week 12, 24 and 76 |
| Change from baseline in Clinical Perfectionism | Self-reported change in Clinical Perfectionism Questionnaire (CPQ), 12 items | Week 12 and 24 |
| Change from baseline to follow-up in Clinical Perfectionism | Self-reported change in Clinical Perfectionism Questionnaire (CPQ), 12 items | Week 12, 24 and 76 |
| Change from baseline in Psychological Flexibility | Self-reported change in the Swedish Acceptance and Action Questionnaire (SAAQ), 6 items | 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 | 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 | 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 | Week 12, 24 and 76 |
| Change from baseline in perceived work ability | Self-rated work ability, 1 single item from Work Ability index (WAI) | 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) | Week 12, 24 and 76 |
| Change from baseline in burnout | Self-rated burnout in Shirom Melamed Burnout Questionnaire (SMBQ), 22 items | Week 12 and 24 |
| Change from baseline to follow-up in burnout | Self-rated burnout in Shirom Melamed Burnout Questionnaire (SMBQ), 22 items | Week 12, 24 and 76 |
| Baseline and at 12 weeks |
| Stockholm |
| Uppland |
| 114 47 |
| Sweden |
| 33153461 | Derived | van de Leur JC, Buhrman M, Ahs F, Rozental A, Jansen GB. Standardized multimodal intervention for stress-induced exhaustion disorder: an open trial in a clinical setting. BMC Psychiatry. 2020 Nov 5;20(1):526. doi: 10.1186/s12888-020-02907-3. |
| D009784 | Occupational Diseases |
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |