Treating Comorbid Pain and Depression in HIV+ Individuals



Status:Recruiting
Conditions:Chronic Pain, Depression, Depression, HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases, Musculoskeletal, Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:3/22/2019
Start Date:November 15, 2016
End Date:May 2021
Contact:Michael Stein, MD
Email:mstein@butler.org
Phone:401-455-6646

Use our guide to learn which trials are right for you!

This study is designed to look at two different programs that may help people who are HIV+
and have pain and depression. The investigators are trying to understand how to help people
learn to live better lives even with these chronic illnesses.

The primary aim of this RCT is to evaluate the HIVPass intervention. HIV+ participants
(n=236) with chronic pain and depression will be recruited at primary care HIV Clinics
through posted advertisements in the waiting rooms of the PCP offices and by physician
referral. After an initial phone study screen, research staff will meet with interested
individuals in their PCP offices for informed consent, baseline interview and randomization
into one of two study groups (Health Education or HIVPass Counseling). Seven intervention
sessions (HE or HIVPASS) will occur during the first 3 months of study participation. For all
participants, the first session is a collaborative in-person joint session with the
participant, his/her PCP and the study BHS. Session 2 is conducted immediately after this
collaborative session, and is also in-person. Sessions 3-7 are conducted by phone. Follow-up
assessment interviews will be at months 1, 2, 3 (post-intervention), 4, 6, 9 and 12.

Inclusion Criteria:

- Chronic Pain (pain duration for at least six months with a mean score of greater than
3.5 on the BPI Pain Interference Scale)

- Pain severity > or equal to 4 on a Numeric Rating Scale indicating "average pain in
the last week"

- At least one trial of PCP-recommended medication (i.e. acetaminophen, NSAIDS, muscle
relaxants) judged through interviews with patients and PCPs

- Quick Inventory of Depression Symptoms (QIDS) score of ≥ 9 (depression severity)

- Stable dose of an antidepressant, if using, for the previous 1 months

- Age > or equal to 18

- HIV+

- Planning to live in the area for the next 6 months

- Access to a telephone that is typically working.

Exclusion Criteria:

- In psychotherapy or a multidisciplinary pain management program

- Planned surgery in the next 6 months

- Pain thought due to cancer

- Current mania

- Past year chronic psychotic condition

- Excessive substance use (Use of cocaine, heroin, or non-prescribe opioids 15 days per
month or more; binge alcohol use 4 days per month or more)

- Suicidality requiring immediate attention

- Pregnancy or planned pregnancy in the next 6 months
We found this trial at
4
sites
Minneapolis, Minnesota 55415
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Boston, Massachusetts 02118
?
mi
from
Boston, MA
Click here to add this to my saved trials
345 Blackstone Blvd
Providence, Rhode Island 02906
(401) 455-6200
Principal Investigator: Michael Stein, MD
Butler Hospital Founded in 1844, Butler Hospital is the state's only non-profit, free-standing psychiatric hospital...
?
mi
from
Providence, RI
Click here to add this to my saved trials
164 Summit Ave
Providence, Rhode Island 02906
(401) 793-2500
Miriam Hospital The Miriam Hospital is a private, not-for-profit hospital, with a history of providing...
?
mi
from
Providence, RI
Click here to add this to my saved trials