Recruiting

A-EMDR

Sponsor:

Centre for Addiction and Mental Health

Code:

NCT07146633

Conditions

Posttraumatic Stress Disorder (PTSD)

Substance Use Disorders

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

A-EMDR

Treatment as Usual (TAU)

Study Details

Brief 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. 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.

Conditions

Posttraumatic Stress Disorder (PTSD)

Substance Use Disorders

Study ID

NCT07146633

Start date

Jan 20, 2026

Status verified date

Aug, 2025

Completion date

Jan 30, 2027

Anticipated

Primary completion date

Jan 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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"

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: A-EMDR

placebo comparator: Regular care

Interventions

A-EMDR

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.

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.

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 ]

Central Contacts and Locations

Locations

100 Stokes St

Recruiting

Toronto, Ontario, Canada

Contacts

Ahmed Hassan, MD

416-535-8501ahmed.hassan@camh.ca

Zeina Beidas, BSc

416-535-8501zeina.beidas@camh.ca

More Information

Sponsor

Centre for Addiction and Mental Health

Last update posted

May 22, 2026

Last verified

Aug, 2025

Keywords

  • EMDR
  • PTSD
  • substance dependence

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre for Addiction and Mental Health on 2026-05-22.