Choosing between two online cognitive behavioral programs for generalized anxiety
ORIGAMI: Internetbaserad Behandling för GAD. Effekten av Att få välja Behandling själv Samtbehandlarens förmåga Att Matcha Patienter Till rätt Behandling. En Randomiserad kontrolleradprövning.
This study tests whether adults with generalized anxiety do better, stick with treatment more, and feel more satisfied when they can choose between two internet-based CBT programs versus being randomly assigned, and whether matching a psychologist's prediction improves results.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 440 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 1 site (Stockholm, Sverige) |
| Trial ID | NCT07201844 on ClinicalTrials.gov |
What this trial studies
A randomized trial at the Internet Psychiatry Clinic in Stockholm will compare outcomes for adults with GAD who either choose between two internet-delivered CBT programs or are randomly assigned to one. Eligible participants (GAD-7 ≥7, Swedish-speaking, with access to a device and Swedish BankID) are randomized 2:1:1 to a choice condition or one of two assignment arms, and a psychologist makes a blinded prediction about which program will suit each patient. The two programs are intolerance-of-uncertainty-based ICBT and metacognition-based ICBT, each delivered over 10 weeks as part of routine online care. The study will compare symptom change, adherence, treatment satisfaction/credibility, sense of agency, and the effect of matching the psychologist's prediction to the received treatment.
Who should consider this trial
Good fit: Adults 18 or older who meet DSM-5 criteria for GAD, have a GAD-7 score of at least 7, speak Swedish fluently, have a smartphone/tablet/computer and Swedish BankID, and can commit to a 10-week online program are ideal candidates.
Not a fit: Patients judged to need a different psychiatric treatment (for example severe depression or high suicide risk), those with current drug or alcohol abuse, major somatic health concerns, severe social vulnerability, or who cannot access Swedish BankID or the online platform are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, allowing choice or better matching to psychologist predictions could lead to greater symptom reduction, higher adherence, and improved satisfaction for people with GAD.
How similar studies have performed: Previous work on patient choice in psychotherapy and digital mental health shows modest gains in engagement and outcomes, but directly comparing these two ICBT approaches together with psychologist prediction is relatively novel.
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 ≥ 7 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, Sverige
- Internet Psychiatry Clinic, Psychiatry Southwest, SLSO, Region Stockholm, Stockholm, Huddinge 14135 — Stockholm, Sverige, Sweden (Recruiting)
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.