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

Karolinska Institutet300 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Adjustment Disorders Exhaustion Disorder

Interventions

Internet-based cognitive behavior therapyBEHAVIORAL

12 week Internet-based cognitive behavior therapy, delivered via an online treatment platform. The treatment includes components such as exercises in conducting recuperating activities, methods to improve sleep, exposure, and behavioral activation. The treatment content is provided through written texts, images and audiofiles in the treatment platform. The participant has access to a therapist who provides support throughout the treatment via asynchronous text messages.

Internet-based structured treatment-as-usualBEHAVIORAL

This is a 12-week treatment, delivered via an online treatment platform. The treatment components in this treatment are designed to be similar to what is typically provided in primary care to these patients and includes information about stress and how different factors such as eating habits, physical exercise, and alcohol can contribute to stress problems. The treatment content is provided through written texts, images and audiofiles in the treatment platform. The participant has access to a therapist who provides support throughout the treatment via asynchronous text messages.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * primary adjustment disorder or exhaustion disorder * regular access to a computer and to the internet * ability to read and write in swedish 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.

Locations (1)

Gustavsbergs Primary Care Center

Gustavsberg, Stockholm County, Sweden

Outcomes

Primary Outcomes

Perceived Stress Scale (PSS-10)

Change in PSS at post-treatment and follow-ups compared to baseline (scale range 0-40, higher score means more symptoms)

Time frame: Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up, 2-year follow-up

Secondary Outcomes

Shirom-Melamed Burnout Questionnaire (SMBQ)

Change in SMBQ at post-treatment and follow-ups compared to baseline (scale range 1-7, higher score means more symptoms)

Time frame: Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up, 2-year follow-up

Montgomery-Åsberg Depression Rating Scale Self-report (MADRS-S)

Change in MADRS-S at post-treatment and follow-ups compared to baseline (scale range 0-54, higher score means more symptoms)

Time frame: Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up

Insomnia Severity Index (ISI)

Change in ISI at post-treatment and follow-ups compared to baseline (scale range 0-28, higher score means more symptoms)

Time frame: Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up, 2-year follow-up

Generalized Anxiety Disorder-7 (GAD-7)

Change in GAD-7 at post-treatment and follow-ups compared to baseline (scale range 0-21, higher score means more symptoms)

Time frame: Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up

Sickness Questionnaire (SQ)

Change in SQ at post-treatment and follow-ups compared to baseline (scale range 0-30, higher score means more symptoms)

Time frame: Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up

Data from ClinicalTrials.gov

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