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

Depression Clinical Trial

— HIVPASS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01735708
• Other study ID #: NR13438
• Secondary ID: R21NR013438
• Status: Completed
• Phase: N/A
• Start date: November 2012
• Est. completion date: August 2015

Study information

• Verified date: September 2022
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: August 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Antiretroviral Adherence
• Chronic Pain
• Depression
• Depressive Disorder
• Pain Interference

Intervention

Behavioral:
• HIVPASS

Other:
• Health Education

Locations

Country	Name	City	State
United States	Butler Hospital	Providence	Rhode Island

Sponsors (3)

Lead Sponsor	Collaborator
Butler Hospital	Brown University, National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	12 months
Secondary	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.	3 months
Secondary	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.	12 months