DepressionCBToolkitNCT06213142
Developing the Unified Protocol-Single Session Experience Platform for Adolescent Mental Health
A study testing CBToolkit in people with Depression and Depression, Anxiety, run by 3-C Institute for Social Development at 1 site in United States.
Trial summary
This SBIR Phase I proposal will develop and test the acceptability and feasibility of a new suite of digital Single-Session Interventions, specifically applying Unified Protocol core principles for emotional disorders, to produce a highly accessible, engaging, and scalable product to help address the clinical needs of… Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Depression, Anxiety, Depression in Adolescence
- What is being tested?
- CBToolkit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 31 Aug 2023
- 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 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- be ages 13 to 17 years old
- be willing and available to take part in the study requirements
- be fluent in English
- have access to the internet with a mobile device or personal computer
- have parent permission
- screen as eligible according to the internalizing subscale from the Pediatric Symptom Checklist
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This SBIR Phase I proposal will develop and test the acceptability and feasibility of a new suite of digital Single-Session Interventions, specifically applying Unified Protocol core principles for emotional disorders, to produce a highly accessible, engaging, and scalable product to help address the clinical needs of youth.
Read the detailed description
This project proposes develop a suite of Single Session Intervention (SSI) modules using the Unified Protocol (UP) core principles. For Phase I, the team will develop two SSI modules from UP: Awareness of Physical Sensations and Emotional Experiences, and Being Flexible in Your Problem Solving. For the acceptability test (Specific Aim 2), investigators will recruit 60 youth who are screened as eligible based on the internalizing subscale of the Pediatric Symptom Checklist. Caregivers/parents of youth will be recruited using targeted social media advertisements, where they can view a brief study description and complete the eligibility screener. If interested, caregivers can provide contact information for the study team to conduct consent and assent processes. Following consent and enrollment, participants will receive private login information to access the prototype and study materials. First, participants will complete pre-surveys that collect demographic information and responses to the Revised Children's Anxiety and Depression Scale (RCADS). Next, participants will take a brief survey to assess knowledge of intervention concepts presented in the first module: Mindful Awareness. Then, they will engage with the module and provide feedback on the quality of its components. Then, they will complete the knowledge assessment again. Participants will complete the same process for the second module: Flexible Problem Solving (pre knowledge check, review, rate the quality, and post knowledge check). Participants will complete a product evaluation to rate their overall experience with the prototype (quality, usability, innovation, feasibility, and value) and the degree they advocate for full product development. Finally, participants will take the RCADS at the end of the review period. There will also be an opportunity for participants to participate in a brief feedback call to provide additional feedback.
- Conditions
- Depression, Depression, Anxiety, Depression in Adolescence, Anxiety
- Being tested
- CBToolkit
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBToolkitOther
CB Toolkit Mindful Awareness module to increase awareness and tolerance of physical sensations and emotional experiences using mindfulness practices. The module involves videos with motion graphics, video demos, voiceover, music, and sound effects intermixed throughout with a variety of interactive exercises tailored to specific core components. The module aims to establish understanding of the intervention concept (psychoeducation), increase self-efficacy in mindfulness skills via active practice and personalized feedback, and facilitate self-reflection and understanding of strengths and improvement areas related to mindfulness. CBToolkit Flexible Problem Solving module to promote cognitive flexibility, applying problem-solving strategies in difficult scenarios, and learning to modify behavioral action tendencies. Videos and activities will be tailored to provide examples of effective problem-solving techniques and provide personalized reinforcing and/or scaffolded feedback.
| Study group | Role | What they receive |
|---|---|---|
| CBToolkit | Experimental | CBToolkit includes two SSI modules: (1) Mindful Awareness, with the goal of increasing awareness and tolerance of physical sensations and emotional experiences using mindfulness practices and tips and (2) Flexible Problem Solving, with the goal of promoting cognitive flexibility, applying problem-solving strategies in difficult scenarios, and learning to modify behavioral action tendencies. Receives: Other: CBToolkit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Program Feedback Scale for Adolescents
Adolescents will complete this 12-item measure, rating the extent to which they agree with statements about the usability, acceptability, and feasibility of the CBToolkit modules. The measure includes 9 Likert items and 3 open-ended items. Responses to the Likert items range from 1 (Really Disagree) to 5 (Really Agree). Total scores are based on the Likert items are range from 0 to 45. Higher scores reflect more positive opinions.
Measured: 2 week followup post module review
Module Knowledge
Adolescents will complete this 9-item measure to determine what they know about key concepts taught in the CBToolkit module prior to and following review of the modules. The measure includes 9 multiple choice items with a 1 correct response per item. Total scores are based on the number of items with correct responses and range from 0 to 9. Higher scores reflect more correct responses.
Measured: Average of 2 weeks apart, as pre- and post-tests
Revised Children's Anxiety and Depression Scale- Shortened
Adolescents will complete the shortened 11-item version of this measure to assess levels of anxiety and depression prior to and following review of the modules. The measure includes 11 Likert items. Responses to the Likert items range from 0- Never to 3- Always. Total scores are based on the Likert items are range from 0 to 33. Higher scores reflect more severe symptoms.
Measured: Average of 2 weeks apart, as pre- and post-tests
Secondary outcomes (2)
Usage Metrics from the CBToolkit system for adolescents
The CBToolkit software will tracks progress through the modules, and the length of time spent on each sections of the module. These metrics are measured in seconds. A longer time generally indicates more time spent with the content.
Measured: The period in which adolescents interact with the system, approximately 2 weeks
Feedback interviews with adolescents
Adolescents will participate in individual interviews. They will be asked about their experience with the CBToolkit, strengths and weaknesses of CBToolkit, and challenges to using CBToolkit.. Comments will be combined and grouped based on themes in a qualitative summary.
Measured: 15-minutes, completed after the test of the CBToolkit system
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start1 Jun 2023
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants in the acceptability test will be assigned to the same set of study tasks, where all participants will engage with the two modules and provide feedback. All participants will complete the RCADS pre and post, in addition to all study-related surveys: demographics, pre- and post-knowledge checks, module component ratings, prototype evaluations, and advocacy ratings. All participants will be invited to the follow-up focus group sessions.
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- 3-C Institute for Social Development
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Miami, Stony Brook University
- Responsible party
- Sponsor
- Investigators
- Melissa DeRosier, PhD, Principal investigator, 3C InstituteJill Ehrenreich-May, PhD, Principal investigator, University of MiamiJessica Schleider, PhD, Principal investigator, StoneyBrook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06213142
- Sponsor's protocol ID
- 3CG078
- Acronym
- CBToolkit
- Status last verified
- Jan 2024
- First submitted
- 29 Dec 2023
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing the Unified Protocol-Single Session Experience Platform for Adolescent Mental Health
- ClinicalTrials.gov ID
- NCT06213142
- Acronym / sponsor ID
- CBToolkit / 3CG078
- Conditions
- Depression, Depression, Anxiety, Depression in Adolescence, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- 3-C Institute for Social DevelopmentIndustry (pharma, biotech, devices)
- Collaborators
- University of Miami, Stony Brook University
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This SBIR Phase I proposal will develop and test the acceptability and feasibility of a new suite of digital Single-Session Interventions, specifically applying Unified Protocol core principles for emotional disorders, to produce a highly accessible, engaging, and scalable product to help address the clinical needs of youth.
Detailed description
This project proposes develop a suite of Single Session Intervention (SSI) modules using the Unified Protocol (UP) core principles. For Phase I, the team will develop two SSI modules from UP: Awareness of Physical Sensations and Emotional Experiences, and Being Flexible in Your Problem Solving. For the acceptability test (Specific Aim 2), investigators will recruit 60 youth who are screened as eligible based on the internalizing subscale of the Pediatric Symptom Checklist. Caregivers/parents of youth will be recruited using targeted social media advertisements, where they can view a brief study description and complete the eligibility screener. If interested, caregivers can provide contact information for the study team to conduct consent and assent processes. Following consent and enrollment, participants will receive private login information to access the prototype and study materials. First, participants will complete pre-surveys that collect demographic information and responses to the Revised Children's Anxiety and Depression Scale (RCADS). Next, participants will take a brief survey to assess knowledge of intervention concepts presented in the first module: Mindful Awareness. Then, they will engage with the module and provide feedback on the quality of its components. Then, they will complete the knowledge assessment again. Participants will complete the same process for the second module: Flexible Problem Solving (pre knowledge check, review, rate the quality, and post knowledge check). Participants will complete a product evaluation to rate their overall experience with the prototype (quality, usability, innovation, feasibility, and value) and the degree they advocate for full product development. Finally, participants will take the RCADS at the end of the review period. There will also be an opportunity for participants to participate in a brief feedback call to provide additional feedback.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants in the acceptability test will be assigned to the same set of study tasks, where all participants will engage with the two modules and provide feedback. All participants will complete the RCADS pre and post, in addition to all study-related surveys: demographics, pre- and post-knowledge checks, module component ratings, prototype evaluations, and advocacy ratings. All participants will be invited to the follow-up focus group sessions.
| Arm | Type | Receives |
|---|---|---|
| CBToolkit | Experimental | Other: CBToolkitCBToolkit includes two SSI modules: (1) Mindful Awareness, with the goal of increasing awareness and tolerance of physical sensations and emotional experiences using mindfulness practices and tips and (2) Flexible Problem Solving, with the goal of promoting cognitive flexibility, applying problem-solving strategies in difficult scenarios, and learning to modify behavioral action tendencies. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- be ages 13 to 17 years old
- be willing and available to take part in the study requirements
- be fluent in English
- have access to the internet with a mobile device or personal computer
- have parent permission
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBToolkitCB Toolkit Mindful Awareness module to increase awareness and tolerance of physical sensations and emotional experiences using mindfulness practices. The module involves videos with motion graphics, video demos, voiceover, music, and sound effects intermixed throughout with a variety of interactive exercises tailored to specific core components. The module aims to establish understanding of the intervention concept (psychoeducation), increase self-efficacy in mindfulness skills via active practice and personalized feedback, and facilitate self-reflection and understanding of strengths and improvement areas related to mindfulness. CBToolkit Flexible Problem Solving module to promote cognitive flexibility, applying problem-solving strategies in difficult scenarios, and learning to modify behavioral action tendencies. Videos and activities will be tailored to provide examples of effective problem-solving techniques and provide personalized reinforcing and/or scaffolded feedback. | Other | CBToolkit |
Primary outcome
Program Feedback Scale for Adolescents
Time frame: 2 week followup post module review
Adolescents will complete this 12-item measure, rating the extent to which they agree with statements about the usability, acceptability, and feasibility of the CBToolkit modules. The measure includes 9 Likert items and 3 open-ended items. Responses to the Likert items range from 1 (Really Disagree) to 5 (Really Agree). Total scores are based on the Likert items are range from 0 to 45. Higher scores reflect more positive opinions.
Module Knowledge
Time frame: Average of 2 weeks apart, as pre- and post-tests
Adolescents will complete this 9-item measure to determine what they know about key concepts taught in the CBToolkit module prior to and following review of the modules. The measure includes 9 multiple choice items with a 1 correct response per item. Total scores are based on the number of items with correct responses and range from 0 to 9. Higher scores reflect more correct responses.
Revised Children's Anxiety and Depression Scale- Shortened
Time frame: Average of 2 weeks apart, as pre- and post-tests
Adolescents will complete the shortened 11-item version of this measure to assess levels of anxiety and depression prior to and following review of the modules. The measure includes 11 Likert items. Responses to the Likert items range from 0- Never to 3- Always. Total scores are based on the Likert items are range from 0 to 33. Higher scores reflect more severe symptoms.
2 secondary outcomes
Usage Metrics from the CBToolkit system for adolescents
Time frame: The period in which adolescents interact with the system, approximately 2 weeks
Feedback interviews with adolescents
Time frame: 15-minutes, completed after the test of the CBToolkit system
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa DeRosier, PhD principal investigator
3C Institute
Jill Ehrenreich-May, PhD principal investigator
University of Miami
Jessica Schleider, PhD principal investigator
StoneyBrook University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBToolkit in people with Depression and Depression, Anxiety, run by 3-C Institute for Social Development 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 6 inclusion and 0 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 19 Jan 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. 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?
Program Feedback Scale for Adolescents (time frame: 2 week followup post module review). 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 19 Jan 2024; AzTrials last refreshed its copy on 27 Oct 2026.