Treating Comorbid Pain and Depression in HIV+ Individuals

Not Applicable

Completed

• Conditions: HIV; Pain; Depression
• Interventions: Behavioral: Health Education; Behavioral: HIVPASS

• Registration Number: NCT02766751
• Lead Sponsor: Butler Hospital

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 Timeline

• Study First Submitted: 2016-05-06
• Study First Submitted QC: 2016-05-09
• Study First Posted: 2016-05-10
• Study Start: 2016-11-15
• Primary Completion: 2020-07
• Study Completion: 2021-05
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-08
• Last Update Posted: 2021-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 187

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Health Education	Health Education	The seven sessions will cover: 1) nutrition (2 sessions), 2) sleep hygiene, 3) building immunity (e.g., how to avoid colds/flu), 4) injury/disease prevention (e.g., seat belts, sunscreen, when to get regular check-ups/screenings etc.), 5) benefits of exercise/cardiac health, 6) alternative medicine (massage, acupuncture). These sessions will be primarily didactic and consist of health education, followed by discussion as to how this information compares to that which the participants may have been exposed to in the past.
HIVPASS	HIVPASS	Over 7 sessions, the interventionist and the participant will explore the relationship between pain, depressive symptoms, and HIV. General information about pain, HIV and depression will be discussed, as will avoidance of physical activity. Psychoeducation about these areas will be tied to the participant's stated life goals, and exposure exercises and goal lists will be developed. Later sessions will integrate continued efforts towards reaching goals and reducing avoidance. A release of information will be obtained from the participant to allow study session chart notes to be placed in the medical record at the participant's PCP office and to allow the PCP and the study interventionist to discuss treatment coordination.

Primary Outcome Measures

Name	Time	Method
pain interference	3 months	Brief pain inventory, interference scale

Secondary Outcome Measures

Name	Time	Method
activity level	3 months; 12 months	Assessed with actigraphy
viral load	3 months, 12 months
depression	3 months; 12 months	Quick Inventory of depression symptoms
perception of global improvement	3 months, 12 months	Patient Global Impression of Change Scale
health related quality of life	3 months, 12 onths	Short Form 36 Health Survey
ART adherence	3 months, 12 months	AIDS Clinical Trial Group questionnaire
pain interference	12 months	brief pain inventory, interference scale
anxiety	3 months; 12 months	State-Trait Anxiety Inventory

Trial Locations

Locations (4)

Boston University/Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States

Butler Hospital; 🇺🇸 Providence, Rhode Island, United States

Hennepin Healthcare; 🇺🇸 Minneapolis, Minnesota, United States

The Miriam Hospital; 🇺🇸 Providence, Rhode Island, United States