RCT Investigating EMDR for Suicidal Ideation

Suicidal Ideation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04181047
• Other study ID #: Pro00090989
• Status: Completed
• Phase: N/A
• Start date: April 12, 2021
• Est. completion date: April 4, 2024

Study information

• Verified date: April 2024
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: April 4, 2024
• Est. primary completion date: August 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion criteria include

1. adults (ages 18 to 65) with suicidal ideation in the last week.

2. 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).

3. Participants must have a primary service provider.

4. 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.

5. Participants must be willing to refrain from benzodiazepine, cannabis or illicit substance use in the 24 hours before or after EMDR sessions.

6. Participants must be willing to adhere to the study safety precautions

Exclusion criteria

1. At the time of assessment, suicidal ideation is not accompanied by intent or plan to follow through with suicide.

2. Known pregnancy, as there is limited information about the impact of EMDR in pregnancy.

3. DES score above 34 or severe dissociative symptoms (see below), psychotic symptoms or manic symptoms.

4. 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

1. hearing internal voices,

2. amnestic episodes, or dissociative fugue states

3. passivity experiences or first rank symptoms under stress, or

4. the subjective experience of having alter personality self-states.

5. severe isolation of affect, with inability to feel body sensations or tune into emotions

Related Conditions & MeSH terms

• Suicidal Ideation

Intervention

Behavioral:
• Eye Movement Desensitization and Reprocessing (EMDR)
Psychotherapy.

Other:
• Usual care
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.

Locations

Country	Name	City	State
Canada	Alberta Hospital Edmonton - recruiting from AHS clinics internally	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Alberta Health services

Country where clinical trial is conducted

Canada, 

References & Publications (4)

Bentum JSV, Sijbrandij M, Huibers MJH, Huisman A, Arntz A, Holmes EA, Kerkhof AJFM. Treatment of Intrusive Suicidal Imagery Using Eye Movements. Int J Environ Res Public Health. 2017 Jun 30;14(7):714. doi: 10.3390/ijerph14070714. — View Citation

Fereidouni Z, Behnammoghadam M, Jahanfar A, Dehghan A. The Effect of Eye Movement Desensitization and Reprocessing (EMDR) on the severity of suicidal thoughts in patients with major depressive disorder: a randomized controlled trial. Neuropsychiatr Dis Treat. 2019 Aug 27;15:2459-2466. doi: 10.2147/NDT.S210757. eCollection 2019. — View Citation

van Bentum JS, Sijbrandij M, Kerkhof AJFM, Huisman A, Arntz AR, Holmes EA, Franx G, Mokkenstorm J, Huibers MJH. Treating repetitive suicidal intrusions using eye movements: study protocol for a multicenter randomized clinical trial. BMC Psychiatry. 2019 May 9;19(1):143. doi: 10.1186/s12888-019-2129-0. — View Citation

Van Woudenberg C, Voorendonk EM, Bongaerts H, Zoet HA, Verhagen M, Lee CW, van Minnen A, De Jongh A. Effectiveness of an intensive treatment programme combining prolonged exposure and eye movement desensitization and reprocessing for severe post-traumatic stress disorder. Eur J Psychotraumatol. 2018 Jul 10;9(1):1487225. doi: 10.1080/20008198.2018.1487225. eCollection 2018. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.

External Links

•   This link has a downloadable report outlining a pilot program using EMDR for people in suicidal crisis in the UK, led by Simon Proudlock.