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AnxietyNCT05720741

Project THINK: Trial of a Brief Cognitive Restructuring Intervention

A study testing Project THINK and Project SHARE in people with Anxiety and Depression, run by Harvard University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 to 16 yearsHealthy volunteers can take part
Conditions the study is for
Anxiety, Depression, Stress
What is being tested?
Project THINK and Project SHARE
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
597 participants
Where
1 siteUnited States
Study dates
1 Mar 2023to 1 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Harvard University

    Cambridge, Massachusetts, 02138

Other trials in United States

About this study

Official title: Project THINK: Testing a Single-Session, Digital Cognitive Restructuring Intervention for Youth Mental Health in a Randomized Controlled Trial

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.

Read the detailed description

More than one in five adolescents will experience at least one mental health disorder requiring treatment; however, 75% of these adolescents will never receive mental health care, in large part due to the fact that there are far fewer trained clinicians than are necessary to address growing youth mental healthcare needs. Furthermore, the disparity between the number of available clinicians and those in need of mental health services is increasing. Between 2016 and 2020, the number of American children ages 3-17 diagnosed with an anxiety disorder or depression grew by 29% and 27%, respectively, whereas the American Psychological Association (APA) reports that the number of clinicians treating youth has continued to remain low, with only 4,000 out of 100,000 U.S. clinical psychologists identifying as child and adolescent clinicians. One possible solution to this issue of treatment access is to emphasize prevention and intervention strategies that can help reduce the number of young people who may develop mental health problems requiring more intensive care. However, even such prevention efforts have historically required large amounts of human capital for implementation. Fortunately, in recent years, digital mental health interventions have emerged as a potential solution to this issue as they offer scalable and cost-effective ways of preventing and intervening on mental health problems. Digital interventions requiring little-to-no professional support are especially appealing because they are easy to implement. Further, digital mental health interventions have been found to be efficacious for common mental health problems such as depression and anxiety, and some are effective for young people even in a single session.

The investigators propose one such intervention utilizing technology to address issues of access to mental health resources: 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.

Aim 1. In collaboration with U.S. middle schools, the investigators aim to conduct a randomized trial examining the efficacy of Project THINK relative to an active control condition, Project SHARE (i.e., Sharing Feelings)-which teaches users to identify their emotions and share them with trusted adults-on improving symptoms of mental health and well-being among adolescents. The investigators aim to recruit 1,625 participants in grades 5-10 (ages 10-16 years). According to a priori power analyses and after accounting for high expected attrition, this target sample size will provide sufficient power (1-β; 80%) to detect overall mean group differences and moderation effects of small effect size (.2; minimum N=788) using two-tailed tests with α = .05. The use of Project SHARE is appropriate in this context given that it has been used in past research studies and it has been found to be useful for young people, but it is not designed to target symptoms of psychopathology.

During a time selected by school partners (likely to be a wellness/physical education/gym class), participating students will choose whether they will assent to participate in the study. Only those participants whose parents have not elected to opt their child out of the study beforehand will be asked if they would like to participate. If students assent via an online form, they will be directed to an online battery of validated measures focused on mental health and well-being (e.g., Behaviors and Feelings Survey, and the Emotion Regulation Questionnaire--Child/Adolescent Version-Cognitive Reappraisal Subscale). Students will then be randomized to complete the Project THINK intervention or the Project SHARE active control online program; these two programs are similar in length and format. Immediately following completion of one of the two programs, participants will be asked to answer online demographic questions and to provide feedback on the intervention's helpfulness. All study procedures will be conducted via Qualtrics, and the investigators will conduct separate analyses for the subsample of students with elevated symptoms of psychopathology at baseline to assess the potentially different effects of Project THINK as a universal versus indicated prevention program.

Aim 2. The investigators aim to examine the effects of Project THINK relative to Project SHARE over time. Toward this end, participating students will be asked to complete a battery of measures at three follow-up timepoints: 1-month, 3-months, and 6-months after the baseline assessment and intervention administration. These follow-up measures represent a subset of the measures assessed at baseline (i.e., all measures assessed at baseline except demographic questions and feedback regarding intervention helpfulness). Once more, the investigators will conduct separate analyses for the subsample of students with elevated symptoms of psychopathology at the baseline assessment.

A secondary aim of this study is to interview a subset of student participants (10-30) from one of the partner schools. Following the one-month follow-up survey, the investigators will select an equal number of participants who are either 'responders' or 'not responders' to the Project THINK intervention. 'Responders' will be operationalized as those who were randomized to Project THINK and experienced a decline in internalizing symptoms (as measured by the Behavior and Feelings Survey). 'Non-responders' will be operationalized as those whose internalizing symptoms are not reduced. Through a semi-structured interview and thematic analysis in NVivo software, the investigators aim to identify patterns or themes that emerge in participants' experiences, and then examine whether these themes differ based on differential symptom trajectories. The investigators aim to examine the participants' recall of intervention content, comprehension of skills, perceived relevance of the skills, ways they used the skills following the intervention, as well as overall thoughts on the intervention and its delivery (sample questions are below). The participants who are selected for the interview will be excluded from the primary analyses at the 3 and 6-month follow-ups due to the potential interventional effects of the interview.

Being tested
Project THINK, Project SHARE
Keywords
digital, mental health intervention
Medical subject headings
Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Project THINKBehavioural

    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 SHAREBehavioural

    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).

Study groups in NCT05720741
Study groupRoleWhat they receive
Project THINKExperimentalProject 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.
Receives: Behavioral: Project THINK
Project SHAREPlacebo comparatorIntervention 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).
Receives: Behavioral: Project SHARE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to 1-month follow-up

  2. 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.

    Measured: Baseline to 3-month follow-up

  3. 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.

    Measured: Baseline to 6-month follow-up

Secondary outcomes (8)
  1. Perceived Program Acceptability and Helpfulness

    Post-intervention feedback on the program's perceived acceptability and helpfulness as measured via a 7-item scale, with each item rated on a 1-5 scale, with higher scores indicating greater acceptability and helpfulness.

    Measured: Immediately post-intervention

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

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

    Measured: Baseline to 1-month follow-up

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

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

    Measured: Baseline to 3-month follow-up

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

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

    Measured: Baseline to 6-month follow-up

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

    Trajectories of self-reported tendency to regulate emotions using cognitive reappraisal strategies from the 6-item (each item rated on a 1 to 7 scale with 7 indicating more use of cognitive reappraisal emotion regulation strategies) Cognitive Reappraisal Facet of the Emotion Regulation Questionnaire.

    Measured: Baseline to 1-month follow-up

  6. Change in Emotion Regulation Questionnaire-Child/Adolescent Version (Cognitive Reappraisal Subscale) from Baseline to 3-month follow-up

    Trajectories of self-reported tendency to regulate emotions using cognitive reappraisal strategies from the 6-item (each item rated on a 1 to 7 scale with 7 indicating more use of cognitive reappraisal emotion regulation strategies) Cognitive Reappraisal Facet of the Emotion Regulation Questionnaire.

    Measured: Baseline to 3-month follow-up

  7. Change in Emotion Regulation Questionnaire--Child/Adolescent Version (Cognitive Reappraisal Subscale) from Baseline to 6-month follow-up

    Trajectories of self-reported tendency to regulate emotions using cognitive reappraisal strategies from the 6-item (each item rated on a 1 to 7 scale with 7 indicating more use of cognitive reappraisal emotion regulation strategies) Cognitive Reappraisal Facet of the Emotion Regulation Questionnaire.

    Measured: Baseline to 6-month follow-up

  8. Treatment Expectancy Measure

    Treatment expectations will be assessed at pre-intervention via a novel 4-item measure (0-10 scale) evaluating participants' expectations of intervention effects.

    Measured: Immediately pre-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2023
  2. Study start1 Mar 2023
  3. Primary completion15 Nov 2023
  4. Study completion1 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
597 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05720741
Sponsor's protocol ID
IRB22-1364
Status last verified
Feb 2024
First submitted
31 Jan 2023
Last updated
28 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Analytic code will be made available upon publication of trial results. Study protocol and SAP are available with this registration submission.

Questions about this trial

What is this clinical trial studying?

A study testing Project THINK and Project SHARE in people with Anxiety and Depression, run by Harvard University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Behavior and Feelings Survey (Internalizing Subscale) from Baseline to 1-month Follow-up (time frame: Baseline to 1-month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.

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