Posttraumatic Stress Disorder (PTSD)NCT07146633
Efficacy of an EMDR App for PTSD and SUD
A study testing A-EMDR and Treatment as Usual (TAU) in people with Posttraumatic Stress Disorder (PTSD) and Substance Use Disorders, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial summary
The current proposal is aimed to confirm the efficacy of this novel therapeutic method (autonomous eye movement desensitization and reprocessing; A-EMDR) in a patient group (PTSD and SUD), and to assess the feasibility of the application within this group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder (PTSD), Substance Use Disorders
- What is being tested?
- A-EMDR and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 20 Jan 2026to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Aged 18-years old or older
- Fluent in English
- Diagnosed with PTSD by the PTSD Checklist for DSM-5 (PCL-5 past month version score >32)
- Diagnosed with past-year substance use disorder other than caffeine by structured clinical interview for DSM-5 (SCID-5)
- Agrees not to participate in other treatments during the study duration (e.g., mindfulness, yoga, biofeedback, self-hypnosis or tai chi) except individuals who have been already on continuous therapies for at least three months
Who cannot join
- Diagnosis of a severe or unstable mental illness that precludes safe participation in the study by a healthcare practitioner such as acute psychosis or mania diagnosed by a healthcare practitioner
- Current suicidality risk as indicated during the conduct of the Columbia Suicide Severity Rating Scale (C-SSRS) (21) with concurrence after a study physician's evaluation if the response to C-SSRS questions 1 or 2 is "yes"
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
100 Stokes St
Toronto, Ontario
Ahmed Hassan, MD, 416-535-8501, ahmed.hassan@camh.ca
Zeina Beidas, BSc, 416-535-8501 ext. 31995, zeina.beidas@camh.ca
About this study
Official title: Efficacy and Feasibility of Autonomous Eye Movement Desensitization and Reprocessing (A-EMDR) for Patients With Posttraumatic Stress Disorder (PTSD) and Substance Use Disorders
The current proposal is aimed to confirm the efficacy of this novel therapeutic method (autonomous eye movement desensitization and reprocessing; A-EMDR) in a patient group (PTSD and SUD), and to assess the feasibility of the application within this group. While there is no basis to assume lower efficacy of the treatment with this population, confirming that hypothesis is an important and helpful step before a full-performance research study can be initiated. Furthermore, this study proposal will provide additional information regarding the feasibility for this population, which will allow for a more tailored approach in future study.
Read the detailed description
This is an open-label pilot randomized, wait-list controlled trial evaluating A-EMDR for the treatment of PTSD in patients with SUD for four weeks with a follow up at week eight. Primary outcomes will be measured at the end of the study (week 4) for both groups and at follow up (week 8) for the A-EMDR group.
- Being tested
- A-EMDR, Treatment as Usual (TAU)
- Keywords
- EMDR, PTSD, substance dependence
- Medical subject headings
- Stress Disorders, Post-Traumatic, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A-EMDRBehavioural
Participants in the treatment group will receive Autonomous Eye movement desensitization and reprocessing (A-EMDR) therapy delivered through an app on their device. Participants will be asked to complete 3 sessions per week for 4 consecutive weeks. During the treatment period, participants will also attend clinical sessions which will focus on factors such as the therapeutic alliance, assessing the participant's current state, reviewing recent alcohol and drug use, reviewing PTSD symptoms, providing a brief counseling intervention, enhancing positive expectancies, inspiring hope, and encouraging adherence to the study protocol.
Participants are advised to continue seeking mental health care as usual and will be added to a waitlist for A-EMDR. They will also attend two clinical sessions. Sessions may last 15 to 60 minutes and will focus on factors such as the therapeutic alliance, assessing the participant's current state, reviewing recent alcohol and drug use, reviewing PTSD symptoms, providing a brief counseling intervention, enhancing positive expectancies, inspiring hope, and encouraging adherence to the study protocol. Participants will continue to receive any usual healthcare services as per local standard of care. TAU and other medical appointments will be checked for attendance throughout the study period.
| Study group | Role | What they receive |
|---|---|---|
| A-EMDR | Experimental | Not described Receives: Behavioral: A-EMDR |
| Regular care | Placebo comparator | Not described Receives: Other: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in PTSD symptoms and alcohol/drug consumption during 4 weeks of treatment.
We will monitor changes in PTSD symptoms using the clinician-administered PTSD Scale DSM-5 (CAPS-5)/PTSD checklist for DSM-5 (PCL-5) from baseline to weeks four and eight. We will monitor overall alcohol and drug consumption and cravings using the TLFB and CEQ, respectively, over the eight weeks period. In line with previous studies, we will use the Brief Coping Orientation to Problems Experienced (COPE) and subjective measures of substance use coping questionnaire (i.e., How many times have you used a problematic substance for trauma-related problems in the last week? 1) to evaluate the exact frequency of substance used for coping with trauma-related problems from baseline to weeks four and eight. The change in these outcomes will be compared between the A-EMDR and TAU groups.
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (1)
The feasibility and engagement of A-EMDR during 4 weeks of treatment.
We will assess the feasibility and engagement of A-EMDR by evaluating the rate of retention (number of participants enrolled after deemed eligible, number of sessions completed for each participant, number of participants who withdraw and/or lost-to-follow-up after enrollment in the study) in the group over the four-week treatment period. We will assess acceptability using quantitative scales to determine their satisfaction with the treatment at weeks four and eight.
Measured: From enrollment to the end of the treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start20 Jan 2026
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07146633
- Sponsor's protocol ID
- 167-2023
- Status last verified
- Aug 2025
- First submitted
- 13 Aug 2025
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Feasibility of Autonomous Eye Movement Desensitization and Reprocessing (A-EMDR) for Patients With Posttraumatic Stress Disorder (PTSD) and Substance Use Disorders
- ClinicalTrials.gov ID
- NCT07146633
- Acronym / sponsor ID
- 167-2023
- Keywords
- EMDR, PTSD, substance dependence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 28 Aug 2025 (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.
The current proposal is aimed to confirm the efficacy of this novel therapeutic method (autonomous eye movement desensitization and reprocessing; A-EMDR) in a patient group (PTSD and SUD), and to assess the feasibility of the application within this group. While there is no basis to assume lower efficacy of the treatment with this population, confirming that hypothesis is an important and helpful step before a full-performance research study can be initiated. Furthermore, this study proposal will provide additional information regarding the feasibility for this population, which will allow for a more tailored approach in future study.
Detailed description
This is an open-label pilot randomized, wait-list controlled trial evaluating A-EMDR for the treatment of PTSD in patients with SUD for four weeks with a follow up at week eight. Primary outcomes will be measured at the end of the study (week 4) for both groups and at follow up (week 8) for the A-EMDR group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A-EMDR | Experimental | Behavioral: A-EMDR |
| Regular care | Placebo comparator | Other: Treatment as Usual (TAU) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18-years old or older
- Fluent in English
- Diagnosed with PTSD by the PTSD Checklist for DSM-5 (PCL-5 past month version score >32)
- Diagnosed with past-year substance use disorder other than caffeine by structured clinical interview for DSM-5 (SCID-5)
- Agrees not to participate in other treatments during the study duration (e.g., mindfulness, yoga, biofeedback, self-hypnosis or tai chi) except individuals who have been already on continuous therapies for at least three months
Key exclusion criteria (2 listed)
- Diagnosis of a severe or unstable mental illness that precludes safe participation in the study by a healthcare practitioner such as acute psychosis or mania diagnosed by a healthcare practitioner
- Current suicidality risk as indicated during the conduct of the Columbia Suicide Severity Rating Scale (C-SSRS) (21) with concurrence after a study physician's evaluation if the response to C-SSRS questions 1 or 2 is "yes"
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 |
|---|---|---|
| A-EMDRParticipants in the treatment group will receive Autonomous Eye movement desensitization and reprocessing (A-EMDR) therapy delivered through an app on their device. Participants will be asked to complete 3 sessions per week for 4 consecutive weeks. During the treatment period, participants will also attend clinical sessions which will focus on factors such as the therapeutic alliance, assessing the participant's current state, reviewing recent alcohol and drug use, reviewing PTSD symptoms, providing a brief counseling intervention, enhancing positive expectancies, inspiring hope, and encouraging adherence to the study protocol. | Behavioural | A-EMDR |
| Treatment as Usual (TAU)Participants are advised to continue seeking mental health care as usual and will be added to a waitlist for A-EMDR. They will also attend two clinical sessions. Sessions may last 15 to 60 minutes and will focus on factors such as the therapeutic alliance, assessing the participant's current state, reviewing recent alcohol and drug use, reviewing PTSD symptoms, providing a brief counseling intervention, enhancing positive expectancies, inspiring hope, and encouraging adherence to the study protocol. Participants will continue to receive any usual healthcare services as per local standard of care. TAU and other medical appointments will be checked for attendance throughout the study period. | Other | Regular care |
Primary outcome
Changes in PTSD symptoms and alcohol/drug consumption during 4 weeks of treatment.
Time frame: From enrollment to the end of treatment at 4 weeks
We will monitor changes in PTSD symptoms using the clinician-administered PTSD Scale DSM-5 (CAPS-5)/PTSD checklist for DSM-5 (PCL-5) from baseline to weeks four and eight. We will monitor overall alcohol and drug consumption and cravings using the TLFB and CEQ, respectively, over the eight weeks period. In line with previous studies, we will use the Brief Coping Orientation to Problems Experienced (COPE) and subjective measures of substance use coping questionnaire (i.e., How many times have you used a problematic substance for trauma-related problems in the last week? 1) to evaluate the exact frequency of substance used for coping with trauma-related problems from baseline to weeks four and eight. The change in these outcomes will be compared between the A-EMDR and TAU groups.
1 secondary outcome
The feasibility and engagement of A-EMDR during 4 weeks of treatment.
Time frame: From enrollment to the end of the treatment at 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A-EMDR and Treatment as Usual (TAU) in people with Posttraumatic Stress Disorder (PTSD) and Substance Use Disorders, 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 5 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: looking for participants now, as of the sponsor's last update on 22 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in PTSD symptoms and alcohol/drug consumption during 4 weeks of treatment. (time frame: From enrollment to the end of treatment at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2026.