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

Primary Purpose

Pain Interference, Depression, Antiretroviral Adherence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HIVPASS
Health Education
Sponsored by
Butler Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain Interference focused on measuring pain, depression, HIV, adherence

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Butler Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Health Education

HIVPASS Intervention

Arm Description

Participants in the Health Education arm will receive 7 individual sessions, each of which will focus on a different health education topic.

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.

Outcomes

Primary Outcome Measures

Brief Pain Inventory Interference Scale at 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 Outcome Measures

Brief Pain Inventory Interference Scale at 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.
Quick Inventory of Depression Symptoms at 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.
Quick Inventory of Depression Symptoms at 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.

Full Information

First Posted
November 26, 2012
Last Updated
September 15, 2022
Sponsor
Butler Hospital
Collaborators
Brown University, National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT01735708
Brief Title
Treating Chronic Pain and Depression in HIV+ Patients in Primary Care Settings
Acronym
HIVPASS
Official Title
Treating Chronic Pain and Depression in HIV+ Patients in Primary Care Settings
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Butler Hospital
Collaborators
Brown University, National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Interference, Depression, Antiretroviral Adherence
Keywords
pain, depression, HIV, adherence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
187 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Health Education
Arm Type
Placebo Comparator
Arm Description
Participants in the Health Education arm will receive 7 individual sessions, each of which will focus on a different health education topic.
Arm Title
HIVPASS Intervention
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
HIVPASS
Intervention Type
Other
Intervention Name(s)
Health Education
Primary Outcome Measure Information:
Title
Brief Pain Inventory Interference Scale at 3 Months
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Brief Pain Inventory Interference Scale at 12 Months
Description
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.
Time Frame
12 months
Title
Quick Inventory of Depression Symptoms at 3 Months
Description
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.
Time Frame
3 months
Title
Quick Inventory of Depression Symptoms at 12 Months
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Stein, MD
Organizational Affiliation
Butler Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27115400
Citation
Uebelacker LA, Weisberg RB, Herman DS, Bailey GL, Pinkston-Camp MM, Garnaat SL, Stein MD. Pilot Randomized Trial of Collaborative Behavioral Treatment for Chronic Pain and Depression in Persons Living with HIV/AIDS. AIDS Behav. 2016 Aug;20(8):1675-81. doi: 10.1007/s10461-016-1397-7.
Results Reference
derived

Learn more about this trial

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

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