Clinical trial NCT05820568: Internet Delivered Cognitive Behavior Therapy Based on Intolerance of Uncertainty
Official title: Effects and Mechanisms of Change of Two Different Treatments Targeting Worry in Generalised Anxiety Disorder: Study 1 - IU Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Generalized Anxiety Disorder
Keywords: internet delivered treatment
digital mental health services
psychiatry
cognitive behavior therapy
intolerance of uncertainty
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2023-04-19
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Generalized Anxiety Disorder 7-item (GAD7)
timeFrame: 10 weeks after treatment start
Secondary outcomes:
measure: Treatment credibility
timeFrame: 2 weeks into treatment
measure: Satisfaction with treatment
timeFrame: 10 weeks after treatment start
measure: Symptoms of depression including suicidal ideation
timeFrame: 10 weeks after treatment start
measure: Intolerance of uncertainty
timeFrame: 10 weeks after treatment start
measure: Excessive worry
timeFrame: 10 weeks after treatment start
measure: Symptoms of depression
timeFrame: 10 weeks after treatment start
measure: WHO Disability Assessment Schedule (WHODAS 2.0) self report (12 items)
timeFrame: 10 weeks after treatment start
Other outcomes:
measure: Rate of treatment dropout
timeFrame: 10 weeks after treatment start
measure: Adherence
timeFrame: 10 weeks after treatment start
Locations:
city: Stockholm
country: Sweden
facility: Internet Psychiatry Clinic, Psychiatry Southwest, SLSO, Region Stockholm
state: Huddinge
Study officials:
References: