Treating Chronic Pain and Depression in HIV+ Patients in Primary Care Settings

Study Overview
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Brief Summary
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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.

Official Title
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Treating Chronic Pain and Depression in HIV+ Patients in Primary Care Settings

Conditions
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Pain Interference, Depression, Antiretroviral Adherence

Intervention / Treatment
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* Behavioral: HIVPASS
* Other: Health Education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Health Education<br>Participants in the Health Education arm will receive 7 individual sessions, each of which will focus on a different health education topic. | Other: Health Education<br> <br> |
| Active Comparator: HIVPASS Intervention<br>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. | Behavioral: HIVPASS<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 
| 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. | 3 months | 
| 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, depression, HIV, adherence