Harmonized Healing: Personalized Music Interventions to Address Chronic Pain in People Living With HIV

Mass General Brigham

Status: Begins enrollment in 3 months

Conditions: Chronic Pain; Hiv

Treatments: Behavioral: Harmonized Healing App; Behavioral: Psychoeducation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07214077

2025P002274

Details and patient eligibility

About

The goal of this randomized controlled trial is to understand the feasibility and acceptability of a music-based mobile application to address chronic pain in people with HIV. Participants in the intervention group will use the Harmonized Healing music app daily, or as needed, for 3 months. Participants in the control group will receive psychoeducation on chronic pain and strategies for pain management. All participants will attend monthly follow-up visits during the 3-month intervention period, and an additional follow-up visit at Month 6.

Full description

Harmonized Healing is a novel, smartphone-driven, music-based behavioral intervention designed to help manage chronic pain in people with HIV. This two-arm pilot randomized controlled trial will enroll 60 individuals living with HIV and chronic pain. Participants will be randomized to receive either Harmonized Healing plus psychoeducation (intervention arm) or psychoeducation alone (control arm). Those in the intervention arm will be asked to use the Harmonized Healing music app daily, or as needed, for 3 months. Participants in both groups will attend monthly study visits during the 3-month intervention period, and one additional follow-up visit at Month 6.

The primary objective of this pilot study is to evaluate the feasibility and acceptability of the Harmonized Healing app. In addition, qualitative feedback will be collected from participants who used Harmonized Healing to better understand their experiences with the intervention and participation in the study.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult ≥ 18 years old
• Owns a smartphone
• Living with HIV
• Currently prescribed antiretroviral therapy (ART) for HIV
• Experience with chronic pain (determined by self-reported pain of ≥3 on the Brief Pain Inventory for at least 3 months)

Exclusion criteria

• Have a significant hearing loss
• HIV-negative
• Have been prescribed naltrexone

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Harmonized Healing App

Experimental group

Description:

Participants will receive psychoeducation related to drivers of chronic pain in the context of HIV and tips for managing pain, and the Harmonized Healing app. Participants will use the app at least once daily, or as needed, to manage and alleviate pain exacerbations for 3 months.

Treatment:

Behavioral: Psychoeducation

Behavioral: Harmonized Healing App

Control

Active Comparator group

Description:

Participants will receive psychoeducation related to drivers of chronic pain in the context of HIV and tips for managing pain. Participants will review the information at least once before each monthly visit (Month 1 to 3 Visits).

Treatment:

Behavioral: Psychoeducation