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Completed

NCT Number: NCT01735708

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.

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Key information

Conditions

Pain Interference Antiretroviral Adherence Behavior Behavioral Symptoms Depression Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Butler Hospital

Providence, Rhode Island, 02906, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HIVPASS

Behavioral

Health education

Other

Primary outcomes

  1. Brief Pain Inventory Interference Scale at 3 Months

    Time frame: 3 months

    Title: Brief Pain Inventory Interference Scale. Abbreviation: BPI-I. Measures: self-report of interference due to pain. Scale range: 0-10. Higher scores represent a worse outcome.

Secondary outcomes

  1. Brief Pain Inventory Interference Scale at 12 Months

    Time frame: 12 months

    Title: Brief Pain Inventory Interference Scale. Abbreviation: BPI-I. Measures: self-report of interference due to pain. Scale range: 0-10. Higher scores represent a worse outcome.

  2. Quick Inventory of Depression Symptoms at 3 Months

    Time frame: 3 months

    Quick Inventory of Depressive Symptoms. Abbreviation: QIDS. Measures: clinician-based assessment of depression symptom severity. Scale range: 0-27. Higher scores represent a worse outcome.

  3. Quick Inventory of Depression Symptoms at 12 Months

    Time frame: 12 months

    Quick Inventory of Depressive Symptoms. Abbreviation: QIDS. Measures: clinician-based assessment of depression symptom severity. Scale range: 0-27. Higher scores represent a worse outcome.

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Collaborators

  • Brown University
  • National Institute of Nursing Research (NINR)

Registry information

Acronym: HIVPASS

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Nov 28, 2012
Registry last updated
Oct 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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