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

Not Applicable

Not yet recruiting

• Conditions: Chronic Pain; Hiv

• Registration Number: NCT07214077
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

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

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.

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-01
• Study First Submitted QC: 2025-10-02
• Last Update Submitted: 2025-10-02
• Study First Posted: 2025-10-09
• Last Update Posted: 2025-10-09
• Study Start: 2026-06-01
• Primary Completion: 2028-06
• Study Completion: 2028-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Intervention Feasibility: Recruitment	Month 3 Study Visits	Intervention feasibility will be assessed by the proportion of eligible individuals from the available recruitment pool.
Intervention Feasibility: Enrollment	Month 3 Study Visits	Intervention feasibility will be assessed by the proportion of eligible individuals who consent and enroll, and the proportion of the target sample size achieved.
Intervention Feasibility: Attrition	Month 3 and Month 6 Study Visits	Intervention feasibility will be assessed by the proportion of participants retained at each follow-up visit.
Intervention Feasibility: Adherence to Assessment Battery	Month 3 and Month 6 Study Visits	Intervention feasibility will be assessed by the proportion of participants who completed the assessment battery at each study visit. In the intervention condition, this includes the proportion of EMA completion.
Intervention Feasibility: FIM	Month 3 Study Visit	The Feasibility of Intervention Measure (FIM) is a 4-item Likert feasibility scale ranging from 1 (Completely disagree) to 5 (Completely agree). A mean score is calculated, resulting in a continuous score with higher scores indicating greater intervention feasibility.
Intervention Acceptability: Fidelity	Month 3 Study Visit	Intervention fidelity will be assessed by adherence to assigned study activities. In the intervention arm, this includes the proportion of days adherent to the prescribed app use. In the control arm, this includes the proportion of psychoeducation reviews completed before monthly visits.
Intervention Acceptability: Engagement (Percentage of days used)	Month 3 Study Visit	Intervention engagement will be assessed by the proportion of days with app use.
Intervention Acceptability: Engagement (Minutes engaged per week)	Month 3 Study Visit	Intervention engagement will be assessed by minutes of app engagement per week.
Intervention Acceptability: AIM	Month 3 Study Visit	The Acceptability of Intervention Measure (AIM) is a 4-item Likert agreeability scale ranging from 1 (Completely disagree) to 5 (Completely agree). A mean score is calculated, resulting in a continuous score with higher scores indicating greater intervention acceptability.
Intervention Acceptability: Qualitative Exit Interviews	Month 3 Study Visit	Intervention acceptability will be assessed via qualitative interviews exploring participants' lived experiences using the Harmonized Healing app, including facilitators and barriers to use, and engagement with the app.