Internet Delivered Cognitive Behavior Therapy Based on Intolerance of Uncertainty

Not Applicable

Completed

• Conditions: Generalized Anxiety Disorder
• Interventions: Behavioral: ICBT-IU

• Registration Number: NCT05820568
• Lead Sponsor: Karolinska Institutet

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-02
• Study First Submitted: 2022-12-08
• Study First Submitted QC: 2023-04-17
• Study First Posted: 2023-04-19
• Primary Completion: 2023-05-22
• Study Completion: 2023-05-22
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-29
• Last Update Posted: 2023-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	ICBT-IU	Patients receiving ICBT-IU

Primary Outcome Measures

Name	Time	Method
Generalized Anxiety Disorder 7-item (GAD7)	10 weeks after treatment start	Symptoms of generalized anxiety disorder measured by the self report measure GAD7. Scores range from 0-21 with higher scores indicating more generalized anxiety

Secondary Outcome Measures

Name	Time	Method
Treatment credibility	2 weeks into treatment	A version of the credibility expectancy questionnaire used at the Internet Psychiatry Clinic in Sweden. Scores range from 5 to 50 with higher scores indicating more credibility.
Satisfaction with treatment	10 weeks after treatment start	Client Satisfaction Questionnaire 8 item version (CSQ8). Scores range from 8 to 32; scores of 8-13 indicate poor satisfaction, 14-19 fair satisfaction, 20-25 good satisfaction, and 26-32 excellent satisfaction.
Intolerance of uncertainty	10 weeks after treatment start	Measured with the Intolerance of Uncertainty Scale short version (IUS-12). Scores range from 12-60 with higher scores indicating more intolerance of uncertainty.
Symptoms of depression	10 weeks after treatment start	Measured with the Patient Health Questionnaire-9 item self report measure (PHQ9).The scale range is 0-27 with higher scores indication more depression.
WHO Disability Assessment Schedule (WHODAS 2.0) self report (12 items)	10 weeks after treatment start	A health and disability metric developed by WHO. Scores range from 0-100% and represent the level of disability with 100% being complete disability to function in everyday life.
Symptoms of depression including suicidal ideation	10 weeks after treatment start	Measured with the Montgomery Åsberg Depression Rating Scale- Self report (MADRS-S). Scores range from 0-54 with higher scores indicating more depression
Excessive worry	10 weeks after treatment start	Measured with the Penn State Worry Questionnaore (PSWQ). Scores range from 16-80 points with more points indicating more worry

Trial Locations

Locations (1)

Internet Psychiatry Clinic, Psychiatry Southwest, SLSO, Region Stockholm; 🇸🇪 Stockholm, Huddinge, Sweden