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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
  Purpose

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
Depression
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:

U.S. FDA Resources

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


Estimated Enrollment: 40
Study Start Date: November 2012
Estimated Study Completion Date: August 2014
Estimated 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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01735708

Contacts
Contact: Michael Stein, MD 401-445-6646 michael_stein@brown.edu

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

No publications provided

Responsible Party: Michael Stein, MD, Principal Investigator, Butler Hospital
ClinicalTrials.gov Identifier: NCT01735708     History of Changes
Other Study ID Numbers: NR13438, R21NR013438
Study First Received: November 26, 2012
Last Updated: November 27, 2012
Health Authority: United States: Federal Government

Keywords provided by Butler Hospital:
pain
depression
HIV
adherence

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013