RCT Investigating EMDR for Suicidal Ideation

Study Overview
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Brief Summary
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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
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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.

Official Title
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RCT Investigating Virtual Eye Movement Desensitization and Reprocessing (EMDR) for Adults With Suicidal Ideation

Conditions
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Suicidal Ideation

Intervention / Treatment
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* Behavioral: Eye Movement Desensitization and Reprocessing (EMDR)
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion criteria include adults (ages 18 to 65) with suicidal ideation in the last week. Participants must volunteer to be in the study, be able to give informed consent and be able to follow up twice weekly until treatment is complete (a total of 12 sessions). Participants must have a primary service provider. Participants must have access to their own laptop or desktop computer that enables BLS with a working screen, camera, and microphone, and access to a quiet, private, well-lit space for therapy. Participants must be willing to refrain from benzodiazepine, cannabis or illicit substance use in the 24 hours before or after EMDR sessions. Participants must be willing to adhere to the study safety precautions Exclusion criteria At the time of assessment, suicidal ideation is not accompanied by intent or plan to follow through with suicide. Known pregnancy, as there is limited information about the impact of EMDR in pregnancy. DES score above 34 or severe dissociative symptoms (see below), psychotic symptoms or manic symptoms. Participants undergoing or planning to undergo electroconvulsive therapy (ECT) or another trauma focused psychotherapy in the 4-month study period. Referred potential participants will also be excluded on the basis of the assessment interview if they report a history of severe dissociative symptoms in keeping with a separate dissociative disorder, such as hearing internal voices, amnestic episodes, or dissociative fugue states passivity experiences or first rank symptoms under stress, or the subjective experience of having alter personality self-states. severe isolation of affect, with inability to feel body sensations or tune into emotions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Non-blinded randomized controlled trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual EMDR<br>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. | Behavioral: Eye Movement Desensitization and Reprocessing (EMDR)<br>* Psychotherapy.<br>Other: Usual care<br>* Access to usual care, including psychiatrist, medications, mental health therapist, general community mental health programs. TAU will NOT include electroconvulsive therapy or another trauma specific psychotherapy.<br>|
| Active Comparator: Treatment as usual<br>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. | Other: Usual care<br>* Access to usual care, including psychiatrist, medications, mental health therapist, general community mental health programs. TAU will NOT include electroconvulsive therapy or another trauma specific psychotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Scale for Suicide ideation (BSS) | 21 item questionnaire on suicidal ideation and behaviour in past 1week. Score range 0 to 42, with higher scores worse in outcome. | Baseline | 
| Beck Scale for Suicide ideation (BSS) | 21 item questionnaire on suicidal ideation and behaviour in past 1week. Score range 0 to 42, with higher scores worse in outcome. | 2 months after baseline | 
| Beck Scale for Suicide ideation (BSS) | 21 item questionnaire on suicidal ideation and behaviour in past 1week. Score range 0 to 42, with higher scores worse in outcome. | 4 months after baseline | 
| Columbia Suicide Severity Rating Scale (CSSRS) Recent (self report of past 1 week) | 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. | Baseline | 
| Columbia Suicide Severity Rating Scale (CSSRS) Recent (self report of past 1 week) | 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. | 2 months | 
| Columbia Suicide Severity Rating Scale (CSSRS) Recent (self report of past 1 week) | 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. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ACES Questionnaire (ACES) | 10 questions about childhood adversity, which can be added. Score ranges from 0 to 10, with higher number indicating worse adversity before age 18. | Baseline only | 
| DES II (Dissociative Experiences Scale II). | 28 item scale, with score ranging from 0 to 100, with higher score indicating higher dissociative symptoms and severity. | Baseline | 
| DES II (Dissociative Experiences Scale II). | 28 item scale, with score ranging from 0 to 100, with higher score indicating higher dissociative symptoms and severity. | 4 months after baseline | 
| BDI II (Beck Depression Inventory II) | 21 item questionnaire on depressive symptoms, score ranges from 0 to 63, with higher scores indicating worse depression. | Baseline | 
| BDI II (Beck Depression Inventory II) | 21 item questionnaire on depressive symptoms, score ranges from 0 to 63, with higher scores indicating worse depression. | 2 months after baseline | 
| BDI II (Beck Depression Inventory II) | 21 item questionnaire on depressive symptoms, score ranges from 0 to 63, with higher scores indicating worse depression. | 4 months after baseline | 
| PHQ-9 (Patient Health Questionnaire 9). | 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. | Baseline | 
| PHQ-9 (Patient Health Questionnaire 9). | 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. | 2 months after baseline | 
| PHQ-9 (Patient Health Questionnaire 9). | 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. | 4 months after baseline | 
| GAD 7 (Generalized Anxiety Disorder 7) | 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. | Baseline | 
| GAD 7 (Generalized Anxiety Disorder 7) | 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. | 2 months after baseline | 
| GAD 7 (Generalized Anxiety Disorder 7) | 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. | 4 months after baseline | 
| IES-R (Impact of Events Revised) | 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). | Baseline | 
| IES-R (Impact of Events Revised) | 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). | 2 months after baseline | 
| IES-R (Impact of Events Revised) | 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). | 4 months after baseline | 
| DERS (Difficulties in Emotion Regulation Scale) | 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. | Baseline | 
| DERS (Difficulties in Emotion Regulation Scale) | 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. | 2 months after baseline | 
| DERS (Difficulties in Emotion Regulation Scale) | 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. | 4 months after baseline | 
| Healthcare care utilization | Differences between the two arms with respect to number of emergency room visits and hospitalizations in the year before and after study. | Comparing one year before to one year after study enrolment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eye movement desensitization and Reprocessing, Suicide