RCT Investigating EMDR for Suicidal Ideation
- Conditions
- Suicidal Ideation
- Interventions
- Behavioral: Eye Movement Desensitization and Reprocessing (EMDR)Other: Usual care
- Registration Number
- NCT04181047
- Lead Sponsor
- University of Alberta
- Brief Summary
Suicide is a major public health issue, and is the 9th leading cause of death overall. Suicidal thinking and behaviours have been linked to painful childhood experiences, stressors, and psychological trauma. Stressful experiences are also strongly linked to the development of a variety of mental health problems, including anxiety, depression and posttraumatic stress disorder. However, patients with suicidal ideas are often left out of trauma treatment, for fear that it will worsen their distress and increase their suicidal thinking. However, there is preliminary evidence that treating posttraumatic stress symptoms in patients with suicidal thoughts can lead to improvement in their symptoms and a reduction in suicidal thinking.
For many individuals, overwhelming emotions and/or painful negative beliefs stemming from traumatic experiences contribute to a desire to escape though suicide or self-harm. Eye Movement Desensitization and Reprocessing (EMDR) is an evidence-based therapy for posttraumatic stress disorder that desensitizes painful memories, so that reminders in the present no longer provoke the overwhelming emotional responses. It has also been used for depression and a variety of other mental health problems.
This study aims to test the safety and effectiveness of virtual/remotely delivered EMDR for adults with suicidal ideation. Patients will be randomly assigned to receive either EMDR therapy plus Treatment as usual (TAU) or TAU alone. Symptoms of anxiety, depression, post-traumatic stress, distressing emotions, and suicidal thinking will be compared before and after therapy. For the EMDR group, side effects to EMDR will be tracked. The number of emergency room visits and hospitalizations will also be compared before and after therapy for each group.
- Detailed Description
Suicide is the second leading cause of death among those aged 10-29 years, the 9th leading cause of death overall, and there are 4000 completed suicides per year in Canada. Adverse childhood experiences, interpersonal stressors and trauma correlate strongly with suicidal behaviour and the later development of psychopathology such as depression. For many individuals, overwhelming emotions and/or painful negative beliefs stemming from traumatic experiences contribute to a desire to escape though suicide or self-harm. Eye Movement Desensitization and Reprocessing (EMDR) is an evidence-based therapy for posttraumatic stress disorder that desensitizes painful memories, so that reminders in the present no longer provoke the overwhelming emotional responses.
The COVID-19 pandemic has forced a rapid shift from in-person psychotherapy to remotely delivered psychotherapy services, both to reduce the spread of COVID-19 as well as to maintain access to services. Given this rapid shift to remote delivery and the need for a review of evidence, a recent systematic scoping review was undertaken regarding the scope and quality of peer reviewed literature on remotely delivered psychotherapeutic digital health interventions for military members, veterans and public safety personnel with posttraumatic stress injury (Jones et al 2020). This review yielded 38 studies for inclusion, demonstrating level 1a evidence for prolonged exposure therapy, cognitive processing therapy, behavioral activation and therapeutic exposure in this population. There was evidence that remote delivery of these therapies can be as effective as in-person treatment, and also possibly reduce stigma and improve access to care. There was limited information about EMDR, despite the fact that online EMDR has been widely adopted around the world clinically.
This project had originally aimed to enroll inpatients in face to face therapy and transition them to the outpatient environment. However, the COVID-19 pandemic has resulted in shorter inpatient length of stay, extremely limited mobility for inpatients on and off the units, and shortages of appropriate spaces, making this untenable. There has also been an increase in demand for mental health services at the same time as a reduction in availability of in-person mental health supports. Furthermore, public health measures have necessitated periodic self-isolation, leading to clinic cancellations. For all these reasons, this project will deliver EMDR via Zoom videoconferencing, rather than in person.
This real-world, non-blinded randomized study aims to evaluate the safety and efficacy of EMDR for adults (ages 18 to 65) with suicidal ideation. Eighty participants will be randomized into one of two groups. Group one will receive EMDR therapy to desensitize and reprocess the experiences associated with suicidal thinking. This will be delivered online via encrypted Zoom, due to the COVID-19 pandemic. Group two will be randomized to "treatment as usual" (TAU), which will serve as a control group. TAU will include regular psychiatric care. Clinical measures of anxiety, depression, post-traumatic symptoms, emotional dysregulation, and suicidal thinking will be compared before and after therapy. The impact on emergency room visits, re-hospitalizations and healthcare costs will also be evaluated one year after study completion.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Virtual EMDR Eye Movement Desensitization and Reprocessing (EMDR) Patients will receive 1 to 3 preparation sessions (which will include psychoeducation and preparation exercises before EMDR), followed by up to 12 EMDR sessions, delivered over encrypted Zoom videoconferencing. EMDR is an evidence based trauma therapy. These EMDR sessions will focus on the experiences, urges or negative thoughts associated with their suicidal thoughts. The sessions will be 90 minutes in length and occur twice per week. This group will also have access to usual psychiatric care, which usually includes a family doctor or psychiatrist, mental health therapist and having access to Edmonton's community mental health programs. Treatment as usual Usual care This group will also have access to usual care, which usually includes a family doctor or psychiatrist, mental health therapist and having access to Edmonton's community mental health programs. Virtual EMDR Usual care Patients will receive 1 to 3 preparation sessions (which will include psychoeducation and preparation exercises before EMDR), followed by up to 12 EMDR sessions, delivered over encrypted Zoom videoconferencing. EMDR is an evidence based trauma therapy. These EMDR sessions will focus on the experiences, urges or negative thoughts associated with their suicidal thoughts. The sessions will be 90 minutes in length and occur twice per week. This group will also have access to usual psychiatric care, which usually includes a family doctor or psychiatrist, mental health therapist and having access to Edmonton's community mental health programs.
- Primary Outcome Measures
Name Time Method Beck Scale for Suicide ideation (BSS) 4 months after baseline 21 item questionnaire on suicidal ideation and behaviour in past 1week. Score range 0 to 42, with higher scores worse in outcome.
Columbia Suicide Severity Rating Scale (CSSRS) Recent (self report of past 1 week) 4 months 6 questions on suicidal ideation. First Questions 3, 4, and 5 are answered only if Question 2 ("Have you actually had any thoughts of killing yourself") is answered as a yes. Questions 3 to 5 elaborate on suicidal ideation. Scored as "yes or no" for each question, as dichotomous variables.
- Secondary Outcome Measures
Name Time Method GAD 7 (Generalized Anxiety Disorder 7) 4 months after baseline 7 Item questionnaire on anxiety symptoms, each ranked from 0 (not at all) to 3 (nearly every day), with a score ranging from 0 to 21. Higher scores indicate worse anxiety.
ACES Questionnaire (ACES) Baseline only 10 questions about childhood adversity, which can be added. Score ranges from 0 to 10, with higher number indicating worse adversity before age 18.
BDI II (Beck Depression Inventory II) 4 months after baseline 21 item questionnaire on depressive symptoms, score ranges from 0 to 63, with higher scores indicating worse depression.
DES II (Dissociative Experiences Scale II). 4 months after baseline 28 item scale, with score ranging from 0 to 100, with higher score indicating higher dissociative symptoms and severity.
IES-R (Impact of Events Revised) 4 months after baseline 22 item questionnaire on traumatic or stressful events. Each item ranges from 0 (not at all) to 4 (extremely), with scores ranging from 0 to 88 (higher is more severe).
DERS (Difficulties in Emotion Regulation Scale) 4 months after baseline 36 item questionnaire on emotion regulation, with each question ranked from 1 (almost never; 0-10% of the time) to 5 (almost always; 91-100% of the time). Scores range from 36 to 180, with higher scores indicating worse emotion regulation. Subscales indicate specific type of difficulties.
Healthcare care utilization Comparing one year before to one year after study enrolment. Differences between the two arms with respect to number of emergency room visits and hospitalizations in the year before and after study.
PHQ-9 (Patient Health Questionnaire 9). 4 months after baseline Nine item questionnaire on depressive symptoms, ranging from 0 (not at all) to 3 (nearly every day) for each item, scores range from 0 to 27 (worst symptoms). Then symptoms ranked as either Not difficult, somewhat difficult, Very difficult or Extremely difficult.
Trial Locations
- Locations (1)
Alberta Hospital Edmonton - recruiting from AHS clinics internally
🇨🇦Edmonton, Alberta, Canada