Internet Delivered Cognitive Behavior Therapy Based on Intolerance of Uncertainty (ORIGAMI)

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

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.

Study Overview

• Status: Completed
• Conditions: Generalized Anxiety Disorder
• Intervention / Treatment: Behavioral: ICBT-IU

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vilgot Huhn, MSc; Email: vilgot.huhn@ki.se

Study Locations

• Sweden
  • Huddinge
    • Stockholm, Huddinge, Sweden, 14135
      • Internet Psychiatry Clinic, Psychiatry Southwest, SLSO, Region Stockholm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of treatment dropout	Patient terminates treatment ahead of schedule	10 weeks after treatment start
Adherence	Number of modules completed	10 weeks after treatment start

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Region Stockholm

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2022
• Primary Completion (Actual): May 22, 2023
• Study Completion (Actual): May 22, 2023

Study Registration Dates

• First Submitted: December 8, 2022
• First Submitted That Met QC Criteria: April 17, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Actual): October 2, 2023
• Last Update Submitted That Met QC Criteria: September 29, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: cognitive behavior therapy; psychiatry; intolerance of uncertainty; internet delivered treatment; digital mental health services
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2022-02380-01-Pilot

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No