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

Butler Hospital

Status: Completed

Conditions: Pain Interference; Antiretroviral Adherence; Depression

Treatments: Other: Health Education; Behavioral: HIVPASS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01735708

R21NR013438 (U.S. NIH Grant/Contract)

NR13438

Details and patient eligibility

About

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.

Enrollment: 187 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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187 participants in 2 patient groups, including a placebo group

Health Education

Placebo Comparator group

Description:

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

Treatment:

Other: Health Education

HIVPASS Intervention

Active Comparator group

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.

Treatment:

Behavioral: HIVPASS