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

NCT ID: NCT03360136

Last Updated: 2023-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2020-12-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Exhaustion; Syndrome Burnout, Professional Burnout Syndrome Adjustment Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open Clinical Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Multi-professional CBT-rehabilitation

24 weeks CBT-based multi-professional rehabilitation.

Group Type OTHER

Multi-professional CBT-rehabilitation

Intervention Type BEHAVIORAL

See "Detailed description"

Interventions

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Multi-professional CBT-rehabilitation

See "Detailed description"

Intervention Type BEHAVIORAL

Eligibility Criteria

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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 pÄ SMBQ

Exclusion Criteria

* Abuse of alcohol or drugs
* Moderate-high suicidal risk
* Severe psychiatric illness (severe depression, bipolar, schizophrenia etc.)
* Untreated PTSD
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PBM Sweden AB

UNKNOWN

Sponsor Role collaborator

Uppsala University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gunilla Brodda Jansen, Assoc. Proff.

Role: STUDY_CHAIR

Karolinska University

Locations

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PBM Sweden AB Globen

Stockholm, Södermanland County, Sweden

Site Status

PBM Sweden City

Stockholm, Uppland, Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 38783205 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37821913 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33153461 (View on PubMed)

Other Identifiers

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2016/1834- 31/2

Identifier Type: -

Identifier Source: org_study_id

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