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

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Karolinska Institute

Status

Completed

Conditions

Generalized Anxiety Disorder

Treatments

Behavioral: ICBT-IU

Study type

Interventional

Funder types

Other

Identifiers

NCT05820568
2022-02380-01-Pilot

Details and patient eligibility

About

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.

Enrollment

22 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

22 participants in 1 patient group

Treatment
Experimental group
Description:
Patients receiving ICBT-IU
Treatment:
Behavioral: ICBT-IU

Trial contacts and locations

1

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Central trial contact

Erik Forsell, PhD; Vilgot Huhn, MSc

Data sourced from clinicaltrials.gov

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