Music Workshops in the EMPOWER Clinic

Not Applicable

Withdrawn

• Conditions: Trauma; Sexual Violence; Sex Trafficking
• Interventions: Behavioral: Music Workshop

• Registration Number: NCT02897505
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-30
• Study First Submitted QC: 2016-09-07
• Study First Posted: 2016-09-13
• Study Start: 2016-10
• Primary Completion: 2018-05-29
• Study Completion: 2018-05-29
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-03
• Last Update Posted: 2019-04-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

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

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Exclusion Criteria

• Unwilling or unable to participate or provide informed consent.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Depression, Anxiety, and Stress Scale (DASS-21)	Baseline to Three (3) Months	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.

Secondary Outcome Measures

Name	Time	Method
Life Events Checklist (LEC-5):	Baseline to Three (3) Months	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.
Physiological and Emotion Thermometers Survey	Baseline to Three (3) Months	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.