Clinical trial NCT05811156: A Biopsychosocial Treatment for Exhaustion Due to Persistent Non-traumatic Stress
Official title: A Biopsychosocial Treatment Model for Exhaustion Due to Persistent Non-traumatic Stress, Administered Through a Multimodal Digital Intervention - A Pilot Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Exhaustion Disorder
Clinical Burnout
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: PBM Sweden AB
First posted: 2023-04-13
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with SED who are accepted to treatment for a Multimodal digital intervention within a specialized healthcare initiative called "The healthcare choice for treatment of longstanding pain with or without comorbidity, and SED."

Brief summary: Currently, there are no established theoretical models for developing and maintaining Exhaustion due to persistent non-traumatic stress (ENTS). Therefore, the current pilot study aims to evaluate a Multimodal hybrid intervention built around an internet-delivered cognitive behavioral therapy based on a new biopsychosocial treatment model of ENTS.

Detailed description: Since 2009 long term sick-leave rates due to mental disorders have been increasing in Sweden and are today the leading cause of long-term sick leave. Exhaustion due to persistent non-traumatic stress (ENTS) accounts for most of this increase. Unfortunately, despite several published treatment studies, no evidence-based treatments exist for ENTS, and little is still known about the focus of treatment.

Currently, there are no established theoretical models for the development and maintenance of ENTS. Many of the published clinical ENTS trials consist of long (6 months or more) Multimodal interventions (MMI) containing various medical, psychological, and physiotherapeutic methods with a low degree of understanding of what components are critical for treatment success. Even if ENTS patients participating in MMI report symptom improvements and work resumption, MMI is generally personnel intensive and challenging to administer. These factors increase the risk of extended healthcare lead times and obstruct treatment dissemination.

Considering the increasing sick-leave rates due to ENTS, there is an apparent need for more accessible treatments based on pronounced theoretical models focusing on specific change processes. Therefore, the current pilot study aims to evaluate a hybrid MMI built around an internet-delivered cognitive behavioral therapy based on a new biopsychosocial treatment model of ENTS.

Outcome measures will be collected before and after treatment and at three and six-month follow-ups. Weekly measurements of putative processes of change will also be collected. The current study aims to evaluate whether this more restricted and theoretically coherent hybrid MMI shows promising results before we test the treatment solely as a cognitive behavioral therapy via the internet in a randomized controlled trial.

Eligibility criteria: Inclusion Criteria:

* Referred for Stress-induced exhaustion disorder (SED)
* Fulfilled the criteria for SED
* Scored \> 5 on the Shirom-Melamed Burnout Questionnaire (a cut-off determined by the Health Care Services Stockholm County)
* Scored 19 \> on Karolinska Exhaustion Disorder Scale
* In need of sick-leave due to SED d) access to internet

Exclusion Criteria:

* 100 % sick leave of more than one year
* abuse of alcohol or drugs
* participating in any other form of MMI
* severe depression, moderate/high risk of suicide, psychosis, or untreated PTSD.

Primary outcomes:
measure: Karolinska Exhaustion Disorder Scale
timeFrame: Baseline measurement, weekly (up to 12 weeks) change during from treatment baseline to immediately after treatment, change between immediately after treatment and 3 months follow-up, change between 3 months follow up and 6 months follow-up
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, change between baseline and immediately after treatment, change between immediately after treatment and 6 months follow-up
measure: Flourishing scale
timeFrame: Baseline, change between baseline and immediately after treatment, change between immediately after treatment and 6 months follow-up
measure: The current percentage of working time and sick-leave
timeFrame: Baseline, change between baseline and immediately after treatment, change between immediately after treatment and 6 months follow-up
measure: WHO Disability Assessment Schedule 2.0-12 (Rated by independent rater)
timeFrame: Baseline, change between baseline and immediately after treatment, change between immediately after treatment and 6 months follow-up
measure: Client satisfaction Questionnaire- 8
timeFrame: immediately after treatment
measure: Negative Effects Questionnaire
timeFrame: immediately after treatment
Other outcomes:
measure: Perfectionistic concerns, sub scale av Clinical Perfectionism Questionnaire
timeFrame: weekly (for up to 12 weeks) change during from treatment baseline to end of treatment,
measure: Penn-state worry questionnaire-brief
timeFrame: weekly (for up to 12 weeks) change during from treatment baseline to end of treatment,
measure: Psy-flex
timeFrame: weekly (for up to 12 weeks) change during from treatment baseline to end of treatment,
measure: Insomnia severity index (3-item version)
timeFrame: weekly (for up to 12 weeks) change during from treatment baseline to end of treatment,
Locations:
city: Stockholm
country: Sweden
facility: PBM Sweden AB Globen
state: Södermanland
Study officials:
References: