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

This study has been completed.
Brown University
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Michael Stein, MD, Butler Hospital Identifier:
First received: November 26, 2012
Last updated: September 9, 2015
Last verified: September 2015

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.

Condition Intervention
Pain Interference
Antiretroviral Adherence
Behavioral: HIVPASS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treating Chronic Pain and Depression in HIV+ Patients in Primary Care Settings

Resource links provided by NLM:

Further study details as provided by Butler Hospital:

Primary Outcome Measures:
  • 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

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

Enrollment: 23
Study Start Date: November 2012
Study Completion Date: August 2015
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: HIVPASS


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts 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
  Contacts and Locations
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 identifier: NCT01735708

United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Butler Hospital
Brown University
National Institute of Nursing Research (NINR)
Principal Investigator: Michael Stein, MD Butler Hospital
  More Information

No publications provided

Responsible Party: Michael Stein, MD, Principal Investigator, Butler Hospital Identifier: NCT01735708     History of Changes
Other Study ID Numbers: NR13438, R21NR013438
Study First Received: November 26, 2012
Last Updated: September 9, 2015
Health Authority: United States: Federal Government

Keywords provided by Butler Hospital:

Additional relevant MeSH terms:
Chronic Pain
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms processed this record on October 07, 2015