Efficacy of an EMDR App for PTSD and SUD

NCT ID: NCT07146633

Last Updated: 2025-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-01

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Posttraumatic Stress Disorder (PTSD) Substance Use Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A-EMDR

Group Type EXPERIMENTAL

A-EMDR

Intervention Type 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.

Regular care

Group Type PLACEBO_COMPARATOR

Treatment as Usual (TAU)

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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"
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre for Addiction and Mental Health

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

167-2023

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Reconsolidation and EMDR
NCT02572830 COMPLETED NA
Cognitive Therapy for PTSD in Addiction Treatment
NCT00685451 COMPLETED PHASE1/PHASE2