Open Clinical Trial of CBT-based Multiprofessional Rehabilitation for Exhaustion Disorder

Sponsor

Uppsala University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03360136

Collaborator

PBM Sweden AB (Other)

400

Enrollment

Locations

Arm

38.9

Anticipated Duration (Months)

200

Patients Per Site

5.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Exhaustion; Syndrome Burnout, Professional Burnout Syndrome Adjustment Disorders	Behavioral: Multi-professional CBT-rehabilitation	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Open Clinical TrialOpen Clinical Trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Multiprofessional Rehabilitation for Exhaustion Disorder

Actual Study Start Date :

Oct 1, 2017

Anticipated Primary Completion Date :

Dec 29, 2020

Anticipated Study Completion Date :

Dec 29, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: Multi-professional CBT-rehabilitation 24 weeks CBT-based multi-professional rehabilitation.	Behavioral: Multi-professional CBT-rehabilitation See "Detailed description"

Arm

Intervention/Treatment

Other: Multi-professional CBT-rehabilitation

24 weeks CBT-based multi-professional rehabilitation.

Behavioral: Multi-professional CBT-rehabilitation

See "Detailed description"

Outcome Measures

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
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 in perceived work ability [Week 12 and 24]
Self-rated work ability, 1 single item from Work Ability index (WAI)
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

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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