Comparing two online therapies for Generalized Anxiety Disorder
Effects and Mechanisms of Change of Internet Delivered Cognitive Behavior Therapy for Generalized Anxiety Disorder Based on Intolerance of Uncertainty or Metacognitive Theory
This study is testing which of two online therapy programs is better for helping people with Generalized Anxiety Disorder feel less anxious.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Stockholm, Huddinge) |
| Trial ID | NCT05849493 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of two internet-based cognitive behavioral therapy (ICBT) programs for treating Generalized Anxiety Disorder (GAD). Participants will be randomly assigned to either an Intolerance of Uncertainty-based ICBT or a Metacognition-based ICBT, each consisting of 8 modules over a 10-week period. Throughout the treatment, participants will engage with written materials, complete exercises, and receive feedback from a psychologist via an online platform. The study will assess how well these treatments work and whether changes in targeted variables predict improvements in anxiety symptoms.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who meet the diagnostic criteria for GAD and can participate in the treatment in Swedish.
Not a fit: Patients with severe psychiatric conditions, high suicide risk, or significant substance abuse issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective online treatment options for patients suffering from Generalized Anxiety Disorder.
How similar studies have performed: Previous studies have shown promising results for internet-delivered cognitive behavioral therapies, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * 18 years or older. * Meet diagnostic criteria for GAD according to DSM-5, as assessed by a psychologist on a video-call. * Self-rated score \> 10 on GAD-7. * Can read and speak Swedish fluently. * Have access to a smartphone, tablet, or computer and a Swedish BankID which allows access to the video-calls and treatment platform. * Have the time and possibility to participate in the 10 week treatment. * Consents to participate. Exclusion criteria: * Patients that are judged to be in greater need of another psychiatric treatment for another psychiatric diagnosis (for example severe depression) and/or is judged to have a high risk of suicide. * Current drug or alcohol abuse. * Current severe somatic health concern or social vulnerability if this is judged to be too great an obstacle for the patient to carry out the treatment.
Where this trial is running
Stockholm, Huddinge
- Internet Psychiatry Clinic, Psychiatry Southwest, SLSO, Region Stockholm — Stockholm, Huddinge, Sweden (Recruiting)
Study contacts
- Principal investigator: Erik Forsell, PhD — Karolinska Institutet
- Study coordinator: Erik Forsell, PhD
- Email: erik.forsell@ki.se
- Phone: +46704903681
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.