Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 1 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) - 2 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)

Exclusion Criteria

  • 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Compare intervention to a treatment as usual comparison condition
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)
Masking Description
Eight-week and 16-week assessments will be completed by assessor who is masked to intervention condition. Baseline assessment takes place before randomization

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
mhealth-pc for alcohol and chronic pain
Smartphone-based intervention
  • Behavioral: mhealth-pc for alcohol and pain
    Smartphone-based intervention that includes in-person initial session and 8 video lessons, daily activities, and weekly check-ins.
Active Comparator
Treatment As Usual
In person session that provides enhanced treatment as usual
  • Behavioral: Treatment As Usual
    psychoeducation on pain and alcohol use and treatment resource information

Recruiting Locations

Boston University Department of Psychological and Brain Sciences
Boston, Massachusetts 02215
Contact:
Tibor P. Palfai, PhD
617-353-9345
palfai@bu.edu

More Details

Status
Recruiting
Sponsor
Boston University Charles River Campus

Study Contact

Tibor Palfai, PhD
617-353-9345
palfai@bu.edu

Detailed Description

Heavy alcohol use represents a significant risk for morbidity and mortality. Unfortunately, addressing unhealthy patterns of alcohol use in primary care is often a challenge as patients typically present with co-morbid conditions that: (1) may make unhealthy drinking a lower priority health issue and (2) may impact the capacity for sustained alcohol-related change. Chronic pain is among the most common of these conditions among primary care patients. Pain is a frequent source of distress and disability among primary care patients and is one of the most frequent causes for visits. Pain is also an important trigger for alcohol use among primary care patients who drink and is associated with the experience of negative alcohol-related consequences and unhealthy drinking over time. The experience of pain has also been shown to be associated with poorer responses to alcohol interventions. Primary care physicians face a number of challenges when attempting to treat co-occurring unhealthy drinking and pain among their patients. Pain management and reduction of alcohol use among those who engage in heavy alcohol use is often not adequately achieved with pharmacological treatments nor are pharmacological treatments indicated for common pain conditions. Moreover, despite the availability of evidence-based psychosocial interventions for unhealthy drinking and chronic pain, patients with each of these conditions typically show poor adherence to treatment. Given the rates of pain and unhealthy alcohol use among primary care patients and their impact on functioning and medical outcomes, there would be considerable benefit to an accessible, easily utilized, integrative approach to treat heavy alcohol use and pain that can be readily incorporated into the primary care setting. The objectives of this study are to develop a smartphone-based intervention for reducing heavy 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 outcomes, and develop procedures to conduct a Stage II efficacy trial.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.