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

NCT ID: NCT07214077

Last Updated: 2025-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-06-30

Study Completion Date

2028-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Pain Hiv

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Harmonized Healing App

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.

Group Type EXPERIMENTAL

Harmonized Healing App

Intervention Type BEHAVIORAL

A smartphone-driven music-based intervention designed to support daily or as-needed use of personalized music to manage and alleviate pain exacerbations.

Psychoeducation

Intervention Type BEHAVIORAL

Educational materials on drivers of chronic pain in the context of HIV and strategies for pain management.

Control

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).

Group Type ACTIVE_COMPARATOR

Psychoeducation

Intervention Type BEHAVIORAL

Educational materials on drivers of chronic pain in the context of HIV and strategies for pain management.

Interventions

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Harmonized Healing App

A smartphone-driven music-based intervention designed to support daily or as-needed use of personalized music to manage and alleviate pain exacerbations.

Intervention Type BEHAVIORAL

Psychoeducation

Educational materials on drivers of chronic pain in the context of HIV and strategies for pain management.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Fenway Institute

OTHER

Sponsor Role collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Peter R Chai MD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter Chai, MD, MMS

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Central Contacts

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Peter Chai, MD, MMS

Role: CONTACT

8573136721

Peevara Srimanus, MPH

Role: CONTACT

8573136721

Other Identifiers

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2025P002274

Identifier Type: -

Identifier Source: org_study_id

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