An interventional study of Online transdiagnostic CBT and Primary care as usual in Common Mental Disorders (CMD), sponsored by Karolinska Institutet. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
The goal of this randomized controlled trial is to investigate if online transdiagnostic cognitive behavior therapy (CBT) can be effective in the treatment of common mental disorders 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 a common mental disorder.
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.
Background: Common mental disorders (anxiety, depression and stress-related disorders) are a main driver of disease burden and primary care is the first-line of care. There are substantial disadvantages and barriers to implementing single-disorder psychological treatment leading to low treatment accessibility. These problems can potentially be overcome by the use of online transdiagnostic CBT, which draws on shared underlying mechanisms and is resource-efficient. There is still clear limitations in its evidence-base and online transdiagnostic CBT needs to be further investigated in randomized controlled trials in a primary care context.
Purpose and aims: The overall purpose of the current research project is to build evidence for an accessible online transdiagnostic CBT for primary care patients with common mental disorders. A randomized controlled trial will be conducted where adult primary care patients with a common mental disorder will receive online transdiagnostic CBT or care as usual.
The main aim (I) of the study is to investigate if Internet-delivered transdiagnostic CBT yields superior symptomatic improvement compared to care-as-usual when given in a primary care context to patients with a manifest common mental disorder. 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 a manifest common mental disorder whereas the other (separately registered with clinicaltrials.gov) will include patients with subsyndromal complaints.
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.
Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
To be included patients have to:
Participants randomized to this arm will receive the intervention online transdiagnostic CBT (see Interventions).
Behavioral: Online transdiagnostic CBT
Patients randomized to this study condition will receive health care services as usual in primary care.
Other: Primary care as usual
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.
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.
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.
Time frame: Baseline, weeks 2, 4, 6, 8, 10 (primary endpoint), and 1-and 2-year follow-up
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
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
The Work Ability Index measures work ability with a sum score range 7 to 49 where a higher score indicates higher work ability.
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
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.
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
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.
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
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.
Time frame: Baseline, week 10, 1- and 2-year follow-ups
Client Satisfaction Questionnaire at 10-week follow-up
This is an 8-item measure of client satisfaction with the care received, with a sum score range 8 to 32 where a higher score indicates higher client satisfaction.
Time frame: 10-week follow-up
Negative Effects Questionnaire at 10-week follow-up
The Negative Effects Questionnaire is a 20-item measure of potential negative effects related to the received treatment.
Time frame: 10-week follow-up
Credibility Scale (C-scale) 2 weeks after baseline
The C-scale is a measure of treatment credibility with a sum score range 0 to 50 where a higher score indicates higher treatment credibility.
Time frame: 2 weeks after baseline
Change in EQ5D from baseline to 10-week, and 1- and 2-year follow-up
The EQ5D is a measure of health-related quality of life with a score range 0 to 1 where a higher score indicates higher quality of life. This measure will be used when calculating cost-utility in the health economic analysis.
Time frame: Baseline, week 10, 1- and 2-year follow-ups
Change in Difficulties in Emotion Regulation Scale-16 from baseline to 10-week, and 1- and 2-year follow-up
The Difficulties in Emotion Regulation Scale-16 is a scale with a sum score range 16 to 80 where a higher score indicates more difficulties in emotion regulation. This scale will be used as a putative mediator in mediation analysis.
Time frame: Baseline, weeks 2, 4, 6, 8, 10, and 1-and 2-year follow-up
Change in Brief Experiential Avoidance Questionnaire from baseline to 10-week, and 1-and 2-year follow-up
The Brief Experiential Avoidance Questionnaire is a scale with a sum score range 15 to 90 where a higher score indicates more experiential avoidance. This scale will be used as a putative mediator in mediation analysis.
Time frame: Baseline, weeks 2, 4, 6, 8, 10, and 1-and 2-year follow-up
Change in TIPI scale Openness to experience from baseline to 10-week, and 1-and 2-year follow-up
This is a subscale of the Ten Item Personality Inventory that measures the personality construct openness to experience with a sum score range 1 to 7 where a higher score indicates more openness to experience. This will be used as a statistical control mediator in mediation analysis, i.e., we expect this scale will not mediate improvement.
Time frame: Baseline, weeks 2, 4, 6, 8, 10, and 1-and 2-year follow-up
Rate of healthcare consumption, by type
Data will be collected from Region Stockholm's database (VAL) that provides information about all publicly funded healthcare provided in Stockholm County.
Time frame: The 1-year period preceding baseline, 1- and 2-year periods after baseline
Socioeconomic information regarding income type
Data will be retrieved from Statistics Sweden's LISA database (Longitudinal Integration Database for Health Insurance and Labour Market Studies) and include information about the type of income.
Time frame: The 1-year period preceding baseline, 1- and 2-year periods after baseline
Number of participants with prescribed medication
Registry data: National Board of Health and Welfares registry. From the Prescribed Drug Register: Dispensed prescribed medications.
Time frame: The 1-year period preceding baseline, 1- and 2-year periods after baseline
Clinical Global Impression Severity (CGI-S) at baseline
The CGI-S is a measure of global severity of psychiatric symptoms with a scale range 1 to 7 where a higher score indicates higher severity.
Time frame: Baseline
Plan to share: 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.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Karolinska Institutet