NCT07201844 The Effect of Patient Preference for Treatment Model in Internet Delivered Cognitive Behavior Therapy for Generalized Anxiety Disorder
| NCT ID | NCT07201844 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | Generalized Anxiety Disorder (GAD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 440 participants |
| Start Date | 2025-08-26 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 440 participants in total. It began in 2025-08-26 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to investigate the effect of allowing patients to choose between two internet-based cognitive behavioral treatments (ICBT) for generalized anxiety disorder (GAD). The goal is also to examine psychologists' ability to predict which of the two treatments the patient will benefit most from. The main questions it aims to answer are: * Do patients who are randomized to choose their treatment improve more in their GAD symptoms compared to patients who are randomly assigned to a treatment? * Does allowing patients to choose their treatment increase treatment adherence, compared to being randomly assigned to a treatment? * Does allowing patients to choose their treatment increase treatment satisfaction and credibility, compared to being randomly assigned to a treatment? * Does allowing patients to choose their treatment increase patients' sense of agency related to the treatment process, compared to being randomly assigned to a treatment? * Do patients who receive a treatment that matches the psychologist's prediction of which treatment would fit the patient best show better treatment outcomes (primarily reduction in GAD symptoms over time, but also secondary outcomes such as satisfaction), compared to patients who receive a treatment that does not match the psychologist's prediction? Participants included in the trial will be randomized to one of two conditions: 1) read short descriptions of the two treatment programs and based on that choose the preferred treatment, 2) randomly being allocated to one of the two treatments. The two internet-based treatment programs which the patients can choose between or be randomly allocated to are: 1) Intolerance of uncertainty-based ICBT and 2) Metacognition-based ICBT. Both programs consist of 8 treatment modules and run for 10 weeks. Patients in both conditions receive continuous support by a psychologist through a built-in message function on the treatment platform. The patient will receive feedback from the psychologist on their assignments and exercises and the psychologist will respond to the participants' messages.
Eligibility 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.
Frequently Asked Questions
Who can join the NCT07201844 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Generalized Anxiety Disorder (GAD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07201844 currently recruiting?
Yes, NCT07201844 is actively recruiting participants. Visit ClinicalTrials.gov or contact Karolinska Institutet to inquire about joining.
Where is the NCT07201844 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT07201844 clinical trial?
NCT07201844 is sponsored by Karolinska Institutet. The trial plans to enroll 440 participants.
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