ORIGAMI: Internet Delivered Cognitive Behavior Therapy Based on Intolerance of Uncertainty

Sponsor

Karolinska Institutet (Other)

Overall Status

Recruiting

CT.gov ID

NCT05820568

Collaborator

Region Stockholm (Other)

Enrollment

Location

Arm

6.6

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Generalized Anxiety Disorder	Behavioral: ICBT-IU	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

PilotPilot

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 2, 2022

Anticipated Primary Completion Date :

May 22, 2023

Anticipated Study Completion Date :

May 22, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Treatment

Patients receiving ICBT-IU

Behavioral: ICBT-IU

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

Outcome Measures

Primary Outcome Measures

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

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.
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
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.
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
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.

Other Outcome Measures

Rate of treatment dropout [10 weeks after treatment start]
Patient terminates treatment ahead of schedule
Adherence [10 weeks after treatment start]
Number of modules completed

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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