Neurofeedback for Post-Traumatic Stress Disorder (N-PTSD). A Randomized Trial of Neurofeedback.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Clinician Administered PTSD Scale (CAPS)
研究概览
简要总结
A two-arm randomized pilot of standard neurofeedback and a waiting list for patients with treatment resistent PTSD.
详细描述
This study will be a randomized-controlled pilot and in a later study virtual reality based neurofeedback will be tested. In this study 30 subjects will be randomised into one of two arms of the study. Treatment as usual (TAU) entails both psychotherapy, medication and other interventions.
- TAU + Neurofeedback using a PC-screen (experimental group)
- TAU as a waiting list (control group) - the participants in the control group will be offered to choose one of the two experimental treatments at the end of the trial.
The 30 participants will be randomized to one arm of the study (15 participants per group). The subjects will be recruited from Psychiatric Outpatient Care at Sahlgrenska University Hospital, Crisis and Trauma Center Gothenburg and Psychiatric Care Center in Tranås, Jönköping.
Participants in the experimental group will have 24 sessions in total, (twice a week. 12 week period) with a trained neurofeedback specialist or trained neurofeedback physician. Before session 1 and after session 24, a clinician will fill in the clinical scales and questionnaires.
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
盲法说明
Statistical analysis will be done seperately
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CAPS Cutoff >44
- •Stable psychopharmacological treatment (stable dose, no planned changes during the course of the trial)
- •AUDIT cut off <16
- •DUDIT cut off <8
- •Already undergone at least one treatment with psychotherapy and/or pharmacological treatment for a minimum of 6 months.
- •18 years or older
排除标准
- •Diagnosis of traumatic brain injury (TBI) affecting capability to give informed consent
- •Ongoing traumatic exposure (such as domestic violence)
- •Balance problems
- •Active suicide risk or life-threatening self-harm
- •A diagnosis of schizophrenia or psychotic disorder
- •Ongoing compulsory care
- •If the patient changes dose or medication strategy during the trial.
- •If the neurofeedback treatment is identified as a primary reason for worsening of participant's well being.
结局指标
主要结局
Clinician Administered PTSD Scale (CAPS)
时间窗: Through study completion, an average of 3 months
An interview based scale of symptoms of PTSD
次要结局
- Impact of Event Scale - Revised (IES-R)(4 weeks after finished intervention for the two intervention arms.)
- Clinician Administered PTSD Scale (CAPS)(For those that have finished the intervention CAPS at one month post treatment)
- Visual Analogue Scale for Wellbeing (VAS-W)(Before and after each session 1-24 for the two intervention arms.)
- Wisconsin Card Sorting Test (WCST)(4 weeks after finished intervention, an average of 4 months)
- Insomnia Severity Index (ISI)(4 weeks after finished intervention for the two intervention arms.)
研究者
Steinn Steingrimsson
Principal investigator & clinical associate professor
Sahlgrenska University Hospital, Sweden