Integrated Digital Health Approach to Reduce Hazardous Alcohol Use and Chronic Pain Among Rural Populations
maanantai 31. elokuuta 2026 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Ei vielä rekrytointia
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Interventio
Ilmoittautuminen (Arvioitu)
260
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskeluyhteys
- Nimi: Tibor P Palfai, PhD
- Puhelinnumero: 617-353-9345
- Sähköposti: palfai@bu.edu
Tutki yhteystietojen varmuuskopiointi
- Nimi: Sarah Fraher, BA
- Sähköposti: sfraher@bu.edu
Opiskelupaikat
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Massachusetts
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Boston, Massachusetts, Yhdysvallat, 02215
- Boston University
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Ottaa yhteyttä:
- Tibor Palfai, PhD
- Puhelinnumero: 617-353-9345
- Sähköposti: palfai@bu.edu
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Ottaa yhteyttä:
- Sarah Fraher, BA
- Puhelinnumero: 617353-0962
- Sähköposti: sfraher@bu.edu
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Päätutkija:
- Tibor Palfai, PhD
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-
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Ei
Kuvaus
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).
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Active Comparator: 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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Kokeellinen: 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
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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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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Pain, Enjoyment of Life, and General Activity Scale (PEG)
Aikaikkuna: 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
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Average number of alcohol-containing drinks consumed per week: Time-Line Followback-30
Aikaikkuna: 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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Calendar-based measure of alcohol consumption in the past 30 days
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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]
Aikaikkuna: 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
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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.
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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
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Short Inventory of Problems - Revised
Aikaikkuna: 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
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Seventeen, 4-category Likert scale item (from never to daily/almost daily) that assesses 17 common alcohol-related consequences
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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
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Tutkijat
- Päätutkija: Tibor P Palfai, PhD, Boston University
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
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Opintoihin ilmoittautumispäivät
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Ensimmäinen toimitettu, joka täytti QC-kriteerit
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Ensimmäinen Lähetetty (Todellinen)
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Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Perjantai 4. syyskuuta 2026
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
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Viimeksi vahvistettu
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Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 8707E
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
JOO
IPD-suunnitelman kuvaus
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-jaon aikakehys
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-jaon käyttöoikeuskriteerit
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-jakamista tukeva tietotyyppi
- STUDY_PROTOCOL
- ICF
Lääke- ja laitetiedot, tutkimusasiakirjat
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