Optimizing the AYA Survivors' Coping and Emotional Needs Toolkit
Part of paid clinical trials in Greenville, North Carolina.
- Sponsor
- East Carolina University
- Study ID
- NCT07173205
- Status
- Recruiting
Conditions
- Adolescent
- Adult
- Cancer
- Depression
- Young Adult
Eligibility Criteria
- Sex
- ALL
- Age
- 15 Years - 39 Years
- Healthy Volunteers
- Not accepted
Interventions
- AYA Survivors Coping and Emotional Needs Toolkit (ASCENT) — BEHAVIORALParticipants will receive access to a digital depression self-management tool (ASCENT), which aims to help AYAs manage symptoms of depression post-treatment. All users will have access to the core tool which includes daily mood tracking and a psychoeducational module about cancer and depression. Depending on assigned condition, participants will also receive access to up to 4 intervention modules which have been adapted from existing evidence-based treatments for digital delivery to AYAs through a rigorous user-centered design process. Within each module there are 6 micro-lessons that include an educational video, a real story from an AYA that demonstrates the topic, multiple choice questions that ask the participant to apply the educational information to the AYA story, open-ended questions that ask the participant to apply the educational information to their own experience, and a practice activity in which they are asked to try out a relevant skill.
Study Details
Our team has developed a digital intervention that aims to help adolescent and young adult cancer survivors (AYAs) manage symptoms of depression. This tool includes one psychoeducation component and four components that are based on evidence-based interventions for depression. The goal of this study is to test which component or combination of components meaningfully contribute to improvements in depressive symptoms among AYAs.
Key Dates
- Start date
- Oct 25, 2025
- Status verified
- Jan 2026
- Primary completion
- Dec 31, 2026
- Completion
- Mar 31, 2027
Study Design
- Enrollment
- 208 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- FACTORIAL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Condition 1Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression).
- Experimental: Condition 2Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Positivity component of ASCENT (an adaptation of a suite of evidence-based positive psychology interventions that aims to help AYAs savor the good things in life, use their strengths, and practice gratitude and kindness).
- Experimental: Condition 3Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Being component of ASCENT (an adaptation of mindfulness training that aims to help AYAs maintain contact with the present moment with an attitude of acceptance).
- Experimental: Condition 4Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Being component of ASCENT (an adaptation of mindfulness training that aims to help AYAs maintain contact with the present moment with an attitude of acceptance); Positivity component of ASCENT (an adaptation of a suite of evidence-based positive psychology interventions that aims to help AYAs savor the good things in life, use their strengths, and practice gratitude and kindness).
- Experimental: Condition 5Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Thinking component of ASCENT (an adaptation of cognitive restructuring that aims to help AYAs identify, evaluate, and restructure their negative automatic thoughts and core beliefs).
- Experimental: Condition 6Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Thinking component of ASCENT (an adaptation of cognitive restructuring that aims to help AYAs identify, evaluate, and restructure their negative automatic thoughts and core beliefs); Positivity component of ASCENT (an adaptation of a suite of evidence-based positive psychology interventions that aims to help AYAs savor the good things in life, use their strengths, and practice gratitude and kindness).
- Experimental: Condition 7Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Thinking component of ASCENT (an adaptation of cognitive restructuring that aims to help AYAs identify, evaluate, and restructure their negative automatic thoughts and core beliefs); Being component of ASCENT (an adaptation of mindfulness training that aims to help AYAs maintain contact with the present moment with an attitude of acceptance).
- Experimental: Condition 8Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Thinking component of ASCENT (an adaptation of cognitive restructuring that aims to help AYAs identify, evaluate, and restructure their negative automatic thoughts and core beliefs); Being component of ASCENT (an adaptation of mindfulness training that aims to help AYAs maintain contact with the present moment with an attitude of acceptance); Positivity component of ASCENT (an adaptation of a suite of evidence-based positive psychology interventions that aims to help AYAs savor the good things in life, use their strengths, and practice gratitude and kindness)
- Experimental: Condition 9Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Doing component of ASCENT (an adaptation of behavioral activation that aims to help AYAs engage in enjoyable activities, achieve their goals, and live in accordance with their values).
- Experimental: Condition 10Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Doing component of ASCENT (an adaptation of behavioral activation that aims to help AYAs engage in enjoyable activities, achieve their goals, and live in accordance with their values); Positivity component of ASCENT (an adaptation of a suite of evidence-based positive psychology interventions that aims to help AYAs savor the good things in life, use their strengths, and practice gratitude and kindness).
- Experimental: Condition 11Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Doing component of ASCENT (an adaptation of behavioral activation that aims to help AYAs engage in enjoyable activities, achieve their goals, and live in accordance with their values); Being component of ASCENT (an adaptation of mindfulness training that aims to help AYAs maintain contact with the present moment with an attitude of acceptance).
- Experimental: Condition 12Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Doing component of ASCENT (an adaptation of behavioral activation that aims to help AYAs engage in enjoyable activities, achieve their goals, and live in accordance with their values); Being component of ASCENT (an adaptation of mindfulness training that aims to help AYAs maintain contact with the present moment with an attitude of acceptance); Positivity component of ASCENT (an adaptation of a suite of evidence-based positive psychology interventions that aims to help AYAs savor the good things in life, use their strengths, and practice gratitude and kindness).
- Experimental: Condition 13Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Doing component of ASCENT (an adaptation of behavioral activation that aims to help AYAs engage in enjoyable activities, achieve their goals, and live in accordance with their values); Thinking component of ASCENT (an adaptation of cognitive restructuring that aims to help AYAs identify, evaluate, and restructure their negative automatic thoughts and core beliefs).
- Experimental: Condition 14Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Doing component of ASCENT (an adaptation of behavioral activation that aims to help AYAs engage in enjoyable activities, achieve their goals, and live in accordance with their values); Thinking component of ASCENT (an adaptation of cognitive restructuring that aims to help AYAs identify, evaluate, and restructure their negative automatic thoughts and core beliefs); Positivity component of ASCENT (an adaptation of a suite of evidence-based positive psychology interventions that aims to help AYAs savor the good things in life, use their strengths, and practice gratitude and kindness).
- Experimental: Condition 15Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Doing component of ASCENT (an adaptation of behavioral activation that aims to help AYAs engage in enjoyable activities, achieve their goals, and live in accordance with their values); Thinking component of ASCENT (an adaptation of cognitive restructuring that aims to help AYAs identify, evaluate, and restructure their negative automatic thoughts and core beliefs); Being component of ASCENT (an adaptation of mindfulness training that aims to help AYAs maintain contact with the present moment with an attitude of acceptance)
- Experimental: Condition 16Feeling component of ASCENT (psychoeducation about AYA cancer survivorship and depression); Doing component of ASCENT (an adaptation of behavioral activation that aims to help AYAs engage in enjoyable activities, achieve their goals, and live in accordance with their values); Thinking component of ASCENT (an adaptation of cognitive restructuring that aims to help AYAs identify, evaluate, and restructure their negative automatic thoughts and core beliefs); Being component of ASCENT (an adaptation of mindfulness training that aims to help AYAs maintain contact with the present moment with an attitude of acceptance); and Positivity component of ASCENT (an adaptation of a suite of evidence-based positive psychology interventions that aims to help AYAs savor the good things in life, use their strengths, and practice gratitude and kindness)
Primary Outcome Measure
Change in Depressive Symptoms during Intervention Period [ Time Frame: Baseline to Week 6 ]
Central Contacts
- AnneMarie Coffey, BS252-328-6244
- Lane Williamson
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| East Carolina University | Greenville | North Carolina | 27858 | Karly Murphy, PhD (PRINCIPAL_INVESTIGATOR) |
| Wake Forest University | Winston-Salem | North Carolina | 27109 | John Salsman, PhD |
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