Internet Delivered Cognitive Behavior Therapy Based on Intolerance of Uncertainty

Generalized Anxiety Disorder Clinical Trial

— ORIGAMI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05820568
• Other study ID #: 2022-02380-01-Pilot
• Status: Completed
• Phase: N/A
• Start date: November 2, 2022
• Est. completion date: May 22, 2023

Study information

• Verified date: September 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 22, 2023
• Est. primary completion date: May 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

Behavioral:
• ICBT-IU
Internet delivered Cognitive Behavior Therapy for Generalized Anxiety Disorder based on the Intolerance of uncertainty model of worry

Locations

Country	Name	City	State
Sweden	Internet Psychiatry Clinic, Psychiatry Southwest, SLSO, Region Stockholm	Stockholm	Huddinge

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Region Stockholm

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of treatment dropout	Patient terminates treatment ahead of schedule	10 weeks after treatment start
Other	Adherence	Number of modules completed	10 weeks after treatment start
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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