Alcohol Drinking, Chronic Pain
Conditions
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.
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.
Interventions
BEHAVIORALmhealth-pc for alcohol and pain
Smartphone-based intervention that includes in-person initial session and 8 video lessons, daily activities, and weekly check-ins.
BEHAVIORALTreatment As Usual
psychoeducation on pain and alcohol use and treatment resource information
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Boston University Charles River Campus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
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
Intervention model description
Compare intervention to a treatment as usual comparison condition
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol Time Line Followback (30)- Heavy Drinking Episode Days in the Past 30 Days | Past 30 days as assessed at the 16-week timepoint | Number of heavy drinking episode days (i.e., days with consumption of 5+ drinks men/4+ drinks women) |
| Alcohol Time Line Followback (30)- Average Drinks Per Week in the Past 30 Days | Past 30 days as assessed at the 16-week timepoint | Average number of standard alcohol-containing drinks per week over the past 30 days |
| The Pain, Enjoyment of Life, General Activity (PEG) Scale | Past 7 days as assessed at the 16-week timepoint | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity - Brief Pain Inventory (BPI) Items | past 7 days as assessed at the 16-week timepoint | Four items from the Brief Pain Inventory (BPI) comprise the pain severity subscale. Pain severity score reflects the mean item rating of these 4 items. Range 0-10. Higher scores reflect worse outcomes. |
| Pain Interference | past 7 days as assessed at the 16-week timepoint | Seven items from the BPI are used to assess chronic pain interference. Each item is 0-10. The pain interference score is the mean of these seven items and ranges from 0-10. Higher scores reflect worse outcomes |
Countries
United States
Participant flow
Pre-assignment details
There were 49 participants who signed to consent form. One person decided NOT to participate post-consent and therefore did not complete any baseline information or get randomized to condition. Therefore only 48 completed baseline and were randomized to condition
Participants by arm
| Arm | Count |
|---|---|
| Mhealth-pc for Alcohol and Chronic Pain Smartphone-based intervention
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. | 24 |
| Treatment As Usual In person session that provides enhanced treatment as usual
Treatment As Usual: psychoeducation on pain and alcohol use and treatment resource information | 24 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Mhealth-pc for Alcohol and Chronic Pain | Treatment As Usual | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 6 Participants | 11 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 18 Participants | 37 Participants |
| Age, Continuous | 53.17 years STANDARD_DEVIATION 13.15 | 52.42 years STANDARD_DEVIATION 17.35 | 52.79 years STANDARD_DEVIATION 15.23 |
| Average number of drinks per week over the past 30 days | 22.33 drinks/week STANDARD_DEVIATION 22.27 | 18.36 drinks/week STANDARD_DEVIATION 15.89 | 20.35 drinks/week STANDARD_DEVIATION 19.24 |
| Number of heavy drinking episode days in the past 30 days | 11.25 heavy drinking days STANDARD_DEVIATION 11.78 | 8.79 heavy drinking days STANDARD_DEVIATION 8.93 | 10.02 heavy drinking days STANDARD_DEVIATION 10.41 |
| Pain, Enjoyment, General Activity (PEG) | 6.36 units on a scale STANDARD_DEVIATION 1.69 | 5.76 units on a scale STANDARD_DEVIATION 1.83 | 6.06 units on a scale STANDARD_DEVIATION 1.77 |
| Pain Intensity: Brief Pain Inventory | 5.4 units on a scale STANDARD_DEVIATION 1.71 | 4.66 units on a scale STANDARD_DEVIATION 1.46 | 5.03 units on a scale STANDARD_DEVIATION 1.61 |
| Pain Interference: Brief Pain Inventory | 6.21 units on a scale STANDARD_DEVIATION 1.88 | 5.24 units on a scale STANDARD_DEVIATION 2.15 | 5.72 units on a scale STANDARD_DEVIATION 2.06 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 20 Participants | 40 Participants |
| Region of Enrollment United States | 24 participants | 24 participants | 48 participants |
| Sex: Female, Male Female | 14 Participants | 14 Participants | 28 Participants |
| Sex: Female, Male Male | 10 Participants | 10 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 |
| other Total, other adverse events | 1 / 24 | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 | 1 / 24 |
Outcome results
Primary
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
Time frame: Past 30 days as assessed at the 16-week timepoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mhealth-pc for Alcohol and Chronic Pain | Alcohol Time Line Followback (30)- Average Drinks Per Week in the Past 30 Days | 16.89 drinks per week | Standard Deviation 20.6 |
| Treatment As Usual | Alcohol Time Line Followback (30)- Average Drinks Per Week in the Past 30 Days | 10.56 drinks per week | Standard Deviation 9.02 |
Primary
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)
Time frame: Past 30 days as assessed at the 16-week timepoint
Population: multiple imputation was used in analyses for primary outcomes only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mhealth-pc for Alcohol and Chronic Pain | Alcohol Time Line Followback (30)- Heavy Drinking Episode Days in the Past 30 Days | 7.9 heavy drinking days | Standard Deviation 11.32 |
| Treatment As Usual | Alcohol Time Line Followback (30)- Heavy Drinking Episode Days in the Past 30 Days | 4.3 heavy drinking days | Standard Deviation 5.57 |
Primary
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
Time frame: Past 7 days as assessed at the 16-week timepoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mhealth-pc for Alcohol and Chronic Pain | The Pain, Enjoyment of Life, General Activity (PEG) Scale | 4.60 score on a scale | Standard Deviation 2.56 |
| Treatment As Usual | The Pain, Enjoyment of Life, General Activity (PEG) Scale | 4.82 score on a scale | Standard Deviation 1.79 |
Secondary
Pain Intensity - Brief Pain Inventory (BPI) Items
Four items from the Brief Pain Inventory (BPI) comprise the pain severity subscale. Pain severity score reflects the mean item rating of these 4 items. Range 0-10. Higher scores reflect worse outcomes.
Time frame: past 7 days as assessed at the 16-week timepoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mhealth-pc for Alcohol and Chronic Pain | Pain Intensity - Brief Pain Inventory (BPI) Items | 3.98 score on a scale | Standard Deviation 1.93 |
| Treatment As Usual | Pain Intensity - Brief Pain Inventory (BPI) Items | 4.16 score on a scale | Standard Deviation 1.21 |
Secondary
Pain Interference
Seven items from the BPI are used to assess chronic pain interference. Each item is 0-10. The pain interference score is the mean of these seven items and ranges from 0-10. Higher scores reflect worse outcomes
Time frame: past 7 days as assessed at the 16-week timepoint
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mhealth-pc for Alcohol and Chronic Pain | Pain Interference | 4.37 score on a scale | Standard Deviation 2.63 |
| Treatment As Usual | Pain Interference | 4.68 score on a scale | Standard Deviation 2.36 |