A Biopsychosocial Treatment for Exhaustion Due to Persistent Non-traumatic Stress

Exhaustion Disorder Clinical Trial

Official title:

A Biopsychosocial Treatment Model for Exhaustion Due to Persistent Non-traumatic Stress, Administered Through a Multimodal Digital Intervention - A Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05811156
• Other study ID #: 2022-06789-01
• Status: Active, not recruiting
• Start date: February 14, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: February 2024
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 26
• Est. completion date: July 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Burnout, Psychological
• Exhaustion Disorder

Intervention

Behavioral:
• Hybrid Multimodal digital intervention
Multimodal digital intervention, including an internet-delivered CBT treatment based on a biopsychosocial exposure treatment, tailored explicitly for Exhaustion due to persistent non-traumatic stress.

Locations

Country	Name	City	State
Sweden	PBM Sweden AB Globen	Stockholm	Södermanland

Sponsors (2)

Lead Sponsor	Collaborator
Uppsala University	PBM Sweden AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Perfectionistic concerns, sub scale av Clinical Perfectionism Questionnaire	A measure of perfectionistic concerns, a putative process variable in treatment	weekly (for up to 12 weeks) change during from treatment baseline to end of treatment,
Other	Penn-state worry questionnaire-brief	A measure of pathological worry, a putative process variable in treatment	weekly (for up to 12 weeks) change during from treatment baseline to end of treatment,
Other	Psy-flex	A measure of psychological flexibility, a putative process variable in treatment	weekly (for up to 12 weeks) change during from treatment baseline to end of treatment,
Other	Insomnia severity index (3-item version)	A measure of psychological dimensions of insomnia, a putative process variable in treatment	weekly (for up to 12 weeks) change during from treatment baseline to end of treatment,
Primary	Karolinska Exhaustion Disorder Scale	Measures symptoms of Exhaustion. It is specifically tailored to measure symptoms from the Swedish diagnosis of Stress-induced exhaustion disorder.	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	Hospital Anxiety and Depression Scale (HADS)	Measure of depression and anxiety	Baseline, change between baseline and immediately after treatment, change between immediately after treatment and 6 months follow-up
Secondary	Flourishing scale	brief 8-item summary measure of the respondent's self-perceived success in important areas such as relationships, self-esteem, purpose, and optimism	Baseline, change between baseline and immediately after treatment, change between immediately after treatment and 6 months follow-up
Secondary	The current percentage of working time and sick-leave	Rated by independent rater through telephone interview	Baseline, change between baseline and immediately after treatment, change between immediately after treatment and 6 months follow-up
Secondary	WHO Disability Assessment Schedule 2.0-12 (Rated by independent rater)	Measures difficulties due to health conditions	Baseline, change between baseline and immediately after treatment, change between immediately after treatment and 6 months follow-up
Secondary	Client satisfaction Questionnaire- 8	Measure of treatment satisfaction	immediately after treatment
Secondary	Negative Effects Questionnaire	Measures negative effects attributable to treatment	immediately after treatment