Online cognitive behavior therapy for patients with mild mental health issues
Internet-based Transdiagnostic Cognitive Behavior Therapy and Care As Usual for Primary Care Patients with Mental Ill-health (RCT-2: Subsyndromal Mental Ill-health)
This study tests if online cognitive behavior therapy can help adults with mild mental health issues feel better and improve their quality of life compared to regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Gustavsberg, Stockholm County) |
| Trial ID | NCT06804954 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of online transdiagnostic cognitive behavior therapy (CBT) compared to standard care for adult primary care patients experiencing subsyndromal mental ill-health. Participants will be randomly assigned to receive either online CBT, which includes psychoeducation and therapeutic exercises delivered through a secure web platform, or care as usual. The study aims to determine if the online CBT can lead to greater symptomatic improvement and enhance quality of life for these patients. The trial addresses a significant gap in treatment options for individuals who do not meet the criteria for specific psychiatric disorders but still require mental health support.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with subsyndromal mental health issues related to anxiety, depression, or stress who can access the internet and read Swedish.
Not a fit: Patients with severe psychiatric disorders requiring specialized care or those currently undergoing psychological treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide accessible and effective mental health treatment for patients with mild symptoms, improving their overall well-being.
How similar studies have performed: While there is limited data on this specific approach, other studies have shown promise for online CBT in treating various mental health conditions.
Eligibility criteria
Show full inclusion / exclusion 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 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.
Where this trial is running
Gustavsberg, Stockholm County
- Region Stockholm, Gustavsberg Primary Care Center — Gustavsberg, Stockholm County, Sweden (Recruiting)
Study contacts
- Principal investigator: Erik Hedman-Lagerlöf, PhD, professor — Region Stockholm and Karolinska Institutet
- Study coordinator: Mari von Bahr Bentzer, MSc.
- Email: mari.vonbahr-bentzer@regionstockholm.se
- Phone: +46 8 123 395 50
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.