NCT06804954 Transdiagnostic Online CBT Vs. Care As Usual for Primary Care Patients with Subsyndromal Mental Ill-health ( PRIMARITA-2 )
| NCT ID | NCT06804954 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | Mental Ill-health |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2025-02-25 |
| Primary Completion | 2029-02-06 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: To be included patients have to: 1. 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, 2. be at least 18 years old, 3. have regular access to a device with an Internet connection, 4. be able to read and write in Swedish, 5. have no severe psychiatric disorder that requires specialized psychiatric care, such as psychosis, bipolar disorder, or anorexia nervosa, 6. if on medication with monoamine agonist, have stable dosage in the past month, 7. have no on-going psychological treatment, and 8. provide written informed consent for participation and complete baseline assessment Exclusion criteria: 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 pho