Music Workshops in the EMPOWER Clinic

NCT02897505 | Withdrawn

• 1 other identifier: 15-01524
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Sex Trafficking; Sexual Violence; Trauma

Keywords

post traumatic stress disorder (PTSD)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Life Events Checklist (LEC-5):

  Baseline to Three (3) Months

• Physiological and Emotion Thermometers Survey

  Baseline to Three (3) Months

Study Arms (1)

Women enrolled in Empower Clinic

EXPERIMENTAL

Women who are enrolled in the Empower Sanctuary will be asked to participate in a Music Workshop

Behavioral: Music Workshop

Interventions

Music Workshop BEHAVIORAL

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.

Women enrolled in Empower Clinic

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Unwilling or unable to participate or provide informed consent.

Sponsors & Collaborators

• NYU Langone Health: lead

MeSH Terms

Conditions

Wounds and Injuries; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Veronica Ades, MD

  New York University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: September 13, 2016
• Study Start: October 1, 2016
• Primary Completion: May 29, 2018
• Study Completion: May 29, 2018
• Last Updated: April 5, 2019

Record last verified: 2019-04