Integrated Digital Health Approach to Reduce Hazardous Alcohol Use and Chronic Pain Among Rural Populations
2026년 8월 31일 업데이트: Tibor Palfai, Boston University Charles River Campus
Alcohol Use and Pain in Rural Populations
The current proposal seeks to test the benefit of a brief intervention combined with a digital program delivered though a smartphone app for reducing chronic pain and hazardous drinking among those in rural settings.
Participants are recruited through social media and complete an online pre-screener and telephone screener to determine eligibility.
All subsequent study assessment procedures are conducted through videoconferencing online.
Participants complete 3 assessments over the course of 8 months.
Following the first (baseline assessment) participants are randomized to either the INTERVENTION (INTV) or a treatment-as-usual CONTROL (CTL) condition.
Those in the INTV condition meet with a health counselor for up to 50 minutes and then complete an 8-week smartphone-based intervention with weekly SMS based brief coaching.
This in the CTL group meet with the health counselor only.
Participants complete additional assessments at 3-months and 8-months post -baseline.
Measures of alcohol use and pain are assessed after the intervention at 3 months and at the final outcome period at 8-months post-baseline.
연구 개요
상태
상태
아직 모집하지 않음
정황
정황
개입 / 치료
개입 / 치료
상세 설명
The current proposal represents an extension of previous research on the use of a smartphone-based intervention to reduce chronic pain and hazardous drinking among those in rural settings.
The study is a randomized controlled trial that tests the efficacy of digital intervention for reducing pain intensity and interference and the quantity of alcohol consumption.
Participants are recruited through social media and complete an online pre-screener to determine eligibility.
This is followed by a telephone screener to confirm eligibility before scheduling baseline.
All subsequent study assessment procedures are conducted through videoconferencing online.
Following baseline assessment guided by an RA, participants are randomized to the INTERVENTION (INTV) or a treatment-as-usual CONTROL (CTL).
Those in the INTV condition meet with a health counselor for up to 50 minutes and then complete an 8-week smartphone-based intervention with weekly SMS based brief coaching.
This in the CTL group meet with the health counselor only.
Participants complete additional assessments at 3-months and 8-months post -baseline.
The 8-month assessment is the primary timepoint and assesses pain experience and alcohol use as measured by self-report and phosphatidylethanol (PEth) from a participant administered, RA supervised, finger stick.
It is hypothesized that those in the INTV condition will show lower ratings of pain and less alcohol consumption at 8-months post-baseline.
연구 유형
연구 유형
중재적
등록 (추정된)
등록
260
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Tibor P Palfai, PhD
- 전화번호: 617-353-9345
- 이메일: palfai@bu.edu
연구 연락처 백업
- 이름: Sarah Fraher, BA
- 이메일: sfraher@bu.edu
연구 장소
-
-
Massachusetts
-
Boston, Massachusetts, 미국, 02215
- Boston University
-
연락하다:
- Tibor Palfai, PhD
- 전화번호: 617-353-9345
- 이메일: palfai@bu.edu
-
연락하다:
- Sarah Fraher, BA
- 전화번호: 617353-0962
- 이메일: sfraher@bu.edu
-
수석 연구원:
- Tibor Palfai, PhD
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Reside in a US rural area (non-metropolitan country) as defined by the Rural-Urban Commuting Codes from US Dept. of Agriculture
- At least 18 years of age
- Engage in hazardous drinking (either by exceeding weekly NIAAA guidelines of 7 standard drinks for women [>7] and those > 65 and older or 14 for men [>14] <65, and/or having at least one heavy drinking episode in the past month as measured by >3 drinks for women and those > 65 and >4 drinks for men < 65), - - Experience chronic pain (at least 3 months in duration) of at least moderate severity (4 or greater on the Numerical Pain Rating Scale)
- Fluent in English
- Use of a personal smartphone
- Able to provide the name and contact information for one or more individuals who may be contacted in case the participant cannot be reached at follow-up.
Exclusion Criteria:
- History of bipolar disorder, schizophrenia, or other psychotic disorders
- Prior history of serious alcohol-related withdrawal symptoms (i.e., withdrawal-related seizures or delirium tremens)
- Current psychological/behavioral treatment for alcohol use disorder
- Current psychological/behavioral treatment for chronic pain
- Cancer-related pain
- Intent to have surgery for a pain-related condition in the next 8-months
- If using psychoactive medications for pain management or alcohol use must be using a stable medication dose (same dose for at least 2 months).
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
활성 비교기: Control (CTL) arm refers to a treatment-as-usual condition.
Participants in the CTL condition receive psychoeducation about pain and alcohol and referral resources should they wish to obtain additional treatment from a health counselor
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Participants are provided with psychoeducation about the reciprocal influences of hazardous drinking and chronic pain and their joint effects on health outcomes.
In addition, they are provided with information about free web-based national resources should they wish to receive more information or additional help with pain or drinking
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실험적: Intervention (INTV)
The Intervention (INTV) condition consists of a brief intervention with a health counselor followed by an 8-week smartphone-based program to provide cognitive behavioral and self-management skills to reduce hazardous drinking and chronic pain
|
The Intervention (INTV) is a brief motivational intervention with a health counselor followed by an 8-week smartphone-based program in which participants are provided with cognitive behavioral and self-management skills to reduce hazardous drinking and chronic pain.
They practice skills using the app and have weekly contact with the health counselor through instant messaging
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pain, Enjoyment of Life, and General Activity Scale (PEG)
기간: rating in the past week taken at (1) Baseline (2) 12-weeks post baseline, (3) 32-weeks post baseline. Note that 12-week and 32-week measures have up to 1 month window [i.e., 1 month post scheduled date for assessment] for completion
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3-item, 0-10 numerical scale measure of pain
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rating in the past week taken at (1) Baseline (2) 12-weeks post baseline, (3) 32-weeks post baseline. Note that 12-week and 32-week measures have up to 1 month window [i.e., 1 month post scheduled date for assessment] for completion
|
|
Average number of alcohol-containing drinks consumed per week: Time-Line Followback-30
기간: past 30 day drinking report taken at (1) Baseline (2) 12-weeks post baseline, (3) 32-weeks post baseline. Note that 12-week and 32-week measures have up to 1 month window [i.e., 1 month post scheduled date for assessment] for completion
|
Calendar-based measure of alcohol consumption in the past 30 days
|
past 30 day drinking report taken at (1) Baseline (2) 12-weeks post baseline, (3) 32-weeks post baseline. Note that 12-week and 32-week measures have up to 1 month window [i.e., 1 month post scheduled date for assessment] for completion
|
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Number of heavy drinking days in past month: Time-Line Followback-30 [TLFB-30]
기간: number of days in the past 30. drinking report taken at (1) Baseline (2) 12-weeks post baseline, (3) 32-weeks post baseline.. Note that 12-week and 32-week measures have up to 1 month window [i.e., 1 month post scheduled date for assessment] for comple
|
From the TLFB-30, the number of days in the past month in which a participant engaged in heavy drinking [defined as 4+ for women and 5+ for men], 4 or more for those 65 and over.
|
number of days in the past 30. drinking report taken at (1) Baseline (2) 12-weeks post baseline, (3) 32-weeks post baseline.. Note that 12-week and 32-week measures have up to 1 month window [i.e., 1 month post scheduled date for assessment] for comple
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Short Inventory of Problems - Revised
기간: consequences in past 90 days....measure taken at baseline, 12-weeks post-baseline, and 32-weeks post-baseline. Note that 12-week and 32-week measures have up to 1 month window [i.e., 1 month post scheduled date for assessment] for completion
|
Seventeen, 4-category Likert scale item (from never to daily/almost daily) that assesses 17 common alcohol-related consequences
|
consequences in past 90 days....measure taken at baseline, 12-weeks post-baseline, and 32-weeks post-baseline. Note that 12-week and 32-week measures have up to 1 month window [i.e., 1 month post scheduled date for assessment] for completion
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
수사관
- 수석 연구원: Tibor P Palfai, PhD, Boston University
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)
연구 시작
2027년 2월 1일
기본 완료 (추정된)
기본 완료
2030년 11월 1일
연구 완료 (추정된)
연구 완료
2030년 12월 1일
연구 등록 날짜
최초 제출
최초 제출
2026년 8월 28일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 8월 31일
처음 게시됨 (실제)
처음 게시됨
2026년 9월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 9월 4일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 31일
마지막으로 확인됨
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 8707E
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Data will be shared following release within one year of the trial project period to investigators who make specific requests in writing regarding analysis plans. Plans will be reviewed with co-investigators to ensure that there is no overlap with planned analyses. A specific de-identified data set with IPD relevant to analyses will be provided to other researchers after this review. All IPD collected and deindentified will be eligible upon request
In addition, data will be shared according to the guidelines for the National Institute of Mental Health Data Archive (NDA).
IPD 공유 기간
IPD and supporting information will be available by June 2032 which is 1 year following the end of the project period.
Information will be available for a minimum of 2 years
IPD 공유 액세스 기준
Investigators will request data and submit a data analysis plan for the project investigators to review.
Deidentified data will be shared after a data sharing agreement is signed with the project institution and transferred through IT-approved data sharing processes.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- ICF
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. .