PTSDFlash-EMDRNCT05262127
Clinical Assessment of the Flash - Eye Movement Desensitization and Reprocessing
A study testing Flash Version of EMDR in people with PTSD, run by York University at 2 sites in Canada.
Trial summary
To assess the Flash version of EMDR in reductions of the disturbance of upsetting memories at post-intervention, and 1-month follow up within a double-blinded, online 2-arm randomized controlled trial (RCT) with self-report outcomes. We will assess 45 per group, adequate for the detection of a medium effect size. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- PTSD
- What is being tested?
- Flash Version of EMDR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Sep 2021to 1 Mar 2023
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Moderately upsetting or > memory of an event that occurred > 2 years ago and has since not repeated
- Moderately upsetting or > memory remains moderately upsetting when recalled
- Memory is not tied to an earlier memory that is equally disturbing or >
Who cannot join
- Bipolar Disorder
- Borderline Personality Disorder
- Obsessive-Compulsive Disorder
- Schizophrenia
- Substance Abuse/Addiction in past 3 months
- Suicidal ideation or attempted suicide in the past 6 months
Trial locations and contacts
2 sites in 1 country.
Canada2 sites, 2 recruiting
- Recruiting
York University
Toronto, Ontario, M3J 1P3
Paul Ritvo, PhD
- Recruiting
York University - School of Kinesiology and Health Science
Toronto, Ontario, M4E 3C1
Paul Ritvo, PhD, 4165808021, pritvo@yorku.ca
Nazanin Babaei, BSc, 4167362100, nazaninb@my.yorku.ca
About this study
Official title: Clinical Assessment of the Flash Version of Eye Movement Desensitization and Reprocessing in Memory Distress: A Double Blinded Randomized Controlled Trial
To assess the Flash version of EMDR in reductions of the disturbance of upsetting memories at post-intervention, and 1-month follow up within a double-blinded, online 2-arm randomized controlled trial (RCT) with self-report outcomes. We will assess 45 per group, adequate for the detection of a medium effect size.
This double-blinded, RCT will assess the comparative efficacy of these two online interventions designed to reduce memory disturbance.
Read the detailed description
This double-blinded, RCT compares the efficacy of 2 online interventions (Flash Version - EMDR; EMDR alone) designed to reduce memory disturbance.Inclusion Criteria: (1) approved for engagement assessment by the CloudResearch platform; (2) 25-60 years; 3) US-Canada residence; (4) a recalled disturbing memory of an event that has not repeated and was moderately upsetting, or greater when event occurred; (5) memory remains moderately upsetting or greater on recall. The disturbance of upsetting memories at post-intervention, and 1-month follow up will be assessed with self-report outcomes. We will assess 45 / group, adequate for the detection of a medium effect size. linked to an earlier memory (that is equally or more disturbing). Exclusion Criteria: Diagnosis of: (1) bipolar disorder; (2) borderline personality disorder; (3) obsessive compulsive disorder; (4) schizophrenia; (5) substance abuse/addiction in the past 3 months; (6) any suicidal ideation; (7) suicide attempt in the past 6 months. Interventions: Experimental participants observe video instructions of full FT, while controls receive an online intervention that follows traditional EMDR. Measures: Primary outcome: State Anxiety subscale of the State Trait Anxiety Inventory (STAI) at baseline, post-intervention, and after 1-month follow up; Post Traumatic Stress Disorder symptoms (PTSD) measured by PCL-5 (1 month follow up).
Secondary outcomes: the Subjective Units of Disturbance (SUDs) assessing change in immediately reported disturbance of recalled memories (baseline and post-intervention); depression measured by Patient Health Questionnaire (PHQ9) and Positive-Negative Affect measured by the Positive and Negative Affect Scale (PANAS).
- Conditions
- PTSD
- Being tested
- Flash Version of EMDR
- Keywords
- behavioural internet intervention, post-traumatic stress
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flash Version of EMDRBehavioural
EMDR and the inclusion of a positive engaging focus generated autonomously by participant
| Study group | Role | What they receive |
|---|---|---|
| Flash Version of EMDR | Active comparator | Flash methods (e.g. positive engaging focus) are used in addition to the standard EMDR techniques conveyed by video viewed online Receives: Behavioral: Flash Version of EMDR |
| EMDR - alone | Active comparator | Use of standard EMDR techniques conveyed by video online Receives: Behavioral: Flash Version of EMDR |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Checklist for DSM-5 (PCL-5) 1 - 44
Self Report Questionnaire
Measured: 1 month follow up
State-Trait Anxiety Inventory - State 0 - 80.
Self Report Questionnaire
Measured: 1 month follow up
Secondary outcomes (2)
Patient Health Questionnaire 0 - 27
Self Report Questionnaire
Measured: 1 month follow up
Positive and Negative Affect Schedule 20 - 100
Self Report Questionnaire
Measured: 1 month followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start1 Sep 2021
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2023 (estimated)
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 PTSDStudies 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
- Parallel group, double-blind randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- York University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Ritvo, York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05262127
- Sponsor's protocol ID
- 2021-141
- Acronym
- Flash-EMDR
- Status last verified
- Feb 2022
- First submitted
- 29 Dec 2021
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request, an anonymized data sheet (excel) will be sent
Publications
Babaei N, Kerry C, Goode K, Dang K, Mirzadeh P, Pirbaglou M, Kirk MA, Ritvo P. Clinical Assessment of Eye Movement Desensitization and Reprocessing in Memory Distress: Protocol for a Double-Blinded Randomized Controlled Trial. JMIR Res Protoc. 2023 May 12;12:e38552. doi: 10.2196/38552.
PubMed 37171869
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of the Flash Version of Eye Movement Desensitization and Reprocessing in Memory Distress: A Double Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05262127
- Acronym / sponsor ID
- Flash-EMDR / 2021-141
- Conditions
- PTSD
- Keywords
- behavioural internet intervention, post-traumatic stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- York UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 2 Mar 2022 (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.
To assess the Flash version of EMDR in reductions of the disturbance of upsetting memories at post-intervention, and 1-month follow up within a double-blinded, online 2-arm randomized controlled trial (RCT) with self-report outcomes. We will assess 45 per group, adequate for the detection of a medium effect size.
This double-blinded, RCT will assess the comparative efficacy of these two online interventions designed to reduce memory disturbance.
Detailed description
This double-blinded, RCT compares the efficacy of 2 online interventions (Flash Version - EMDR; EMDR alone) designed to reduce memory disturbance.Inclusion Criteria: (1) approved for engagement assessment by the CloudResearch platform; (2) 25-60 years; 3) US-Canada residence; (4) a recalled disturbing memory of an event that has not repeated and was moderately upsetting, or greater when event occurred; (5) memory remains moderately upsetting or greater on recall. The disturbance of upsetting memories at post-intervention, and 1-month follow up will be assessed with self-report outcomes. We will assess 45 / group, adequate for the detection of a medium effect size. linked to an earlier memory (that is equally or more disturbing). Exclusion Criteria: Diagnosis of: (1) bipolar disorder; (2) borderline personality disorder; (3) obsessive compulsive disorder; (4) schizophrenia; (5) substance abuse/addiction in the past 3 months; (6) any suicidal ideation; (7) suicide attempt in the past 6 months. Interventions: Experimental participants observe video instructions of full FT, while controls receive an online intervention that follows traditional EMDR. Measures: Primary outcome: State Anxiety subscale of the State Trait Anxiety Inventory (STAI) at baseline, post-intervention, and after 1-month follow up; Post Traumatic Stress Disorder symptoms (PTSD) measured by PCL-5 (1 month follow up).
Secondary outcomes: the Subjective Units of Disturbance (SUDs) assessing change in immediately reported disturbance of recalled memories (baseline and post-intervention); depression measured by Patient Health Questionnaire (PHQ9) and Positive-Negative Affect measured by the Positive and Negative Affect Scale (PANAS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel group, double-blind randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Flash Version of EMDR | Active comparator | Behavioral: Flash Version of EMDRFlash methods (e.g. positive engaging focus) are used in addition to the standard EMDR techniques conveyed by video viewed online |
| EMDR - alone | Active comparator | Behavioral: Flash Version of EMDRUse of standard EMDR techniques conveyed by video online |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Moderately upsetting or > memory of an event that occurred > 2 years ago and has since not repeated
- Moderately upsetting or > memory remains moderately upsetting when recalled
- Memory is not tied to an earlier memory that is equally disturbing or >
Key exclusion criteria (6 listed)
- Bipolar Disorder
- Borderline Personality Disorder
- Obsessive-Compulsive Disorder
- Schizophrenia
- Substance Abuse/Addiction in past 3 months
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 |
|---|---|---|
| Flash Version of EMDREMDR and the inclusion of a positive engaging focus generated autonomously by participant | Behavioural | EMDR - alone, Flash Version of EMDR |
Primary outcome
PTSD Checklist for DSM-5 (PCL-5) 1 - 44
Time frame: 1 month follow up
Self Report Questionnaire
State-Trait Anxiety Inventory - State 0 - 80.
Time frame: 1 month follow up
Self Report Questionnaire
2 secondary outcomes
Patient Health Questionnaire 0 - 27
Time frame: 1 month follow up
Positive and Negative Affect Schedule 20 - 100
Time frame: 1 month followup
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Derived from this study: PubMed 37171869Babaei N, Kerry C, Goode K, Dang K, Mirzadeh P, Pirbaglou M, Kirk MA, Ritvo P. Clinical Assessment of Eye Movement Desensitization and Reprocessing in Memory Distress: Protocol for a Double-Blinded Randomized Controlled Trial. JMIR Res Protoc. 2023 May 12;12:e38552. doi: 10.2196/38552.
- Individual participant dataSharing planned: Yes. Upon request, an anonymized data sheet (excel) will be sent
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flash Version of EMDR in people with PTSD, run by York University at 2 sites 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul Ritvo, PhD (4165808021, pritvo@yorku.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Checklist for DSM-5 (PCL-5) 1 - 44 (time frame: 1 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 NCT05262127, 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 4 Jan 2023.