Digitally Recording Heart Rate Variability Via the Patient's Finger: Is There a Difference Between Eye Movements and no Eye Movements During Eye Movement Desensitisation Reprocessing Treatment for Post Traumatic Stress Disorder?
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Heart Rate Variability (HRV)
研究概览
简要总结
The purpose of the study is to gain greater insight into Eye Movement Desensitisation Reprocessing (EMDR). EMDR is an NHS recommended treatment, which can significantly reduce trauma symptoms. There is some debate regarding how it actually works, however there is evidence to suggest that the eye movements component helps reduce anxiety and increase relaxation levels. To measure these arousal levels during EMDR previous research has used electrocardiography (ECG) to measure heart rate, which offers insight into the effectiveness of eye movements (EM). All studies to date have used ECG to measure arousal levels which requires technical knowledge to administer and interpret. Furthermore, applying electrodes to a patient experiencing PTSD may heighten anxiety. The present study will use new technology which is a small device that would be gently attached to the end of the patient's index finger. This device is very similar to one that measures oxygen levels in the blood and therefore is a very simple piece of equipment and should cause no discomfort to the patient. The study also requires patient's faces to be video recorded throughout and it will only be their face that is recorded. This is to match the stages of treatment (i.e. when EM starts and stops) to their corresponding arousal level outcome. The new technology will digitally measure the patient's anxious and relaxed arousal levels during EM and no EM treatment sessions. 10 NHS patients would be recruited to receive two treatment sessions; one with EM and one without and then continue with treatment as usual without any of the recording devices. EM and no EM phases occur at least three times within a treatment session and therefore several measurements can be taken and analysed.
详细描述
DESIGN Each patient will receive an Eye Movement Desensitisation Reprocessing (EMDR) treatment session with eye movements (EM) and an EMDR treatment session without EM. Half will complete the EM session first and the other half will complete the no EM session first. After the first session is complete the patients will cross over to complete the other treatment session, which will be approximately one week later. This is known as a cross over design and allows patients to act as their own control group. Furthermore they will be randomly allocated into which condition they complete first to reduce order effects. During both treatment sessions patients will have their arousal levels digitally measured and face video recorded.
METHODOLOGY Patients who have been referred for trauma will be allocated from the NHS Tayside waiting list. From January 2013 to January 2014 there were approximately 72 patients across Tayside who were treated for Post Traumatic Stress Disorder (PTSD) and/or 'reaction to severe stress, and adjustment disorders'. This was taken from the online patient database (MiDIS), which is mandatory for all clinicians in NHS Tayside to complete.
PROCEDURE NHS Tayside Adult Psychological Therapies Service receives electronic referrals, usually from the GP, stating the reason for referral. The patients' symptoms/diagnoses and CHI number are then documented in a diary waiting to be allocated to the next available appointment. The clinicians will look through the diary, noting the ones who appear to meet the relevant diagnosis/symptoms to ensure that they will be seen by an EMDR qualified clinician if they choose to be seen by psychology at all. Patient's who appear to meet the initial criteria, will be sent a standard protocol appointment letter, stating that they must contact the service within 2 weeks if they still wish to be seen by psychology. Those who choose to be seen will be provided with an initial assessment session, where information is gathered about their presenting problems and history. They will also be asked to complete routine questionnaires. This will be completed by the EMDR qualified clinician, who at the same time will offer them to take part in the study if they believe the patient is suitable for EMDR. If the therapist believes the patient is not suitable for EMDR then as part of standard protocol the assessment will be completed and the patient will be allocated to the next available clinician for treatment. If the patient is suitable then the clinician will explain the parameters of the study which will include, digitally measuring arousal levels and video recording the patient's face during their first two treatment sessions of EMDR therapy with the assessing clinician. Also at their first session the clinician will show the equipment that will be used and provide them with a participant information letter about the study for them to take away and think about. Within the information letter they will be informed that choosing not to take part will not affect their routine care and even if they choose to take part they can drop out at any time and continue with treatment as usual. The chief investigator's contact details will also be provided, should they require further information. At the end of the letter they will be provided with 2 options: 1. I agree to take part in the study. 2. I do not wish to take part in the study. They will need to contact the service within 5 days of their first session to inform us of their decision. This is to allow the equipment to be set up in advance if they agree to take part. Regardless of whether they decide to take part in the study or not, their next session will be within 2 weeks of the initial assessment, which will be with the same clinician if they take part, but may be a different clinician of they do not take part, which is within standard service protocol.
Those who agree to take part in the study will be required to bring their signed consent form (contained within the participant information letter) to their second session or complete another one on the day before engaging within the study. Their second session will either be to complete the assessment process/other formal measures (documented below) or start with EMDR treatment. This will be up to the clinician depending on how much information was gathered in session 1. This is within standard service protocol. Before treatment can begin each patient must complete the formal assessment measures. Only the 2 treatment sessions will use the recording equipment and following this they will continue with treatment without being part of the study. If at any point they decide that they no longer wish to take part, treatment will continue as usual, without the recording devices.
EMDR trained clinicians will administer the EMDR treatment with 3 or 4 patients each. As standard service protocol, patients will receive a minimum of one hour per treatment session and each session will take place in an NHS psychological therapies service building.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
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
- •Patients on the waiting list for psychological treatment who meet criteria for PTSD and/or sub clinical PTSD.
- •Patients over the age of
- •Patients able to give informed consent
- •Single trauma event
排除标准
- •Patients in other psychological treatment.
- •Patients unable to provide informed consent
- •Patients who are actively suicidal
- •Patients who score above 30 on the dissociative experiences scale (DES).
- •Difficulties with eye sight, where vision cannot be corrected with glasses or lenses (EMDR requires the patient to accurately follow their finger with their eyes)
研究组 & 干预措施
Eye Movements
Eye Movement Desensitisation Reprocessing with eye movements (measuring Heart Rate Variability using HeartMath)
干预措施: Eye Movement Desensitisation Reprocessing (Other)
Eye Movements
Eye Movement Desensitisation Reprocessing with eye movements (measuring Heart Rate Variability using HeartMath)
干预措施: HeartMath measuring Heart Rate Variability (HRV) (Device)
No Eye Movements
Eye Movement Desensitisation Reprocessing without eye movements (measuring Heart Rate Variability using HeartMath)
干预措施: HeartMath measuring Heart Rate Variability (HRV) (Device)
No Eye Movements
Eye Movement Desensitisation Reprocessing without eye movements (measuring Heart Rate Variability using HeartMath)
干预措施: Eye Movement Desensitisation Reprocessing (Other)
结局指标
主要结局
Heart Rate Variability (HRV)
时间窗: up to 7 months
This is the variation in the beat-to-beat interval and measures the sympathetic nervous system (SNS). A minimum of 3 arousal level (HRV) measurements will be taken within each treatment session. An average measurement will be calculated for each patient during each condition. Paired sample t-tests will be used to compare heart rate variability (arousal levels) outcomes between eye movements and no eye movements for each patient. A repeated measures ANOVA will be used to analyse any differences across each session of eye movements and no eye movements (containing a minimum of 3 phases in each session), to see if there is an improvement in HRV (i.e. a reduction in anxiety arousal and increase in relaxed arousal) over each session.
次要结局
- Subjective Units of Distress (SUDs)(up to 7 months)