Mental Health IssuePOETNCT05032547
Primary Care Online Emotion-regulation Treatment
A study testing Therapist-supported digitally delivered transdiagnostic emotion regulation treatment and Therapist-supported digitally delivered supportive treatment in people with Mental Health Issue, run by Region Stockholm at 1 site in Sweden.
Trial summary
We will evaluate a transdiagnostic digital emotion regulation treatment for youth with mental health problems. 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?
- Therapist-supported digitally delivered transdiagnostic emotion regulation treatment and Therapist-supported digitally delivered supportive treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 16 Oct 2022to 6 Jun 2023
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Presenting with mental health problems
Who cannot join
- Acute suicidality and severe mental illness that require specialized care
Trial locations and contacts
1 site in 1 country.
About this study
We will evaluate a transdiagnostic digital emotion regulation treatment for youth with mental health problems.
Read the detailed description
Mental health problems in youth are a global problem, causing incalculable suffering in youth and families, harming long-term prospects of youths, and are creating substantial economic costs to society. Existing treatments are not fully addressing these problems because they focus on a subset of mental health problems; they are limited in efficacy; and are not provided to most youth in need. Transdiagnostic digital treatments that address mechanisms underlying mental health problems, such as emotion regulation, have been called for to address these problems. As an initial pilot study we will include 60 participants aged 12-17 years and their parents in a randomized controlled feasibility trial comparing a 6-week Primary care Online Emotion-regulation Treatment (POET) to a 6-week active Supportive Treatment (ST). Both interventions will be delivered in blended format combining online therapist-supported treatment modules with a video-link session. The primary study aims are to examine the feasibility and acceptability of study protocol and treatment protocols. Preliminary utility of the experimental condition will be evaluated by youth-reported, parent-reported, and clinical-reported outcomes.
- Conditions
- Mental Health Issue
- Being tested
- Therapist-supported digitally delivered transdiagnostic emotion regulation treatment, Therapist-supported digitally delivered supportive treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapist-supported digitally delivered transdiagnostic emotion regulation treatmentBehavioural
Please see description of experimental arm (arm one)
Therapist-supported digitally delivered supportive treatmentBehavioural
Please see description of active comparator arm (arm two)
| Study group | Role | What they receive |
|---|---|---|
| Primary Care Online Emotion-Regulation Treatment | Experimental | The youth component in the experimental condition will include psychoeducation, addressing maladaptive beliefs about emotions and emotion regulation, and teaching adaptive emotion regulation strategies, such as mindfulness practice and acceptance of emotions and flexible cognitive reappraisal. The parent component will include psychoeducation and teaching effective responding to their children's and their own emotions. Receives: Behavioral: Therapist-supported digitally delivered transdiagnostic emotion regulation treatment |
| Supportive Treatment | Active comparator | The intervention will be delivered in a blended treatment format combining asynchronous therapist-guided online modules (text/videos/audio/messaging function) with a synchronous session delivered over video-link. Receives: Behavioral: Therapist-supported digitally delivered supportive treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of assessments
Completion of follow-up will be defined as completing at least one clinical outcome at end of intervention.
Measured: End of treatment 6 weeks after baseline
The fraction of eligible participants who consent to inclusion and randomization
We will determine the fraction of potential participants as the number of eligible persons compared to the number of randomized persons.
Measured: End of treatment 6 weeks after baseline
Compliance
Compliance with the experimental intervention will be defined as completing at least three of six modules/sessions.
Measured: End of treatment 6 weeks after baseline
Child version or the Cognitive Emotion Regulation Questionnaire as explorative primary clinical outcome
Measure of emotion regulation
Measured: Change from baseline, once every week during treatment (0-6 weeks after baseline)
Revised Child Anxiety and Depression Scale as explorative primary clinical outcome
Measure of anxiety and depression symptoms
Measured: Change from baseline, once every week during treatment (0-6 weeks after baseline)
Secondary outcomes (6)
Children's Global Assessment Scale
Measure of global functioning
Measured: Change from baseline, 6 weeks after treatment starts
Strengths and Difficulties Questionnaire
Measure of youth strengths and difficulties
Measured: Change from baseline, 6 weeks after treatment starts
Brief 16-item Version of the Difficulties In Emotion Regulation
Measure of difficulties in emotion regulation
Measured: Change from baseline, 6 weeks after treatment starts
Emotion Regulation Questionnaire Child/Adolescents Version
Measure of difficulties in cognitive reappraisal and suppression
Measured: Change from baseline, 6 weeks after treatment starts
Beliefs About Emotions Questionnaire
Measure of beliefs about emotions
Measured: Change from baseline, 6 weeks after treatment starts
Emotion Regulation Diversity Index
Measure of emotion regulation flexibility
Measured: Change from baseline, 6 weeks after treatment starts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start16 Oct 2022
- Primary completion24 Feb 2023
- Study completion6 Jun 2023
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 Region StockholmThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Johan Bjureberg, Karolinska Institutet
- Investigators
- Johan Bjureberg, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05032547
- Sponsor's protocol ID
- POETF2022
- Acronym
- POET
- Status last verified
- Jan 2024
- First submitted
- 27 Aug 2021
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sjoblom K, Frankenstein K, Klintwall L, Nilbrink J, Zetterqvist M, Hesser H, Hedman-Lagerlof E, Gross JJ, Hellner C, Bellander M, Bjureberg J. Online Transdiagnostic Emotion Regulation Treatment for Adolescents With Mental Health Problems: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jun 2;8(6):e2514871. doi: 10.1001/jamanetworkopen.2025.14871.
PubMed 40498482
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Care Online Emotion-regulation Treatment
- ClinicalTrials.gov ID
- NCT05032547
- Acronym / sponsor ID
- POET / POETF2022
- Conditions
- Mental Health Issue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Karolinska Institutet
- Study start
- 16 Oct 2022 (actual)
- Primary completion
- 24 Feb 2023 (actual)
- Study completion
- 6 Jun 2023 (actual)
- First posted
- 2 Sep 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.
We will evaluate a transdiagnostic digital emotion regulation treatment for youth with mental health problems.
Detailed description
Mental health problems in youth are a global problem, causing incalculable suffering in youth and families, harming long-term prospects of youths, and are creating substantial economic costs to society. Existing treatments are not fully addressing these problems because they focus on a subset of mental health problems; they are limited in efficacy; and are not provided to most youth in need. Transdiagnostic digital treatments that address mechanisms underlying mental health problems, such as emotion regulation, have been called for to address these problems. As an initial pilot study we will include 60 participants aged 12-17 years and their parents in a randomized controlled feasibility trial comparing a 6-week Primary care Online Emotion-regulation Treatment (POET) to a 6-week active Supportive Treatment (ST). Both interventions will be delivered in blended format combining online therapist-supported treatment modules with a video-link session. The primary study aims are to examine the feasibility and acceptability of study protocol and treatment protocols. Preliminary utility of the experimental condition will be evaluated by youth-reported, parent-reported, and clinical-reported outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Care Online Emotion-Regulation Treatment | Experimental | Behavioral: Therapist-supported digitally delivered transdiagnostic emotion regulation treatmentThe youth component in the experimental condition will include psychoeducation, addressing maladaptive beliefs about emotions and emotion regulation, and teaching adaptive emotion regulation strategies, such as mindfulness practice and acceptance of emotions and flexible cognitive reappraisal. The parent component will include psychoeducation and teaching effective responding to their children's and their own emotions. |
| Supportive Treatment | Active comparator | Behavioral: Therapist-supported digitally delivered supportive treatmentThe intervention will be delivered in a blended treatment format combining asynchronous therapist-guided online modules (text/videos/audio/messaging function) with a synchronous session delivered over video-link. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Presenting with mental health problems
Key exclusion criteria (1 listed)
- Acute suicidality and severe mental illness that require specialized care
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 |
|---|---|---|
| Therapist-supported digitally delivered transdiagnostic emotion regulation treatmentPlease see description of experimental arm (arm one) | Behavioural | Primary Care Online Emotion-Regulation Treatment |
| Therapist-supported digitally delivered supportive treatmentPlease see description of active comparator arm (arm two) | Behavioural | Supportive Treatment |
Primary outcome
Completion of assessments
Time frame: End of treatment 6 weeks after baseline
Completion of follow-up will be defined as completing at least one clinical outcome at end of intervention.
The fraction of eligible participants who consent to inclusion and randomization
Time frame: End of treatment 6 weeks after baseline
We will determine the fraction of potential participants as the number of eligible persons compared to the number of randomized persons.
Compliance
Time frame: End of treatment 6 weeks after baseline
Compliance with the experimental intervention will be defined as completing at least three of six modules/sessions.
Child version or the Cognitive Emotion Regulation Questionnaire as explorative primary clinical outcome
Time frame: Change from baseline, once every week during treatment (0-6 weeks after baseline)
Measure of emotion regulation
Revised Child Anxiety and Depression Scale as explorative primary clinical outcome
Time frame: Change from baseline, once every week during treatment (0-6 weeks after baseline)
Measure of anxiety and depression symptoms
6 secondary outcomes
Children's Global Assessment Scale
Time frame: Change from baseline, 6 weeks after treatment starts
Strengths and Difficulties Questionnaire
Time frame: Change from baseline, 6 weeks after treatment starts
Brief 16-item Version of the Difficulties In Emotion Regulation
Time frame: Change from baseline, 6 weeks after treatment starts
Emotion Regulation Questionnaire Child/Adolescents Version
Time frame: Change from baseline, 6 weeks after treatment starts
Beliefs About Emotions Questionnaire
Time frame: Change from baseline, 6 weeks after treatment starts
Emotion Regulation Diversity Index
Time frame: Change from baseline, 6 weeks after treatment starts
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 10 Jan 2024.
- Derived from this study: PubMed 40498482Sjoblom K, Frankenstein K, Klintwall L, Nilbrink J, Zetterqvist M, Hesser H, Hedman-Lagerlof E, Gross JJ, Hellner C, Bellander M, Bjureberg J. Online Transdiagnostic Emotion Regulation Treatment for Adolescents With Mental Health Problems: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jun 2;8(6):e2514871. doi: 10.1001/jamanetworkopen.2025.14871.
- Individual participant dataSharing planned: No
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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.
Johan Bjureberg, PhD 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 Therapist-supported digitally delivered transdiagnostic emotion regulation treatment and Therapist-supported digitally delivered supportive treatment in people with Mental Health Issue, run by Region Stockholm 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 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 10 Jan 2024. 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?
Completion of assessments (time frame: End of treatment 6 weeks after baseline). The study lists 5 primary outcomes in all. 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 NCT05032547, 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 10 Jan 2024.