- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07577401
Calming Minds Study
Understanding the Mechanisms Driving the Reduction of Repetitive Negative Thought
The goal of this study is to understand why certain treatments help people reduce repetitive negative thinking (RNT), which is common in many mental health problems. We want to:
- Figure out what actually causes repetitive negative thinking to decrease when people use cognitive-behavioral therapy (CBT).
- Find out which parts of RNT-focused CBT are the most important - the parts that truly make a difference in reducing RNT.
The main result we will look at is how much a person's repetitive negative thought patterns change from the start of the study to the end of treatment (16 weeks). We will measure this using the Perseverative Thinking Questionnaire at baseline and week 16.
연구 개요
상태
상세 설명
Participants in this study will be randomly assigned to one of 16 different treatment groups. Each group will get a different mix of 1-5 tools or strategies taken from Rumination-Focused Cognitive Behavioral Therapy (RF-CBT).
All participants, regardless of their treatment assignment, will get a basic set of lessons about repetitive negative thinking (RNT) and how CBT can help. This means every participant gets therapeutic support.
Participants will use a digital therapy program through the MyDataHelps app. The CBT lessons are available in English or Spanish, according to the participant's preference. Each participant will also be offered 3-6 meetings with a coach from our team, to review the lessons and tools in the digital therapy program. It is expected that the digital therapy program and coaching sessions will be completed within 4 months on study. Once 4 months have passed since their start on study, participants are asked to complete online questionnaires that will measure their recent symptom experiences. Participants are then asked to complete these questionnaires again 1 year after starting on study. These questionnaires are used to measure changes in symptom experiences from baseline (before starting the digital therapy program).
In addition to the primary goals listed in the brief summary, this study also aims to look at the following:
- How anxiety and depression symptoms change during their use of the digital therapy program.
- Whether people's mental health symptoms change over time after using the digital therapy program.
d) Who benefits most from which components, so therapy can be more personalized in the future.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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California
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Imperial, California, 미국, 92251
- Imperial Valley College
-
연락하다:
- Research Coordinator
- 전화번호: (310) 825-8403
- 이메일: calmingminds@mednet.ucla.edu
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Aged 18+ years
- Able to provide a valid Imperial Valley College email address
- Access to a suitable smartphone/device (iPhone 8+ running iOS 16.4 or higher, or Android version 8 or higher)
- Access to internet
- Elevated repetitive negative thought (RNT) based on scores from Ruminative Response Scale Brood subscale (RSS-brood) and Penn State Worry Questionnaire (PSWQ)
Exclusion Criteria:
- Concurrent psychotherapy
- Self-reported current or past diagnosis or treatment for Psychosis
- Self-reported current or past diagnosis or treatment for Bipolar disorder
- Self-reported current or past diagnosis or currently receiving, or waiting to receive, treatment for substance abuse/dependence
- Self-reported current diagnosis or currently receiving, or waiting to receive, treatment for alcohol abuse/dependence
- Antidepressant/anxiolytic medication that has changed in dose or nature in last 6 weeks
- Current severe PTSD defined as measured by the adapted International Trauma Questionnaire
- Active suicidal thoughts or self-harm
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Psychoeducation Only
Participants receive only core psychoeducation without any additional RF-CBT components.
|
Digital therapy lessons and coaching that provide foundational information about repetitive negative thinking and why it occurs.
Helping participants understand explanations for their symptoms and difficulties, which reduces the search for understanding, insight and certainty shown to drive RNT, and normalizes their experiences.
This corresponds with the RF-CBT components of individualized rationale, psychoeducation, empathy and understanding.
|
|
실험적: Be Specific
Participants receive training in increasing specificity and concreteness ("Be Specific") in addition to standard psychoeducation.
|
Digital therapy lessons and coaching that provide foundational information about repetitive negative thinking and why it occurs.
Helping participants understand explanations for their symptoms and difficulties, which reduces the search for understanding, insight and certainty shown to drive RNT, and normalizes their experiences.
This corresponds with the RF-CBT components of individualized rationale, psychoeducation, empathy and understanding.
Digital therapy lessons and coaching that emphasize skills in shifting from unhelpful abstract to helpful concrete processing style.
Helping participants make changes to processing style to improve problem-solving and reduce emotional reactivity.
Training concrete thinking to reduce RNT by increasing specific contextualized detail in description of events and plans.
|
|
실험적: Be Kind
Participants receive training in self-compassion ("Be Kind") in addition to standard psychoeducation.
|
Digital therapy lessons and coaching that provide foundational information about repetitive negative thinking and why it occurs.
Helping participants understand explanations for their symptoms and difficulties, which reduces the search for understanding, insight and certainty shown to drive RNT, and normalizes their experiences.
This corresponds with the RF-CBT components of individualized rationale, psychoeducation, empathy and understanding.
Digital therapy lessons and coaching that emphasize skills for replacing self-criticism with self-compassion.
Helping participants shift toward a kinder, more validating way of relating to themselves to reduce the emotional patterns that sustain RNT.
Training self-compassion skills to counter harsh self-evaluation and support emotional regulation.
|
|
실험적: Break Habit
Participants receive training in breaking the habit of repetitive negative thinking ("Break Habit") in addition to standard psychoeducation.
|
Digital therapy lessons and coaching that provide foundational information about repetitive negative thinking and why it occurs.
Helping participants understand explanations for their symptoms and difficulties, which reduces the search for understanding, insight and certainty shown to drive RNT, and normalizes their experiences.
This corresponds with the RF-CBT components of individualized rationale, psychoeducation, empathy and understanding.
Digital therapy lessons and coaching that emphasize skills for disrupting repetitive negative thinking as a habitual mental behavior.
Helping participants identify early warning signs, use stimulus-control strategies, form implementation intentions, and practice alternative responses to build more adaptive habits.
Training new behavioral and cognitive routines to replace automatic RNT patterns.
|
|
실험적: Be Present
Participants receive training in absorption in direct experience ("Be Present") in addition to standard psychoeducation.
|
Digital therapy lessons and coaching that provide foundational information about repetitive negative thinking and why it occurs.
Helping participants understand explanations for their symptoms and difficulties, which reduces the search for understanding, insight and certainty shown to drive RNT, and normalizes their experiences.
This corresponds with the RF-CBT components of individualized rationale, psychoeducation, empathy and understanding.
Digital therapy lessons and coaching that emphasize skills for improving attention to present-moment experience.
Helping participants redirect attention away from unhelpful mental ruminations by strengthening mindfulness and task absorption.
Training present-moment awareness to interrupt the cognitive processes that maintain RNT by cultivating absorption in direct sensory experience.
|
|
실험적: Be Specific + Be Kind
Participants receive training in both specificity/concreteness and self-compassion in addition to standard psychoeducation.
|
Digital therapy lessons and coaching that provide foundational information about repetitive negative thinking and why it occurs.
Helping participants understand explanations for their symptoms and difficulties, which reduces the search for understanding, insight and certainty shown to drive RNT, and normalizes their experiences.
This corresponds with the RF-CBT components of individualized rationale, psychoeducation, empathy and understanding.
Digital therapy lessons and coaching that emphasize skills in shifting from unhelpful abstract to helpful concrete processing style.
Helping participants make changes to processing style to improve problem-solving and reduce emotional reactivity.
Training concrete thinking to reduce RNT by increasing specific contextualized detail in description of events and plans.
Digital therapy lessons and coaching that emphasize skills for replacing self-criticism with self-compassion.
Helping participants shift toward a kinder, more validating way of relating to themselves to reduce the emotional patterns that sustain RNT.
Training self-compassion skills to counter harsh self-evaluation and support emotional regulation.
|
|
실험적: Be Specific + Be Present
Participants receive training in both specificity/concreteness and absorption in direct experience in addition to standard psychoeducation.
|
Digital therapy lessons and coaching that provide foundational information about repetitive negative thinking and why it occurs.
Helping participants understand explanations for their symptoms and difficulties, which reduces the search for understanding, insight and certainty shown to drive RNT, and normalizes their experiences.
This corresponds with the RF-CBT components of individualized rationale, psychoeducation, empathy and understanding.
Digital therapy lessons and coaching that emphasize skills in shifting from unhelpful abstract to helpful concrete processing style.
Helping participants make changes to processing style to improve problem-solving and reduce emotional reactivity.
Training concrete thinking to reduce RNT by increasing specific contextualized detail in description of events and plans.
Digital therapy lessons and coaching that emphasize skills for improving attention to present-moment experience.
Helping participants redirect attention away from unhelpful mental ruminations by strengthening mindfulness and task absorption.
Training present-moment awareness to interrupt the cognitive processes that maintain RNT by cultivating absorption in direct sensory experience.
|
|
실험적: Be Kind + Be Present
Participants receive training in both self-compassion and absorption in direct experience in addition to standard psychoeducation.
|
Digital therapy lessons and coaching that provide foundational information about repetitive negative thinking and why it occurs.
Helping participants understand explanations for their symptoms and difficulties, which reduces the search for understanding, insight and certainty shown to drive RNT, and normalizes their experiences.
This corresponds with the RF-CBT components of individualized rationale, psychoeducation, empathy and understanding.
Digital therapy lessons and coaching that emphasize skills for replacing self-criticism with self-compassion.
Helping participants shift toward a kinder, more validating way of relating to themselves to reduce the emotional patterns that sustain RNT.
Training self-compassion skills to counter harsh self-evaluation and support emotional regulation.
Digital therapy lessons and coaching that emphasize skills for improving attention to present-moment experience.
Helping participants redirect attention away from unhelpful mental ruminations by strengthening mindfulness and task absorption.
Training present-moment awareness to interrupt the cognitive processes that maintain RNT by cultivating absorption in direct sensory experience.
|
|
실험적: Be Specific + Be Kind + Be Present
Participants receive training in specificity/concreteness, self-compassion, and absorption in direct experience in addition to standard psychoeducation.
|
Digital therapy lessons and coaching that provide foundational information about repetitive negative thinking and why it occurs.
Helping participants understand explanations for their symptoms and difficulties, which reduces the search for understanding, insight and certainty shown to drive RNT, and normalizes their experiences.
This corresponds with the RF-CBT components of individualized rationale, psychoeducation, empathy and understanding.
Digital therapy lessons and coaching that emphasize skills in shifting from unhelpful abstract to helpful concrete processing style.
Helping participants make changes to processing style to improve problem-solving and reduce emotional reactivity.
Training concrete thinking to reduce RNT by increasing specific contextualized detail in description of events and plans.
Digital therapy lessons and coaching that emphasize skills for replacing self-criticism with self-compassion.
Helping participants shift toward a kinder, more validating way of relating to themselves to reduce the emotional patterns that sustain RNT.
Training self-compassion skills to counter harsh self-evaluation and support emotional regulation.
Digital therapy lessons and coaching that emphasize skills for improving attention to present-moment experience.
Helping participants redirect attention away from unhelpful mental ruminations by strengthening mindfulness and task absorption.
Training present-moment awareness to interrupt the cognitive processes that maintain RNT by cultivating absorption in direct sensory experience.
|
|
실험적: Break Habit + Be Specific
Participants receive training in both breaking the habit of RNT and increasing specificity/concreteness in addition to standard psychoeducation.
|
Digital therapy lessons and coaching that provide foundational information about repetitive negative thinking and why it occurs.
Helping participants understand explanations for their symptoms and difficulties, which reduces the search for understanding, insight and certainty shown to drive RNT, and normalizes their experiences.
This corresponds with the RF-CBT components of individualized rationale, psychoeducation, empathy and understanding.
Digital therapy lessons and coaching that emphasize skills in shifting from unhelpful abstract to helpful concrete processing style.
Helping participants make changes to processing style to improve problem-solving and reduce emotional reactivity.
Training concrete thinking to reduce RNT by increasing specific contextualized detail in description of events and plans.
Digital therapy lessons and coaching that emphasize skills for disrupting repetitive negative thinking as a habitual mental behavior.
Helping participants identify early warning signs, use stimulus-control strategies, form implementation intentions, and practice alternative responses to build more adaptive habits.
Training new behavioral and cognitive routines to replace automatic RNT patterns.
|
|
실험적: Break Habit + Be Kind
Participants receive training in both breaking the habit of RNT and self-compassion in addition to standard psychoeducation.
|
Digital therapy lessons and coaching that provide foundational information about repetitive negative thinking and why it occurs.
Helping participants understand explanations for their symptoms and difficulties, which reduces the search for understanding, insight and certainty shown to drive RNT, and normalizes their experiences.
This corresponds with the RF-CBT components of individualized rationale, psychoeducation, empathy and understanding.
Digital therapy lessons and coaching that emphasize skills for replacing self-criticism with self-compassion.
Helping participants shift toward a kinder, more validating way of relating to themselves to reduce the emotional patterns that sustain RNT.
Training self-compassion skills to counter harsh self-evaluation and support emotional regulation.
Digital therapy lessons and coaching that emphasize skills for disrupting repetitive negative thinking as a habitual mental behavior.
Helping participants identify early warning signs, use stimulus-control strategies, form implementation intentions, and practice alternative responses to build more adaptive habits.
Training new behavioral and cognitive routines to replace automatic RNT patterns.
|
|
실험적: Break Habit + Be Specific + Be Kind
Participants receive training in breaking the habit of RNT, specificity/concreteness, and self-compassion in addition to standard psychoeducation.
|
Digital therapy lessons and coaching that provide foundational information about repetitive negative thinking and why it occurs.
Helping participants understand explanations for their symptoms and difficulties, which reduces the search for understanding, insight and certainty shown to drive RNT, and normalizes their experiences.
This corresponds with the RF-CBT components of individualized rationale, psychoeducation, empathy and understanding.
Digital therapy lessons and coaching that emphasize skills in shifting from unhelpful abstract to helpful concrete processing style.
Helping participants make changes to processing style to improve problem-solving and reduce emotional reactivity.
Training concrete thinking to reduce RNT by increasing specific contextualized detail in description of events and plans.
Digital therapy lessons and coaching that emphasize skills for replacing self-criticism with self-compassion.
Helping participants shift toward a kinder, more validating way of relating to themselves to reduce the emotional patterns that sustain RNT.
Training self-compassion skills to counter harsh self-evaluation and support emotional regulation.
Digital therapy lessons and coaching that emphasize skills for disrupting repetitive negative thinking as a habitual mental behavior.
Helping participants identify early warning signs, use stimulus-control strategies, form implementation intentions, and practice alternative responses to build more adaptive habits.
Training new behavioral and cognitive routines to replace automatic RNT patterns.
|
|
실험적: Break Habit + Be Present
Participants receive training in both breaking the habit of RNT and absorption in direct experience in addition to standard psychoeducation.
|
Digital therapy lessons and coaching that provide foundational information about repetitive negative thinking and why it occurs.
Helping participants understand explanations for their symptoms and difficulties, which reduces the search for understanding, insight and certainty shown to drive RNT, and normalizes their experiences.
This corresponds with the RF-CBT components of individualized rationale, psychoeducation, empathy and understanding.
Digital therapy lessons and coaching that emphasize skills for disrupting repetitive negative thinking as a habitual mental behavior.
Helping participants identify early warning signs, use stimulus-control strategies, form implementation intentions, and practice alternative responses to build more adaptive habits.
Training new behavioral and cognitive routines to replace automatic RNT patterns.
Digital therapy lessons and coaching that emphasize skills for improving attention to present-moment experience.
Helping participants redirect attention away from unhelpful mental ruminations by strengthening mindfulness and task absorption.
Training present-moment awareness to interrupt the cognitive processes that maintain RNT by cultivating absorption in direct sensory experience.
|
|
실험적: Break Habit + Be Specific+ Be Present
Participants receive training in breaking the habit of RNT, specificity/concreteness, and absorption in direct experience in addition to standard psychoeducation.
|
Digital therapy lessons and coaching that provide foundational information about repetitive negative thinking and why it occurs.
Helping participants understand explanations for their symptoms and difficulties, which reduces the search for understanding, insight and certainty shown to drive RNT, and normalizes their experiences.
This corresponds with the RF-CBT components of individualized rationale, psychoeducation, empathy and understanding.
Digital therapy lessons and coaching that emphasize skills in shifting from unhelpful abstract to helpful concrete processing style.
Helping participants make changes to processing style to improve problem-solving and reduce emotional reactivity.
Training concrete thinking to reduce RNT by increasing specific contextualized detail in description of events and plans.
Digital therapy lessons and coaching that emphasize skills for disrupting repetitive negative thinking as a habitual mental behavior.
Helping participants identify early warning signs, use stimulus-control strategies, form implementation intentions, and practice alternative responses to build more adaptive habits.
Training new behavioral and cognitive routines to replace automatic RNT patterns.
Digital therapy lessons and coaching that emphasize skills for improving attention to present-moment experience.
Helping participants redirect attention away from unhelpful mental ruminations by strengthening mindfulness and task absorption.
Training present-moment awareness to interrupt the cognitive processes that maintain RNT by cultivating absorption in direct sensory experience.
|
|
실험적: Break Habit + Be Kind + Be Present
Participants receive training in breaking the habit of RNT, self-compassion, and absorption in direct experience in addition to standard psychoeducation.
|
Digital therapy lessons and coaching that provide foundational information about repetitive negative thinking and why it occurs.
Helping participants understand explanations for their symptoms and difficulties, which reduces the search for understanding, insight and certainty shown to drive RNT, and normalizes their experiences.
This corresponds with the RF-CBT components of individualized rationale, psychoeducation, empathy and understanding.
Digital therapy lessons and coaching that emphasize skills for replacing self-criticism with self-compassion.
Helping participants shift toward a kinder, more validating way of relating to themselves to reduce the emotional patterns that sustain RNT.
Training self-compassion skills to counter harsh self-evaluation and support emotional regulation.
Digital therapy lessons and coaching that emphasize skills for disrupting repetitive negative thinking as a habitual mental behavior.
Helping participants identify early warning signs, use stimulus-control strategies, form implementation intentions, and practice alternative responses to build more adaptive habits.
Training new behavioral and cognitive routines to replace automatic RNT patterns.
Digital therapy lessons and coaching that emphasize skills for improving attention to present-moment experience.
Helping participants redirect attention away from unhelpful mental ruminations by strengthening mindfulness and task absorption.
Training present-moment awareness to interrupt the cognitive processes that maintain RNT by cultivating absorption in direct sensory experience.
|
|
실험적: ALL
Participants receive training in all four RF-CBT components: breaking the habit of RNT, specificity/concreteness, self-compassion, and absorption in direct experience; in addition to standard psychoeducation.
|
Digital therapy lessons and coaching that provide foundational information about repetitive negative thinking and why it occurs.
Helping participants understand explanations for their symptoms and difficulties, which reduces the search for understanding, insight and certainty shown to drive RNT, and normalizes their experiences.
This corresponds with the RF-CBT components of individualized rationale, psychoeducation, empathy and understanding.
Digital therapy lessons and coaching that emphasize skills in shifting from unhelpful abstract to helpful concrete processing style.
Helping participants make changes to processing style to improve problem-solving and reduce emotional reactivity.
Training concrete thinking to reduce RNT by increasing specific contextualized detail in description of events and plans.
Digital therapy lessons and coaching that emphasize skills for replacing self-criticism with self-compassion.
Helping participants shift toward a kinder, more validating way of relating to themselves to reduce the emotional patterns that sustain RNT.
Training self-compassion skills to counter harsh self-evaluation and support emotional regulation.
Digital therapy lessons and coaching that emphasize skills for disrupting repetitive negative thinking as a habitual mental behavior.
Helping participants identify early warning signs, use stimulus-control strategies, form implementation intentions, and practice alternative responses to build more adaptive habits.
Training new behavioral and cognitive routines to replace automatic RNT patterns.
Digital therapy lessons and coaching that emphasize skills for improving attention to present-moment experience.
Helping participants redirect attention away from unhelpful mental ruminations by strengthening mindfulness and task absorption.
Training present-moment awareness to interrupt the cognitive processes that maintain RNT by cultivating absorption in direct sensory experience.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Perseverative Thinking Questionnaire score from baseline to post-intervention
기간: Baseline, 16 weeks
|
Change in repetitive negative thought as indexed by the Perseverative Thinking questionnaire
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Baseline, 16 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in GAD-7 score from baseline to post-intervention
기간: Baseline, 16 weeks & 52 weeks
|
Change in anxiety measured with GAD-7
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Baseline, 16 weeks & 52 weeks
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Change in PHQ-9 score from baseline to post-intervention
기간: Baseline, 16 weeks & 52 weeks
|
Change in depression measured with PHQ-9
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Baseline, 16 weeks & 52 weeks
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Change in WEMWBS from baseline to post-intervention
기간: Baseline, 16 weeks & 52 weeks
|
Change in mental wellbeing measured with WEMWBS (Warwick-Edinburgh Mental Wellbeing Scale short-form)
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Baseline, 16 weeks & 52 weeks
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Change in RRS-Brooding subscale from baseline to post-intervention
기간: Baseline, 16 weeks & 52 weeks
|
Change in levels of rumination measured with RRS-Brooding subscale
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Baseline, 16 weeks & 52 weeks
|
|
Change in PSWQ score from baseline to post-intervention
기간: Baseline, 16 weeks & 52 weeks
|
Change in levels of worry measured with PSWQ (Penn State Worry Questionnaire short-form)
|
Baseline, 16 weeks & 52 weeks
|
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Change in WSAS score from baseline to post-intervention
기간: Baseline, 16 weeks & 52 weeks
|
Change in social functioning measured with WSAS (Work and Social Adjustment Scale)
|
Baseline, 16 weeks & 52 weeks
|
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Change in EMA from baseline to post-intervention
기간: Baseline, 16 weeks
|
Change in repetitive negative thought (RNT) in everyday life measured with ecological momentary assessment (EMA) (aggregrate person-level ratings of RNT across 10 day period; variability of RNT; relationship of RNT to mood state & contextual events; automaticity of RNT, based on EMA items).
This provides an ecologically valid measure, in the real-world, of extent of RNT and how it changes pre-to-post intervention.
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Baseline, 16 weeks
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- IRB-25-1994
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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Psychoeducation에 대한 임상 시험
-
University of Colorado, DenverNational Cancer Institute (NCI)모집하지 않고 적극적으로
-
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