Recruiting

MI vs. SC

Sponsor:

Columbia University

Code:

NCT05945264

Conditions

Preterm Birth

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Not accepted

Interventions

Music Intervention (MI)

Sham Control (SC)

Study Details

Brief summary:

This study will test a music intervention (MI) versus a sham control (SC) arm which only includes a verbal intervention, to determine if the effects of the music intervention will reduce the biological impact of chronic stress among pregnant Black women, reduce preterm birth, and improve infant outcomes.

Conditions

Preterm Birth

Study ID

NCT05945264

Start date

Sep 29, 2026

Status verified date

Aug, 2026

Completion date

Aug 29, 2027

Anticipated

Primary completion date

Jul 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 40

Healthy Volunteers: Not accepted

Inclusion Criteria

  • Aged 18 to 40 years
  • Generally healthy pregnant women in the first trimester of pregnancy

Exclusion Criteria:

  • Non-pregnant women
  • Women with a chronic medical condition that could impact pregnancy health or duration
  • Women regularly taking any medications other than prenatal vitamins

Study Design

Enrollment

142 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Music Intervention (MI) Group

Music therapist will meet individually with each participant and provide music therapy content that reflects their culture and mood states.

active comparator: Sham Control (SC) Group

Music/Verbal therapist will meet individually with each participant but will provide verbal discourse only (i.e., no music therapy and verbal intervention only).

Interventions

Music Intervention (MI)

The intervention will involve listening, playing and/or singing melodies or songs, that are meaningful to the participant, with interpretation/reflection on their relevance/capacity to alter stress.

Sham Control (SC)

The intervention will be to support a woman to talk about anything she wants that is important to her.

Primary outcome measure

  • Score on the Perceived Stress Scale (PSS) [ Time Frame: Week 1 ]
  • Score on the Perceived Stress Scale (PSS) [ Time Frame: Week 5 ]
  • Score on the Perceived Stress Scale (PSS) [ Time Frame: Week 10 ]
  • Mean Gestational Age [ Time Frame: Up to 43 weeks ]

Central Contacts and Locations

Central contacts

Jacquelyn Taylor, PhD

347-978-2871jyt2116@cumc.columbia.edu

Joanne V. Loewy, DA, LCAT, MT-BC

212-420-3484joanne.loewy@mountsinai.org

Locations

Columbia University Irving Medical Center/NewYork Presbyterian

Recruiting

New York, New York, United States, 10032

Contacts

Jacquelyn Taylor, PhD

347-978-2871jyt2116@cumc.columbia.edu

Principal Investigator:

Jacquelyn Taylor, PhD

More Information

Sponsor

Columbia University

Last update posted

Oct 5, 2026

Last verified

Aug, 2026

Keywords

  • Chronic stress
  • Preterm birth
  • Black women stress
  • Metabolomics of chronic stress
  • Music and medicine
  • Music intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-06. This information was provided to ClinicalTrials.gov by Columbia University on 2026-10-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.