Adjustment DisordersNCT04797273
Internet-based CBT vs. TAU for Stress-related Disorders
A study testing Internet-based cognitive behavior therapy and Internet-based structured treatment-as-usual in people with Adjustment Disorders and Exhaustion Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Adjustment Disorders, Exhaustion Disorder
- What is being tested?
- Internet-based cognitive behavior therapy and Internet-based structured treatment-as-usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSweden
- Study dates
- 25 Mar 2021to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary adjustment disorder or exhaustion disorder
- regular access to a computer and to the internet
- ability to read and write in swedish
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Gustavsbergs Primary Care Center
Gustavsberg, Stockholm County, 13440
About this study
Official title: 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.
Read the 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.
- Conditions
- Adjustment Disorders, Exhaustion Disorder
- Being tested
- Internet-based cognitive behavior therapy, Internet-based structured treatment-as-usual
- Keywords
- Internet-based treatment, Randomized controlled trial
- Medical subject headings
- Adjustment Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based cognitive behavior therapyBehavioural
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-usualBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Internet-based cognitive behavior therapy | Experimental | Not described Receives: Behavioral: Internet-based cognitive behavior therapy |
| Internet-based structured treatment-as-usual | Active comparator | Not described Receives: Behavioral: Internet-based structured treatment-as-usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up, 2-year follow-up
Secondary outcomes (12)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
Self-rated Health (SRH)
Change in SRH at post-treatment and follow-ups compared to baseline (scale range 1-5, higher score means better self-rated health)
Measured: Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
World Health Organization's Disability Assessment Scale (WHODAS 2.0)
Change in WHODAS at post-treatment and follow-ups compared to baseline (scale range 0-100, higher score means more functional disability)
Measured: Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
EuroQol 5D (EQ5D 5L)
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
Measured: 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)
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.
Measured: Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
Physical Health Questionnaire (PHQ-15)
Change in PHQ-15 at post-treatment and follow-ups compared to baseline (scale range 0-30, higher score means more symptoms)
Measured: Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
Cognitive impairment
Test-battery of cognitive tests measuring executive functions at post-treatment and follow-ups compared to baseline
Measured: Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
Sick leave
Sick leave data from the Microdata for Analysis of Social Security (MiDAS) registry. Analyzed as full-day equivalents.
Measured: 1 year prior to baseline up to 2 years after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start25 Mar 2021
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adjustment DisordersStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Erik Hedman, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04797273
- Sponsor's protocol ID
- ICBT vs TAU for Stress
- Status last verified
- Sep 2025
- First submitted
- 11 Mar 2021
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sennerstam V, Franke Foyen L, Kontio E, Svardman F, Lekander M, Lindsater E, Hedman-Lagerlof E. Internet-Delivered Treatment for Stress-Related Disorders: A Randomized Controlled Superiority Trial of Cognitive Behavioral Therapy versus General Health Promotion. Psychother Psychosom. 2025;94(4):273-288. doi: 10.1159/000546221. Epub 2025 May 7.
PubMed 40334656Franke Foyen L, Sennerstam V, Kontio E, Lekander M, Hedman-Lagerlof E, Lindsater E. Objective cognitive functioning in patients with stress-related disorders: a cross-sectional study using remote digital cognitive testing. BMC Psychiatry. 2023 Aug 7;23(1):565. doi: 10.1186/s12888-023-05048-5.
PubMed 37550693
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Cognitive Behavior Therapy for Stress-related Disorders
- ClinicalTrials.gov ID
- NCT04797273
- Acronym / sponsor ID
- ICBT vs TAU for Stress
- Conditions
- Adjustment Disorders, Exhaustion Disorder
- Keywords
- Internet-based treatment, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 15 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet-based cognitive behavior therapy | Experimental | Behavioral: Internet-based cognitive behavior therapy |
| Internet-based structured treatment-as-usual | Active comparator | Behavioral: Internet-based structured treatment-as-usual |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- primary adjustment disorder or exhaustion disorder
- regular access to a computer and to the internet
- ability to read and write in swedish
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based cognitive behavior therapy12 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. | Behavioural | Internet-based cognitive behavior therapy |
| Internet-based structured treatment-as-usualThis 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. | Behavioural | Internet-based structured treatment-as-usual |
Primary outcome
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)
12 secondary outcomes
Shirom-Melamed Burnout Questionnaire (SMBQ)
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)
Time frame: 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
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: 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
Self-rated Health (SRH)
Time frame: 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
EuroQol 5D (EQ5D 5L)
Time frame: 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
Physical Health Questionnaire (PHQ-15)
Time frame: 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
Sick leave
Time frame: 1 year prior to baseline up to 2 years after baseline.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Derived from this study: PubMed 40334656Sennerstam V, Franke Foyen L, Kontio E, Svardman F, Lekander M, Lindsater E, Hedman-Lagerlof E. Internet-Delivered Treatment for Stress-Related Disorders: A Randomized Controlled Superiority Trial of Cognitive Behavioral Therapy versus General Health Promotion. Psychother Psychosom. 2025;94(4):273-288. doi: 10.1159/000546221. Epub 2025 May 7.
- Derived from this study: PubMed 37550693Franke Foyen L, Sennerstam V, Kontio E, Lekander M, Hedman-Lagerlof E, Lindsater E. Objective cognitive functioning in patients with stress-related disorders: a cross-sectional study using remote digital cognitive testing. BMC Psychiatry. 2023 Aug 7;23(1):565. doi: 10.1186/s12888-023-05048-5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based cognitive behavior therapy and Internet-based structured treatment-as-usual in people with Adjustment Disorders and Exhaustion Disorder, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Scale (PSS-10) (time frame: Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up, 2-year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04797273, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.