Online cognitive behavior therapy for patients with mild mental health issues

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.