Effectiveness of EMDR in patients with substance use disorder and comorbid PTSD study protocol for a randomized controlled trial

TY - JOUR

T1 - Effectiveness of EMDR in patients with substance use disorder and comorbid PTSD study protocol for a randomized controlled trial

AU - Schäfer, Ingo

AU - Chuey-Ferrer, Laycen

AU - Hofmann, Arne

AU - Lieberman, Peter

AU - Mainusch, Günter

AU - Lotzin, Annett

PY - 2017/3/16

Y1 - 2017/3/16

N2 - BACKGROUND: Eye Movement Desensitization and Reprocessing (EMDR) is an evidence-based treatment for PTSD. However, it is unclear whether EMDR shows the same effectiveness in patients with substance use disorders (SUD) and comorbid PTSD. In this trial, we examine the effectiveness of EMDR in reducing PTSD symptoms in patients with SUD and PTSD.METHODS/DESIGN: We conduct a single-blinded RCT among 158 patients with SUD and comorbid PTSD admitted to a German addiction rehabilitation center specialized for the treatment of patients with SUD and comorbid PTSD. Patients are randomized to receive either EMDR, added to SUD rehabilitation and non-trauma-focused PTSD treatment (TAU), or TAU alone. The primary outcome is change from baseline in PTSD symptom severity as measured by the Clinician-Administered PTSD Scale at 6-month follow-up. Secondary outcomes are change from baseline in substance use, addiction-related problems, depressive symptoms, dissociative symptoms, emotion dysregulation and quality of life. Assessments are carried out by blinded raters at admission, at end of treatment, and at 3- and 6-month follow-up. We expect that EMDR plus TAU will be more effective in reducing PTSD symptoms than TAU alone. Mixed models will be conducted using an intention-to-treat and per-protocol approach.DISCUSSION: This study aims to expand the knowledge about the effectiveness of EMDR in patients with SUD and comorbid PTSD. The expected finding of the superiority of EMDR in reducing PTSD symptoms compared to non-trauma-focused PTSD treatment may enhance the use of trauma-focused treatment approaches for patients with SUD and co-morbid PTSD.TRIAL REGISTRATION: German Clinical Trials Register: DRKS00009007 ; U1111-1172-9213. Retrospectively registered 01 Juni 2016.

AB - BACKGROUND: Eye Movement Desensitization and Reprocessing (EMDR) is an evidence-based treatment for PTSD. However, it is unclear whether EMDR shows the same effectiveness in patients with substance use disorders (SUD) and comorbid PTSD. In this trial, we examine the effectiveness of EMDR in reducing PTSD symptoms in patients with SUD and PTSD.METHODS/DESIGN: We conduct a single-blinded RCT among 158 patients with SUD and comorbid PTSD admitted to a German addiction rehabilitation center specialized for the treatment of patients with SUD and comorbid PTSD. Patients are randomized to receive either EMDR, added to SUD rehabilitation and non-trauma-focused PTSD treatment (TAU), or TAU alone. The primary outcome is change from baseline in PTSD symptom severity as measured by the Clinician-Administered PTSD Scale at 6-month follow-up. Secondary outcomes are change from baseline in substance use, addiction-related problems, depressive symptoms, dissociative symptoms, emotion dysregulation and quality of life. Assessments are carried out by blinded raters at admission, at end of treatment, and at 3- and 6-month follow-up. We expect that EMDR plus TAU will be more effective in reducing PTSD symptoms than TAU alone. Mixed models will be conducted using an intention-to-treat and per-protocol approach.DISCUSSION: This study aims to expand the knowledge about the effectiveness of EMDR in patients with SUD and comorbid PTSD. The expected finding of the superiority of EMDR in reducing PTSD symptoms compared to non-trauma-focused PTSD treatment may enhance the use of trauma-focused treatment approaches for patients with SUD and co-morbid PTSD.TRIAL REGISTRATION: German Clinical Trials Register: DRKS00009007 ; U1111-1172-9213. Retrospectively registered 01 Juni 2016.

KW - Adult

KW - Combined Modality Therapy

KW - Comorbidity

KW - Evidence-Based Medicine

KW - Eye Movement Desensitization Reprocessing

KW - Female

KW - Follow-Up Studies

KW - Germany

KW - Humans

KW - Interview, Psychological

KW - Male

KW - Middle Aged

KW - Quality of Life

KW - Rehabilitation Centers

KW - Single-Blind Method

KW - Stress Disorders, Post-Traumatic

KW - Substance-Related Disorders

KW - Treatment Outcome

KW - Young Adult

KW - Journal Article

KW - Randomized Controlled Trial

U2 - 10.1186/s12888-017-1255-9

DO - 10.1186/s12888-017-1255-9

M3 - SCORING: Journal article

C2 - 28302084

VL - 17

SP - 95

JO - BMC PSYCHIATRY

JF - BMC PSYCHIATRY

SN - 1471-244X

IS - 1

ER -