Project THINK: Trial of a Brief Cognitive Restructuring Intervention (NCT05720741) | Clinical Trial Compass
CompletedNot Applicable
Project THINK: Trial of a Brief Cognitive Restructuring Intervention
United States597 participantsStarted 2023-03-01
Plain-language summary
This project will involve testing a brief (\~30 minute) digital intervention aimed at teaching youth the evidence-based strategy of changing unhelpful thoughts (i.e., cognitive restructuring). The investigators will test the intervention's efficacy compared to an active control condition. Participants (students in grades 5-10 in U.S. schools) will be asked to complete measures of mental health and well-being prior to the intervention as well as 1, 3, and 6-months after the intervention. If the intervention is found to be effective, its brevity and scalability would make it an invaluable resource for supplementing traditional psychotherapy and potentially preventing the onset of mental illness requiring specialized intensive care.
Who can participate
Age range
10 Years – 16 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
. Adolescent is in grades 5-10 (inclusive) at partnering schools
. Adolescent is between the ages of 10 through 16 years (inclusive) at the time of study enrollment
. Adolescent and at least one guardian consent to adolescent participation in study
. Adolescent reads English well enough to effectively complete the digital programs
. Adolescent has access to a digital device
Exclusion criteria
. Adolescent is non-English speaking, as the programs are only available in English
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 Behavior and Feelings Survey (Internalizing Subscale) from Baseline to 1-month Follow-up
Timeframe: Baseline to 1-month follow-up
2
Change in Behavior and Feelings Survey (Internalizing Subscale) from Baseline to 3-month Follow-up
Timeframe: Baseline to 3-month follow-up
3
Change in Behavior and Feelings Survey (Internalizing Subscale) from Baseline to 6-month Follow-up