Online Transdiagnostic Cognitive Behavioral Therapy Versus Usual Primary Care for Adults With Subsyndromal Mental Ill-health

What this Trial Is About

Researchers are evaluating the effectiveness of online transdiagnostic cognitive behavior therapy CBT compared to usual primary care for adults with subsyndromal mental ill-health. This trial focuses on individuals who experience mental health symptoms like anxiety, depression, or stress that do not meet criteria for specific psychiatric disorders but still require treatment. The study aims to see if online CBT can provide better symptom improvement, quality of life, and functional outcomes while also assessing cost-effectiveness and treatment moderators. Participants will be randomly assigned to either online transdiagnostic CBT or care as usual. The online CBT is delivered through a secure web platform offering psychoeducation, worksheets, and exercises in modules, with weekly written feedback from a therapist primarily via messaging. Some face-to-face or video sessions may be provided for technical or therapeutic support. Those in the care-as-usual group will receive standard primary care treatments, which are not controlled by the study but are expected to be active treatments. During the study, participants will complete assessments at baseline, during treatment, and at 10 weeks, as well as 1- and 2-year follow-ups. Measurements include symptom changes using the Depression Anxiety Stress Scales-21, quality of life, work ability, functional impairment, sickness absence, and neuroticism. The total study duration includes these follow-ups, and data will be analyzed to compare symptom improvement and other outcomes between the two groups. The trial plans to enroll 500 adults and is sponsored by Karolinska Institutet.

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