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Cognitive Restructuring Intervention for Mental Health and Well-Being

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

Awards & highlights

Study 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.

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.Check my eligibility

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ between the 1 and 3-month follow-ups

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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 outcome measures

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Harvard UniversityLead Sponsor

229 Previous Clinical Trials

473,986 Total Patients Enrolled

26 Trials studying Depression

9,321 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are geriatric patients being considered for participation in this trial?

"To be included in this medical trial, the patient must fall within a decade of age between 10 and 16 years old."

Answered by AI

Is there availability for volunteers to join this clinical investigation?

"According to clinicaltrials.gov, this specific medical trial is not seeking patients at the moment. It was first posted on February 1st 2023 and its latest update occurred on April 8th of that same year. Yet, there are still over 1400 other research studies recruiting participants currently."

Answered by AI

How can I become a participant in this research effort?

"This clinical trial is targeting 1625 minors, aged 10 to 16 years old who suffer from depression. Those that meet the following criteria are eligible for enrolment: being in grades 5-10 at partnering schools; comprehending English well enough to complete digital programs; and having access to a computer device or mobile phone. Additionally, both the patient's assent and guardian's consent must be obtained prior participation."

Answered by AI

What is the ultimate objective of this research endeavor?

"This study aims to measure the primary outcome of Change in Behavior and Feelings Survey (Internalizing Subscale) from Baseline to 1-month Follow-up, with secondary outcomes including Trajectories of self-reported misbehavior from the 6-item Externalizing subscale at intervals of 1 month, 3 months, and 6 months. Ratings for each item will range between 0 and 4, corresponding to lower or higher levels of symptoms respectively."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Project THINK: Trial of a Brief Cognitive Restructuring Intervention

Joshua Steinberg 2023. "Project THINK: Trial of a Brief Cognitive Restructuring Intervention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05720741.