Project THINK: Trial of a Brief Cognitive Restructuring Intervention

NCT05720741 | Completed

• 1 other identifier: IRB22-1364
• Study Type: interventional
• Target: 597
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety; Depression; Stress

Keywords

digital; mental health intervention

Outcome Measures

Primary Outcomes (3)

• Change in Behavior and Feelings Survey (Internalizing Subscale) from Baseline to 1-month Follow-up

  Trajectories of self-reported symptoms of anxiety and depression from the 6-item (each item rated on a 0-4 scale, with higher ratings indicating more symptoms) Internalizing subscale of the Behavior and Feelings Survey. Total scores range from 0 to 24, with higher scores indicating more symptoms.

  Baseline to 1-month follow-up

• Change in Behavior and Feelings Survey (Internalizing Subscale) from Baseline to 3-month Follow-up

  Trajectories of self-reported symptoms of anxiety and depression from the 6-item (each item rated on a 0-4 scale, with higher ratings indicating more symptoms) Internalizing subscale of the Behavior and Feelings Survey. Total scores range from 0 to 24, with higher scores indicating more symptoms.

  Baseline to 3-month follow-up

• Change in Behavior and Feelings Survey (Internalizing Subscale) from Baseline to 6-month Follow-up

  Trajectories of self-reported symptoms of anxiety and depression from the 6-item (each item rated on a 0-4 scale, with higher ratings indicating more symptoms) Internalizing subscale of the Behavior and Feelings Survey. Total scores range from 0 to 24, with higher scores indicating more symptoms.

  Baseline to 6-month follow-up

Secondary Outcomes (8)

• Perceived Program Acceptability and Helpfulness

  Immediately post-intervention

• Change in Behavior and Feelings Survey (Externalizing Subscale) from Baseline to 1-month Follow-up

  Baseline to 1-month follow-up

• Change in Behavior and Feelings Survey (Externalizing Subscale) from Baseline to 3-month Follow-up

  Baseline to 3-month follow-up

• Change in Behavior and Feelings Survey (Externalizing Subscale) from Baseline to 6-month Follow-up

  Baseline to 6-month follow-up

• Change in Emotion Regulation Questionnaire--Child/Adolescent Version (Cognitive Reappraisal Subscale) from Baseline to 1-month follow-up

  Baseline to 1-month follow-up

Other Outcomes (1)

• Qualitative Responses via Semi-Structured Interview

  Between the 1 and 3-month follow-ups

Study Arms (2)

Project THINK

EXPERIMENTAL

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.

Behavioral: Project THINK

Project SHARE

PLACEBO COMPARATOR

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).

Behavioral: Project SHARE

Interventions

Project THINK BEHAVIORAL

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 never formally tested in a randomized trial, Project Think has been used by hundreds of students, and feedback has been very positive.

Project THINK

Project SHARE BEHAVIORAL

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).

Project SHARE

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Adolescent is non-English speaking, as the programs are only available in English
• Adolescent does not have access to a digital device
• Adolescent has an intellectual disability that precludes comprehension of the program content

Sponsors & Collaborators

• Harvard University: lead

Study Sites (1)

Harvard University

Cambridge, Massachusetts, 02138, United States

Location

Related Links

• Statistical Analysis Plan

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants (anticipated N=1,625), ages 10-16 years, will be randomized to complete one 30-minute, digital programs: (1) Project THINK: a program designed to teach adolescents how to identify and modify unhelpful thoughts; or (2) Project SHARE: a control program designed to teach adolescents to identify and share emotions with trusted adults. A priori power analyses revealed that N=788 participants are needed to detect a small effect size (.2, the approximate effect size found in recent brief digital intervention RCTs) using two-tailed tests with α = .05. In line with findings from similar studies, attrition in online survey studies with students is high; a recent meta-analysis of \~1,000 studies that used online assessments found a mean attrition rate of 51.5%. Assuming this level of attrition, to achieve the desired sample (N=788), the most conservative estimate of the minimum number of participants needed is 1,625 students at baseline.

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: February 9, 2023
• Study Start: March 1, 2023
• Primary Completion: November 15, 2023
• Study Completion: February 1, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

US (1)