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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Brown University
Information provided by (Responsible Party):
Michael Stein, MD, Butler Hospital
ClinicalTrials.gov Identifier:
NCT01735708
First received: November 26, 2012
Last updated: July 16, 2014
Last verified: July 2014

November 26, 2012
July 16, 2014
November 2012
August 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01735708 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Treating Chronic Pain and Depression in HIV+ Patients in Primary Care Settings
Treating Chronic Pain and Depression in HIV+ Patients in Primary Care Settings

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pain Interference
  • Depression
  • Antiretroviral Adherence
Behavioral: HIVPASS
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
August 2014
August 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01735708
NR13438, R21NR013438
Yes
Michael Stein, MD, Butler Hospital
Butler Hospital
  • Brown University
  • National Institute of Nursing Research (NINR)
Principal Investigator: Michael Stein, MD Butler Hospital
Butler Hospital
July 2014

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