RecruitingNot ApplicableNCT07201844

The Effect of Patient Preference for Treatment Model in Internet Delivered Cognitive Behavior Therapy for Generalized Anxiety Disorder

ORIGAMI: Internetbaserad Behandling för GAD. Effekten av Att få välja Behandling själv Samtbehandlarens förmåga Att Matcha Patienter Till rätt Behandling. En Randomiserad kontrolleradprövning.


Sponsor

Karolinska Institutet

Enrollment

440 participants

Start Date

Aug 26, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether patients with generalized anxiety disorder (GAD) who get to choose their preferred format of internet-based cognitive behavioral therapy (CBT) — either therapist-guided or self-guided — do better than those randomly assigned to a format. The goal is to understand how patient preference affects treatment outcomes. **You may be eligible if...** - You are 18 or older - You have been diagnosed with generalized anxiety disorder (GAD) by a psychologist - Your GAD-7 self-rating score is 7 or higher - You speak and read Swedish fluently - You have access to a smartphone, tablet, or computer with a Swedish BankID - You are available to participate in the 10-week treatment **You may NOT be eligible if...** - You have another psychiatric condition that requires more urgent treatment - You have a high risk of suicide - You have current drug or alcohol abuse - You have a severe physical health condition or major social vulnerability Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALMetacognitive Internet delivered Cognitive Behavior Therapy

Specialist Guided Internet delivered Cognitive Behavior Therapy based on the metacognitive model of excessive worry

BEHAVIORALIntolerance of uncertainty based Internet delivered Cognitive Behavior Therapy

Specialist Guided Internet delivered Cognitive Behavior Therapy based on the Intolerance of uncertainty model of excessive worry


Locations(1)

Internet Psychiatry Clinic, Psychiatry Southwest, SLSO, Region Stockholm, Stockholm, Huddinge 14135

Stockholm, Sverige, Sweden

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NCT07201844


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