Recording Heart Rate Variability During Eye Movement Desensitisation Reprocessing With or Without Eye Movement

NCT02565563 | Withdrawn

• 1 other identifier: 173479
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Post Traumatic Stress Disorder

Keywords

EMDR; Mechanisms; Eye Movement Desensitisation Reprocessing

Outcome Measures

Primary Outcomes (1)

• Heart Rate Variability (HRV)

  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.

  up to 7 months

Secondary Outcomes (1)

• Subjective Units of Distress (SUDs)

  up to 7 months

Study Arms (2)

Eye Movements

ACTIVE COMPARATOR

Eye Movement Desensitisation Reprocessing with eye movements (measuring Heart Rate Variability using HeartMath)

Other: Eye Movement Desensitisation Reprocessing; Device: HeartMath measuring Heart Rate Variability (HRV)

No Eye Movements

ACTIVE COMPARATOR

Eye Movement Desensitisation Reprocessing without eye movements (measuring Heart Rate Variability using HeartMath)

Other: Eye Movement Desensitisation Reprocessing; Device: HeartMath measuring Heart Rate Variability (HRV)

Interventions

Eye Movement Desensitisation Reprocessing OTHER

The purpose of this study is not to assess the device itself. The new device will seek to measure heart rate variabilty during the administration of the treatment EMDR. It will measure the patients sympathetic nervous systems (anxiety arousal). Previous reseach studies have used Electrocardiography (ECG) and the purpose of this study is to determine whether or not this device will obtain similar findings as ECG has done.

Eye Movements; No Eye Movements

HeartMath measuring Heart Rate Variability (HRV) DEVICE

This small device will be attached to the patients finger to allow their heart rate variability to be measured.

Eye Movements; No Eye Movements

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients on the waiting list for psychological treatment who meet criteria for PTSD and/or sub clinical PTSD.
• Patients over the age of 18.
• Patients able to give informed consent
• Single trauma event

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Tayside: collaborator

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2015
• First Posted: October 1, 2015
• Study Start: October 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: March 1, 2016
• Last Updated: April 8, 2016

Record last verified: 2015-09