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Clinical Trials/NCT01735708
NCT01735708
Completed
Not Applicable

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

Butler Hospital1 site in 1 country187 target enrollmentNovember 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain Interference
Sponsor
Butler Hospital
Enrollment
187
Locations
1
Primary Endpoint
Brief Pain Inventory Interference Scale at 3 Months
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2012
End Date
August 2015
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lisa Uebelacker

Principal Investigator

Butler Hospital

Eligibility 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

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

Outcomes

Primary Outcomes

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

  • Brief Pain Inventory Interference Scale at 12 Months(12 months)
  • Quick Inventory of Depression Symptoms at 12 Months(12 months)
  • Quick Inventory of Depression Symptoms at 3 Months(3 months)

Study Sites (1)

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