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Not Yet Recruiting
NCT07804914
Integrated Digital Health Approach to Reduce Hazardous Alcohol Use and Chronic Pain Among Rural Populations
Conditions: Chronic Pain, Unhealthy Alcohol Use
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 260
Sponsor: Boston University Charles River Campus
Location: Boston University Boston Massachusetts
Summary
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.
Eligibility Criteria
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 \[\>14\] \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).
Source: ClinicalTrials.gov (NCT07804914). StuddyBuddy aggregates publicly available trial information.