Treating Comorbid Pain and Depression in HIV+ Individuals
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Butler Hospital
- Enrollment
- 187
- Locations
- 8
- Primary Endpoint
- pain interference
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Outcomes
Primary Outcomes
pain interference
Time Frame: 3 months
Brief pain inventory, interference scale
Secondary Outcomes
- depression(3 months; 12 months)
- activity level(3 months; 12 months)
- anxiety(3 months; 12 months)
- viral load(3 months, 12 months)
- perception of global improvement(3 months, 12 months)
- health related quality of life(3 months, 12 onths)
- ART adherence(3 months, 12 months)
- pain interference(12 months)
Investigators
Michael Stein, MD
Principal Investigator
Butler Hospital