Internet Delivered Cognitive Behavior Therapy Based on Intolerance of Uncertainty

Study Overview
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Brief Summary
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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.

Official Title
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Effects and Mechanisms of Change of Two Different Treatments Targeting Worry in Generalised Anxiety Disorder: Study 1 - IU Pilot

Conditions
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Generalized Anxiety Disorder

Intervention / Treatment
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* Behavioral: ICBT-IU


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Pilot
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Patients receiving ICBT-IU | Behavioral: ICBT-IU<br>* Internet delivered Cognitive Behavior Therapy for Generalized Anxiety Disorder based on the Intolerance of uncertainty model of worry<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment credibility | 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. | 2 weeks into treatment | 
| Satisfaction with treatment | 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. | 10 weeks after treatment start | 
| Symptoms of depression including suicidal ideation | Measured with the Montgomery Åsberg Depression Rating Scale- Self report (MADRS-S). Scores range from 0-54 with higher scores indicating more depression | 10 weeks after treatment start | 
| Intolerance of uncertainty | Measured with the Intolerance of Uncertainty Scale short version (IUS-12). Scores range from 12-60 with higher scores indicating more intolerance of uncertainty. | 10 weeks after treatment start | 
| Excessive worry | Measured with the Penn State Worry Questionnaore (PSWQ). Scores range from 16-80 points with more points indicating more worry | 10 weeks after treatment start | 
| Symptoms of depression | Measured with the Patient Health Questionnaire-9 item self report measure (PHQ9).The scale range is 0-27 with higher scores indication more depression. | 10 weeks after treatment start | 
| WHO Disability Assessment Schedule (WHODAS 2.0) self report (12 items) | 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. | 10 weeks after treatment start | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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internet delivered treatment, digital mental health services, psychiatry, cognitive behavior therapy, intolerance of uncertainty