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Recruiting NCT07146633

Efficacy of an EMDR App for PTSD and SUD

No phase Interventional Posttraumatic Stress Disorder (PTSD) Substance Use Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: A-EMDR, Treatment as Usual (TAU).
Who it may be relevant to
Registry conditions: Posttraumatic Stress Disorder (PTSD), Substance Use Disorders. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Behavioral 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, provi
  • Other 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 proto

Primary outcome measures

  • 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]
Secondary outcome measures (1)
  • 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]

Eligibility criteria

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"

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • 100 Stokes St — Toronto

Identifiers

NCT: NCT07146633 · 167-2023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗