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
About this trial
This is an interventional treatment trial for Pain Interference focused on measuring pain, depression, HIV, adherence
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
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
NCT ID
NCT01735708
First Posted
November 26, 2012
Last Updated
September 15, 2022
Sponsor
Butler Hospital
Collaborators
Brown University, National Institute of Nursing Research (NINR)
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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