Efficacy of an EMDR App for PTSD and SUD

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Changes in PTSD symptoms and alcohol/drug consumption during 4 weeks of treatment. — From enrollment to the end of treatment at 4 weeks
  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.

Trial sites (1)

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