Work-focused Versus Generic Internet-based Interventions for Stress-related Disorders

NCT05240495 | Completed

• 1 other identifier: iStress3
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief Summary

Objective The aim of the current study was to evaluate the efficacy of an internet-based cognitive-behavioural intervention for stress-related disorders integrating work-related aspects (W-iCBT), compared with a generic iCBT and a waitlist control group (WLC). Method In this trial, 182 employees, mainly employed in the healthcare, IT or educational sector, who fulfilled the criteria for a stress-related disorder, were randomized to a 10-week W-iCBT (n=61), generic iCBT (n=61) or WLC (n=60). Self-rated questionnaires on perceived stress, burnout, exhaustion and other mental-health and work-related outcomes were administered pre- and post-treatment, and at a six- and 12-months follow-up. Results Compared to WLC, participants of the W-iCBT and iCBT showed equal and significant reduction on the primary outcome (SMBQ) from pre to post assessment (d=1.00 and 0.83 respectively) and at the six months follow-up (d=0.74 and 0.74). Significant moderate-to-large effect sizes were also found on the secondary health and work-related outcomes. The W-iCBT was the only group who exhibited significant effects on work ability and sickness absence. Sickness absence was 445 days (7.29 days per participant) lower compared to the WLC and 324 days (5.31 days per participant) compared to the iCBT intervention. However, no significant differences were found on work experience or long-term sick leave. Conclusion The work-focused and generic iCBT interventions proved to be superior and equally effective compared to the control condition in reducing chronic stress and several other mental health related symptoms. Interestingly, effects on work ability and sickness absence were only seen between the work-focused iCBT intervention and the WLC. These preliminary results are promising, as they provide further evidence that treatments that integrate work-aspects has great potential in accelerating both recovery and reduce sickness absence due to stress-related disorders.

Conditions

Adjustment Disorders

Keywords

Stress; Burnout; Exhaustion; Work-focused; Internet-based; Sickness absence

Outcome Measures

Primary Outcomes (1)

• Shirom-Melamed Burnout Questionnaire

  The Shirom-Melamed Burnout Questionnaire (SMBQ; Melamed et al., 1992, 1999), is a 22-item scale (graded 1-7) used to assess different aspects of chronic stress and burnout (Physical Fatigue, Cognitive weariness, Tension, and Listlessness). This scale correlates significantly \[58\] with other well established questionnaires measuring burnout, e.g., Maslach Burnout Inventory \[59\]. The SMBQ has an internal consistency reliability (Cronbach's alpha) of .92. \[56\].

  Change between baseline and end of treatment after ten weeks and follow-up at 6 month and 1 year after treatment

Secondary Outcomes (11)

• Perceived Stress Scale

  Change between baseline and end of treatment after ten weeks and follow-up at 6 month and 1 year after treatment

• Karolinska Exhaustion Disorder Scale

  Change between baseline and end of treatment after ten weeks and follow-up at 6 month and 1 year after treatment

• Montgomery Åsberg Depression Rating Scale

  Change between baseline and end of treatment after ten weeks and follow-up at 6 month and 1 year after treatment

• Generalised Anxiety Disorder Scale

  Change between baseline and end of treatment after ten weeks and follow-up at 6 month and 1 year after treatment

• Insomnia Severity Index

  Change between baseline and end of treatment after ten weeks and follow-up at 6 month and 1 year after treatment

Study Arms (3)

Internet-based Cognitive-behavioural therapy group (n=61)

EXPERIMENTAL

TThe generic iCBT program was based on contemporary CBT techniques adapted for stress-related disorders, and recovery from work training inspired by Hahn et al. \[2011\]. The iCBT consisted of ten modules distributed over ten weeks, with modules lasting 60-120 min per week. In the first module (introduction), the participants received information about the outline of the program, stress physiology and defined individual treatment goals. During the second week participants were introduced to different recovery techniques and applied relaxation. The third and fourth week contained exercises related to behavioral activation, work-home balance, and values-based action skills. Between weeks five and ten, participants were able to choose between different exposure-based exercises. In addition, participants with insomnia could choose to focus on sleep management.

Behavioral: Internet-based Cognitive-behavioural therapy

Internet-based Work-focused Cognitive-behavioural therapy group (n=61)

EXPERIMENTAL

The internet-based and work-focused cognitive-behavioral therapy (W-iCBT) consisted of the generic treatment for stress-related disorders (iCBT), plus components focusing on work and return-to-work. These sections were integrated and represented in each of the ten modules. Work-focused CBT is built on the same conceptual framework as regular CBT. For example, CBT principles are used to change the appraisal of work stressors, change the dysfunctional behaviour, or increase health promoting behaviours. The CBT principal, exposure, is given special attention. Gradual exposure can help individuals develop more effective coping skills when dealing with work-related stressors (e.g., assertiveness) and stimulate gradual return to the work setting for individuals on a long-term sick leave \[27\].

Behavioral: Internet-based Cognitive-behavioural therapy; Behavioral: Work-focused Cognitive-behavioural therapy

Wait-list control group (n=60)

NO INTERVENTION

Wait-list control group received equal and parallell assessment and eligibility procedure as the two experimental konditions. Wait-list control group gained access to iCBT/W-iCBT program after the six months follow-up.

Interventions

Internet-based Cognitive-behavioural therapy BEHAVIORAL

Internet-based Cognitive-behavioural therapy protocol was based on contemporary CBT techniques adapted for adjustment disorders, and recovery from work training inspired by Hahn et al. \[50\]. The iCBT program consisted of ten modules distributed over ten weeks, with modules lasting 60-120 min per week.

Internet-based Cognitive-behavioural therapy group (n=61); Internet-based Work-focused Cognitive-behavioural therapy group (n=61)

Work-focused Cognitive-behavioural therapy BEHAVIORAL

The Work-focused Cognitive-behavioural therapy consisted of the exact generic iCBT-modules included in the first experimental group and of additional work-focused modules adapted for adjustment disorders. The W-iCBT added about 2-3 regular pages compared to the generic iCBT.

Internet-based Work-focused Cognitive-behavioural therapy group (n=61)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants were employees who had volunteered for the trial. To be eligible for the study, they had to fulfil the criteria for an adjustment disorder described in the subdivision F43 Reaction to severe stress, and adjustment disorders of the ICD-10. The diagnosis was established through telephone interviews using the Mini International Neuropsychiatric Interview, additional criteria from the International Statistical Classification of Diseases and Related Health Problems (ICD-10; 25), and national diagnostic guidelines regarding stress-related disorders.
• In addition to an adjustment disorder, participants had to fulfil the following criteria: (i) a minimum age of 18 years, (ii) mastering Swedish, (iii) have access to a computer or a tablet computer with internet-access, (iv) currently employed, (v) score of \>1.5 points on the Shirom Melamed Burnout Questionnaire (SMBQ), \<34 points on the Montgomery Åsberg Depression Scale-Self Rated (MADRS-S), \<21 points on the Insomnia Severity Index (ISI) and \<14 points on the Alcohol Use Disorders Identification Test (AUDIT). Mild to moderate forms of DSM axis-I diagnosis were accepted as co-morbid conditions, as long as these were considered to be secondary to the primary adjustment disorder. Participants' on full- or part-time sick leave, one year or less, were also included.

You may not qualify if:

• Participants were excluded from the study if they (i) currently in treatment for stress-related disorder, (ii) currently were suffering from bipolar disorder, psychosis, post-traumatic stress disorder (PTSD), eating disorder, substance abuse, severe forms of depression, anxiety disorder or personality disorders, or (iv) were showing suicidal ideation based on item 9 of the MADRS-S. Participants on medication (e.g., antidepressants or sleep medication) were not excluded from the study but were requested to keep their medication constant during the study period.

Sponsors & Collaborators

• Linkoeping University: lead

Study Sites (1)

Department of Behavioral Sciences and Learning, Linköping University

Linköping, Östergötland County, 58183, Sweden

Location

Related Publications (4)

• Eurofound. Sixth European Working Conditions Survey - Overview report (2017 update). Luxembourg: Publications Office of the European Union; 2017.

  BACKGROUND

• World Health Organization. The global burden of disease : 2004 update. Geneva: World Health Organization; 2008.

  BACKGROUND

• Sterling P, Eyer J. A new paradigm to explain arousal pathology. In: Fisher S, Reason J, editors. Handb Life Stress Cogn Health Oxford: John Wiley & Sons; 1988. p. xxxiii, 750.

  BACKGROUND

• Persson Asplund R, Asplund S, von Buxhoeveden H, Delby H, Eriksson K, Svenning Gerhardsson M, Palm J, Skyttberg T, Torstensson J, Ljotsson B, Carlbring P, Andersson G. Work-Focused Versus Generic Internet-Based Interventions for Employees With Stress-Related Disorders: Randomized Controlled Trial. J Med Internet Res. 2023 Apr 25;25:e34446. doi: 10.2196/34446.

  PMID: 37097739 DERIVED

MeSH Terms

Conditions

Adjustment Disorders; Burnout, Psychological

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This study was a three-armed controlled superiority trial in which two internet-based interventions for stress-related disorder: (a) cognitive-behavioural therapy (iCBT; n=61) and (b) work-focused iCBT (W-iCBT; n=61) that integrated work aspects early into the treatment, were compared against a wait-list control group (n=60). The study followed the CONSORT guidelines \[45\]. Sample size was estimated on the basis of previous controlled trials on iCBT for chronic stress (e.g., Persson Asplund et al., 2018), with the aim of detecting an effect size of Cohens'd=0.50 on the primary outcome Shirom-Melamed Burnout Questionnaire (see Measures), at post assessment, based on a power of 0.80 in a two-tailed test with 0.05 significant level. Self-reported outcome assessments were collected at pre- and post-treatment (ten weeks) and at a 6- and 12-month follow-up.

Study Record Dates

• First Submitted: January 15, 2022
• First Posted: February 15, 2022
• Study Start: January 20, 2017
• Primary Completion: August 26, 2019
• Study Completion: August 26, 2019
• Last Updated: February 15, 2022

Record last verified: 2022-02

Locations

SE (1)