Efficacy of an EMDR App for PTSD and SUD

NCT07146633 | Recruiting

• 1 other identifier: 167-2023
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

EMDR; PTSD; substance dependence

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  From enrollment to the end of the treatment at 4 weeks

Study Arms (2)

A-EMDR

EXPERIMENTAL

Behavioral: A-EMDR

Regular care

PLACEBO COMPARATOR

Other: Treatment as Usual (TAU)

Interventions

A-EMDR BEHAVIORAL

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.

A-EMDR

Treatment as Usual (TAU) OTHER

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.

Regular care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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"

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

100 Stokes St

Toronto, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Substance-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Chemically-Induced Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 28, 2025
• Study Start: January 20, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): January 30, 2027
• Last Updated: May 22, 2026

Record last verified: 2025-08

Locations

CA (1)