Suicidal IdeationNCT04181047
RCT Investigating EMDR for Suicidal Ideation
A study testing Eye Movement Desensitization and Reprocessing (EMDR) in people with Suicidal Ideation, run by University of Alberta at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Suicidal Ideation
- What is being tested?
- Eye Movement Desensitization and Reprocessing (EMDR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- 12 Apr 2021to 4 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Alberta Hospital Edmonton - recruiting from AHS clinics internally
Edmonton, Alberta, T5J 2J7
About this study
Official title: RCT Investigating Virtual Eye Movement Desensitization and Reprocessing (EMDR) for Adults With Suicidal Ideation
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.
Read the 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.
- Conditions
- Suicidal Ideation
- Being tested
- Eye Movement Desensitization and Reprocessing (EMDR), Usual care
- Keywords
- Eye movement desensitization and Reprocessing, Suicide
- Medical subject headings
- Suicidal Ideation, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye Movement Desensitization and Reprocessing (EMDR)Behavioural
Psychotherapy.
Usual careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual EMDR | Experimental | 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. Receives: Behavioral: Eye Movement Desensitization and Reprocessing (EMDR); Other: Usual care |
| Treatment as usual | Active comparator | 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. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 4 months
Secondary outcomes (19)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Comparing one year before to one year after study enrolment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start12 Apr 2021
- Primary completion14 Aug 2023
- Study completion4 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Non-blinded randomized controlled trial.
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Health services
- Responsible party
- Sponsor
- Investigators
- Lisa M Burback, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04181047
- Sponsor's protocol ID
- Pro00090989
- Status last verified
- Apr 2024
- First submitted
- 26 Nov 2019
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is not in the plan.
Publications
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.
PubMed 31695382van 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.
PubMed 31072317Bentum 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.
PubMed 28665329Van 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.
PubMed 30013726Burback L, Yap S, Purdon SE, Abba-Aji A, O'Shea K, Bremault-Phillips S, Greenshaw AJ, Winkler O. Randomized controlled trial investigating web-based, therapist delivered eye movement desensitization and reprocessing for adults with suicidal ideation. Front Psychiatry. 2024 Feb 16;15:1361086. doi: 10.3389/fpsyt.2024.1361086. eCollection 2024.
PubMed 38435978Winkler O, Dhaliwal R, Greenshaw A, O'Shea K, Abba-Aji A, Chima C, Purdon SE, Burback L. Web-Based Eye Movement Desensitization and Reprocessing for Adults With Suicidal Ideation: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Nov 4;10(11):e30711. doi: 10.2196/30711.
PubMed 34734835
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT Investigating Virtual Eye Movement Desensitization and Reprocessing (EMDR) for Adults With Suicidal Ideation
- ClinicalTrials.gov ID
- NCT04181047
- Acronym / sponsor ID
- Pro00090989
- Conditions
- Suicidal Ideation
- Keywords
- Eye movement desensitization and Reprocessing, Suicide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Alberta Health services
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 14 Aug 2023 (actual)
- Study completion
- 4 Apr 2024 (actual)
- First posted
- 29 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-blinded randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Virtual EMDR | Experimental | Behavioral: Eye Movement Desensitization and Reprocessing (EMDR), Other: Usual carePatients 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 | Active comparator | Other: Usual careThis 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye Movement Desensitization and Reprocessing (EMDR)Psychotherapy. | Behavioural | Virtual EMDR |
| Usual careAccess 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. | Other | Treatment as usual, Virtual EMDR |
Primary outcome
Beck Scale for Suicide ideation (BSS)
Time frame: Baseline
21 item questionnaire on suicidal ideation and behaviour in past 1week. Score range 0 to 42, with higher scores worse in outcome.
Beck Scale for Suicide ideation (BSS)
Time frame: 2 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.
Beck Scale for Suicide ideation (BSS)
Time frame: 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)
Time frame: Baseline
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.
Columbia Suicide Severity Rating Scale (CSSRS) Recent (self report of past 1 week)
Time frame: 2 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.
Columbia Suicide Severity Rating Scale (CSSRS) Recent (self report of past 1 week)
Time frame: 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.
19 secondary outcomes
ACES Questionnaire (ACES)
Time frame: Baseline only
DES II (Dissociative Experiences Scale II).
Time frame: Baseline
DES II (Dissociative Experiences Scale II).
Time frame: 4 months after baseline
BDI II (Beck Depression Inventory II)
Time frame: Baseline
BDI II (Beck Depression Inventory II)
Time frame: 2 months after baseline
BDI II (Beck Depression Inventory II)
Time frame: 4 months after baseline
PHQ-9 (Patient Health Questionnaire 9).
Time frame: Baseline
PHQ-9 (Patient Health Questionnaire 9).
Time frame: 2 months after baseline
PHQ-9 (Patient Health Questionnaire 9).
Time frame: 4 months after baseline
GAD 7 (Generalized Anxiety Disorder 7)
Time frame: Baseline
GAD 7 (Generalized Anxiety Disorder 7)
Time frame: 2 months after baseline
GAD 7 (Generalized Anxiety Disorder 7)
Time frame: 4 months after baseline
IES-R (Impact of Events Revised)
Time frame: Baseline
IES-R (Impact of Events Revised)
Time frame: 2 months after baseline
IES-R (Impact of Events Revised)
Time frame: 4 months after baseline
DERS (Difficulties in Emotion Regulation Scale)
Time frame: Baseline
DERS (Difficulties in Emotion Regulation Scale)
Time frame: 2 months after baseline
DERS (Difficulties in Emotion Regulation Scale)
Time frame: 4 months after baseline
Healthcare care utilization
Time frame: Comparing one year before to one year after study enrolment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Background: PubMed 31695382Fereidouni 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.
- Background: PubMed 31072317van 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.
- Background: PubMed 28665329Bentum 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.
- Background: PubMed 30013726Van 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.
- Derived from this study: PubMed 38435978Burback L, Yap S, Purdon SE, Abba-Aji A, O'Shea K, Bremault-Phillips S, Greenshaw AJ, Winkler O. Randomized controlled trial investigating web-based, therapist delivered eye movement desensitization and reprocessing for adults with suicidal ideation. Front Psychiatry. 2024 Feb 16;15:1361086. doi: 10.3389/fpsyt.2024.1361086. eCollection 2024.
- Derived from this study: PubMed 34734835Winkler O, Dhaliwal R, Greenshaw A, O'Shea K, Abba-Aji A, Chima C, Purdon SE, Burback L. Web-Based Eye Movement Desensitization and Reprocessing for Adults With Suicidal Ideation: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Nov 4;10(11):e30711. doi: 10.2196/30711.
- This link has a downloadable report outlining a pilot program using EMDR for people in suicidal crisis in the UK, led by Simon Proudlock.Link provided by the sponsor.
- Individual participant dataSharing planned: No. This is not in the plan.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa M Burback, MD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye Movement Desensitization and Reprocessing (EMDR) in people with Suicidal Ideation, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Scale for Suicide ideation (BSS) (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04181047, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2024.