Efficacy of an EMDR App for PTSD and SUD
- Conditions
- Posttraumatic Stress Disorder (PTSD)Substance Use Disorders
- Registration Number
- NCT07146633
- Lead Sponsor
- Centre for Addiction and Mental Health
- 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.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 24
- 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
- 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"
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method The feasibility and engagement of A-EMDR during 4 weeks of treatment. From enrollment to the end of the treatment at 4 weeks We will assess the feasibility and engagement of A-EMDR by evaluating the rate of retention (number of participants enrolled after deemed eligible, number of sessions completed for each participant, number of participants who withdraw and/or lost-to-follow-up after enrollment in the study) in the group over the four-week treatment period. We will assess acceptability using quantitative scales to determine their satisfaction with the treatment at weeks four and eight.