Generalized Anxiety Disorder Clinical Trial
— ORIGAMIOfficial title:
Effects and Mechanisms of Change of Internet Delivered Cognitive Behavior Therapy for Generalized Anxiety Disorder Based on Intolerance of Uncertainty or Metacognitive Theory
The goal of this clinical trial is to compare two psychological treatments for Generalized Anxiety Disorder. The main questions it aims to answer are: How well do these treatments work compared to earlier studies? Is one of the treatments more effective than the other? Are the treatments working the way that we think they do? Specifically, do changes in the variables that these treatments aim to target predict changes in anxiety symptoms? Participants will be randomized to two different internet-based cognitive behavioral therapy (ICBT) programs: Intolerance of uncertainty-based ICBT and metacognition-based ICBT. Both programs consist of 8 treatment modules and run for 10 weeks. A psychologist will respond to the participants assignments and exercises and will respond to messages.
Status | Recruiting |
Enrollment | 400 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion criteria: - 18 years or older. - Meet diagnostic criteria for GAD according to DSM-5, as assessed by a psychologist on a video-call. - Self-rated score > 10 on GAD-7. - Can read and speak Swedish fluently. - Have access to a smartphone, tablet, or computer and a Swedish BankID which allows access to the video-calls and treatment platform. - Have the time and possibility to participate in the 10 week treatment. - Consents to participate. Exclusion criteria: - Patients that are judged to be in greater need of another psychiatric treatment for another psychiatric diagnosis (for example severe depression) and/or is judged to have a high risk of suicide. - Current drug or alcohol abuse. - Current severe somatic health concern or social vulnerability if this is judged to be too great an obstacle for the patient to carry out the treatment. |
Country | Name | City | State |
---|---|---|---|
Sweden | Internet Psychiatry Clinic, Psychiatry Southwest, SLSO, Region Stockholm | Stockholm | Huddinge |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet | Region Stockholm |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Generalized Anxiety Disorder-7 score (GAD-7) | Measures Generalized Anxiety Symptoms. 7 items. Scores range from 0-21 with higher scores indicating more generalized anxiety | From treatment start to 10 weeks after treatment start | |
Primary | Change in Meta-Cognitions Questionnaire-30 score (MCQ-30, negative meta-cognition sub-scale) | Putative mediator. The MCQ-30 negative subscale measures negative meta-cognitive beliefs about the danger and uncontrollability of worry. 6 items. Scores range from 6-36 with higher scores indicating more negative beliefs about worry. | From treatment start to 10 weeks after treatment start | |
Primary | Change in Intolerance of Uncertainty Scale-12 score (IUS-12) | Putative mediator, measures intolerance of uncertainty. 12 items. Scores range from 12-60 with higher scores indicating more intolerance of uncertainty. | From treatment start to 10 weeks after treatment start | |
Secondary | Penn-State Worry Questionnaire (PSWQ) | Measures trait worry. 16 items. Scores range from 16-80 with higher scores indicating more worry. | 10 weeks - pre- and post-treatment. | |
Secondary | Contrast Avoidance Questionnaire-Worry (CAQ-W) | measures Contrast Avoidance related to worry. 25 items. Scores range from 30 to 150 with higher scores indicating a higher degree of using worry to avoid emotional contrasts. | 10 weeks - pre- and post-treatment. | |
Secondary | Montomery-Asberg Depression Rating Scale - Self-rated (MADRS-S) | Measures depression symptoms. 9 items. Scores range from 0 to 54 with higher scores indicating more depressive symptoms. | 10 weeks - pre- and post-treatment. | |
Secondary | Meta-Cognitions Qquestionnaire-30 (MCQ-30 - full scale) | Measures metacognition. 30 items. Scores range from 30-120 with higher scores indicating more potentially dysfunctional metacognitive beliefs about thoughts and worry. | 10 weeks - pre- and post-treatment. | |
Secondary | Patient Health Questionnaire-9 (PHQ-9) | Measures depression symptoms. 9 items. Scores range from 0-27 with higher scores indicating more depressive symptoms. | 10 weeks - pre- and post-treatment. | |
Secondary | World Health Organization Disability Assessment Schedule 2.0 | Measures disability/functional impairment. 12 items. Scores range from 0-48 with higher scores indicating a higher degree of impairment. | 10 weeks - pre- and post-treatment. | |
Secondary | Client satisfaction questionnaire (adapted to the clinic) | Measures satisfaction with treatment. 8 items. Scores range from 8-32 with higher scores indicating more satisfaction with the treatment. | 10 weeks after treatment start. | |
Secondary | Worry Behavior Inventory (WBI) | Inventory of worry behaviors - 10 items. Scores range from 0-40 with higher scores indicating more frequent worry behaviours. | 10 weeks - pre- and post-treatment. |
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