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

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ClinicalTrials.gov Identifier: NCT01735708
Recruitment Status : Completed
First Posted : November 28, 2012
Last Update Posted : November 11, 2015
Sponsor:
Collaborators:
Brown University
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Michael Stein, MD, Butler Hospital

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.

Condition or disease Intervention/treatment Phase
Pain Interference Depression Antiretroviral Adherence Behavioral: HIVPASS Other: Health Education Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treating Chronic Pain and Depression in HIV+ Patients in Primary Care Settings
Study Start Date : November 2012
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other: Health Education
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



Primary Outcome Measures :
  1. pain interference [ Time Frame: 4 months ]
    pain interference will be measured by self-report on the Brief Pain Inventory-Pain Interference Scale


Secondary Outcome Measures :
  1. depression [ Time Frame: 4 months ]
    depression will be measured by self-report on the Quick Inventory of Depression Symptomatology scale

  2. antiretroviral adherence [ Time Frame: 4 months ]
    antiretroviral adherence will be measured by self-report on the AIDS Clinical Trial Group adherence measure



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01735708


Locations
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)
Investigators
Principal Investigator: Michael Stein, MD Butler Hospital

Responsible Party: Michael Stein, MD, Principal Investigator, Butler Hospital
ClinicalTrials.gov Identifier: NCT01735708     History of Changes
Other Study ID Numbers: NR13438
R21NR013438 ( U.S. NIH Grant/Contract )
First Posted: November 28, 2012    Key Record Dates
Last Update Posted: November 11, 2015
Last Verified: September 2015

Keywords provided by Michael Stein, MD, Butler Hospital:
pain
depression
HIV
adherence

Additional relevant MeSH terms:
Depression
Depressive Disorder
Chronic Pain
Behavioral Symptoms
Mood Disorders
Mental Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms