Music Workshops in the EMPOWER Clinic

Evaluating the Effect of Music on Emotional Regulation Among Survivors of Sexual Violence

Women will be recruited from the EMPOWER clinic when they present for care; they may be given a flyer as part of their clinic entry paperwork, or approached by a study staff member in the waiting area of the clinic. Women who are clients of Sanctuary for Families may find out about the music workshops and the study through Sanctuary for Families staff, who will post flyers in their noticeboards or offices.

This study will use a repeated measures survey design to evaluate the effect of a musical workshop intervention to aid in the management of mood, anxiety, and stress among women enrolled in the EMPOWER clinic for survivors of sex trafficking and sexual violence. Assessment of the feasibility and acceptability of this music intervention will be carried out on participants as they are taught to manage stress and emotions.

Study Overview

• Status: Withdrawn
• Conditions: Trauma; Sexual Violence; Sex Trafficking
• Intervention / Treatment: Behavioral: Music Workshop

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women enrolled in the EMPOWER clinic and/or Sanctuary for Families

Exclusion Criteria:

• Unwilling or unable to participate or provide informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Women enrolled in Empower Clinic; Women who are enrolled in the Empower Sanctuary will be asked to participate in a Music Workshop	Behavioral: Music Workshop; At each music workshop, the study staff will collect participants' pre- and post-session Physiological and Emotional Thermometer Surveys. The pre-session survey will be conducted prior to the start of the music workshop, and the post-session survey will be conducted within 15 minutes after the conclusion of the workshop.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression, Anxiety, and Stress Scale (DASS-21)	The DASS-21 is a 21-item self-report questionnaire that measures the severity of a range of core depression, anxiety, and stress symptoms. [6] The DASS-21 has been translated and validated in many languages, including Spanish, French and Chinese. In this study, the DASS-21 is conducted three times: at the beginning of the study (pre-intervention), at the end of the study (post-intervention), and at 3 months after the study (3-month follow-up). The DASS-21 can be completed in 5-7 minutes.	Baseline to Three (3) Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Life Events Checklist (LEC-5):	The LEC is a widely used self-report questionnaire that assesses participants' exposure to 16 potentially traumatic events and one additional stressful event not captured in the other 16 items. The LEC has been translated and validated in many languages, and can be completed in 5-7 minutes.	Baseline to Three (3) Months
Physiological and Emotion Thermometers Survey	The Physiological and Emotion Thermometers Survey records information on participants' physiological indicators (heart rate and blood pressure) and self-reported answers on the Emotion Thermometers, which is a simple visual-analogue tool used to detect and monitor emotional disorders and has been translated in many languages including Spanish, French and Chinese. The survey is conducted at the beginning and at the end of each music workshop (pre- and post-session, respectively) that the participant attends, and can be completed in 2-5 minutes.	Baseline to Three (3) Months

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Veronica Ades, MD, New York University Medical School

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Actual): May 29, 2018
• Study Completion (Actual): May 29, 2018

Study Registration Dates

• First Submitted: August 30, 2016
• First Submitted That Met QC Criteria: September 7, 2016
• First Posted (Estimate): September 13, 2016

Study Record Updates

• Last Update Posted (Actual): April 5, 2019
• Last Update Submitted That Met QC Criteria: April 3, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: post traumatic stress disorder (PTSD)
• Other Study ID Numbers: 15-01524