Open Clinical Trial of CBT-based Multiprofessional Rehabilitation for Exhaustion Disorder
Primary Purpose
Exhaustion; Syndrome, Burnout, Professional, Burnout Syndrome
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Multi-professional CBT-rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Exhaustion; Syndrome focused on measuring Exhaustion Disorder, Burnout, Clinical Burnout
Eligibility Criteria
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
Sites / Locations
- PBM Sweden AB Globen
- PBM Sweden City
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Multi-professional CBT-rehabilitation
Arm Description
24 weeks CBT-based multi-professional rehabilitation.
Outcomes
Primary Outcome Measures
Change from baseline in exhaustion symptoms
Self-reported change in Karolinska Exhaustion Disorder Scale, 9 items
Change from baseline to follow-up in exhaustion symptoms
Self-reported change in Karolinska Exhaustion Disorder Scale, 9 items
Change from baseline in depression
Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items
Change from baseline to follow-up in depression
Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items
Change from baseline in anxiety
Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items
Change from baseline to follow-up in anxiety
Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items
Change from baseline in employment rate
Sick-leave data collected from the Swedish Social Insurance Agency
Change from baseline to follow-up in employment rate
Sick-leave data collected from the Swedish Social Insurance Agency
Secondary Outcome Measures
Change from baseline in Quality of life
Self-reported change in EQ5D, 5 items
Change from baseline to follow-up in Quality of life
Self-reported change in EQ5D, 5 items
Change from baseline in insomnia symptoms
Self-reported change in Insomnia Severity Index (ISI), 7 items
Change from baseline to follow-up in insomnia symptoms
Self-reported change in Insomnia Severity Index (ISI), 7 items
Change from baseline in Clinical Perfectionism
Self-reported change in Clinical Perfectionism Questionnaire (CPQ), 12 items
Change from baseline to follow-up in Clinical Perfectionism
Self-reported change in Clinical Perfectionism Questionnaire (CPQ), 12 items
Change from baseline in Psychological Flexibility
Self-reported change in the Swedish Acceptance and Action Questionnaire (SAAQ), 6 items
Change from baseline to follow-up in Psychological Flexibility
Self-reported change in the Swedish Acceptance and Action Questionnaire (SAAQ), 6 items
Change from baseline in pathological worry
Self reported change in Penn State Worry Questionnaire ultra-brief (PSWQ-brief), 3 items
Change from baseline to follow-up in pathological worry
Self reported change in Penn State Worry Questionnaire ultra-brief (PSWQ-brief), 3 items
Change from baseline in perceived work ability
Self-rated work ability, 1 single item from Work Ability index (WAI)
Change from baseline to follow up in perceived work ability
Self-rated work ability, 1 single item from Work Ability index (WAI)
Change from baseline in burnout
Self-rated burnout in Shirom Melamed Burnout Questionnaire (SMBQ), 22 items
Change from baseline to follow-up in burnout
Self-rated burnout in Shirom Melamed Burnout Questionnaire (SMBQ), 22 items
Full Information
NCT ID
NCT03360136
First Posted
November 27, 2017
Last Updated
February 17, 2023
Sponsor
Uppsala University
Collaborators
PBM Sweden AB
1. Study Identification
Unique Protocol Identification Number
NCT03360136
Brief Title
Open Clinical Trial of CBT-based Multiprofessional Rehabilitation for Exhaustion Disorder
Official Title
Multiprofessional Rehabilitation for Exhaustion Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
December 29, 2020 (Actual)
Study Completion Date
December 29, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University
Collaborators
PBM Sweden AB
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exhaustion; Syndrome, Burnout, Professional, Burnout Syndrome, Adjustment Disorders
Keywords
Exhaustion Disorder, Burnout, Clinical Burnout
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Open Clinical Trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multi-professional CBT-rehabilitation
Arm Type
Other
Arm Description
24 weeks CBT-based multi-professional rehabilitation.
Intervention Type
Behavioral
Intervention Name(s)
Multi-professional CBT-rehabilitation
Intervention Description
See "Detailed description"
Primary Outcome Measure Information:
Title
Change from baseline in exhaustion symptoms
Description
Self-reported change in Karolinska Exhaustion Disorder Scale, 9 items
Time Frame
Week 12 and 24
Title
Change from baseline to follow-up in exhaustion symptoms
Description
Self-reported change in Karolinska Exhaustion Disorder Scale, 9 items
Time Frame
Week 12, 24 and 76
Title
Change from baseline in depression
Description
Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items
Time Frame
Week 12 and 24
Title
Change from baseline to follow-up in depression
Description
Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items
Time Frame
Week 12, 24 and 76
Title
Change from baseline in anxiety
Description
Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items
Time Frame
Week 12 and 24
Title
Change from baseline to follow-up in anxiety
Description
Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items
Time Frame
Week 12, 24 and 76
Title
Change from baseline in employment rate
Description
Sick-leave data collected from the Swedish Social Insurance Agency
Time Frame
Week 24
Title
Change from baseline to follow-up in employment rate
Description
Sick-leave data collected from the Swedish Social Insurance Agency
Time Frame
Week 24 and 76
Secondary Outcome Measure Information:
Title
Change from baseline in Quality of life
Description
Self-reported change in EQ5D, 5 items
Time Frame
Week 24
Title
Change from baseline to follow-up in Quality of life
Description
Self-reported change in EQ5D, 5 items
Time Frame
Week 24 and 76
Title
Change from baseline in insomnia symptoms
Description
Self-reported change in Insomnia Severity Index (ISI), 7 items
Time Frame
Week 12 and 24
Title
Change from baseline to follow-up in insomnia symptoms
Description
Self-reported change in Insomnia Severity Index (ISI), 7 items
Time Frame
Week 12, 24 and 76
Title
Change from baseline in Clinical Perfectionism
Description
Self-reported change in Clinical Perfectionism Questionnaire (CPQ), 12 items
Time Frame
Week 12 and 24
Title
Change from baseline to follow-up in Clinical Perfectionism
Description
Self-reported change in Clinical Perfectionism Questionnaire (CPQ), 12 items
Time Frame
Week 12, 24 and 76
Title
Change from baseline in Psychological Flexibility
Description
Self-reported change in the Swedish Acceptance and Action Questionnaire (SAAQ), 6 items
Time Frame
Week 12 and 24
Title
Change from baseline to follow-up in Psychological Flexibility
Description
Self-reported change in the Swedish Acceptance and Action Questionnaire (SAAQ), 6 items
Time Frame
Week 12, 24 and 76
Title
Change from baseline in pathological worry
Description
Self reported change in Penn State Worry Questionnaire ultra-brief (PSWQ-brief), 3 items
Time Frame
Week 12 and 24
Title
Change from baseline to follow-up in pathological worry
Description
Self reported change in Penn State Worry Questionnaire ultra-brief (PSWQ-brief), 3 items
Time Frame
Week 12, 24 and 76
Title
Change from baseline in perceived work ability
Description
Self-rated work ability, 1 single item from Work Ability index (WAI)
Time Frame
Week 12 and 24
Title
Change from baseline to follow up in perceived work ability
Description
Self-rated work ability, 1 single item from Work Ability index (WAI)
Time Frame
Week 12, 24 and 76
Title
Change from baseline in burnout
Description
Self-rated burnout in Shirom Melamed Burnout Questionnaire (SMBQ), 22 items
Time Frame
Week 12 and 24
Title
Change from baseline to follow-up in burnout
Description
Self-rated burnout in Shirom Melamed Burnout Questionnaire (SMBQ), 22 items
Time Frame
Week 12, 24 and 76
Other Pre-specified Outcome Measures:
Title
Negative Effects of psychotherapy
Description
Self-Reported negative effects in Negative Effects Questionnaire, 32 items
Time Frame
at 24 week only
Title
Treatment credibility rating
Description
Self-reported treatment credibility, treatment Credibility Scale (TCS), 5 items
Time Frame
Baseline and at 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gunilla Brodda Jansen, Assoc. Proff.
Organizational Affiliation
Karolinska University
Official's Role
Study Chair
Facility Information:
Facility Name
PBM Sweden AB Globen
City
Stockholm
State/Province
Södermanland
ZIP/Postal Code
12177
Country
Sweden
Facility Name
PBM Sweden City
City
Stockholm
State/Province
Uppland
ZIP/Postal Code
114 47
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33153461
Citation
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.
Results Reference
derived
Learn more about this trial
Open Clinical Trial of CBT-based Multiprofessional Rehabilitation for Exhaustion Disorder
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