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Efficacy of an EMDR App for PTSD and SUD

C

Center for Addiction and Mental Health (CAMH)

Status

Not yet enrolling

Conditions

Posttraumatic Stress Disorder (PTSD)
Substance Use Disorders

Treatments

Other: Treatment as Usual (TAU)
Behavioral: A-EMDR

Study type

Interventional

Funder types

Other

Identifiers

NCT07146633
167-2023

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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"

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

24 participants in 2 patient groups, including a placebo group

A-EMDR
Experimental group
Treatment:
Behavioral: A-EMDR
Regular care
Placebo Comparator group
Treatment:
Other: Treatment as Usual (TAU)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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