Effects and Mechanisms of Change of Internet Delivered Cognitive Behavior Therapy for Generalized… (NCT05849493) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effects and Mechanisms of Change of Internet Delivered Cognitive Behavior Therapy for Generalized Anxiety Disorder
Sweden400 participantsStarted 2023-05-19
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Generalized Anxiety Disorder-7 score (GAD-7)
Timeframe: From treatment start to 10 weeks after treatment start
2
Change in Meta-Cognitions Questionnaire-30 score (MCQ-30, negative meta-cognition sub-scale)
Timeframe: From treatment start to 10 weeks after treatment start
3
Change in Intolerance of Uncertainty Scale-12 score (IUS-12)
Timeframe: From treatment start to 10 weeks after treatment start