NCT04027452

Brief Summary

This study will investigate whether ECT treatment can reduce the effect of traumatic memories if those memories are recalled immediately prior to the ECT sessions. Participants will be randomized to either a recall of a traumatic memory or a neutral non-traumatic memory prior to their ECT sessions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2016

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 22, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

September 3, 2020

Status Verified

September 1, 2020

Enrollment Period

4.5 years

First QC Date

July 4, 2019

Last Update Submit

September 2, 2020

Conditions

Post Traumatic Stress DisorderDepression

Keywords

electroconvulsive therapypost traumatic stress disorder

Outcome Measures

Primary Outcomes (2)

  • Change in Modified PTSD Symptom Scale (MPSS-SR) score

    17-item self-report measure that assesses the DSM-III-R symptoms of PTSD. Score range from 0-119, higher score indicates greater PTSD symptom severity.

    Baseline, after ECT treatment course (an average of 4 weeks), and at 3 month follow up

  • Change in Clinician Administered PTSD Scale for DSM-5 (CAPS-5) score

    30-item semi structured interview that is used to index of PTSD severity and assess PTSD symptoms over the past week. In addition to assessing the 20 DSM-5 PTSD symptoms, questions target the onset and duration of symptoms, subjective distress, and impact of symptoms on social and occupational functioning, improvement in symptoms since a previous CAPS administration, overall response validity, and features for the dissociative subtype (depersonalization and derealization). Administration requires identification of an index traumatic event to serve as the basis for symptom inquiry. Symptom severity scores range from 0 to 80, higher score indicates greater PTSD symptom severity.

    Baseline, after ECT treatment course (an average of 4 weeks), and at 3 month follow up

Secondary Outcomes (3)

  • Change in heart rate

    Change of heart rate from 0-30 seconds of the audio recording to heart rate from 90-120 seconds of the audio recording.

  • Skin conductance

    Change of skin conductance from 0-30 seconds of the audio recording to skin conductance from 90-120 seconds of the audio recording.

  • Change in The Quick Inventory of Depressive Symptomatology (Self-Report)

    Baseline, after ECT treatment course (an average of 4 weeks), and at 3 month follow up

Study Arms (2)

Traumatic memory reactivation

EXPERIMENTAL

Audio recording of traumatic memory that triggers symptoms of PTSD, anxiety, depression, played before each ECT treatment.

Behavioral: Traumatic memory reactivation

Neutral memory reactivation

PLACEBO COMPARATOR

Audio recording of neutral (non-traumatic) memory played before each ECT treatment.

Behavioral: Neutral memory reactivation

Interventions

Traumatic memory reactivationBEHAVIORAL

125 word long "exposure scripts" of their traumatic memory recorded in a neutral tone. All recordings will be approximately 30 seconds in length and the traumatic script will include five of the physical symptoms related to the memory as described by the patient. The script recording is preceded with short instructions for the subject to concentrate on the script and to imagine the described experience for additional 30 seconds right after the script until a short beep sounds. When the participant enters the treatment room, they will be handed an MP3 player with the audio recording. The patient will have several minutes to listen to the recording while the standard pre-ECT procedures are conducted. The participant will listen to the recording prior to each of their ECT treatments for the duration of their acute treatment course.

Traumatic memory reactivation
Neutral memory reactivationBEHAVIORAL

125 word long "exposure scripts" of a neutral (non-traumatic) memory recorded in a neutral tone. All recordings will be approximately 30 seconds in length and the traumatic script will include five of the physical symptoms related to the memory as described by the patient. The script recording is preceded with short instructions for the subject to concentrate on the script and to imagine the described experience for additional 30 seconds right after the script until a short beep sounds. When the participant enters the treatment room, they will be handed an MP3 player with the audio recording. The patient will have several minutes to listen to the recording while the standard pre-ECT procedures are conducted. The participant will listen to the recording prior to each of their ECT treatments for the duration of their acute treatment course.

Neutral memory reactivation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient referred and accepted for ECT treatment at CAMH
  • Presence of traumatic memories
  • Able to write about their traumatic experience(s)
  • Capable of informed consent to participate in this study
  • Age 18 or greater
  • MPSS-SR re-experiencing score (items 1-4, 17) ≥ 20

You may not qualify if:

  • History of neurological or developmental disorder, including seizures
  • ECT treatment already started

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1L8, Canada

Location

Related Publications (1)

  • Tang VM, Trought K, Gicas KM, Kozak M, Josselyn SA, Daskalakis ZJ, Blumberger DM, Voineskos D, Knyahnytska Y, Pasricha S, Chung Y, Zhou Y, Isserles M, Wong AHC. Electroconvulsive therapy with a memory reactivation intervention for post-traumatic stress disorder: A randomized controlled trial. Brain Stimul. 2021 May-Jun;14(3):635-642. doi: 10.1016/j.brs.2021.03.015. Epub 2021 Mar 27.

    PMID: 33785406DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticDepression

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavioral SymptomsBehavior

Study Officials

  • Albert HC Wong, MD, FRCPC, PhD

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 4, 2019

First Posted

July 22, 2019

Study Start

January 7, 2016

Primary Completion

July 1, 2020

Study Completion

July 1, 2020

Last Updated

September 3, 2020

Record last verified: 2020-09

Locations

CA(1)