Post Traumatic Stress DisorderNCT04027452
Electroconvulsive Therapy for Traumatic Memories
A study testing Traumatic memory reactivation and Neutral memory reactivation in people with Post Traumatic Stress Disorder and Depression, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder, Depression
- What is being tested?
- Traumatic memory reactivation and Neutral memory reactivation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- 7 Jan 2016to 1 Jul 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of neurological or developmental disorder, including seizures
- ECT treatment already started
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electroconvulsive Therapy for Traumatic Memories: A Randomized Controlled Clinical Trial
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.
Read the detailed description
Traumatic events contribute to the genesis of disorders such as post-traumatic stress disorder (PTSD) and depression, and memories of the event can cause ongoing distress. Short-term episodic memories are encoded by the hippocampus and gradually become consolidated through reciprocal connections with the cortex, resulting in long-term memories being stored in a distributed network throughout the cerebral cortex. There are no effective treatments currently for specifically targeting traumatic memories and reducing the distress they cause.
ECT is the most effective treatment for improving mood in patients with depression and there is new evidence emerging that suggests ECT can also improve PTSD symptoms independently of co-morbid depression. In addition, the main side-effect of ECT is memory loss, specifically for autobiographical details surrounding the course of ECT, but not typically affecting long-term episodic memory, nor procedural memories. Memories stored in the hippocampus are vulnerable to disruption by ECT because they rely on synaptic changes that are mediated by relatively unstable modifications in AMPA receptor and metabotropic glutamate receptor density. The investigators propose to exploit this feature of ECT, which normally is considered an undesirable side-effect of treatment, in an attempt to selectively reduce traumatic memories and the distress associated with them.
The investigators propose to recruit patients referred for ECT for treatment-resistant depression, who also have traumatic memories that are causing distress. These patients will be asked to write two narratives, one of the traumatic memory, and the other of a trivial, non-traumatic remote event. Patients will then be asked to listen to an audio recording of either the traumatic memory or the neutral memory (control group) immediately before their ECT sessions. The severity of the traumatic memory related symptoms will be assessed before and after the course of ECT using the Modified PTSD Symptom Scale (MPSS-SR) and the Clinician Administered PTSD Scale for DSM-5 (CAPS-5). Data will be analyzed by comparing the change in overall MPSS-SR scores and CAPS-5 scores pre- and post-ECT between the experimental and control groups. Physiological data will also be collected at each ECT session during the time the participant is listening to the audio recordings. Heart rate and skin conductance will be measured prior to and during listening of the traumatic or non-traumatic memory, in order to determine if there is a change associated with a stress response, and whether this response normalizes in association with reduction of PTSD symptoms with treatment.
- Conditions
- Post Traumatic Stress Disorder, Depression
- Being tested
- Traumatic memory reactivation, Neutral memory reactivation
- Keywords
- electroconvulsive therapy, post traumatic stress disorder
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traumatic memory reactivationBehavioural
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.
Neutral memory reactivationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Traumatic memory reactivation | Experimental | Audio recording of traumatic memory that triggers symptoms of PTSD, anxiety, depression, played before each ECT treatment. Receives: Behavioral: Traumatic memory reactivation |
| Neutral memory reactivation | Placebo comparator | Audio recording of neutral (non-traumatic) memory played before each ECT treatment. Receives: Behavioral: Neutral memory reactivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, after ECT treatment course (an average of 4 weeks), and at 3 month follow up
Secondary outcomes (3)
Change in heart rate
Heart rate change before and after listening to script of traumatic or neutral memory
Measured: 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
Skin conductance change before and after listening to script of traumatic or neutral memory
Measured: 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)
Self report scale of depressive symptoms. Scores range from 0-27, higher score indicates greater depression severity.
Measured: Baseline, after ECT treatment course (an average of 4 weeks), and at 3 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start7 Jan 2016
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies 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
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Albert Wong, Centre for Addiction and Mental Health
- Investigators
- Albert HC Wong, MD, FRCPC, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04027452
- Sponsor's protocol ID
- 063/2015
- Status last verified
- Sep 2020
- First submitted
- 4 Jul 2019
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33785406
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electroconvulsive Therapy for Traumatic Memories: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04027452
- Acronym / sponsor ID
- 063/2015
- Conditions
- Post Traumatic Stress Disorder, Depression
- Keywords
- electroconvulsive therapy, post traumatic stress disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 7 Jan 2016 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 22 Jul 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.
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.
Detailed description
Traumatic events contribute to the genesis of disorders such as post-traumatic stress disorder (PTSD) and depression, and memories of the event can cause ongoing distress. Short-term episodic memories are encoded by the hippocampus and gradually become consolidated through reciprocal connections with the cortex, resulting in long-term memories being stored in a distributed network throughout the cerebral cortex. There are no effective treatments currently for specifically targeting traumatic memories and reducing the distress they cause.
ECT is the most effective treatment for improving mood in patients with depression and there is new evidence emerging that suggests ECT can also improve PTSD symptoms independently of co-morbid depression. In addition, the main side-effect of ECT is memory loss, specifically for autobiographical details surrounding the course of ECT, but not typically affecting long-term episodic memory, nor procedural memories. Memories stored in the hippocampus are vulnerable to disruption by ECT because they rely on synaptic changes that are mediated by relatively unstable modifications in AMPA receptor and metabotropic glutamate receptor density. The investigators propose to exploit this feature of ECT, which normally is considered an undesirable side-effect of treatment, in an attempt to selectively reduce traumatic memories and the distress associated with them.
The investigators propose to recruit patients referred for ECT for treatment-resistant depression, who also have traumatic memories that are causing distress. These patients will be asked to write two narratives, one of the traumatic memory, and the other of a trivial, non-traumatic remote event. Patients will then be asked to listen to an audio recording of either the traumatic memory or the neutral memory (control group) immediately before their ECT sessions. The severity of the traumatic memory related symptoms will be assessed before and after the course of ECT using the Modified PTSD Symptom Scale (MPSS-SR) and the Clinician Administered PTSD Scale for DSM-5 (CAPS-5). Data will be analyzed by comparing the change in overall MPSS-SR scores and CAPS-5 scores pre- and post-ECT between the experimental and control groups. Physiological data will also be collected at each ECT session during the time the participant is listening to the audio recordings. Heart rate and skin conductance will be measured prior to and during listening of the traumatic or non-traumatic memory, in order to determine if there is a change associated with a stress response, and whether this response normalizes in association with reduction of PTSD symptoms with treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traumatic memory reactivation | Experimental | Behavioral: Traumatic memory reactivationAudio recording of traumatic memory that triggers symptoms of PTSD, anxiety, depression, played before each ECT treatment. |
| Neutral memory reactivation | Placebo comparator | Behavioral: Neutral memory reactivationAudio recording of neutral (non-traumatic) memory played before each ECT treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- History of neurological or developmental disorder, including seizures
- ECT treatment already started
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 |
|---|---|---|
| Traumatic memory reactivation125 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. | Behavioural | Traumatic memory reactivation |
| Neutral memory reactivation125 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. | Behavioural | Neutral memory reactivation |
Primary outcome
Change in Modified PTSD Symptom Scale (MPSS-SR) score
Time frame: Baseline, after ECT treatment course (an average of 4 weeks), and at 3 month follow up
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.
Change in Clinician Administered PTSD Scale for DSM-5 (CAPS-5) score
Time frame: Baseline, after ECT treatment course (an average of 4 weeks), and at 3 month follow up
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.
3 secondary outcomes
Change in heart rate
Time frame: 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
Time frame: 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)
Time frame: Baseline, after ECT treatment course (an average of 4 weeks), and at 3 month follow up
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 3 Sep 2020.
- Derived from this study: PubMed 33785406Tang 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.
- Individual participant dataSharing planned: Undecided
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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.
Albert HC Wong, MD, FRCPC, PhD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traumatic memory reactivation and Neutral memory reactivation in people with Post Traumatic Stress Disorder and Depression, run by Centre for Addiction and Mental Health 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 2 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 3 Sep 2020. 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. Some participants in this study may receive a placebo. 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?
Change in Modified PTSD Symptom Scale (MPSS-SR) score (time frame: Baseline, after ECT treatment course (an average of 4 weeks), and at 3 month follow up). The study lists 2 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 NCT04027452, which also lists 1 linked publication.
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 3 Sep 2020.