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

NCT07201844 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2025-10-01

No results posted yet for this study

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.

Conditions

  • Generalized Anxiety Disorder (GAD)

Interventions

BEHAVIORAL

Metacognitive Internet delivered Cognitive Behavior Therapy

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

BEHAVIORAL

Intolerance 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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-26
Primary Completion
2027-08-31
Completion
2028-08-31

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07201844 on ClinicalTrials.gov