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Cognitive Restructuring Intervention for Mental Health and Well-Being

Cambridge, MA
N/A
Waitlist Available
Research Sponsored by Harvard University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up between the 1 and 3-month follow-ups

Summary

This trial tests a 30min digital intervention to teach youth how to change unhelpful thoughts to improve mental health and well-being. Results will shape how psychotherapy is used to prevent mental illness.

See full description
Who is the study for?
This trial is for English-speaking students in grades 5-10, aged between 10 to 16 years, who have consent from a guardian and access to a digital device. It's not suitable for non-English speakers, those with intellectual disabilities that affect program comprehension, or without digital access.
What is being tested?
Project THINK tests a short (~30 minute) digital intervention teaching cognitive restructuring to improve mental health against an active control condition. Participants' well-being will be evaluated before the intervention and at intervals up to six months after.See study design
What are the potential side effects?
Since this is a psychological educational intervention rather than a medical treatment, traditional side effects are not expected. However, discussing mental health could potentially cause temporary discomfort or emotional distress.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~between the 1 and 3-month follow-ups
This trial's timeline: 3 weeks for screening, Varies for treatment, and between the 1 and 3-month follow-ups for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Behavior and Feelings Survey (Internalizing Subscale) from Baseline to 1-month Follow-up
Change in Behavior and Feelings Survey (Internalizing Subscale) from Baseline to 3-month Follow-up
Change in Behavior and Feelings Survey (Internalizing Subscale) from Baseline to 6-month Follow-up
Secondary study objectives
Change in Behavior and Feelings Survey (Externalizing Subscale) from Baseline to 1-month Follow-up
Change in Behavior and Feelings Survey (Externalizing Subscale) from Baseline to 3-month Follow-up
Change in Behavior and Feelings Survey (Externalizing Subscale) from Baseline to 6-month Follow-up
+5 more
Other study objectives
Qualitative Responses via Semi-Structured Interview

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Project THINKExperimental Treatment1 Intervention
Project THINK is a 30-minute self-guided digital intervention designed to teach children and adolescents how to change the way that they think. Specifically, Project THINK is based on the principles of cognitive restructuring, a core component of cognitive behavioral therapy, a gold standard treatment for internalizing disorders. Project THINK uses vignettes, interactive activities, and engaging graphics to teach youth a systematic strategy for assessing the presence of unhelpful thoughts and replacing them with more helpful ones. Although not yet formally tested in a randomized trial, Project Think has been used by hundreds of students, and feedback has been very positive.
Group II: Project SHAREPlacebo Group1 Intervention
Intervention delivered in a web browser that focuses on encouraging feelings disclosure to trusted others using facts about the brain, testimonials from peers, and writing exercises (also referred to as Sharing Feelings Intervention; Schleider et al., 2021).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Project THINK
2023
N/A
~600

Find a Location

Closest Location:Harvard University· Cambridge, MA

Who is running the clinical trial?

Harvard UniversityLead Sponsor
235 Previous Clinical Trials
583,938 Total Patients Enrolled
26 Trials studying Depression
7,297 Patients Enrolled for Depression

Media Library

Project SHARE Clinical Trial Eligibility Overview. Trial Name: NCT05720741 — N/A
Depression Research Study Groups: Project SHARE, Project THINK
Depression Clinical Trial 2023: Project SHARE Highlights & Side Effects. Trial Name: NCT05720741 — N/A
Project SHARE 2023 Treatment Timeline for Medical Study. Trial Name: NCT05720741 — N/A
~205 spots leftby Feb 2026