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

NCT ID: NCT01735708

Last Updated: 2022-10-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

187 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2015-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pain Interference Depression Antiretroviral Adherence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Health Education

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

Group Type PLACEBO_COMPARATOR

Health Education

Intervention Type OTHER

HIVPASS Intervention

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.

Group Type ACTIVE_COMPARATOR

HIVPASS

Intervention Type BEHAVIORAL

Interventions

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HIVPASS

Intervention Type BEHAVIORAL

Health Education

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brown University

OTHER

Sponsor Role collaborator

National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

Butler Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lisa Uebelacker

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Stein, MD

Role: PRINCIPAL_INVESTIGATOR

Butler Hospital

Locations

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Butler Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 27115400 (View on PubMed)

Other Identifiers

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R21NR013438

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NR13438

Identifier Type: -

Identifier Source: org_study_id

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