Internet Delivered Cognitive Behavior Therapy Based on Intolerance of Uncertainty

NCT05820568 | Completed

• 1 other identifier: 2022-02380-01-Pilot
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Keywords

internet delivered treatment; digital mental health services; psychiatry; cognitive behavior therapy; intolerance of uncertainty

Outcome Measures

Primary Outcomes (1)

• Generalized Anxiety Disorder 7-item (GAD7)

  Symptoms of generalized anxiety disorder measured by the self report measure GAD7. Scores range from 0-21 with higher scores indicating more generalized anxiety

  10 weeks after treatment start

Secondary Outcomes (7)

• Treatment credibility

  2 weeks into treatment

• Satisfaction with treatment

  10 weeks after treatment start

• Symptoms of depression including suicidal ideation

  10 weeks after treatment start

• Intolerance of uncertainty

  10 weeks after treatment start

• Excessive worry

  10 weeks after treatment start

Other Outcomes (2)

• Rate of treatment dropout

  10 weeks after treatment start

• Adherence

  10 weeks after treatment start

Study Arms (1)

Treatment

EXPERIMENTAL

Patients receiving ICBT-IU

Behavioral: ICBT-IU

Interventions

ICBT-IU BEHAVIORAL

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

Treatment

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

Internet Psychiatry Clinic, Psychiatry Southwest, SLSO, Region Stockholm

Stockholm, Huddinge, 14135, Sweden

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Pilot

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: April 19, 2023
• Study Start: November 2, 2022
• Primary Completion: May 22, 2023
• Study Completion: May 22, 2023
• Last Updated: October 2, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)