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Completed

NCT Number: NCT05820568

Internet Delivered Cognitive Behavior Therapy Based on Intolerance of Uncertainty

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.

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Key information

Conditions

Generalized Anxiety Disorder Anxiety Disorders Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Internet Psychiatry Clinic, Psychiatry Southwest, SLSO, Region Stockholm

Stockholm, Huddinge, 14135, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ICBT-IU

Behavioral

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

Primary outcomes

  1. Generalized Anxiety Disorder 7-item (GAD7)

    Time frame: 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 outcomes

  1. Treatment credibility

    Time frame: 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.

  2. Satisfaction with treatment

    Time frame: 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.

  3. Symptoms of depression including suicidal ideation

    Time frame: 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

  4. Intolerance of uncertainty

    Time frame: 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.

  5. Excessive worry

    Time frame: 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

  6. Symptoms of depression

    Time frame: 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.

  7. WHO Disability Assessment Schedule (WHODAS 2.0) self report (12 items)

    Time frame: 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 outcomes

  1. Rate of treatment dropout

    Time frame: 10 weeks after treatment start

    Patient terminates treatment ahead of schedule

  2. Adherence

    Time frame: 10 weeks after treatment start

    Number of modules completed

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm

Registry information

Official study title

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

Acronym: ORIGAMI

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 19, 2023
Registry last updated
Oct 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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