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临床试验/NCT06027658
NCT06027658已完成不适用

Psychotherapeutic Care of Women Victims of Sexual Violence, Longitudinal Comparative Study and Therapeutic Evaluation of a Dance As Therapy Program

University of Franche-Comté1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
65
试验地点
1
主要终点
Rate of participants presenting an improvement in RFQ8 score at 6 months

研究概览

简要总结

The objective is to validate a psychotherapeutic group protocol of dance as therapy created by LOBA association with a comparative non-randomized study.

详细描述

This present research is a prospective longitudinal monocentric comparative study of an alternative, non-pharmacological therapy. It is a controlled, non-randomized, and experimental study in which half of the participants benefit from an additional program with speech and movement co-therapy via body activity, and the other half only benefit from standard support (e.g. medical, social, and legal assistance, individual psychotherapy).

The effect of this program will be examined across three dimensions:

  • A clinical trial of N=80 participants to compare symptom improvement between individuals receiving the standard support for victims of sexual violence (N=40) and those receiving, in addition, the RECREATION program (N=40).
  • A longitudinal evaluation of physiological conditions, psychological traits, and social well-being of RECREATION workshop attendees (N=10) versus victims not participating in said workshops (N=10).
  • A qualitative analysis of interviews with program participants and their associated professionals (data saturation sample size).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • French-speaking
  • Over 18 years old
  • Victim of sexual violence

排除标准

  • Non-French-speaking person,
  • Under 18 years old
  • Not woman
  • Not victim of sexual violence

结局指标

主要结局

Rate of participants presenting an improvement in RFQ8 score at 6 months

时间窗: 6 months period between January 2022 and April 2024

Reflexive Functioning Questionnaire in 8 items (RFQ8) scores range from 0 to 18; a higher score means a worse outcome.

Rate of participants presenting an improvement in DASS-21 scores at 6 months

时间窗: 6 months period between January 2022 and April 2024

Depression, Anxiety, and Stress Scale in 21 (DASS-21) items scores range from 0 to 63; a higher score means a worse outcome.

Rate of participants presenting an improvement in PCLS scores at 6 months

时间窗: 6 months period between January 2022 and April 2024

Posttraumatic stress disorder checklist (PCLS) scores range from 0 to 85; a higher score means a worse outcome.

Number of identical themes in participants' and professionals' semi-structured interviews

时间窗: One interview per person between September 2022 and March 2023

Number of identical themes in participants' and professionals' semi-structured interviews

Rate of participants presenting an improvement in QSCPGS scores at 6 months

时间窗: 6 months period between January 2022 and April 2024

Body satisfaction and global self-perception questionnaire (QSCPGS) scores range from -100 to +100; a higher score means a better outcome

Number of participants presenting an improvement in AAI scores at 1 year

时间窗: A year between April 2022 and December 2023

Adult Attachment Interview (AAI) scores range from 0 to 90; a higher score means a better outcome.

Rate of participants presenting an improvement in SF-36 scores at 6 months

时间窗: 6 months period between January 2022 and April 2024

Short Form Health Survey in 36 items (SF-36) scores range from 0 to 100; a higher score means a better outcome

Number of participants presenting an improvement in Rorschach protocol at 1 year

时间窗: A year between April 2022 and December 2023

Rorschach protocols are interpreted both qualitatively and quantitatively (psychogram). This outcome focuses on trauma symptomatology.

Rate of participants presenting an improvement in SSQ6 scores at 6 months

时间窗: 6 months period between January 2022 and April 2024

Social Support Questionnaire in 6 items (SSQ6) scores range from 0 to 54 for the availability subscale and from 6 to 36 for the satisfaction subscale. For both subscales, a higher score means a better outcome

Rate of participants presenting a change in RSQ score at 6 months

时间窗: 6 months period between January 2022 and April 2024

Relationship Scales Questionnaire (RSQ) scores give an attachment profile, attachment strategies and a self and other model.

次要结局

未报告次要终点

研究者

发起方
University of Franche-Comté
申办方类型
Other
责任方
Principal Investigator
主要研究者

Crystal Tomaszewski

Principal Investigator

University of Franche-Comté

研究点 (1)

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