Chronic PainNCT07214077
Harmonized Healing: Personalized Music Interventions to Address Chronic Pain in People Living With HIV
A study testing Harmonized Healing App and Psychoeducation in people with Chronic Pain and Hiv, run by Brigham and Women's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Hiv
- What is being tested?
- Harmonized Healing App and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Have a significant hearing loss
- HIV-negative
- Have been prescribed naltrexone
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Chronic Pain, Hiv
- Being tested
- Harmonized Healing App, Psychoeducation
- Keywords
- Chronic Pain, Music, smartphone app
- Medical subject headings
- Chronic Pain, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Harmonized Healing AppBehavioural
A smartphone-driven music-based intervention designed to support daily or as-needed use of personalized music to manage and alleviate pain exacerbations.
PsychoeducationBehavioural
Educational materials on drivers of chronic pain in the context of HIV and strategies for pain management.
| Study group | Role | What they receive |
|---|---|---|
| Harmonized Healing App | Experimental | 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 twice daily, or as needed, to manage and alleviate pain exacerbations for 3 months. Receives: Behavioral: Harmonized Healing App; Behavioral: Psychoeducation |
| Control | Active comparator | 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). Receives: Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Feasibility: Recruitment
Intervention feasibility will be assessed by the proportion of eligible individuals from the available recruitment pool.
Measured: Month 3 Study Visits
Intervention Feasibility: Enrollment
Intervention feasibility will be assessed by the proportion of eligible individuals who consent and enroll, and the proportion of the target sample size achieved.
Measured: Month 3 Study Visits
Intervention Feasibility: Attrition
Intervention feasibility will be assessed by the proportion of participants retained at each follow-up visit.
Measured: Month 3 and Month 6 Study Visits
Intervention Feasibility: Adherence to Assessment Battery
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.
Measured: Month 3 and Month 6 Study Visits
Intervention Feasibility: FIM
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.
Measured: Month 3 Study Visit
Intervention Acceptability: Fidelity
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.
Measured: Month 3 Study Visit
Intervention Acceptability: Engagement (Percentage of days used)
Intervention engagement will be assessed by the proportion of days with app use.
Measured: Month 3 Study Visit
Intervention Acceptability: Engagement (Minutes engaged per week)
Intervention engagement will be assessed by minutes of app engagement per week.
Measured: Month 3 Study Visit
Intervention Acceptability: AIM
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.
Measured: Month 3 Study Visit
Intervention Acceptability: Qualitative Exit Interviews
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.
Measured: Month 3 Study Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study startSep 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Fenway Institute, National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Peter R Chai MD, Brigham and Women's Hospital
- Investigators
- Peter Chai, MD, MMS, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214077
- Sponsor's protocol ID
- 2025P002274
- Status last verified
- Aug 2026
- First submitted
- 1 Oct 2025
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Identifying information may be redacted and data shared based on reasonable request from researchers.
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harmonized Healing: Personalized Music Interventions to Address Chronic Pain in People Living With HIV
- ClinicalTrials.gov ID
- NCT07214077
- Acronym / sponsor ID
- 2025P002274
- Conditions
- Chronic Pain, Hiv
- Keywords
- Chronic Pain, Music, smartphone app
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- The Fenway Institute, National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 9 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Harmonized Healing App | Experimental | Behavioral: Harmonized Healing App, Behavioral: PsychoeducationParticipants 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 twice daily, or as needed, to manage and alleviate pain exacerbations for 3 months. |
| Control | Active comparator | Behavioral: PsychoeducationParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (3 listed)
- Have a significant hearing loss
- HIV-negative
- Have been prescribed naltrexone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Harmonized Healing AppA smartphone-driven music-based intervention designed to support daily or as-needed use of personalized music to manage and alleviate pain exacerbations. | Behavioural | Harmonized Healing App |
| PsychoeducationEducational materials on drivers of chronic pain in the context of HIV and strategies for pain management. | Behavioural | Control, Harmonized Healing App |
Primary outcome
Intervention Feasibility: Recruitment
Time frame: Month 3 Study Visits
Intervention feasibility will be assessed by the proportion of eligible individuals from the available recruitment pool.
Intervention Feasibility: Enrollment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Month 3 Study Visit
Intervention engagement will be assessed by the proportion of days with app use.
Intervention Acceptability: Engagement (Minutes engaged per week)
Time frame: Month 3 Study Visit
Intervention engagement will be assessed by minutes of app engagement per week.
Intervention Acceptability: AIM
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: Undecided. Identifying information may be redacted and data shared based on reasonable request from researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Chai, MD, MMS principal investigator
Brigham and Women's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Harmonized Healing App and Psychoeducation in people with Chronic Pain and Hiv, run by Brigham and Women's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Chai, MD, MMS (8573136721, pchai@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Feasibility: Recruitment (time frame: Month 3 Study Visits). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.