Trauma-focused Group Music and Imagery With Women Suffering From PTSD/Complex PTSD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 主要终点
- Change from baseline in Posttraumatic Stress Disorder Checklist (version 5) (PCL-5) total score at 3 months (post intervention) and at 6 months (follow- up).
研究概览
简要总结
This study is a mixed methods randomized controlled trial (Wait List Control), that investigates the effects of Group Music and Imagery (GrpMI) therapy in the treatment of women suffering from Post Traumatic Stress Disorder (PTSD) or Complex PTSD.
The aim is to detect if the intervention has an effect on PTSD symptoms, dissociation, quality of life, and the capability of regulating the autonomic nervous system (ANS).
详细描述
Participants are adult women suffering from PTSD or Complex PTSD (n=56) that are randomized to three months of weekly (12) sessions of trauma modified GrpMI therapy or no treatment for an equal amount of time (wait list control).
Primary outcome is pre, post and 3 months follow-up measures of PTSD checklist 5 (PCL-5).
Secondary outcome is pre, post and 3 months follow-up measures of dissociative experience scale (DES), positive state of mind scale (PSOM-S), Hopkins symptoms checklist (HSCL-25), somatoform dissociation questionnaire (SDQ-5), and reactivity and recovery of different physiological measures related to arousal regulation ability in a script driven imagery setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •be suffering from PTSD/CPTSD,
- •be sufficiently stabilised to tolerate being exposed to trauma treatment and listen to other subjects' stories,
- •be able to speak good enough swedish to express themselves without an interpreter,
- •have an interest in working with their problems using artistic languages,
- •have an ability to work with symbolism and inner images.
排除标准
- •difficulties in understanding or making themselves understood in swedish,
- •severe personality disorder or neuropsychiatric disorder,
- •ongoing alcohol or drug abuse,
- •psychotic disorder,
- •suicidality,
- •serious ongoing medical condition,
- •serious psychosocial problems.
研究组 & 干预措施
Music therapy treatment
An intervention consisting of 12 weekly sessions of trauma-focused treatment in form of group music and imagery therapy.
Receptive music therapy.
干预措施: Receptive music therapy (Behavioral)
Wait List Control
No treatment for approximately 12 weeks.
结局指标
主要结局
Change from baseline in Posttraumatic Stress Disorder Checklist (version 5) (PCL-5) total score at 3 months (post intervention) and at 6 months (follow- up).
时间窗: Baseline, 3 months (post intervention) and 6 months (follow- up).
PCL-5 is a 20-item self-assessment scale, measuring symptoms related to posttraumatic stress disorder (PTSD). The total score range are from 0-80. Higher scores indicate more severe PTSD symptoms.
次要结局
- Change from baseline in Dissociative experience scale (DES) mean score at 3 months (post intervention) and at 6 months (follow- up).(Baseline, 3 months (post intervention) and 6 months (follow- up).)
- Change from baseline in Hopkins symptom checklist (HSCL-25) mean scores at 3 months (post intervention) and at 6 months (follow- up).(Baseline, 3 months (post intervention) and 6 months (follow- up).)
- Change from baseline in Positive states of mind scale (PSOM-S) total score at 3 months (post intervention) and at 6 months (follow- up).(Baseline, 3 months (post intervention) and 6 months (follow- up).)
- Change from baseline in Somatoform Dissociation Questionnaire (SDQ5) total score at 3 months (post intervention) and at 6 months (follow- up).(Baseline, 3 months (post intervention) and 6 months (follow- up).)
- Change from baseline in timeline of heart rate during exposure to script-driven trauma imagery at 3 months (post intervention) and 6 months (follow-up).(Baseline, 3 months (post intervention) and 6 months (follow- up).)
- Change from baseline in timeline of peripheral temperature during exposure to script-driven trauma imagery at 3 months (post intervention) and 6 months (follow-up).(Baseline, 3 months (post intervention) and 6 months (follow- up).)
- Change from baseline in timeline of skin conductance level during exposure to script-driven trauma imagery at 3 months (post intervention) and 6 months (follow-up).(Baseline, 3 months (post intervention) and 6 months (follow- up).)
- Change from baseline in timeline of muscle tension during exposure to script-driven trauma imagery at 3 months (post intervention) and 6 months (follow-up).(Baseline, 3 months (post intervention) and 6 months (follow- up).)
- Change from baseline in timeline of the root mean square of successive differences (RMSSD) in intervals between individual heart beats during exposure to script-driven trauma imagery at 3 months (post intervention) and 6 months (follow-up).(Baseline, 3 months (post intervention) and 6 months (follow- up).)
研究者
Gabriella Rudstam
Principal Investigator
Aalborg University