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Completed

NCT Number: NCT04797273

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

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.

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Key information

Conditions

Adjustment Disorders Exhaustion Disorder Mental Disorders Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gustavsbergs Primary Care Center

Gustavsberg, Stockholm County, 13440, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Internet-based Cognitive Behavior Therapy

Behavioral

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-usual

Behavioral

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.

Primary outcomes

  1. Perceived Stress Scale (PSS-10)

    Time frame: 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 outcomes

  1. Shirom-Melamed Burnout Questionnaire (SMBQ)

    Time frame: 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)

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

    Time frame: 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)

  3. Insomnia Severity Index (ISI)

    Time frame: 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)

  4. Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: 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)

  5. Sickness Questionnaire (SQ)

    Time frame: 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)

  6. Self-rated Health (SRH)

    Time frame: 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)

  7. World Health Organization's Disability Assessment Scale (WHODAS 2.0)

    Time frame: 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)

  8. EuroQol 5D (EQ5D 5L)

    Time frame: 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

  9. Trimbos and Institute Medical Technology Assessment of Costs Questionnaire for Psychiatry (TIC-P)

    Time frame: 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.

  10. Physical Health Questionnaire (PHQ-15)

    Time frame: 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)

  11. Cognitive impairment

    Time frame: 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

  12. Sick leave

    Time frame: 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.

Other outcomes

  1. Karolinska Exhaustion Disorder Scale (KEDS)

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

    Exploratory assessment of change at post-treatment and follow-ups compared to baseline (scale range 0-54, higher score means more symptoms)

  2. Negative Events Questionnaire, 20-items (NEQ-20)

    Time frame: week 12 (Post-treatment)

    Post-treatment only report of negative events from treatment (scale range 0-80, higher score indicates more negative events)

  3. Credibility scale (C-scale)

    Time frame: week 3

    week 3 only report of treatment credibility (scale range 0-50, higher score means higher credibility)

  4. The Corona Virus Health Impact Survey -Short (CRISIS short)

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

    Exploratory analysis of the impact of the Corona virus on worry and life style. Change in sum score of items 1,2,3,4,5,8 and 9 will be analyzed. Scale range 0-24. Higher scores mean higher impact of Corona.

  5. Subjective memory

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

    Exploratory analysis of change in subjective memory at post-treatment and follow-ups compared to baseline (scale range 0-26, higher score means more subjective problems with memory)

  6. Recovery Experience Questionnaire short version

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

    Will be analyzed as potential mediator of treatment change. 7 items, scored 0-4. Scale-range 0-28. Higher scores indicate more recovery.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm

Registry information

Official study title

Internet-based Cognitive Behavior Therapy for Stress-related Disorders

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 15, 2021
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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