Mental Health IssuePOETNCT06067165
Primary Care Online Emotion-regulation Treatment (POET)
A study testing POET feeling and Supportive treatment in people with Mental Health Issue, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Mental health problems in youth are a global problem, causing incalculable suffering in youth and families, harming long-term prospects of youths, and creating substantial economic costs to society. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- POET feeling and Supportive treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 388 participants
- Where
- 1 siteSweden
- Study dates
- 16 Oct 2023to 25 Nov 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 12 - 17 years
- Seeking care for mental health problems
- At least one guardian interested in participating in the parent program
- Deemed capable of making decisions
Who cannot join
- Psychiatric problems that require more extensive treatment.
- Low global functioning (under 41 points on clinician rated C-GAS or functioning that requires more extensive treatment).
- Elevated suicide risk
- Insufficient Swedish comprehension.
- Life circumstances that complicate or make treatment impossible (eg severe deficits in parental care, domestic violence).
- Change in psychopharmacological medication in the last 2 months.
- Ongoing psychological treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska Institutet
Stockholm, 113 64
Johan Bjureberg, PhD, +46(0)700009188, johan.bjureberg@ki.se
About this study
Mental health problems in youth are a global problem, causing incalculable suffering in youth and families, harming long-term prospects of youths, and creating substantial economic costs to society.
The overall objective of this study is to build an evidence base for a highly scalable transdiagnostic intervention called the Primary care Online Emotion-regulation Treatment (POET) for youth (12-17 years) seeking treatment for mental health problems.
In a randomized controlled trial, the investigators will examine the effects of POET. The investigators will test if emotion regulation mediates reduction in mental health problems during treatment. In addition the investigators will test if POET is more effective for some individuals than others and evaluate if POET is cost-effective. The investigators will also test whether there are detectable effects of POET on distal outcomes utilizing registry data following participants up to 10 years post treatment.
Read the detailed description
Introduction:
Mental health problems among young people are prevalent and many youth in need of treatment for mental health problems do not meet criteria for any mental health disorder or they meet criteria for several disorders. Most existing treatments focus on a subset of mental disorders and do not address subthreshold or multi-disorder mental health problems. In addition, available treatments do not typically target transdiagnostic disease mechanisms. Furthermore, the available treatments are limited in efficacy and most youth in need do not receive treatment due to social stigma and structural barriers such as geographical distance to treatment providers.
The aim of this randomized clinical trial is to determine the clinical efficacy of a digital emotion regulation treatment in adolescents with mental health problems. Participants will be randomized to a digital emotion regulation treatment or to an active comparator. Treatments in both conditions will include therapist support, and will be delivered in a blended treatment format combining asynchronous therapist-guided online modules with one synchronous session delivered over video-link. The primary endpoint is at post- treatment.
Primary objectives:
- To test the effects of POET on mental health problems.
- To test the effects of POET on emotion regulation.
Secondary objectives:
- To test if emotion regulation mediates reductions in mental health problems during treatment.
- To test if POET is cost-effective.
- To test if POET works better for some individuals than others (i.e., moderation).
- To test if there are detectable differences in distal outcomes between POET and active control 12 to 60 months post treatment and if individual baseline characteristics moderates these effects.
Research questions:
- What are the effects of POET on mental health problems?
- What are the effects of POET on emotion regulation?
- Are reductions in mental health problems during the POET treatment mediated through emotion regulation?
- Is POET feeling cost-effective?
- Does POET work better for some individuals than others?
- Are there detectable differences in distal outcomes between POET and active control 12 to 60 months post treatment and if individual baseline characteristics moderates these effects
- Conditions
- Mental Health Issue
- Being tested
- POET feeling, Supportive treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POET feelingBehavioural
POET is adapted from online Emotion Regulation Individual Therapy for Adolescents developed by the research group (ClinicalTrials.gov Identifier: NCT03353961).
POET is also based on the Modal model of emotion and Process model of emotion regulation that provides a framework for understanding how emotions are generated, experienced and how they can be regulated. The youth component of POET will include psychoeducation, addressing maladaptive beliefs about emotions and emotion regulation, and teaching adaptive emotion regulation strategies, such as acceptance of emotions and flexible cognitive reappraisal. The parent component will include psychoeducation and teaching effective support and responding to their adolescent's and their own emotions.
Supportive treatmentBehavioural
The treatment will include educative material on mental health and self-reflection on themes such as school, family and friends. The parent component will include educative material and self reflection in how to support their adolescent.
| Study group | Role | What they receive |
|---|---|---|
| POET feeling | Experimental | POET will include six guided digital treatment modules for the youth, and six modules for the parents administered over the course of six weeks. Receives: Behavioral: POET feeling |
| Supportive treatment | Active comparator | The active control will be supportive treatment. It includes six guided digital treatment modules for the youth, and six modules for the parents administered over the course of six weeks. Receives: Behavioral: Supportive treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Clinical Global Impressions -Severity scale (CGI-S)
Used to assess symptom severity rated on a single item ranging from 1-7, with higher scores indicating more severe symptoms. Clinician-rated.
Measured: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
Secondary outcomes (20)
The Clinical Global Impressions - Improvement scales (CGI-I)
Used to assess symptom improvement rated on a single item ranging from 1-7, with lower scores indicating more improvement. Clinician-rated.
Measured: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
The Revised Child Anxiety and Depression Scale-C (RCADS-C)
Used to assess symptoms of depression and anxiety. This scale has 47 items, total score ranging from 0 to 141, with higher scores indicating more severe symptoms. Clinician-rated.
Measured: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
The Revised Child Anxiety and Depression Scale-P (RCADS-P)
Used to assess symptoms of depression and anxiety in their offspring. This scale has 47 items, total score ranges from 0 to 141 points, with higher scores indicating more severe symptoms. Caregiver-reported.
Measured: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
Brief 11-item version of the Revised Child Anxiety and Depression Scale for Adolescents (RCADS-11)
Used to assess symptoms of depression and anxiety in children and adolescents. This scale has 11 items, total score ranges from 0-33 points, with higher scores indicating more severe symptoms. Self-rated by adolescents.
Measured: Week 0 and Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 after treatment start and 3,12 and 60 months after treatment has ended
Children's global assessment scale (CGAS)
Used to assess global impairment on a single item ranging from 1 to 100, with a higher value indicating better functioning. Clinician-rated.
Measured: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
The Work and Social Adjustment Scale (WSAS)
Used to assess impaired functioning in school, everyday life, friends and social life, recreation and hobbies and family and close relationships. This scale has 5 items, total score ranges from 0 to 40, with higher scores indicating greater impairment. Clinician-rated.
Measured: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
The Positive and Negative Affect Schedule for Children (PANAS-C)
Used to assess positive and negative feelings. This scale has 2 subscales. Each total subscale score range from 5-25, with higher scores indicating more negative or positive feelings. Self-rated by adolescents.
Measured: Week 0 and Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 after treatment start and 3,12 and 60 months after treatment has ended
The Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA)
Used to assess cognitive reappraisal. The subscale has 6 items, total subscale score ranges from 6-30, with higher scores indicating greater usage of cognitive reappraisal. Self-rated by adolescents.
Measured: Week 0 and Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 after treatment start and 3,12 and 60 months after treatment has ended
Difficulties in Emotion Regulation Scale - 16 item version (DERS-16)
Used to assess difficulties in emotion regulation. The scale has 16 items, total score ranges from 16-80, with higher scores indicating more difficulties. Self-rated by adolescents.
One subscale named impulse (3 items ranging from 3-15) will be administered once every week during treatment.
Measured: Week 0 and Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 after treatment start and 3,12 and 60 months after treatment has ended
The Process Model of Emotion Regulation Questionnaire -short (PMERQ-S)
Used to assesses individual differences in emotion regulation. This scale has 30 items, total score ranges from 30-180, with higher scores indicate a greater usage of emotion regulation. Self-rated by adolescents.
The three subscales named Confront unpleasant situations (3 items, total subscale score ranges from 6-18), Avoid unpleasant situations (3 items, total subscale score ranges from 6-18) and Cognitively distract (3 items, total subscale score ranges 6-18) will administered to adolescents weekly.
Measured: Week 0 and Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 after treatment start and 3,12 and 60 months after treatment has ended
The Perth Alexithymia Questionnaire-Short Form (PAQ-S)
Used to assess alexithymia. This scale has 6 items, total score ranges from 6 to 42, with higher scores indicate higher levels of alexithymia. Self-rated by adolescents.
Measured: Week 0 and Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 after treatment start and 3,12 and 60 months after treatment has ended
Self-Efficacy Questionnaire for Children (SEQ-C)
Used to assess social self-efficacy. The subscale named social self-efficacy has 8 items, total subscale score ranges from 8-40, with higher scores indicating greater social self-efficacy. Self-rated by adolescents.
Measured: Week 0 and Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 after treatment start and 3,12 and 60 months after treatment has ended
Child Health Utility 9D (CHU-9D)
Used to assess health-related quality of life. This scale has 9 items, total score ranges from 9 to 45, with higher scores indicating worse quality of life. Self-rated by adolescents.
Measured: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
Borderline symptoms checklist supplement (BSL-23)
Used to assess high-risk and problematic behaviors. This scale has 10 items, total score ranges from 0 to 40, with higher scores indicating greater usage of high-risk and problematic behaviors. Self-rated by adolescents.
Measured: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
The Emotion Beliefs Questionnaire (EBQ)
Used to assess beliefs about emotions. This scale 16 items, total score ranges from 16 to 112, with higher scores indicating more maladaptive beliefs about emotions. Self-rated by adolescents.
Measured: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
Coping with Children's Negative Emotions Scale Adolescent Version (CCNES-A)
Used to assess parents' perceived ability to cope with children's negative emotions. This scale has six subscales which include emotion focused, problem-focused, minimization, punitive, expressive encouragement, and distress responses. Each subscale has 9 items, total subscale score ranges from 1-7, with higher scores indicating greater usage of a certain parental coping style. Care-giver reported.
Measured: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
Difficulties in Emotion Regulation Scale - 16 item version (DERS-16)
Used to assess difficulties in emotion regulation. The scale has 16 items, total score ranges from 16-80, with higher scores indicating more difficulties. Self-rated by parents.
Measured: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
Behavioral emotion regulation questionnaire (BERQ)
Used to assess parents' perception of the adolescent's behavioral emotion regulation. This scale has 5 subscales. Each total subscale score ranges from 4-20, with higher scores indicating greater usage of a certain strategy. Care-giver reported.
Measured: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
Trimbos Questionnaire for Costs associated with Psychiatric Illness (TiC-P)
Used to assess healthcare and other societal resource use for both children and caregivers. Caregiver-reported.
Measured: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
Deliberate Self-Harm Inventory, Youth version (DSHI-Y)
Used to assess occurrence, method, frequency of deliberate self-harm. This scale has 6 items with higher scores indicating more frequent deliberate self-harm. Self-rated by adolescents.
Measured: 3,12 and 60 months after treatment has ended
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start16 Oct 2023
- Primary completion1 Oct 2026 (estimated)
- Study completion25 Nov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health IssueStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 388 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm, Region Skane, Region Östergötland, Västra Götalandsregionen
- Responsible party
- Principal investigator, Johan Bjureberg, Karolinska Institutet
- Investigators
- Johan Bjureberg, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067165
- Sponsor's protocol ID
- 2023-03652-01
- Other IDs
- 2023
- Acronym
- POET
- Status last verified
- Sep 2025
- First submitted
- 17 Sep 2023
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data are pseudonymized according to national (Swedish) and European Union legislation and cannot be anonymized and published in an open repository. Participants in the study consent for their data to be shared with other international researchers for meta-analyses. Aggregated data can be made available upon reasonable request on a case-by-case basis according to the current legislation and ethical permits
Publications
Sjoblom K, Bellander M, Nilbrink J, Zetterqvist M, Sampaio F, Hedman-Lagerlof E, Hellner C, Gross JJ, Hesser H, Bjureberg J. Randomised superiority trial evaluating an online transdiagnostic emotion regulation treatment for adolescents with mental health conditions: study protocol. BMJ Open. 2026 Jul 29;16(7):e116511. doi: 10.1136/bmjopen-2026-116511.
PubMed 42526916
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Care Online Emotion-regulation Treatment (POET)
- ClinicalTrials.gov ID
- NCT06067165
- Acronym / sponsor ID
- POET / 2023-03652-01
- Conditions
- Mental Health Issue
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 388 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm, Region Skane, Region Östergötland, Västra Götalandsregionen
- Study start
- 16 Oct 2023 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 25 Nov 2031 (estimated)
- First posted
- 4 Oct 2023 (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.
Mental health problems in youth are a global problem, causing incalculable suffering in youth and families, harming long-term prospects of youths, and creating substantial economic costs to society.
The overall objective of this study is to build an evidence base for a highly scalable transdiagnostic intervention called the Primary care Online Emotion-regulation Treatment (POET) for youth (12-17 years) seeking treatment for mental health problems.
In a randomized controlled trial, the investigators will examine the effects of POET. The investigators will test if emotion regulation mediates reduction in mental health problems during treatment. In addition the investigators will test if POET is more effective for some individuals than others and evaluate if POET is cost-effective. The investigators will also test whether there are detectable effects of POET on distal outcomes utilizing registry data following participants up to 10 years post treatment.
Detailed description
Introduction:
Mental health problems among young people are prevalent and many youth in need of treatment for mental health problems do not meet criteria for any mental health disorder or they meet criteria for several disorders. Most existing treatments focus on a subset of mental disorders and do not address subthreshold or multi-disorder mental health problems. In addition, available treatments do not typically target transdiagnostic disease mechanisms. Furthermore, the available treatments are limited in efficacy and most youth in need do not receive treatment due to social stigma and structural barriers such as geographical distance to treatment providers.
The aim of this randomized clinical trial is to determine the clinical efficacy of a digital emotion regulation treatment in adolescents with mental health problems. Participants will be randomized to a digital emotion regulation treatment or to an active comparator. Treatments in both conditions will include therapist support, and will be delivered in a blended treatment format combining asynchronous therapist-guided online modules with one synchronous session delivered over video-link. The primary endpoint is at post- treatment.
Primary objectives:
- To test the effects of POET on mental health problems.
- To test the effects of POET on emotion regulation.
Secondary objectives:
- To test if emotion regulation mediates reductions in mental health problems during treatment.
- To test if POET is cost-effective.
- To test if POET works better for some individuals than others (i.e., moderation).
- To test if there are detectable differences in distal outcomes between POET and active control 12 to 60 months post treatment and if individual baseline characteristics moderates these effects.
Research questions:
- What are the effects of POET on mental health problems?
- What are the effects of POET on emotion regulation?
- Are reductions in mental health problems during the POET treatment mediated through emotion regulation?
- Is POET feeling cost-effective?
- Does POET work better for some individuals than others?
- Are there detectable differences in distal outcomes between POET and active control 12 to 60 months post treatment and if individual baseline characteristics moderates these effects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POET feeling | Experimental | Behavioral: POET feelingPOET will include six guided digital treatment modules for the youth, and six modules for the parents administered over the course of six weeks. |
| Supportive treatment | Active comparator | Behavioral: Supportive treatmentThe active control will be supportive treatment. It includes six guided digital treatment modules for the youth, and six modules for the parents administered over the course of six weeks. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age between 12 - 17 years
- Seeking care for mental health problems
- At least one guardian interested in participating in the parent program
- Deemed capable of making decisions
Key exclusion criteria (7 listed)
- Psychiatric problems that require more extensive treatment.
- Low global functioning (under 41 points on clinician rated C-GAS or functioning that requires more extensive treatment).
- Elevated suicide risk
- Insufficient Swedish comprehension.
- Life circumstances that complicate or make treatment impossible (eg severe deficits in parental care, domestic violence).
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 |
|---|---|---|
| POET feelingPOET is adapted from online Emotion Regulation Individual Therapy for Adolescents developed by the research group (ClinicalTrials.gov Identifier: NCT03353961). POET is also based on the Modal model of emotion and Process model of emotion regulation that provides a framework for understanding how emotions are generated, experienced and how they can be regulated. The youth component of POET will include psychoeducation, addressing maladaptive beliefs about emotions and emotion regulation, and teaching adaptive emotion regulation strategies, such as acceptance of emotions and flexible cognitive reappraisal. The parent component will include psychoeducation and teaching effective support and responding to their adolescent's and their own emotions. | Behavioural | POET feeling |
| Supportive treatmentThe treatment will include educative material on mental health and self-reflection on themes such as school, family and friends. The parent component will include educative material and self reflection in how to support their adolescent. | Behavioural | Supportive treatment |
Primary outcome
The Clinical Global Impressions -Severity scale (CGI-S)
Time frame: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
Used to assess symptom severity rated on a single item ranging from 1-7, with higher scores indicating more severe symptoms. Clinician-rated.
20 secondary outcomes
The Clinical Global Impressions - Improvement scales (CGI-I)
Time frame: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
The Revised Child Anxiety and Depression Scale-C (RCADS-C)
Time frame: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
The Revised Child Anxiety and Depression Scale-P (RCADS-P)
Time frame: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
Brief 11-item version of the Revised Child Anxiety and Depression Scale for Adolescents (RCADS-11)
Time frame: Week 0 and Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 after treatment start and 3,12 and 60 months after treatment has ended
Children's global assessment scale (CGAS)
Time frame: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
The Work and Social Adjustment Scale (WSAS)
Time frame: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
The Positive and Negative Affect Schedule for Children (PANAS-C)
Time frame: Week 0 and Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 after treatment start and 3,12 and 60 months after treatment has ended
The Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA)
Time frame: Week 0 and Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 after treatment start and 3,12 and 60 months after treatment has ended
Difficulties in Emotion Regulation Scale - 16 item version (DERS-16)
Time frame: Week 0 and Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 after treatment start and 3,12 and 60 months after treatment has ended
The Process Model of Emotion Regulation Questionnaire -short (PMERQ-S)
Time frame: Week 0 and Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 after treatment start and 3,12 and 60 months after treatment has ended
The Perth Alexithymia Questionnaire-Short Form (PAQ-S)
Time frame: Week 0 and Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 after treatment start and 3,12 and 60 months after treatment has ended
Self-Efficacy Questionnaire for Children (SEQ-C)
Time frame: Week 0 and Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7 after treatment start and 3,12 and 60 months after treatment has ended
Child Health Utility 9D (CHU-9D)
Time frame: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
Borderline symptoms checklist supplement (BSL-23)
Time frame: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
The Emotion Beliefs Questionnaire (EBQ)
Time frame: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
Coping with Children's Negative Emotions Scale Adolescent Version (CCNES-A)
Time frame: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
Difficulties in Emotion Regulation Scale - 16 item version (DERS-16)
Time frame: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
Behavioral emotion regulation questionnaire (BERQ)
Time frame: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
Trimbos Questionnaire for Costs associated with Psychiatric Illness (TiC-P)
Time frame: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended
Deliberate Self-Harm Inventory, Youth version (DSHI-Y)
Time frame: 3,12 and 60 months after treatment has ended
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Derived from this study: PubMed 42526916Sjoblom K, Bellander M, Nilbrink J, Zetterqvist M, Sampaio F, Hedman-Lagerlof E, Hellner C, Gross JJ, Hesser H, Bjureberg J. Randomised superiority trial evaluating an online transdiagnostic emotion regulation treatment for adolescents with mental health conditions: study protocol. BMJ Open. 2026 Jul 29;16(7):e116511. doi: 10.1136/bmjopen-2026-116511.
- Individual participant dataSharing planned: No. The data are pseudonymized according to national (Swedish) and European Union legislation and cannot be anonymized and published in an open repository. Participants in the study consent for their data to be shared with other international researchers for meta-analyses. Aggregated data can be made available upon reasonable request on a case-by-case basis according to the current legislation and ethical permits
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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.
Johan Bjureberg principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POET feeling and Supportive treatment in people with Mental Health Issue, 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 22 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johan Bjureberg, PhD (+460852480000, johan.bjureberg@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Clinical Global Impressions -Severity scale (CGI-S) (time frame: Week 0, 7 weeks after treatment start and 3,12 and 60 months after treatment has ended). 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 NCT06067165, which also lists 1 linked publication.
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 22 Sep 2025.