Alcohol Use and Chronic Pain Among Primary Care Patients
Integrated Technology-Based Intervention to Reduce Heavy Drinking and Chronic Pain Among Patients in Primary Care
2 other identifiers
interventional
49
1 country
1
Brief Summary
Chronic pain and unhealthy drinking are common co-occurring conditions among patients presenting to primary care. Given their impact on functioning and medical outcomes, there would be considerable benefit to developing an accessible, easily utilized, integrative approach to reduce unhealthy alcohol use and pain that can be readily incorporated into the primary care setting. The objective of this study is to test a smartphone-based intervention for reducing unhealthy alcohol use and pain in primary care patients, determine the feasibility of implementing this intervention in the primary care setting, provide effect size estimates of the intervention on drinking and chronic pain outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2021
CompletedFirst Posted
Study publicly available on registry
July 12, 2021
CompletedStudy Start
First participant enrolled
August 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2023
CompletedResults Posted
Study results publicly available
December 11, 2024
CompletedDecember 11, 2024
December 1, 2024
1.6 years
June 30, 2021
August 10, 2024
December 9, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Alcohol Time Line Followback (30)- Heavy Drinking Episode Days in the Past 30 Days
Number of heavy drinking episode days (i.e., days with consumption of 5+ drinks men/4+ drinks women)
Past 30 days as assessed at the 16-week timepoint
Alcohol Time Line Followback (30)- Average Drinks Per Week in the Past 30 Days
Average number of standard alcohol-containing drinks per week over the past 30 days
Past 30 days as assessed at the 16-week timepoint
The Pain, Enjoyment of Life, General Activity (PEG) Scale
Three items which assess chronic pain intensity and interference. Range of each item is 0-10. Mean rating of the three items indicate the PEG pain score. range of scale is 0-10. Higher scores reflect worse outcomes
Past 7 days as assessed at the 16-week timepoint
Secondary Outcomes (2)
Pain Intensity - Brief Pain Inventory (BPI) Items
past 7 days as assessed at the 16-week timepoint
Pain Interference
past 7 days as assessed at the 16-week timepoint
Study Arms (2)
mhealth-pc for alcohol and chronic pain
EXPERIMENTALSmartphone-based intervention
Treatment As Usual
ACTIVE COMPARATORIn person session that provides enhanced treatment as usual
Interventions
Smartphone-based intervention that includes in-person initial session and 8 video lessons, daily activities, and weekly check-ins.
psychoeducation on pain and alcohol use and treatment resource information
Eligibility Criteria
You may qualify if:
- heavy drinking: defined as either \[1\] an average of more than 7(for women)/14 (for men) standard drinks per week over the past month or \[2\] one or more heavy drinking episodes (4+ standard drinks for women, 5+ standard drinks for men)
- chronic pain: defined as non-cancer related pain of at least 3 months duration rated as moderate or greater (past week pain severity rating of 4 or greater on the BPI severity item)
You may not qualify if:
- psychoactive medication for pain or alcohol use for fewer than 2 months
- history of bipolar disorder or schizophenia
- current expressed suicidal intent
- prior history of alcohol withdrawal related seizures or delirium tremens
- behavioral treatment for pain or alcohol use in the past 3 months
- any scheduled surgery within the next 6 months or acute life threatening illness that requires treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Boston University Department of Psychological and Brain Sciences
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Tibor Palfai, PhD
- Organization
- Boston University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Eight-week and 16-week assessments will be completed by assessor who is masked to intervention condition. Baseline assessment takes place before randomization
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Psychological and Brain Sciences
Study Record Dates
First Submitted
June 30, 2021
First Posted
July 12, 2021
Study Start
August 26, 2021
Primary Completion
March 28, 2023
Study Completion
March 28, 2023
Last Updated
December 11, 2024
Results First Posted
December 11, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be available after all planned reports of study findings have been prepared within one year of project completion. Data will be available upon request for 5 years following these reports
- Access Criteria
- Specific data may be shared based on proposals received and reviewed by the study investigators and determined to have scientific merit.
Data sharing procedures that will be implemented within one year of completion of the study. Specific data may be shared based on proposals received and reviewed by the study investigators and limited public-use data sets might be prepared and made available. In either case, data will be shared only after all planned reports of study findings have been prepared. Data to be shared will be de-identified to minimize the risk of deductive disclosure. Documentation will be provided for all shared data including copies of data collection forms, schedule of study assessments, data dictionaries documenting all original and derived variables, descriptive statistics for all variables included in the data sets, and a written description of the study conduct and noteworthy details anticipated to potentially affect data interpretation. Costs associated with producing data sets and analysis will be the responsibility of investigators seeking the data.