Treating Chronic Pain and Depression in HIV+ Patients in Primary Care Settings (HIVPASS)
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Michael Stein, MD, Butler Hospital
First received: November 26, 2012
Last updated: July 16, 2014
Last verified: July 2014
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.
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||Treating Chronic Pain and Depression in HIV+ Patients in Primary Care Settings
Primary Outcome Measures:
Secondary Outcome Measures:
- depression [ Time Frame: 4 months ] [ Designated as safety issue: No ]
depression will be measured by self-report on the Quick Inventory of Depression Symptomatology scale
- antiretroviral adherence [ Time Frame: 4 months ] [ Designated as safety issue: No ]
antiretroviral adherence will be measured by self-report on the AIDS Clinical Trial Group adherence measure
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||August 2014 (Final data collection date for primary outcome measure)
Placebo Comparator: Health Education
Participants in the Health Education arm will receive 7 individual sessions, each of which will focus on a different health education topic.
Active Comparator: 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.
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01735708
|Providence, Rhode Island, United States, 02906 |
||Michael Stein, MD
No publications provided
||Michael Stein, MD, Principal Investigator, Butler Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 26, 2012
||July 16, 2014
||United States: Federal Government
Keywords provided by Butler Hospital:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 23, 2014
Nervous System Diseases
Signs and Symptoms