Alcohol Use, Unspecified, Chronic Pain
Conditions
Keywords
HIV
Brief summary
This research seeks to develop a novel, integrated behavioral approach to reduce heavy drinking and chronic pain among patients in HIV-care delivered via internet-based videoconferencing. This first open trial pilot study seeks to recruit patients in the clinic through posted flyers, cards and physician referral.
Detailed description
This study seeks to develop an integrated, behavioral video telehealth approach to address pain and heavy alcohol use among patients living with HIV and determine its feasibility and acceptability. Through an open pilot trial, this phase of this project will deliver an integrated alcohol-pain behavioral intervention to people living with HIV/AIDS (PLWHA) through videoconferencing. Intervention evaluation outcomes for this initial phase will include reduction of standard number of drinks per week, reduction in heavy drinking days, reduction of chronic pain severity and interference, ratings of patient satisfaction with treatment, and rate of treatment adherence.
Interventions
BEHAVIORALMotivation and Cognitive Behavioral Management for Alcohol and Pain
Behavioral intervention that includes motivational, cognitive, and behavioral intervention strategies to reduce heavy drinking and chronic pain interference
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Boston University Charles River Campus
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants all undergo assessment and intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* engaged in HIV care, heavy drinking by more than 7/14 drinks per week (women/men) or by single episode of 4/5 (women/men), chronic (at least 3 months duration) moderate or greater (4 or more on the severity scale of the Brief Pain Inventory (BPI) non-cancer related pain.
Exclusion criteria
* psychoactive medication for pain or alcohol use for few than 2 months * history of bipolar disorder, schizophrenia, other psychotic disorder * current suicidal intent * prior history of alcohol withdrawal related seizures or delirium tremens * current behavioral treatment for pain or alcohol use * any scheduled surgery within next 6 months or acute life-threatening illness that requires treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Perceptions of Treatment Questionnaire | past 30 days | Participants were asked about their experiences with different facets of the intervention using items that were scored from 0 - 8 with higher scores reflecting greater satisfaction with the treatment components. |
| Alcohol Time Line Follow Back...Average Drinks Per Week | past 30 days | average number of drinks per week in the past 30 days (total number of drinks 30 days/4.28) |
| Client Satisfaction Questionnaire-8 [Modified] | past 30 days | Evaluative ratings of the intervention received. Eight Likert-scale items regarding different components of treatment satisfaction are rated from 1-4. Some items are reversed scored and then they are summed so that higher scores reflect higher satisfaction with treatment. The possible range of scores is 8-32. |
| Brief Pain Inventory Pain Severity | past 7 days | BPI consists of 11-point scale items that reflect pain severity and pain interference Average pain severity in the past 7-days is measures with a single 11-point scale where 0 is best and 10 is worst. Pain interference is measures as the mean of 7-items, each also rated on a 11-point scale where 0 is best and 10 is worst Scales range from 0 - 10 |
| Brief Pain Inventory Pain Interference | past 7 days | BPI consists of 11-point scale items that reflect pain severity and pain interference Pain interference is measured as the mean of 7-items, each rated on a 11-point scale where 0 is best and 10 is worst Scales range from 0 - 10 |
| Alcohol Time Line Follow Back...Heavy Drinking Episodes | past 30 days | number of heavy drinking episodes in the past 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Goal Systems Assessment Battery-Alcohol | past 30 days | Ratings self-regulatory capacities related to moderating alcohol use. Participants rate their perceived self-regulatory skills related to pain management using 5-point Likert scale items. There are 4 subscales for each of the dimensions of self-regulation assessed; planning, monitoring, self-efficacy, and value about the behavior change goal. A mean scale score is taken for each subscale. The range for each subscale is 0-4. Higher scores reflect better outcomes. |
| Goal Systems Assessment Battery-Pain | past 30 days | Ratings self-regulatory capacities related to pain. Participants rate their perceived self-regulatory skills related to pain management using 5-point Likert scale items. There are 4 subscales for each of the dimensions of self-regulation assessed; planning, monitoring, self-efficacy, and value about the behavior change goal. A mean scale score is taken for each subscale. The range for each subscale is 0-4. Higher scores reflect better outcomes. |
Countries
United States
Participant flow
Recruitment details
Recruited from medical clinic and ongoing cohort
Participants by arm
| Arm | Count |
|---|---|
| Intervention participants all receive the intervention
Motivation and Cognitive Behavioral Management for Alcohol and Pain: Behavioral intervention that includes motivational, cognitive, and behavioral intervention strategies to reduce heavy drinking and chronic pain interference | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age, Continuous | 53.3 years STANDARD_DEVIATION 8.83 |
| Brief Pain Inventory (BPI) pain interference | 4.5 units on a scale STANDARD_DEVIATION 2.24 |
| Brief Pain Inventory (BPI) pain severity | 5.5 units on a scale STANDARD_DEVIATION 1.52 |
| Drinks/week from Timeline FollowBack | 36.50 drinks/week STANDARD_DEVIATION 18.43 |
| Heavy Drinking Episodes | 5.5 episodes STANDARD_DEVIATION 5.62 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Alcohol Time Line Follow Back...Average Drinks Per Week
average number of drinks per week in the past 30 days (total number of drinks 30 days/4.28)
Time frame: past 30 days
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Intervention | Alcohol Time Line Follow Back...Average Drinks Per Week | 13 drinks/week | Standard Deviation 21.57 |
Primary
Alcohol Time Line Follow Back...Heavy Drinking Episodes
number of heavy drinking episodes in the past 30 days
Time frame: past 30 days
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Intervention | Alcohol Time Line Follow Back...Heavy Drinking Episodes | 2.0 number of episodes | Standard Deviation 4.34 |
Primary
Brief Pain Inventory Pain Interference
BPI consists of 11-point scale items that reflect pain severity and pain interference Pain interference is measured as the mean of 7-items, each rated on a 11-point scale where 0 is best and 10 is worst Scales range from 0 - 10
Time frame: past 7 days
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Intervention | Brief Pain Inventory Pain Interference | 2.43 units on a scale | Standard Deviation 2.68 |
Primary
Brief Pain Inventory Pain Severity
BPI consists of 11-point scale items that reflect pain severity and pain interference Average pain severity in the past 7-days is measures with a single 11-point scale where 0 is best and 10 is worst. Pain interference is measures as the mean of 7-items, each also rated on a 11-point scale where 0 is best and 10 is worst Scales range from 0 - 10
Time frame: past 7 days
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Intervention | Brief Pain Inventory Pain Severity | 5.0 units on a scale | Standard Deviation 2.58 |
Primary
Client Satisfaction Questionnaire-8 [Modified]
Evaluative ratings of the intervention received. Eight Likert-scale items regarding different components of treatment satisfaction are rated from 1-4. Some items are reversed scored and then they are summed so that higher scores reflect higher satisfaction with treatment. The possible range of scores is 8-32.
Time frame: past 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Client Satisfaction Questionnaire-8 [Modified] | 29.29 units on a scale | Standard Deviation 2.29 |
Primary
Perceptions of Treatment Questionnaire
Participants were asked about their experiences with different facets of the intervention using items that were scored from 0 - 8 with higher scores reflecting greater satisfaction with the treatment components.
Time frame: past 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Perceptions of Treatment Questionnaire | 7.04 units on a scale | Standard Deviation 1.15 |
Secondary
Goal Systems Assessment Battery-Alcohol
Ratings self-regulatory capacities related to moderating alcohol use. Participants rate their perceived self-regulatory skills related to pain management using 5-point Likert scale items. There are 4 subscales for each of the dimensions of self-regulation assessed; planning, monitoring, self-efficacy, and value about the behavior change goal. A mean scale score is taken for each subscale. The range for each subscale is 0-4. Higher scores reflect better outcomes.
Time frame: past 30 days
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Goal Systems Assessment Battery-Alcohol | Alcohol-Value | 3.0 units on a scale | Standard Deviation 0.87 |
| Intervention | Goal Systems Assessment Battery-Alcohol | Alcohol-Self-efficacy | 3.0 units on a scale | Standard Deviation 0.71 |
| Intervention | Goal Systems Assessment Battery-Alcohol | Alcohol-Monitoring | 2.75 units on a scale | Standard Deviation 0.82 |
| Intervention | Goal Systems Assessment Battery-Alcohol | Alcohol-Planning | 2.75 units on a scale | Standard Deviation 0.89 |
Secondary
Goal Systems Assessment Battery-Pain
Ratings self-regulatory capacities related to pain. Participants rate their perceived self-regulatory skills related to pain management using 5-point Likert scale items. There are 4 subscales for each of the dimensions of self-regulation assessed; planning, monitoring, self-efficacy, and value about the behavior change goal. A mean scale score is taken for each subscale. The range for each subscale is 0-4. Higher scores reflect better outcomes.
Time frame: past 30 days
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Goal Systems Assessment Battery-Pain | Pain-Value | 3.25 score on a scale | Standard Deviation 0.7 |
| Intervention | Goal Systems Assessment Battery-Pain | Pain-Self-efficacy | 3.0 score on a scale | Standard Deviation 0.84 |
| Intervention | Goal Systems Assessment Battery-Pain | Pain-Monitoring | 3.0 score on a scale | Standard Deviation 0.92 |
| Intervention | Goal Systems Assessment Battery-Pain | Pain-Planning | 2.75 score on a scale | Standard Deviation 0.89 |