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

September 8, 2025 updated by: Erik Hedman, Karolinska Institutet

Internet-based Cognitive Behavior Therapy 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Stockholm County
      • Gustavsberg, Stockholm County, Sweden, 13440
        • Gustavsbergs Primary Care Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Internet-based cognitive behavior therapy
Behavioral: Internet-based cognitive behavior therapy
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.
Active Comparator: Internet-based structured treatment-as-usual
Behavioral: Internet-based structured treatment-as-usual
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up, 2-year follow-up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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)
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)
Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
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)
Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up, 2-year follow-up
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)
Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
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)
Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
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)
Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
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)
Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
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
Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
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.
Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
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)
Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
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
Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
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.
1 year prior to baseline up to 2 years after baseline.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
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)
week 12 (Post-treatment)
Credibility scale (C-scale)
Time Frame: week 3
week 3 only report of treatment credibility (scale range 0-50, higher score means higher credibility)
week 3
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.
Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
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)
Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
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.
Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up, 2-year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karolinska Institutet

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Region Stockholm

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 25, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ICBT vs TAU for Stress

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Adjustment Disorders

Clinical Trials on Internet-based cognitive behavior therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings