NCT01735708

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
187

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

November 26, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 28, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
7.2 years until next milestone

Results Posted

Study results publicly available

October 13, 2022

Completed
Last Updated

October 13, 2022

Status Verified

September 1, 2022

Enrollment Period

1.7 years

First QC Date

November 26, 2012

Results QC Date

July 19, 2022

Last Update Submit

September 15, 2022

Conditions

Pain InterferenceDepressionAntiretroviral Adherence

Keywords

paindepressionHIVadherence

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (3)

  • Brief Pain Inventory Interference Scale at 12 Months

    12 months

  • Quick Inventory of Depression Symptoms at 3 Months

    3 months

  • Quick Inventory of Depression Symptoms at 12 Months

    12 months

Study Arms (2)

Health Education

PLACEBO COMPARATOR

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

HIVPASS Intervention

ACTIVE COMPARATOR

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

Interventions

HIVPASSBEHAVIORAL
HIVPASS Intervention
Health EducationOTHER
Health Education

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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+

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (1)

  • 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.

    PMID: 27115400DERIVED

MeSH Terms

Conditions

DepressionPain

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Lisa Uebelacker
Organization
Butler Hospital
luebelacker@butler.org
401-455-6381

Study Officials

  • Michael Stein, MD

    Butler Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 26, 2012

First Posted

November 28, 2012

Study Start

November 1, 2012

Primary Completion

August 1, 2014

Study Completion

August 1, 2015

Last Updated

October 13, 2022

Results First Posted

October 13, 2022

Record last verified: 2022-09

Locations

US(1)