Clinical trial NCT04797273: Internet-based CBT vs. TAU for Stress-related Disorders
Official title: Internet-based Cognitive Behavior Therapy for Stress-related Disorders
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Adjustment Disorders
Exhaustion Disorder
Keywords: Internet-based treatment
Randomized controlled trial
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2021-03-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Perceived Stress Scale (PSS-10)
timeFrame: Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up, 2-year follow-up
Secondary outcomes:
measure: Shirom-Melamed Burnout Questionnaire (SMBQ)
timeFrame: Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up, 2-year follow-up
measure: Montgomery-Åsberg Depression Rating Scale Self-report (MADRS-S)
timeFrame: Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
measure: Insomnia Severity Index (ISI)
timeFrame: Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up, 2-year follow-up
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
measure: Sickness Questionnaire (SQ)
timeFrame: Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
measure: Self-rated Health (SRH)
timeFrame: Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
measure: World Health Organization's Disability Assessment Scale (WHODAS 2.0)
timeFrame: Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
measure: EuroQol 5D (EQ5D 5L)
timeFrame: Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
measure: Trimbos and Institute Medical Technology Assessment of Costs Questionnaire for Psychiatry (TIC-P)
timeFrame: Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
measure: Physical Health Questionnaire (PHQ-15)
timeFrame: Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
measure: Cognitive impairment
timeFrame: Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
measure: Sick leave
timeFrame: 1 year prior to baseline up to 2 years after baseline.
Other outcomes:
measure: Karolinska Exhaustion Disorder Scale (KEDS)
timeFrame: Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
measure: Negative Events Questionnaire, 20-items (NEQ-20)
timeFrame: week 12 (Post-treatment)
measure: Credibility scale (C-scale)
timeFrame: week 3
measure: The Corona Virus Health Impact Survey -Short (CRISIS short)
timeFrame: Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
measure: Subjective memory
timeFrame: Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
measure: Recovery Experience Questionnaire short version
timeFrame: Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up, 2-year follow-up
Locations:
city: Gustavsberg
country: Sweden
facility: Gustavsbergs Primary Care Center
state: Stockholm
Study officials:
References: