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

NCT07201844 | Recruiting

• 1 other identifier: 2025-03553-01 RCT2
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 1

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.

Conditions

Generalized Anxiety Disorder (GAD)

Keywords

Internet interventions; Digital mental health services; cognitive behaviour therapy; patient preferences; psychiatry

Outcome Measures

Primary Outcomes (1)

• Change in Generalized Anxiety Disorder - score (GAD-7)

  Measures generalized anxiety symptoms. 7 items. Scores range from 0-21 with higher scores indicating more generalized anxiety

  Measured weakly from treatment start (pre-treatment) to 10 weeks after treatment start (post-treatment).

Secondary Outcomes (7)

• Therapeutic Agency Inventory (adapted to the clinic)

  4 weeks after treatment start.

• Penn-State Worry Questionnaire (PSWQ)

  At start of treatment (pre-treatment) and at 10 weeks after treatment start (post-treatment).

• Client satisfaction questionnaire (adapted to the clinic)

  10 weeks after treatment start (post-treatment).

• Treatment Credibility Questionnaire (adapted to the clinic)

  2 weeks after treatment start.

• Montomery-Asberg Depression Rating Scale - Self-rated (MADRS-S)

  Measured weakly from treatment start (pre-treatment) to 10 weeks after treatment start (post-treatment).

Study Arms (2)

Treatment choice

EXPERIMENTAL

Patients have been randomized to getting to read about and then choose one of the two treatments

Behavioral: Metacognitive Internet delivered Cognitive Behavior Therapy; Behavioral: Intolerance of uncertainty based Internet delivered Cognitive Behavior Therapy

Random assignment to treatment

EXPERIMENTAL

Patients have been directly randomized into one of the two treatments

Behavioral: Metacognitive Internet delivered Cognitive Behavior Therapy; Behavioral: Intolerance of uncertainty based Internet delivered Cognitive Behavior Therapy

Interventions

Metacognitive Internet delivered Cognitive Behavior Therapy BEHAVIORAL

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

Random assignment to treatment; Treatment choice

Intolerance of uncertainty based Internet delivered Cognitive Behavior Therapy BEHAVIORAL

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

Random assignment to treatment; Treatment choice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

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

Stockholm, Sverige, 14132, Sweden

RECRUITING

MeSH Terms

Conditions

Generalized Anxiety Disorder; Patient Preference

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Patient Satisfaction; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants who do not get to choose treatment are not aware that they could have been assigned to do so.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Researcher

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: October 1, 2025
• Study Start: August 26, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2028
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)