Mental Ill-healthPRIMARITA-2NCT06804954
Transdiagnostic Online CBT vs. Care as Usual for Primary Care Patients With Subsyndromal Mental Ill-health ( PRIMARITA-2 )
A study testing Online transdiagnostic CBT and Primary care as usual in people with Mental Ill-health, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The goal of this randomized controlled trial is to investigate if online transdiagnostic cognitive behavior therapy (CBT) can be effective in the treatment of subsyndromal mental ill-health in adult primary care patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Ill-health
- What is being tested?
- Online transdiagnostic CBT and Primary care as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteSweden
- Study dates
- 25 Feb 2025to 6 Feb 2029
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be included patients have to:
- To be included patients have to: (a) have a subsyndromal mental health problem concerning anxiety, depressive symptoms, or stress-related ill-health that warrants treatment,
- be at least 18 years old,
- have regular access to a device with an Internet connection,
- be able to read and write in Swedish,
- have no severe psychiatric disorder that requires specialized psychiatric care, such as psychosis, bipolar disorder, or anorexia nervosa,
Show all 9Show fewer
- if on medication with monoamine agonist, have stable dosage in the past month,
- have no on-going psychological treatment, and
- provide written informed consent for participation and complete baseline assessment
Who cannot join
- As the targeted population in this trial is primary care patients with subsyndromal mental ill-health that do not have a manifest specific common mental disorder, patients will be excluded if they meet diagnostic criteria for an anxiety disorder (social phobia, panic disorder, agoraphobia, general anxiety disorder, or specific phobia), a health anxiety disorder (hypochondriasis or illness anxiety disorder), obsessive-compulsive disorder, depression (depression or dysthymia), or a stress-related disorder (exhaustion disorder, adjustment disorder, or post-traumatic stress disorder). Note that meeting diagnostic criteria for not otherwise specified disorders (e.g., anxiety not otherwise specified), mixed anxiety and depressive disorder, or disorders subsumed under "other" categories is not a reason for exclusion.
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
Region Stockholm, Gustavsberg Primary Care Center
Gustavsberg, Stockholm County, 134 40
Erik Hedman-Lagerlöf, Phd, Professor, +46 8 123 395 50, erik.hedman-lagerlof@ki.se
About this study
Official title: Internet-based Transdiagnostic Cognitive Behavior Therapy and Care as Usual for Primary Care Patients With Mental Ill-health (RCT-2: Subsyndromal Mental Ill-health)
The goal of this randomized controlled trial is to investigate if online transdiagnostic cognitive behavior therapy (CBT) can be effective in the treatment of subsyndromal mental ill-health in adult primary care patients. The main aim is to investigate:
if online transdiagnostic CBT yields superior symptomatic improvement compared to care-as-usual when given in a primary care context to patients with mental ill-health.
Read more
Researchers will compare online transdiagnostic CBT to primary care as usual to see if psychiatric symptoms can be reduced.
Participants will be randomized to online transdiagnostic CBT or primary care as usual. Participants in online transdiagnostic CBT will receive a cognitive behavioral treatment provided through a secure web platform in which psychoeducation, worksheets, and exercises are presented in online modules similar to chapters in a book. Participants will receive weekly written feedback on their work and progress by a therapist who gives gradual access to the treatment modules. The lion's share of the contact between the therapist and the patient thus takes place through messages (similar to email) in the online treatment platform.
Participants randomized to care as usual will receive health care services as usual in primary care. As this comparator is intended to reflect real routine primary care, the interventions will not be controlled by the research project, but the investigators expect that participants will receive an active treatment.
Read the detailed description
Background: A large proportion of primary care patients with mental ill-health do not meet criteria for a manifest specific psychiatric disorder, but have subsyndromal mental ill-health that nonetheless requires treatment. The available research litterature regarding how to treat this patient group is scarce and the high demand for therapeutic services in primary care typically leads to low treatment accessibility. One possible and practical therapeutic solution is online transdiagnostic CBT, which draws on shared underlying mechanisms and is resource-efficient. There is still clear limitations in its evidence-base there is little data on how this method compares to primary care as usual for this patient group.
Purpose and aims: The overall purpose of the current trial is to build evidence for an accessible online transdiagnostic CBT for primary care patients with subsyndromal mental-ill health. A randomized controlled trial will be conducted where adult primary care patients with mental ill-health (but without manifest specific psychiatric disorder) will receive online transdiagnostic CBT or care as usual.
The main aim (I) of the study is to investigate if online transdiagnostic CBT yields superior symptomatic improvement compared to care-as-usual when given in a primary care context to patients with subsyndromal mental ill-health. Secondary aims are to investigate (II) if the treatment conditions are associated with improvement in quality of life, functional impairment, and neuroticism (III) moderators of treatment outcome, (IV) mediators of improvement, and (V) the cost-effectiveness (including effects on sickness absence) of online transdiagnostic CBT compared to primary care-as-usual. Should the trial fail to show a significant difference on the primary outcome, a secondary aim will also be to (VI) investigate if online transdiagnostic CBT is non-inferior to primary care as usual in reducing psychiatric symptoms.
Methods: This is a randomized controlled superiority trials where consecutively recruited adult primary care patients (N=500) are allocated in a 1:1 ratio to Internet-delivered transdiagnostic CBT or to primary care-as usual. This trial is part of larger project comprising two twin randomized controlled trials that are conducted in parallel where the difference between them is that the current trial will include patients with subsyndromal mental ill-health whereas the other (separately registered with clinicaltrials.gov) will include patients with a manifest psychiatric disorder.
Participants are consecutively recruited from the regular influx of primary care patients. Gustavsberg Primary Health Care Center in Region Stockholm, Sweden, is the basis, but additional primary care centers will be engaged to facilitate the recruitment and treatment of participants. The investigators expect that 10 to 20 primary care centers in Region Stockholm will be engaged for the recruitment and treatment of participants.
Patients who seek help for common mental health problems will be asked if they are interested in applying for the study. Those interested will undergo an assessment interview with a licensed clinician where all inclusion criteria are checked.
Measurements: See section Outcome Measures.
Treatment conditions: See section Arms and Interventions.
Data analysis: Change in the primary outcome measure will be analyzed using mixed effects linear regression. Fixed predictors in these analyses will be time, group and their interaction effect while taking individual variation in baseline symptom levels and change over time into account, i.e., random intercept and slope. Change from baseline to 10-week follow-up will be the primary endpoint. Power analyses show that to have 90% power to detect an effect size of d=0.25 (α=.05), given a correlation between measurements of 0.7, and an expected attrition of 15-20%, 250 participants will be needed in each arm (total sample size N=500). Should the main analysis show that there is a non-significant difference on the primary outcome, the investigators will conduct a secondary analysis of whether online transdiagnostic CBT is non-inferior to primary care-as-usual where the non-inferiority margin on the primary outcome is set to d=0.25, i.e., the bound of the one-sided 95% confidence interval must be within this margin for non-inferiority to be demonstrated. With 500 participants, 15-20% attrition, and a true null effect of zero, the study will have approximately 80% power to detect non-inferiority.
- Conditions
- Mental Ill-health
- Being tested
- Online transdiagnostic CBT, Primary care as usual
- Keywords
- Primary Care, Transdiagnostic CBT, Online treatment, Subsyndromal mental ill-health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online transdiagnostic CBTBehavioural
This treatment is provided through a secure web platform in which psychoeducation, worksheets, and exercises are presented in online modules similar to chapters in a book. Participants will receive weekly written feedback on their work and progress by a therapist who gives gradual access to the treatment modules. The lion's share of the contact between the therapist and the patient thus takes place through messages (similar to email) in the online treatment platform. It is however allowed to also have one to three face-to-face sessions on-site or through video calls to provide technical assistance and therapeutic support in accordance with the treatment model. Core components are: (a) psychoeducation about emotions and CBT, (b) functional analysis, (c) mindfulness practice, (d) breaking dysfunctional emotion-driven behaviors, and (e) exposure exercises.
Primary care as usualOther
It is mandatory for primary care services in Stockholm, Sweden, to have staff with adequate competence in the assessment and treatment of common mental disorders. Typically, these patients are handled by general practitioners, psychologists, nurses, or social workers. As this comparator is intended to reflect real routine primary care, the interventions will not be controlled by the research project. We expect that participants allocated to this condition will receive an active treatment.
| Study group | Role | What they receive |
|---|---|---|
| Online transdiagnostic CBT | Experimental | Participants randomized to this arm will receive the intervention online transdiagnostic CBT (see Interventions). Receives: Behavioral: Online transdiagnostic CBT |
| Primary care as usual | Active comparator | Patients randomized to this study condition will receive health care services as usual in primary care. Receives: Other: Primary care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Depression Anxiety Stress Scales-21 (DASS-21) to 10-week, and 1-and 2- year follow-ups
This is a 21-item scale with a sum score range 0 to 126 where a higher score indicates more symptoms.
Measured: Baseline, weeks 2, 4, 6, 8, 10 (primary endpoint), and 1-and 2-year follow-up
Secondary outcomes (5)
Change in WHODAS from baseline to 10-week, and 1- and 2-year follow-ups
WHODAS is a 12-item measure of disability with a sum score range 0 to 100 where a higher score indicates more disability
Measured: Baseline, week 10, 1- and 2-year follow-ups
Change in Work Ability Index from baseline to 10-week, and 1- and 2-year follow-ups
The Work Ability Index measures work ability with a sum score range 7 to 49 where a higher score indicates higher work ability
Measured: Baseline, week 10, 1- and 2-year follow-ups
Change in Brunnsviken Brief Quality of Life Index from baseline to 10-week, and 1- and 2-year follow-ups
This is a measure of quality of life with a sum score range 0 to 96 where a higher score indicates higher quality of life
Measured: Baseline, week 10, 1- and 2-year follow-ups
Change in sickness absence from 1 year before baseline to 1- and 2-year follow-ups
Net days of sickness absence (including disability pension) will be calculated based on data from the Swedish Microdata for Analysis of Social Security (MiDAS) registry of the National Insurance Agency.
Measured: The 1-year period preceding baseline, 1- and 2-year periods after baseline
Change in EPQR-A Neuroticism scale from baseline to 10-week, and 1-and 2-year follow-ups
The EPQR-A (Eyesenck Personality Questionnaire Revised-Abbreviated) Neuroticism scale is a 6-item measure of neuroticism with a sum score range 0 to 6 where a higher score indicates more neuroticism.
Measured: Baseline, week 10, 1- and 2-year follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start25 Feb 2025
- Primary completion6 Feb 2029 (estimated)
- Study completion6 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Ill-healthStudies 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Erik Hedman, Karolinska Institutet
- Investigators
- Erik Hedman-Lagerlöf, PhD, professor, Principal investigator, Region Stockholm and Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804954
- Sponsor's protocol ID
- TRANS SUB 2024-06008-01 RCT-2
- Acronym
- PRIMARITA-2
- Status last verified
- Aug 2026
- First submitted
- 28 Jan 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The information collected in the study contains sensitive personal data and is protected by Swedish and European data secrecy regulations. Any data sharing is thus subject to assessment by relevant authorities and is not something the principal investigator can decide upon.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Transdiagnostic Cognitive Behavior Therapy and Care as Usual for Primary Care Patients With Mental Ill-health (RCT-2: Subsyndromal Mental Ill-health)
- ClinicalTrials.gov ID
- NCT06804954
- Acronym / sponsor ID
- PRIMARITA-2 / TRANS SUB 2024-06008-01 RCT-2
- Conditions
- Mental Ill-health
- Keywords
- Primary Care, Transdiagnostic CBT, Online treatment, Subsyndromal mental ill-health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 6 Feb 2029 (estimated)
- Study completion
- 6 Feb 2029 (estimated)
- First posted
- 3 Feb 2025 (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.
The goal of this randomized controlled trial is to investigate if online transdiagnostic cognitive behavior therapy (CBT) can be effective in the treatment of subsyndromal mental ill-health in adult primary care patients. The main aim is to investigate:
if online transdiagnostic CBT yields superior symptomatic improvement compared to care-as-usual when given in a primary care context to patients with mental ill-health.
Researchers will compare online transdiagnostic CBT to primary care as usual to see if psychiatric symptoms can be reduced.
Participants will be randomized to online transdiagnostic CBT or primary care as usual. Participants in online transdiagnostic CBT will receive a cognitive behavioral treatment provided through a secure web platform in which psychoeducation, worksheets, and exercises are presented in online modules similar to chapters in a book. Participants will receive weekly written feedback on their work and progress by a therapist who gives gradual access to the treatment modules. The lion's share of the contact between the therapist and the patient thus takes place through messages (similar to email) in the online treatment platform.
Participants randomized to care as usual will receive health care services as usual in primary care. As this comparator is intended to reflect real routine primary care, the interventions will not be controlled by the research project, but the investigators expect that participants will receive an active treatment.
Detailed description
Background: A large proportion of primary care patients with mental ill-health do not meet criteria for a manifest specific psychiatric disorder, but have subsyndromal mental ill-health that nonetheless requires treatment. The available research litterature regarding how to treat this patient group is scarce and the high demand for therapeutic services in primary care typically leads to low treatment accessibility. One possible and practical therapeutic solution is online transdiagnostic CBT, which draws on shared underlying mechanisms and is resource-efficient. There is still clear limitations in its evidence-base there is little data on how this method compares to primary care as usual for this patient group.
Purpose and aims: The overall purpose of the current trial is to build evidence for an accessible online transdiagnostic CBT for primary care patients with subsyndromal mental-ill health. A randomized controlled trial will be conducted where adult primary care patients with mental ill-health (but without manifest specific psychiatric disorder) will receive online transdiagnostic CBT or care as usual.
The main aim (I) of the study is to investigate if online transdiagnostic CBT yields superior symptomatic improvement compared to care-as-usual when given in a primary care context to patients with subsyndromal mental ill-health. Secondary aims are to investigate (II) if the treatment conditions are associated with improvement in quality of life, functional impairment, and neuroticism (III) moderators of treatment outcome, (IV) mediators of improvement, and (V) the cost-effectiveness (including effects on sickness absence) of online transdiagnostic CBT compared to primary care-as-usual. Should the trial fail to show a significant difference on the primary outcome, a secondary aim will also be to (VI) investigate if online transdiagnostic CBT is non-inferior to primary care as usual in reducing psychiatric symptoms.
Methods: This is a randomized controlled superiority trials where consecutively recruited adult primary care patients (N=500) are allocated in a 1:1 ratio to Internet-delivered transdiagnostic CBT or to primary care-as usual. This trial is part of larger project comprising two twin randomized controlled trials that are conducted in parallel where the difference between them is that the current trial will include patients with subsyndromal mental ill-health whereas the other (separately registered with clinicaltrials.gov) will include patients with a manifest psychiatric disorder.
Participants are consecutively recruited from the regular influx of primary care patients. Gustavsberg Primary Health Care Center in Region Stockholm, Sweden, is the basis, but additional primary care centers will be engaged to facilitate the recruitment and treatment of participants. The investigators expect that 10 to 20 primary care centers in Region Stockholm will be engaged for the recruitment and treatment of participants.
Patients who seek help for common mental health problems will be asked if they are interested in applying for the study. Those interested will undergo an assessment interview with a licensed clinician where all inclusion criteria are checked.
Measurements: See section Outcome Measures.
Treatment conditions: See section Arms and Interventions.
Data analysis: Change in the primary outcome measure will be analyzed using mixed effects linear regression. Fixed predictors in these analyses will be time, group and their interaction effect while taking individual variation in baseline symptom levels and change over time into account, i.e., random intercept and slope. Change from baseline to 10-week follow-up will be the primary endpoint. Power analyses show that to have 90% power to detect an effect size of d=0.25 (α=.05), given a correlation between measurements of 0.7, and an expected attrition of 15-20%, 250 participants will be needed in each arm (total sample size N=500). Should the main analysis show that there is a non-significant difference on the primary outcome, the investigators will conduct a secondary analysis of whether online transdiagnostic CBT is non-inferior to primary care-as-usual where the non-inferiority margin on the primary outcome is set to d=0.25, i.e., the bound of the one-sided 95% confidence interval must be within this margin for non-inferiority to be demonstrated. With 500 participants, 15-20% attrition, and a true null effect of zero, the study will have approximately 80% power to detect non-inferiority.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online transdiagnostic CBT | Experimental | Behavioral: Online transdiagnostic CBTParticipants randomized to this arm will receive the intervention online transdiagnostic CBT (see Interventions). |
| Primary care as usual | Active comparator | Other: Primary care as usualPatients randomized to this study condition will receive health care services as usual in primary care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- To be included patients have to: (a) have a subsyndromal mental health problem concerning anxiety, depressive symptoms, or stress-related ill-health that warrants treatment,
- be at least 18 years old,
- have regular access to a device with an Internet connection,
- be able to read and write in Swedish,
- have no severe psychiatric disorder that requires specialized psychiatric care, such as psychosis, bipolar disorder, or anorexia nervosa,
Key exclusion criteria (1 listed)
- As the targeted population in this trial is primary care patients with subsyndromal mental ill-health that do not have a manifest specific common mental disorder, patients will be excluded if they meet diagnostic criteria for an anxiety disorder (social phobia, panic disorder, agoraphobia, general anxiety disorder, or specific phobia), a health anxiety disorder (hypochondriasis or illness anxiety disorder), obsessive-compulsive disorder, depression (depression or dysthymia), or a stress-related disorder (exhaustion disorder, adjustment disorder, or post-traumatic stress disorder). Note that meeting diagnostic criteria for not otherwise specified disorders (e.g., anxiety not otherwise specified), mixed anxiety and depressive disorder, or disorders subsumed under "other" categories is not a reason for exclusion.
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 |
|---|---|---|
| Online transdiagnostic CBTThis treatment is provided through a secure web platform in which psychoeducation, worksheets, and exercises are presented in online modules similar to chapters in a book. Participants will receive weekly written feedback on their work and progress by a therapist who gives gradual access to the treatment modules. The lion's share of the contact between the therapist and the patient thus takes place through messages (similar to email) in the online treatment platform. It is however allowed to also have one to three face-to-face sessions on-site or through video calls to provide technical assistance and therapeutic support in accordance with the treatment model. Core components are: (a) psychoeducation about emotions and CBT, (b) functional analysis, (c) mindfulness practice, (d) breaking dysfunctional emotion-driven behaviors, and (e) exposure exercises. | Behavioural | Online transdiagnostic CBT |
| Primary care as usualIt is mandatory for primary care services in Stockholm, Sweden, to have staff with adequate competence in the assessment and treatment of common mental disorders. Typically, these patients are handled by general practitioners, psychologists, nurses, or social workers. As this comparator is intended to reflect real routine primary care, the interventions will not be controlled by the research project. We expect that participants allocated to this condition will receive an active treatment. | Other | Primary care as usual |
Primary outcome
Change from baseline in Depression Anxiety Stress Scales-21 (DASS-21) to 10-week, and 1-and 2- year follow-ups
Time frame: Baseline, weeks 2, 4, 6, 8, 10 (primary endpoint), and 1-and 2-year follow-up
This is a 21-item scale with a sum score range 0 to 126 where a higher score indicates more symptoms.
5 secondary outcomes
Change in WHODAS from baseline to 10-week, and 1- and 2-year follow-ups
Time frame: Baseline, week 10, 1- and 2-year follow-ups
Change in Work Ability Index from baseline to 10-week, and 1- and 2-year follow-ups
Time frame: Baseline, week 10, 1- and 2-year follow-ups
Change in Brunnsviken Brief Quality of Life Index from baseline to 10-week, and 1- and 2-year follow-ups
Time frame: Baseline, week 10, 1- and 2-year follow-ups
Change in sickness absence from 1 year before baseline to 1- and 2-year follow-ups
Time frame: The 1-year period preceding baseline, 1- and 2-year periods after baseline
Change in EPQR-A Neuroticism scale from baseline to 10-week, and 1-and 2-year follow-ups
Time frame: Baseline, week 10, 1- and 2-year follow-ups
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 17 Aug 2026.
- Individual participant dataSharing planned: No. The information collected in the study contains sensitive personal data and is protected by Swedish and European data secrecy regulations. Any data sharing is thus subject to assessment by relevant authorities and is not something the principal investigator can decide upon.
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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.
Erik Hedman-Lagerlöf, PhD, professor principal investigator
Region Stockholm and 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 Online transdiagnostic CBT and Primary care as usual in people with Mental Ill-health, 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 9 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: looking for participants now, as of the sponsor's last update on 17 Aug 2026. 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 Mari von Bahr Bentzer, MSc. (+46 8 123 395 50, mari.vonbahr-bentzer@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Depression Anxiety Stress Scales-21 (DASS-21) to 10-week, and 1-and 2- year follow-ups (time frame: Baseline, weeks 2, 4, 6, 8, 10 (primary endpoint), and 1-and 2-year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2026.