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

This study is currently recruiting participants.

Verified November 2012 by Butler Hospital

Sponsor:

Collaborators:

Brown University

National Institute of Nursing Research (NINR)

Information provided by (Responsible Party):

Michael Stein, MD, Butler Hospital

ClinicalTrials.gov Identifier:

NCT01735708

First received: November 26, 2012

Last updated: November 27, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 26, 2012

Last Updated Date

November 27, 2012

Start Date ^ICMJE

November 2012

Estimated Primary Completion Date

August 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

pain interference [ Time Frame: 4 months ] [ Designated as safety issue: No ]

pain interference will be measured by self-report on the Brief Pain Inventory-Pain Interference Scale

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01735708 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Pain Interference
Depression
Antiretroviral Adherence

Intervention ^ICMJE

Behavioral: HIVPASS

Study Arm (s)

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.

Intervention: Behavioral: HIVPASS

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

August 2014

Estimated Primary Completion Date

August 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Michael Stein, MD

401-445-6646

michael_stein@brown.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01735708

Other Study ID Numbers ^ICMJE

NR13438, R21NR013438

Has Data Monitoring Committee

Yes

Responsible Party

Michael Stein, MD, Butler Hospital

Study Sponsor ^ICMJE

Butler Hospital

Collaborators ^ICMJE

Brown University
National Institute of Nursing Research (NINR)

Investigators ^ICMJE

Principal Investigator:

Michael Stein, MD

Butler Hospital

Information Provided By

Butler Hospital

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top