Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06804954

Transdiagnostic Online CBT Vs. Care As Usual for Primary Care Patients with Subsyndromal Mental Ill-health ( PRIMARITA-2 )

Led by Karolinska Institutet · Updated on 2025-03-07

500

Participants Needed

1

Research Sites

206 weeks

Total Duration

On this page

Sponsors

K

Karolinska Institutet

Lead Sponsor

R

Region Stockholm

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Transdiagnostic Online CBT Vs. Care As Usual for Primary Care Patients with Subsyndromal Mental Ill-health ( PRIMARITA-2 )

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have a subsyndromal mental health problem involving anxiety, depressive symptoms, or stress-related ill-health that requires 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 requiring specialized psychiatric care such as psychosis, bipolar disorder, or anorexia nervosa
  • If on monoamine agonist medication, have had a stable dosage for the past month
  • Have no ongoing psychological treatment
  • Provide written informed consent and complete baseline assessment
Not Eligible

You will not qualify if you...

  • Meet diagnostic criteria for anxiety disorders including social phobia, panic disorder, agoraphobia, general anxiety disorder, or specific phobia
  • Have a health anxiety disorder such as hypochondriasis or illness anxiety disorder
  • Have obsessive-compulsive disorder
  • Have depression or dysthymia
  • Have stress-related disorders such as exhaustion disorder, adjustment disorder, or post-traumatic stress disorder

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Region Stockholm, Gustavsberg Primary Care Center

Gustavsberg, Stockholm County, Sweden, 134 40

Actively Recruiting

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Research Team

M

Mari von Bahr Bentzer, MSc.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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