Internet Delivered Cognitive Behavior Therapy Based on Intolerance of Uncertainty

NCT ID: NCT05820568

Last Updated: 2023-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-02
• Study Completion Date: 2023-05-22

Brief Summary

The goal of this clinical is to pilot test an internet delivered cognitive behavior therapy (ICBT) based on intolerance of uncertainty (one of several existing specific cognitive models for how worry works) in treating generalised anxiety disorder (GAD). The main aims is to:

• Test the preliminary effect of the intervention in lowering symptoms of GAD as measured by the self report scale GAD-7
• Test procedures for recruitment, assessment, treatment and follow up
• Test the acceptability of the intervention as measured by the Client Satisfaction questionnaire-8, dropout and adverse events

Participants will apply for treatment in an online system, be assessed via video by a licensed clinical psychologist and then receive a 10 week long ICBT intervention based on the intolerance of uncertainty model. This is a pilot study for an upcoming randomized controlled trial.

Conditions

Generalized Anxiety Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Patients receiving ICBT-IU

Group Type: EXPERIMENTAL

ICBT-IU

Intervention Type: BEHAVIORAL

Internet delivered Cognitive Behavior Therapy for Generalized Anxiety Disorder based on the Intolerance of uncertainty model of worry

Interventions

ICBT-IU

Internet delivered Cognitive Behavior Therapy for Generalized Anxiety Disorder based on the Intolerance of uncertainty model of worry

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 18 years old or more.
• Diagnosis of GAD based on clinical assessment.
• At least 10 points on GAD-7 at screening.
• Proficient in written Swedish.
• Access to internet enabled device and Swedish BankID for authentication
• Able to make sufficient time for the 10 week long treatment
• Consents to study

Exclusion Criteria

• In need of treatment for other psychiatric diagnosis as priority (eg depression, psychosis) or high risk of suicide based on clinical assessment
• Ongoing risk use of alcohol or drugs
• Ongoing serious somatic of social disease/problem that is deemed to be to much of a hindrance for the completion of the treatment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Stockholm

OTHER_GOV

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Erik Forsell

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Internet Psychiatry Clinic, Psychiatry Southwest, SLSO, Region Stockholm

Stockholm, Huddinge, Sweden

Countries

Sweden

Other Identifiers

2022-02380-01-Pilot

Identifier Type: -

Identifier Source: org_study_id