RCT Investigating EMDR for Suicidal Ideation

NCT04181047 | Completed

• 1 other identifier: Pro00090989
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicidal Ideation

Keywords

Eye movement desensitization and Reprocessing, Suicide

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (19)

• ACES Questionnaire (ACES)

  Baseline only

• DES II (Dissociative Experiences Scale II).

  Baseline

• DES II (Dissociative Experiences Scale II).

  4 months after baseline

• BDI II (Beck Depression Inventory II)

  Baseline

• BDI II (Beck Depression Inventory II)

  2 months after baseline

Study Arms (2)

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.

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.

Other: Usual care

Interventions

Eye Movement Desensitization and Reprocessing (EMDR) BEHAVIORAL

Psychotherapy.

Virtual EMDR

Usual care OTHER

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.

Treatment as usual; Virtual EMDR

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• Alberta Health services: collaborator

Study Sites (1)

Alberta Hospital Edmonton - recruiting from AHS clinics internally

Edmonton, Alberta, T5J 2J7, Canada

Location

Related Publications (6)

• 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.

  PMID: 31695382 BACKGROUND

• 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.

  PMID: 31072317 BACKGROUND

• 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.

  PMID: 28665329 BACKGROUND

• 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.

  PMID: 30013726 BACKGROUND

• Burback 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.

  PMID: 38435978 DERIVED

• Winkler 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.

  PMID: 34734835 DERIVED

MeSH Terms

Conditions

Suicidal Ideation; Suicide

Interventions

Eye Movement Desensitization Reprocessing

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Lisa M Burback, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Non-blinded randomized controlled trial.

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: November 29, 2019
• Study Start: April 12, 2021
• Primary Completion: August 14, 2023
• Study Completion: April 4, 2024
• Last Updated: April 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)