Antiretroviral Adherence, Depression, Pain Interference
Conditions
Keywords
pain, depression, HIV, adherence
Brief summary
The purpose of this study is to determine whether participation in the study intervention, which involves collaboration between the study interventionist and the participant's primary care physician, will reduce symptoms of pain and depression in HIV+ patients.
Interventions
BEHAVIORALHIVPASS
OTHERHealth Education
Sponsors
Brown University
National Institute of Nursing Research (NINR)
Butler Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Chronic Pain (pain duration for at least six months with a mean score of 5 or higher on the BPI Pain Interference Scale) * Pain severity of 40 or higher on a Visual Analog Scale (0-100) indicating worst pain in the last week * At least one trial of PCP-recommended medication (i.e. acetominophen, NSAIDS, skeletal muscle relaxants) judged through interviews with patients and PCPs * QIDS score of ≥ 9 (depression severity) * Stable dose of an antidepressant, if using, for the previous 2 months * Age 18 or older * HIV+
Exclusion criteria
* Lifetime DSM-IV diagnosis of bipolar disorder, schizophrenia, or other chronic psychotic condition * Current DSM-IV diagnosis of substance dependence for alcohol, sedative/ hypnotic drugs, stimulants, or cocaine * Suicidal ideation or behavior requiring immediate attention * In psychotherapy or in a multidisciplinary pain management program * Expected surgery in the next 6 months * Pain thought to be due to cancer, infection, or inflammatory arthritis * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain Inventory Interference Scale at 3 Months | 3 months | Title: Brief Pain Inventory Interference Scale. Abbreviation: BPI-I. Measures: self-report of interference due to pain. Scale range: 0-10. Higher scores represent a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain Inventory Interference Scale at 12 Months | 12 months | Title: Brief Pain Inventory Interference Scale. Abbreviation: BPI-I. Measures: self-report of interference due to pain. Scale range: 0-10. Higher scores represent a worse outcome. |
| Quick Inventory of Depression Symptoms at 3 Months | 3 months | Quick Inventory of Depressive Symptoms. Abbreviation: QIDS. Measures: clinician-based assessment of depression symptom severity. Scale range: 0-27. Higher scores represent a worse outcome. |
| Quick Inventory of Depression Symptoms at 12 Months | 12 months | Quick Inventory of Depressive Symptoms. Abbreviation: QIDS. Measures: clinician-based assessment of depression symptom severity. Scale range: 0-27. Higher scores represent a worse outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Health Education Participants in the Health Education arm will receive 7 individual sessions, each of which will focus on a different health education topic. | 95 |
| HIVPASS Intervention Participants in the HIVPASS intervention arm will receive 7 individual sessions with the study interventionist, the first of which is a collaborative meeting with the PCP. Sessions will focus on pain interference and depression management. | 92 |
| Total | 187 |
Baseline characteristics
| Characteristic | Health Education | HIVPASS Intervention | Total |
|---|---|---|---|
| Age, Continuous | 51.2 years STANDARD_DEVIATION 11.4 | 51.7 years STANDARD_DEVIATION 8.8 | 51.4 years STANDARD_DEVIATION 10.2 |
| Antiretroviral therapy (ART) adherence | 91.5 % Adherence STANDARD_DEVIATION 18.4 | 95.1 % Adherence STANDARD_DEVIATION 0.5 | 93.3 % Adherence STANDARD_DEVIATION 15.1 |
| Average pain severity, past week | 6.37 units on a scale STANDARD_DEVIATION 1.88 | 6.48 units on a scale STANDARD_DEVIATION 1.87 | 6.43 units on a scale STANDARD_DEVIATION 1.87 |
| Brief Pain Inventory - Interference Scale | 6.44 units on a scale STANDARD_DEVIATION 2.15 | 6.16 units on a scale STANDARD_DEVIATION 1.98 | 6.30 units on a scale STANDARD_DEVIATION 1.56 |
| Detectable viral load | 20 Participants | 13 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 13 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 83 Participants | 79 Participants | 162 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| PROMIS Anxiety | 24.5 units on a scale STANDARD_DEVIATION 6.44 | 24.5 units on a scale STANDARD_DEVIATION 6.63 | 24.5 units on a scale STANDARD_DEVIATION 6.39 |
| Quick Inventory of Depressive Symptoms | 14.4 units on a scale STANDARD_DEVIATION 2.93 | 14.0 units on a scale STANDARD_DEVIATION 3.04 | 14.2 units on a scale STANDARD_DEVIATION 2.99 |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 6 Participants | 9 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 34 Participants | 27 Participants | 61 Participants |
| Race (NIH/OMB) More than one race | 16 Participants | 12 Participants | 28 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 11 Participants | 16 Participants |
| Race (NIH/OMB) White | 37 Participants | 35 Participants | 72 Participants |
| Sex/Gender, Customized Gender Female | 37 Participants | 43 Participants | 80 Participants |
| Sex/Gender, Customized Gender Male | 56 Participants | 49 Participants | 105 Participants |
| Sex/Gender, Customized Gender Non-binary | 2 Participants | 0 Participants | 2 Participants |
| SF-36 Mental Health component | -1.83 units on a scale STANDARD_DEVIATION 1.09 | -1.77 units on a scale STANDARD_DEVIATION 1.21 | -1.80 units on a scale STANDARD_DEVIATION 1.15 |
| SF-36 Physical Health component | -1.67 units on a scale STANDARD_DEVIATION 0.94 | -1.42 units on a scale STANDARD_DEVIATION 1.07 | -1.55 units on a scale STANDARD_DEVIATION 1.01 |
| Worst pain severity, past week | 8.27 units on a scale STANDARD_DEVIATION 1.52 | 8.14 units on a scale STANDARD_DEVIATION 1.61 | 8.21 units on a scale STANDARD_DEVIATION 2.07 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 95 | 2 / 92 |
| other Total, other adverse events | 40 / 95 | 35 / 92 |
| serious Total, serious adverse events | 39 / 95 | 21 / 92 |
Outcome results
Primary
Brief Pain Inventory Interference Scale at 3 Months
Title: Brief Pain Inventory Interference Scale. Abbreviation: BPI-I. Measures: self-report of interference due to pain. Scale range: 0-10. Higher scores represent a worse outcome.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Education | Brief Pain Inventory Interference Scale at 3 Months | 5.03 score on a scale | Standard Deviation 2.98 |
| HIVPASS Intervention | Brief Pain Inventory Interference Scale at 3 Months | 4.23 score on a scale | Standard Deviation 2.84 |
p-value: 0.00895% CI: [-2.28, -0.34]Mixed Models Analysis
Secondary
Brief Pain Inventory Interference Scale at 12 Months
Title: Brief Pain Inventory Interference Scale. Abbreviation: BPI-I. Measures: self-report of interference due to pain. Scale range: 0-10. Higher scores represent a worse outcome.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Education | Brief Pain Inventory Interference Scale at 12 Months | 4.74 score on a scale | Standard Deviation 3.12 |
| HIVPASS Intervention | Brief Pain Inventory Interference Scale at 12 Months | 4.95 score on a scale | Standard Deviation 3.01 |
p-value: 0.25195% CI: [-1.53, 0.4]Mixed Models Analysis
Secondary
Quick Inventory of Depression Symptoms at 12 Months
Quick Inventory of Depressive Symptoms. Abbreviation: QIDS. Measures: clinician-based assessment of depression symptom severity. Scale range: 0-27. Higher scores represent a worse outcome.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Education | Quick Inventory of Depression Symptoms at 12 Months | 10.18 score on a scale | Standard Deviation 5.05 |
| HIVPASS Intervention | Quick Inventory of Depression Symptoms at 12 Months | 9.80 score on a scale | Standard Deviation 5.6 |
p-value: 0.54595% CI: [-2.18, 1.15]Mixed Models Analysis
Secondary
Quick Inventory of Depression Symptoms at 3 Months
Quick Inventory of Depressive Symptoms. Abbreviation: QIDS. Measures: clinician-based assessment of depression symptom severity. Scale range: 0-27. Higher scores represent a worse outcome.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Health Education | Quick Inventory of Depression Symptoms at 3 Months | 10.35 score on a scale | Standard Deviation 4.81 |
| HIVPASS Intervention | Quick Inventory of Depression Symptoms at 3 Months | 10.25 score on a scale | Standard Deviation 4.81 |
p-value: 0.84495% CI: [-1.32, 1.61]Mixed Models Analysis