Internet-based CBT vs. TAU for Stress-related Disorders

Not Applicable

Active, not recruiting

• Conditions: Adjustment Disorders; Exhaustion Disorder
• Interventions: Behavioral: Internet-based cognitive behavior therapy; Behavioral: Internet-based structured treatment-as-usual

• Registration Number: NCT04797273
• Lead Sponsor: Karolinska Institutet

Brief Summary

Stress-related mental illness is common and one of the main causes of sick leave in Sweden. Cognitive behavior therapy (CBT) is a promising treatment, but access to treatment is low. In a previously conducted study, we found that internet-based CBT in comparison to a waitlist control group was effective in reducing symptoms of stress. The aim of the present study is to take the next step and compare Internet-based CBT for stress-related disorders to an active control condition.

Detailed Description

Non traumatic stress-related mental illness, in this study operationalized as adjustment disorder or exhaustion disorder, is highly prevalent in the general population and associated with high societal costs relating to productivity loss. Cognitive behavior therapy (CBT) is the most well-studied psychological treatment and has demonstrated promising effects in terms of symptom reduction. The overall evidence-base for CBT for these disorders is however fairly week and access to treatment is low. In a previously published randomized controlled trial we found that internet-based CBT can yield large effects on core symptoms of stress for these disorders. Delivering CBT via the internet has the large advantage of enabling increased accessibility as each therapist can have up to 80 patients in ongoing treatment. In the previously conducted trial we compared the treatment to a waitlist control and between-group comparisons of treatment effects were only done at post-treatment as the waitlist condition was crossed over to treatment after this time point. It is now therefore important to take the next step and investigate the effects of internet-based CBT in comparison to an active control condition. The primary aim of this study was to compare two internet-based treatments, CBT vs. structured treatment-as-usual, for adjustment disorder and exhaustion disorder.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-03-11
• Study First Submitted QC: 2021-03-11
• Study First Posted: 2021-03-15
• Study Start: 2021-03-25
• Primary Completion: 2024-06-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-24
• Last Update Posted: 2024-10-26
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• primary adjustment disorder or exhaustion disorder
• regular access to a computer and to the internet
• ability to read and write in swedish

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Exclusion Criteria

• substance abuse in the past 6 months
• lifetime psychosis or bipolar disorder
• suicide risk
• initiated or changed psychopharmacological treatment for depression or anxiety in the past month
• concurrent psychological treatment
• cognitive behavior therapy for stress-related symptoms in the past year.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Internet-based cognitive behavior therapy	Internet-based cognitive behavior therapy	-
Internet-based structured treatment-as-usual	Internet-based structured treatment-as-usual	-

Primary Outcome Measures

Name	Time	Method
Perceived Stress Scale (PSS-10)	Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up, 2-year follow-up	Change in PSS at post-treatment and follow-ups compared to baseline (scale range 0-40, higher score means more symptoms)

Secondary Outcome Measures

Name	Time	Method
Shirom-Melamed Burnout Questionnaire (SMBQ)	Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up, 2-year follow-up	Change in SMBQ at post-treatment and follow-ups compared to baseline (scale range 1-7, higher score means more symptoms)
Montgomery-Åsberg Depression Rating Scale Self-report (MADRS-S)	Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up	Change in MADRS-S at post-treatment and follow-ups compared to baseline (scale range 0-54, higher score means more symptoms)
Sickness Questionnaire (SQ)	Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up	Change in SQ at post-treatment and follow-ups compared to baseline (scale range 0-30, higher score means more symptoms)
World Health Organization's Disability Assessment Scale (WHODAS 2.0)	Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up	Change in WHODAS at post-treatment and follow-ups compared to baseline (scale range 0-100, higher score means more functional disability)
Cognitive impairment	Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up	Test-battery of cognitive tests measuring executive functions at post-treatment and follow-ups compared to baseline
Sick leave	1 year prior to baseline up to 2 years after baseline.	Sick leave data from the Microdata for Analysis of Social Security (MiDAS) registry. Analyzed as full-day equivalents.
Insomnia Severity Index (ISI)	Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up, 2-year follow-up	Change in ISI at post-treatment and follow-ups compared to baseline (scale range 0-28, higher score means more symptoms)
Self-rated Health (SRH)	Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up	Change in SRH at post-treatment and follow-ups compared to baseline (scale range 1-5, higher score means better self-rated health)
Generalized Anxiety Disorder-7 (GAD-7)	Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up	Change in GAD-7 at post-treatment and follow-ups compared to baseline (scale range 0-21, higher score means more symptoms)
EuroQol 5D (EQ5D 5L)	Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up	Change in EQ5D at post-treatment and follow-ups compared to baseline (The answers given in EQ-5D were combined to generate a utility score of health states ranging from 0 to 1, with 0 representing death and 1 representing full health) death and 1 representing full health
Trimbos and Institute Medical Technology Assessment of Costs Questionnaire for Psychiatry (TIC-P)	Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up	The TIC-P enables estimation of costs by collecting information about participant resource utilization and costs related to production loss. Change in costs will be analysed at post-treatment and follow-ups compared to baseline.
Physical Health Questionnaire (PHQ-15)	Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up	Change in PHQ-15 at post-treatment and follow-ups compared to baseline (scale range 0-30, higher score means more symptoms)

Trial Locations

Locations (1)

Gustavsbergs Primary Care Center; 🇸🇪 Gustavsberg, Stockholm, Sweden