Treating Chronic Pain and Depression in HIV+ Patients in Primary Care Settings
- Conditions
- Antiretroviral AdherencePain InterferenceDepression
- Interventions
- Behavioral: HIVPASSOther: Health Education
- Registration Number
- NCT01735708
- Lead Sponsor
- Butler Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 187
- 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+
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HIVPASS Intervention HIVPASS 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. Health Education Health Education Participants in the Health Education arm will receive 7 individual sessions, each of which will focus on a different health education topic.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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.
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.
Trial Locations
- Locations (1)
Butler Hospital
🇺🇸Providence, Rhode Island, United States