Clinical trial NCT02766751: Treating Comorbid Pain and Depression in HIV+ Individuals
Official title: Treating Comorbid Pain and Depression in HIV+ Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Depression
Pain
Lead sponsor: Butler Hospital
Sponsor class: OTHER
First posted: 2016-05-10
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: pain interference
timeFrame: 3 months
Secondary outcomes:
measure: depression
timeFrame: 3 months; 12 months
measure: activity level
timeFrame: 3 months; 12 months
measure: anxiety
timeFrame: 3 months; 12 months
measure: viral load
timeFrame: 3 months, 12 months
measure: ART adherence
timeFrame: 3 months, 12 months
measure: perception of global improvement
timeFrame: 3 months, 12 months
measure: health related quality of life
timeFrame: 3 months, 12 onths
measure: pain interference
timeFrame: 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University/Boston Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: Hennepin Healthcare
state: Minnesota
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
affiliation: Butler Hospital
name: Michael Stein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pinkston MM, Busch AM, Stein M, Baker J, Caviness C, Herman D, Weisberg R, Abrantes AM, Uebelacker LA. Improving functioning in HIV+ patients with chronic pain and comorbid depression: Protocol for a randomized clinical trial testing a collaborative behavioral health intervention based on behavioral activation. Contemp Clin Trials. 2022 Aug;119:106842. doi: 10.1016/j.cct.2022.106842. Epub 2022 Jun 28.