Exhaustion; SyndromeNCT03360136
Open Clinical Trial of CBT-based Multiprofessional Rehabilitation for Exhaustion Disorder
A study testing Multi-professional CBT-rehabilitation in people with Exhaustion; Syndrome and Burnout, Professional, run by Uppsala University at 2 sites in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Exhaustion; Syndrome, Burnout, Professional, Burnout Syndrome
- What is being tested?
- Multi-professional CBT-rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Oct 2017to 29 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Abuse of alcohol or drugs
- Moderate-high suicidal risk
- Severe psychiatric illness (severe depression, bipolar, schizophrenia etc.)
- Untreated PTSD
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
PBM Sweden AB Globen
Stockholm, Södermanland County, 12177
PBM Sweden City
Stockholm, Uppland, 114 47
About this study
Official title: Multiprofessional Rehabilitation for Exhaustion Disorder
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.
Read the 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.
- Being tested
- Multi-professional CBT-rehabilitation
- Keywords
- Exhaustion Disorder, Burnout, Clinical Burnout
- Medical subject headings
- Syndrome, Burnout, Professional, Burnout, Psychological, Adjustment Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-professional CBT-rehabilitationBehavioural
See "Detailed description"
| Study group | Role | What they receive |
|---|---|---|
| Multi-professional CBT-rehabilitation | Other | 24 weeks CBT-based multi-professional rehabilitation. Receives: Behavioral: Multi-professional CBT-rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in exhaustion symptoms
Self-reported change in Karolinska Exhaustion Disorder Scale, 9 items
Measured: Week 12 and 24
Change from baseline to follow-up in exhaustion symptoms
Self-reported change in Karolinska Exhaustion Disorder Scale, 9 items
Measured: Week 12, 24 and 76
Change from baseline in depression
Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items
Measured: Week 12 and 24
Change from baseline to follow-up in depression
Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items
Measured: Week 12, 24 and 76
Change from baseline in anxiety
Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items
Measured: Week 12 and 24
Change from baseline to follow-up in anxiety
Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items
Measured: Week 12, 24 and 76
Change from baseline in employment rate
Sick-leave data collected from the Swedish Social Insurance Agency
Measured: Week 24
Change from baseline to follow-up in employment rate
Sick-leave data collected from the Swedish Social Insurance Agency
Measured: Week 24 and 76
Secondary outcomes (14)
Change from baseline in Quality of life
Self-reported change in EQ5D, 5 items
Measured: Week 24
Change from baseline to follow-up in Quality of life
Self-reported change in EQ5D, 5 items
Measured: Week 24 and 76
Change from baseline in insomnia symptoms
Self-reported change in Insomnia Severity Index (ISI), 7 items
Measured: Week 12 and 24
Change from baseline to follow-up in insomnia symptoms
Self-reported change in Insomnia Severity Index (ISI), 7 items
Measured: Week 12, 24 and 76
Change from baseline in Clinical Perfectionism
Self-reported change in Clinical Perfectionism Questionnaire (CPQ), 12 items
Measured: Week 12 and 24
Change from baseline to follow-up in Clinical Perfectionism
Self-reported change in Clinical Perfectionism Questionnaire (CPQ), 12 items
Measured: Week 12, 24 and 76
Change from baseline in Psychological Flexibility
Self-reported change in the Swedish Acceptance and Action Questionnaire (SAAQ), 6 items
Measured: 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
Measured: 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
Measured: 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
Measured: Week 12, 24 and 76
Change from baseline in perceived work ability
Self-rated work ability, 1 single item from Work Ability index (WAI)
Measured: 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)
Measured: Week 12, 24 and 76
Change from baseline in burnout
Self-rated burnout in Shirom Melamed Burnout Questionnaire (SMBQ), 22 items
Measured: Week 12 and 24
Change from baseline to follow-up in burnout
Self-rated burnout in Shirom Melamed Burnout Questionnaire (SMBQ), 22 items
Measured: Week 12, 24 and 76
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start1 Oct 2017
- Primary completion29 Dec 2020
- Study completion29 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Exhaustion; SyndromeStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open Clinical Trial
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- PBM Sweden AB
- Responsible party
- Sponsor
- Investigators
- Gunilla Brodda Jansen, Assoc. Proff., Study chair, Karolinska University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360136
- Sponsor's protocol ID
- 2016/1834- 31/2
- Status last verified
- Feb 2023
- First submitted
- 27 Nov 2017
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38783205van 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.
PubMed 37821913van 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.
PubMed 33153461
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiprofessional Rehabilitation for Exhaustion Disorder
- ClinicalTrials.gov ID
- NCT03360136
- Acronym / sponsor ID
- 2016/1834- 31/2
- Keywords
- Exhaustion Disorder, Burnout, Clinical Burnout
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- PBM Sweden AB
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 29 Dec 2020 (actual)
- Study completion
- 29 Dec 2020 (actual)
- First posted
- 2 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Multi-professional CBT-rehabilitation | Other | Behavioral: Multi-professional CBT-rehabilitation24 weeks CBT-based multi-professional rehabilitation. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Abuse of alcohol or drugs
- Moderate-high suicidal risk
- Severe psychiatric illness (severe depression, bipolar, schizophrenia etc.)
- Untreated PTSD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-professional CBT-rehabilitationSee "Detailed description" | Behavioural | Multi-professional CBT-rehabilitation |
Primary outcome
Change from baseline in exhaustion symptoms
Time frame: Week 12 and 24
Self-reported change in Karolinska Exhaustion Disorder Scale, 9 items
Change from baseline to follow-up in exhaustion symptoms
Time frame: Week 12, 24 and 76
Self-reported change in Karolinska Exhaustion Disorder Scale, 9 items
Change from baseline in depression
Time frame: Week 12 and 24
Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items
Change from baseline to follow-up in depression
Time frame: Week 12, 24 and 76
Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items
Change from baseline in anxiety
Time frame: Week 12 and 24
Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items
Change from baseline to follow-up in anxiety
Time frame: Week 12, 24 and 76
Self-reported change in Hospital Anxiety Depressin Scale (HADS), 14 items
Change from baseline in employment rate
Time frame: Week 24
Sick-leave data collected from the Swedish Social Insurance Agency
Change from baseline to follow-up in employment rate
Time frame: Week 24 and 76
Sick-leave data collected from the Swedish Social Insurance Agency
14 secondary outcomes
Change from baseline in Quality of life
Time frame: Week 24
Change from baseline to follow-up in Quality of life
Time frame: Week 24 and 76
Change from baseline in insomnia symptoms
Time frame: Week 12 and 24
Change from baseline to follow-up in insomnia symptoms
Time frame: Week 12, 24 and 76
Change from baseline in Clinical Perfectionism
Time frame: Week 12 and 24
Change from baseline to follow-up in Clinical Perfectionism
Time frame: Week 12, 24 and 76
Change from baseline in Psychological Flexibility
Time frame: Week 12 and 24
Change from baseline to follow-up in Psychological Flexibility
Time frame: Week 12, 24 and 76
Change from baseline in pathological worry
Time frame: Week 12 and 24
Change from baseline to follow-up in pathological worry
Time frame: Week 12, 24 and 76
Change from baseline in perceived work ability
Time frame: Week 12 and 24
Change from baseline to follow up in perceived work ability
Time frame: Week 12, 24 and 76
Change from baseline in burnout
Time frame: Week 12 and 24
Change from baseline to follow-up in burnout
Time frame: Week 12, 24 and 76
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Derived from this study: PubMed 38783205Martensson 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.
- Derived from this study: PubMed 37821913van 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.
- Derived from this study: PubMed 33153461van 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunilla Brodda Jansen, Assoc. Proff. study chair
Karolinska University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-professional CBT-rehabilitation in people with Exhaustion; Syndrome and Burnout, Professional, run by Uppsala University at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in exhaustion symptoms (time frame: Week 12 and 24). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03360136, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.