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Increasing Engagement With Digital Behavioral Health

2026년 9월 17일 업데이트: Hackensack Meridian Health

Development of a Peer Digital Coach Intervention to Increase Adolescent and Young Adult Cancer Survivors' Engagement With a Digital Behavioral Health Intervention

This is a phased mixed-methods behavioral intervention study that will develop and test Mindful Peer Coach, a peer-supported mindfulness program for adolescent and young adult (AYA) cancer survivors. Phase 1 is a formative qualitative study designed to identify survivor-reported needs and preferences for increasing engagement with a mindfulness meditation app. Phase 2 is a pilot intervention study that will examine the feasibility, acceptability, and preliminary engagement outcomes of the Mindful Peer Coach program using participant surveys, app-use data, peer-coach training, coaching sessions, weekly text-message check-ins, and exit interviews with survivors and coaches.

연구 개요

상태

아직 모집하지 않음

정황

연구 유형

중재적

등록 (추정된)

13

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

    • New Jersey
      • Nutley, New Jersey, 미국, 07110
        • HMH Center for Discovery and Innovation
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • at least one year from treatment completion
  • ability to speak conversational English,
  • per self-report, not being treated for posttraumatic stress disorder (PTSD), psychosis, or epilepsy/seizures.
  • have experience with mindfulness and/or be willing to attend training and supervision sessions (only for coaches)
  • at least two years from treatment completion (only for coaches) ;

Exclusion Criteria:

  • outside age range
  • closer to treatment completion than specified above

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Mindful Peer Coaching

Mindful Peer Coach consists of 1) live virtual and 2) text message coaching.

Participants will complete six structured weekly videoconference sessions designed to cultivate mindfulness practice and increase engagement with the Happier Meditation app.

Each session follows a standardized framework outlined in the training manual to ensure consistency and fidelity.

Between sessions, coaches will provide support and accountability via text messaging. The frequency of messages will be determined collaboratively during Session 1.

Each exchange begins with a previously tested mindfulness message, followed by tailored responses to reinforce practice, address questions, and sustain engagement.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Minutes use per day (User engagement)
기간: Minutes used per day will be captured daily through the app and summarized weekly across the full 3-month study period, including the 8-week intervention phase

Minutes use per day with the mindfulness-based mobile app obtained from the Happier Meditation dashboard.

Minutes used per day will be captured daily through the app and summarized weekly across the full 3-month study period, including the 8-week intervention phase
Number of days used per week (User engagement)
기간: Number of days used per week will be captured daily through the app and summarized weekly across the full 3-month study period, including the 8-week intervention phase.

Number of days used per week with the mindfulness-based mobile app obtained from the Happier Meditation dashboard.

Number of days used per week will be captured daily through the app and summarized weekly across the full 3-month study period, including the 8-week intervention phase.
Depression
기간: Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks

Depression symptoms will be assessed using the PROMIS Depression measure. PROMIS Depression is an 8-item scale with each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression.

Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks
Anxiety
기간: Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks

Anxiety symptoms will be assessed using the PROMIS Anxiety measure. PROMIS Anxiety is an 7-item scale with each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 7 to 35 with higher scores indicating greater severity of anxiety.

Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks
Mindfulness
기간: Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks

Mindfulness will be assessed using the Mindful Attention Awareness Scale measure. Your score falls into a range of 1 to 6, calculated by taking the average of all 15 responses. Higher average scores indicate greater overall mindfulness.

Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks
Emotion Regulation
기간: Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks

Emotion Regulation will be assessed using the emotional experience subscale from the Emotion Regulation Questionnaire (ERQ) measure. The Emotion Regulation has 6 items on a 7-point Likert scale, with 1 indicating "strongly disagree" and 7 indicating "strongly agree" ranging from 6 to 42 (computed as the mean of the 6 items). Higher scores indicate a greater tendency to alter how you think about a situation to change its emotional impact.

Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks
Positive and Negative Emotions
기간: Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks

Positive and Negative Emotions will be assessed using I-PANAS-SF (International Positive and Negative Affect Schedule Short-Form). It is a 10-item psychological tool that assesses affect. It evaluates both Positive Affect and Negative Affect on two separate 5-item subscales. Each of the 10 emotions is rated on a 5-point Likert scale, resulting in score ranges of 5 to 25 for both the Positive and Negative subscales. Higher scores indicate higher levels of that specific effect.

Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks
Distress
기간: Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks

Distress will be assessed using the Perceived Stress Scale. The Perceived Stress Scale (PSS-10) is a 10 item scale that has a total score range from 0 to 40, with higher scores indicating higher levels of perceived stress.

Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks
Overall Wellbeing
기간: Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks

Overall Wellbeing will be assessed using the PROMIS Global Health scale. For the standard PROMIS Global Health (PROMIS-GH-10) assessment, the 10 items produce two distinct summary scales: Global Physical Health and Global Mental Health. Because both subscales are made up of 4 items measured on a 1-5 point scale, the raw score range for each subscale is 4 to 20. While raw scores are simply the sum of your responses, they are not used directly to interpret health status. Instead, raw scores are converted into standardized T-scores using an established lookup algorithm:

A T-score of 50 represents the average health of the U.S. general population. Every 10 points away from 50 equates to one standard deviation. Higher T-scores indicate better self-reported health, regardless of whether it is the physical or mental subscale.

Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks
Sleep Disturbance
기간: Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks

Sleep Disturbance will be assessed using the PROMIS Sleep Disturbance scale. The raw score range for the PROMIS Sleep Disturbance Scale 4-Item Short Forms: is generally 4 to 20. Higher raw scores correspond to a greater severity of sleep disturbance. These raw scores are then converted into a standardized T-score (where the general U.S. population average is 50, with a standard deviation of 10) using PROMIS Standardized Lookup Tables.

Assessed at baseline, 2 weeks, 4 weeks, and 8 weeks

2차 결과 측정

결과 측정
측정값 설명
기간
Exit Interview
기간: At the end of the 8-week intervention period

Qualitative feedback collected through semi-structured exit interviews; no quantifiable data will be generated. Themes will be identified and presented using descriptive statistics.

At the end of the 8-week intervention period

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Gary Kwok, PhD, Hackensack Meridian Health Center for Discovery and Innovation

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 12월 15일

기본 완료 (추정된)

2029년 12월 14일

연구 완료 (추정된)

2030년 3월 15일

연구 등록 날짜

최초 제출

2026년 9월 17일

QC 기준을 충족하는 최초 제출

2026년 9월 17일

처음 게시됨 (실제)

2026년 9월 23일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 23일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 17일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • Pro2024-0069
  • K01CA308858 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다