Adjustment DisorderNCT02540317
Internet-based Cognitive Behavior Therapy for Stress Disorders: a Randomized Trial
A study testing Internet-based CBT in people with Adjustment Disorder and Burnout Syndrome, run by Karolinska Institutet.
Trial summary
Stress disorders in form of adjustment disorder and burnout syndrom are highly prevalent and cause substantial suffering. Prior evidence suggest that these disorders may be effectively treated with cognitive behavior therapy (CBT), but access to psychological treatment is limited. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Adjustment Disorder, Burnout Syndrome
- What is being tested?
- Internet-based CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to 1 Oct 2017
- 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
- To be included in the study participants must be between 18 and 65 years of age and suffer from primary stress-related disorders by meeting diagnostic criteria for adjustment disorder or burnout syndrome. Participants must have access to a computer and to the Internet, as well as being able to write and write in Swedish.
Who cannot join
- Exclusion criteria include (a) meeting the criteria for another axis-1 diagnosis that is assessed to be the primary area of difficulty, (b) suffering from substance abuse/dependence in the past 6 months, (c) suffering from current or past psychosis or bipolar disorder, (d) moderate to high suicide risk, (e) initiated or changed pharmachological treatment for depression or anxiety in the past month and (f) other on-going psychological treatment for stress-related difficulties, and (g) not having received CBT for stress-related ill-health in the past year.
About this study
Stress disorders in form of adjustment disorder and burnout syndrom are highly prevalent and cause substantial suffering. Prior evidence suggest that these disorders may be effectively treated with cognitive behavior therapy (CBT), but access to psychological treatment is limited. One possible solution is to provide therapy via the Internet, which has been shown to be effective for anxiety disorders and depression. In the present study, we will investigate the efficacy of Internet-based CBT (ICBT) for adjustment disorders and burnout syndrom in a randomized controlled trial (N=100). Participants will be randomized to active treatment (n=50) or a control condition on waiting list.
Read the detailed description
Stress disorders in form of adjustment disorder and burnout syndrom are highly prevalent and cause substantial suffering. Prior evidence suggest that these disorders may be effectively treated with cognitive behavior therapy (CBT), but access to psychological treatment is limited. One possible solution is to provide therapy via the Internet, which has been shown to be effective for anxiety disorders and depression. Internet-based CBT can be described as online bibliotherapy with therapist support via a secure messaging system. In this study psychologists will deliver the treatment. We will investigate the efficacy of Internet-based CBT (ICBT) for adjustment disorder and burnout syndrom in a randomized controlled trial (N=100). Participants will be randomized to active treatment (n=50) or a control condition on waiting list. We expect that participants who receive ICBT will make superior improvements compared to the control condition on measures of stress, burnout, depressive symptoms, general anxiety and general functioning.
- Conditions
- Adjustment Disorder, Burnout Syndrome
- Being tested
- Internet-based CBT
- Medical subject headings
- Adjustment Disorders, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based CBTBehavioural
Internet-based treatment with therapist support using an asynchronous messaging system. The treatment is comprised of 12 modules (similar to chapters) and the treatment is 12 weeks long. The treatment is based on cognitive behavior therapy
| Study group | Role | What they receive |
|---|---|---|
| Active treatment, Internet-based CBT | Experimental | Internet-based treatment with therapist support using an asynchronous messaging system. The treatment is comprised of 12 modules (similar to chapters) and the treatment is 12 weeks long. The treatment is based on cognitive behavior therapy. Participants will be stratified based on diagnosis, i.e. adjustment disorder and burnout. Receives: Behavioral: Internet-based CBT |
| Waiting list control | No intervention | The control condition is a waiting list. Participants in this arm receive no active treatment. After 12 weeks on waiting list, participants are crossed over to treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Perceived stress scale (PSS)
Change in PSS at post-treatment and follow-up compared to baseline
Measured: baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
Secondary outcomes (15)
Shirlom Melamed Burnout Questionnaire (SMBQ)
Change in SMBQ at post-treatment and follow-up compared to baseline
Measured: baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
Insomnia Severity Index (IS)
Change in ISI at post-treatment and follow-up compared to baseline
Measured: baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
Generalized AnxietyDisorder-7 (GAD-7)
Change in GAD-7 at post-treatment and follow-up compared to baseline
Measured: baseline, post-treatment (12 weeks), 6 month follow-up
Physical Health Questionnaire-15 (PHQ-15)
Change in PHQ-15 at post-treatment and follow-up compared to baseline
Measured: baseline, post-treatment (12 weeks), 6 month follow-up
Montgomery Åsberg Depression Rating Scale - self-rated (MADRS-S)
Change in MADRS-S at post-treatment and follow-up compared to baseline
Measured: baseline, post-treatment (12 weeks), 6 month follow-up
Self-rated health (SRH)
Change in SRH at post-treatment and follow-up compared to baseline
Measured: baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
Work Ability Index (WAI)
Change in WAI at post-treatment and follow-up compared to baseline
Measured: baseline, post-treatment (12 weeks), 6 month follow-up
Euroqol 5 dimensions (EQ5D)
Change in EQ5D at post-treatment and follow-up compared to baseline
Measured: baseline, post-treatment (12 weeks), 6 month follow-up
Brunnsviken Brief Quality of life inventory (BBQ)
Change in BBQ at post-treatment and follow-up compared to baseline
Measured: baseline, post-treatment (12 weeks), 6 month follow-up
World Health Organization Disability Assessment Schedule (WHODAS)
Change in WHODAS at post-treatment and follow-up compared to baseline.
Measured: baseline, post-treatment (12 weeks), 6 month follow-up
Alcohol Disorders Identification Test (AUDIT)
This instrument will be used for screening purpose only
Measured: Baseline
Sickness questionnaire state (SQ)
Change in SQ at post-treatment and follow-up compared to baseline
Measured: baseline, post-treatment (12 weeks), 6 month follow-up
Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P) Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)
Change in TIC-P at post-treatment and follow-up compared to baseline
Measured: baseline, post-treatment (12 weeks), 6 month follow-up
Karolinska Sleep Questionnaire (KSQ)
Change in KSQ at post-treatment and follow-up compared to baseline
Measured: baseline, post-treatment (12 weeks), 6 month follow-up
Client Satisfaction Questionnaire (CSQ)
Mean and standard deviations will be presented
Measured: Post-treatment (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study startOct 2015
- Primary completion1 Oct 2017
- Study completion1 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Adjustment DisorderStudies 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
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik Hedman, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02540317
- Sponsor's protocol ID
- ICBT for stress
- Status last verified
- Dec 2019
- First submitted
- 1 Sep 2015
- Last updated
- 16 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Lindsater E, Axelsson E, Salomonsson S, Santoft F, Ljotsson B, Akerstedt T, Lekander M, Hedman-Lagerlof E. Cost-Effectiveness of Therapist-Guided Internet-Based Cognitive Behavioral Therapy for Stress-Related Disorders: Secondary Analysis of a Randomized Controlled Trial. J Med Internet Res. 2019 Sep 13;21(9):e14675. doi: 10.2196/14675.
PubMed 31586370Lindsater E, Axelsson E, Salomonsson S, Santoft F, Ejeby K, Ljotsson B, Akerstedt T, Lekander M, Hedman-Lagerlof E. Internet-Based Cognitive Behavioral Therapy for Chronic Stress: A Randomized Controlled Trial. Psychother Psychosom. 2018;87(5):296-305. doi: 10.1159/000490742. Epub 2018 Jul 24.
PubMed 30041167Axelsson E, Lindsater E, Ljotsson B, Andersson E, Hedman-Lagerlof E. The 12-item Self-Report World Health Organization Disability Assessment Schedule (WHODAS) 2.0 Administered Via the Internet to Individuals With Anxiety and Stress Disorders: A Psychometric Investigation Based on Data From Two Clinical Trials. JMIR Ment Health. 2017 Dec 8;4(4):e58. doi: 10.2196/mental.7497.
PubMed 29222080
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Cognitive Behavior Therapy for Stress Disorders: a Randomized Trial
- ClinicalTrials.gov ID
- NCT02540317
- Acronym / sponsor ID
- ICBT for stress
- Conditions
- Adjustment Disorder, Burnout Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 1 Oct 2017 (actual)
- First posted
- 3 Sep 2015 (estimated)
- 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 disorders in form of adjustment disorder and burnout syndrom are highly prevalent and cause substantial suffering. Prior evidence suggest that these disorders may be effectively treated with cognitive behavior therapy (CBT), but access to psychological treatment is limited. One possible solution is to provide therapy via the Internet, which has been shown to be effective for anxiety disorders and depression. In the present study, we will investigate the efficacy of Internet-based CBT (ICBT) for adjustment disorders and burnout syndrom in a randomized controlled trial (N=100). Participants will be randomized to active treatment (n=50) or a control condition on waiting list.
Detailed description
Stress disorders in form of adjustment disorder and burnout syndrom are highly prevalent and cause substantial suffering. Prior evidence suggest that these disorders may be effectively treated with cognitive behavior therapy (CBT), but access to psychological treatment is limited. One possible solution is to provide therapy via the Internet, which has been shown to be effective for anxiety disorders and depression. Internet-based CBT can be described as online bibliotherapy with therapist support via a secure messaging system. In this study psychologists will deliver the treatment. We will investigate the efficacy of Internet-based CBT (ICBT) for adjustment disorder and burnout syndrom in a randomized controlled trial (N=100). Participants will be randomized to active treatment (n=50) or a control condition on waiting list. We expect that participants who receive ICBT will make superior improvements compared to the control condition on measures of stress, burnout, depressive symptoms, general anxiety and general functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active treatment, Internet-based CBT | Experimental | Behavioral: Internet-based CBTInternet-based treatment with therapist support using an asynchronous messaging system. The treatment is comprised of 12 modules (similar to chapters) and the treatment is 12 weeks long. The treatment is based on cognitive behavior therapy. Participants will be stratified based on diagnosis, i.e. adjustment disorder and burnout. |
| Waiting list control | No intervention | –The control condition is a waiting list. Participants in this arm receive no active treatment. After 12 weeks on waiting list, participants are crossed over to treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- To be included in the study participants must be between 18 and 65 years of age and suffer from primary stress-related disorders by meeting diagnostic criteria for adjustment disorder or burnout syndrome. Participants must have access to a computer and to the Internet, as well as being able to write and write in Swedish.
Key exclusion criteria (1 listed)
- Exclusion criteria include (a) meeting the criteria for another axis-1 diagnosis that is assessed to be the primary area of difficulty, (b) suffering from substance abuse/dependence in the past 6 months, (c) suffering from current or past psychosis or bipolar disorder, (d) moderate to high suicide risk, (e) initiated or changed pharmachological treatment for depression or anxiety in the past month and (f) other on-going psychological treatment for stress-related difficulties, and (g) not having received CBT for stress-related ill-health in the past year.
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 CBTInternet-based treatment with therapist support using an asynchronous messaging system. The treatment is comprised of 12 modules (similar to chapters) and the treatment is 12 weeks long. The treatment is based on cognitive behavior therapy | Behavioural | Active treatment, Internet-based CBT |
Primary outcome
Change in Perceived stress scale (PSS)
Time frame: baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
Change in PSS at post-treatment and follow-up compared to baseline
15 secondary outcomes
Shirlom Melamed Burnout Questionnaire (SMBQ)
Time frame: baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
Insomnia Severity Index (IS)
Time frame: baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
Generalized AnxietyDisorder-7 (GAD-7)
Time frame: baseline, post-treatment (12 weeks), 6 month follow-up
Physical Health Questionnaire-15 (PHQ-15)
Time frame: baseline, post-treatment (12 weeks), 6 month follow-up
Montgomery Åsberg Depression Rating Scale - self-rated (MADRS-S)
Time frame: baseline, post-treatment (12 weeks), 6 month follow-up
Self-rated health (SRH)
Time frame: baseline, weekly during treatment, post-treatment (12 weeks), 6 month follow-up
Work Ability Index (WAI)
Time frame: baseline, post-treatment (12 weeks), 6 month follow-up
Euroqol 5 dimensions (EQ5D)
Time frame: baseline, post-treatment (12 weeks), 6 month follow-up
Brunnsviken Brief Quality of life inventory (BBQ)
Time frame: baseline, post-treatment (12 weeks), 6 month follow-up
World Health Organization Disability Assessment Schedule (WHODAS)
Time frame: baseline, post-treatment (12 weeks), 6 month follow-up
Alcohol Disorders Identification Test (AUDIT)
Time frame: Baseline
Sickness questionnaire state (SQ)
Time frame: baseline, post-treatment (12 weeks), 6 month follow-up
Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P) Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)
Time frame: baseline, post-treatment (12 weeks), 6 month follow-up
Karolinska Sleep Questionnaire (KSQ)
Time frame: baseline, post-treatment (12 weeks), 6 month follow-up
Client Satisfaction Questionnaire (CSQ)
Time frame: Post-treatment (12 weeks)
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 16 Dec 2019.
- Derived from this study: PubMed 31586370Lindsater E, Axelsson E, Salomonsson S, Santoft F, Ljotsson B, Akerstedt T, Lekander M, Hedman-Lagerlof E. Cost-Effectiveness of Therapist-Guided Internet-Based Cognitive Behavioral Therapy for Stress-Related Disorders: Secondary Analysis of a Randomized Controlled Trial. J Med Internet Res. 2019 Sep 13;21(9):e14675. doi: 10.2196/14675.
- Derived from this study: PubMed 30041167Lindsater E, Axelsson E, Salomonsson S, Santoft F, Ejeby K, Ljotsson B, Akerstedt T, Lekander M, Hedman-Lagerlof E. Internet-Based Cognitive Behavioral Therapy for Chronic Stress: A Randomized Controlled Trial. Psychother Psychosom. 2018;87(5):296-305. doi: 10.1159/000490742. Epub 2018 Jul 24.
- Derived from this study: PubMed 29222080Axelsson E, Lindsater E, Ljotsson B, Andersson E, Hedman-Lagerlof E. The 12-item Self-Report World Health Organization Disability Assessment Schedule (WHODAS) 2.0 Administered Via the Internet to Individuals With Anxiety and Stress Disorders: A Psychometric Investigation Based on Data From Two Clinical Trials. JMIR Ment Health. 2017 Dec 8;4(4):e58. doi: 10.2196/mental.7497.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based CBT in people with Adjustment Disorder and Burnout Syndrome, run by Karolinska Institutet.
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 1 inclusion and 1 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 16 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in Perceived stress scale (PSS) (time frame: baseline, weekly during treatment, post-treatment (12 weeks), 6 month 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 NCT02540317, which also lists 3 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 16 Dec 2019.