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

Primary Purpose

Generalized Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
ICBT-IU
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring internet delivered treatment, digital mental health services, psychiatry, cognitive behavior therapy, intolerance of uncertainty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Internet Psychiatry Clinic, Psychiatry Southwest, SLSO, Region Stockholm

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Patients receiving ICBT-IU

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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
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.
Excessive worry
Measured with the Penn State Worry Questionnaore (PSWQ). Scores range from 16-80 points with more points indicating more worry
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.
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.

Full Information

First Posted
December 8, 2022
Last Updated
September 29, 2023
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
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1. Study Identification

Unique Protocol Identification Number
NCT05820568
Brief Title
Internet Delivered Cognitive Behavior Therapy Based on Intolerance of Uncertainty
Acronym
ORIGAMI
Official Title
Effects and Mechanisms of Change of Two Different Treatments Targeting Worry in Generalised Anxiety Disorder: Study 1 - IU Pilot
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 2, 2022 (Actual)
Primary Completion Date
May 22, 2023 (Actual)
Study Completion Date
May 22, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Region Stockholm

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
Keywords
internet delivered treatment, digital mental health services, psychiatry, cognitive behavior therapy, intolerance of uncertainty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pilot
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Patients receiving ICBT-IU
Intervention Type
Behavioral
Intervention Name(s)
ICBT-IU
Intervention Description
Internet delivered Cognitive Behavior Therapy for Generalized Anxiety Disorder based on the Intolerance of uncertainty model of worry
Primary Outcome Measure Information:
Title
Generalized Anxiety Disorder 7-item (GAD7)
Description
Symptoms of generalized anxiety disorder measured by the self report measure GAD7. Scores range from 0-21 with higher scores indicating more generalized anxiety
Time Frame
10 weeks after treatment start
Secondary Outcome Measure Information:
Title
Treatment credibility
Description
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.
Time Frame
2 weeks into treatment
Title
Satisfaction with treatment
Description
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.
Time Frame
10 weeks after treatment start
Title
Symptoms of depression including suicidal ideation
Description
Measured with the Montgomery Åsberg Depression Rating Scale- Self report (MADRS-S). Scores range from 0-54 with higher scores indicating more depression
Time Frame
10 weeks after treatment start
Title
Intolerance of uncertainty
Description
Measured with the Intolerance of Uncertainty Scale short version (IUS-12). Scores range from 12-60 with higher scores indicating more intolerance of uncertainty.
Time Frame
10 weeks after treatment start
Title
Excessive worry
Description
Measured with the Penn State Worry Questionnaore (PSWQ). Scores range from 16-80 points with more points indicating more worry
Time Frame
10 weeks after treatment start
Title
Symptoms of depression
Description
Measured with the Patient Health Questionnaire-9 item self report measure (PHQ9).The scale range is 0-27 with higher scores indication more depression.
Time Frame
10 weeks after treatment start
Title
WHO Disability Assessment Schedule (WHODAS 2.0) self report (12 items)
Description
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.
Time Frame
10 weeks after treatment start
Other Pre-specified Outcome Measures:
Title
Rate of treatment dropout
Description
Patient terminates treatment ahead of schedule
Time Frame
10 weeks after treatment start
Title
Adherence
Description
Number of modules completed
Time Frame
10 weeks after treatment start

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Internet Psychiatry Clinic, Psychiatry Southwest, SLSO, Region Stockholm
City
Stockholm
State/Province
Huddinge
ZIP/Postal Code
14135
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

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Internet Delivered Cognitive Behavior Therapy Based on Intolerance of Uncertainty

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