Treating Comorbid Pain and Depression in HIV+ Individuals

NCT02766751 | Completed DMC

• 1 other identifier: 840019
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 4

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.

Conditions

HIV; Depression; Pain

Outcome Measures

Primary Outcomes (1)

• pain interference

  Brief pain inventory, interference scale

  3 months

Secondary Outcomes (8)

• depression

  3 months; 12 months

• activity level

  3 months; 12 months

• anxiety

  3 months; 12 months

• viral load

  3 months, 12 months

• ART adherence

  3 months, 12 months

Study Arms (2)

Health Education

PLACEBO COMPARATOR

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.

Behavioral: Health Education

HIVPASS

EXPERIMENTAL

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.

Behavioral: HIVPASS

Interventions

HIVPASS BEHAVIORAL

The 7-session HIVPASS intervention is provided to individuals randomized to the HIVPASS study arm.

HIVPASS

Health Education BEHAVIORAL

The 7-sessions of Health Education is provided to individuals randomized to the Health Education study arm.

Health Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Butler Hospital: lead

Study Sites (4)

Boston University/Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Hennepin Healthcare

Minneapolis, Minnesota, 55415, United States

Location

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (2)

• Uebelacker LA, Pinkston MM, Busch AM, Baker JV, Anderson B, Caviness CM, Herman DS, Weisberg RB, Abrantes AM, Stein MD. HIV-PASS (Pain and Sadness Support): Randomized Controlled Trial of a Behavioral Health Intervention for Interference Due to Pain in People Living With HIV, Chronic Pain, and Depression. Psychosom Med. 2023 Apr 1;85(3):250-259. doi: 10.1097/PSY.0000000000001172. Epub 2023 Feb 3.

  PMID: 36799731 DERIVED

• 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.

  PMID: 35777696 DERIVED

MeSH Terms

Conditions

Depression; Pain

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Stein, MD

  Butler Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 6, 2016
• First Posted: May 10, 2016
• Study Start: November 15, 2016
• Primary Completion: July 1, 2020
• Study Completion: May 1, 2021
• Last Updated: June 10, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)