Alcohol Use and Chronic Pain Among Primary Care Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Integrated Technology-Based Intervention to Reduce Heavy Drinking and Chronic Pain Among Patients in Primary Care

Conditions
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Alcohol Drinking, Chronic Pain

Intervention / Treatment
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* Behavioral: mhealth-pc for alcohol and pain
* Behavioral: Treatment As Usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Compare intervention to a treatment as usual comparison condition
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alcohol Time Line Followback (30)- Heavy Drinking Episodes | Number of heavy drinking episodes on a single occasion (5+ drinks men/4+ drinks women) | Past 30 days | 
| Alcohol Time Line Followback (30)- Average Drinks per Week | Average number of standard alcohol-containing drinks per week | Past 30 days | 
| The Pain, Enjoyment of Life, General Activity (PEG) Scale | Three items from the Brief Pain Inventory (BPI) to assess chronic pain. Range 0-30. Higher scores reflect worse outcomes | Past 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity - Brief Pain Inventory (BPI) items | Four items from the BPI to assess chronic pain intensity. Each item 0-10. Higher scores reflect worse outcomes | 7 days | 
| Pain Interference | Seven items from the BPI to assess chronic pain interference. Each item is 0-10. Higher scores reflect worse outcomes | 7 days |