Eye Movement Desensitization and Reprocessing as a Treatment for Substance Use Disorders
Primary Purpose
Substance Use Disorders
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
EMDR
TAU
Sponsored by
About this trial
This is an interventional treatment trial for Substance Use Disorders
Eligibility Criteria
Inclusion Criteria:
- A primary DSM-5 diagnosis of moderate to severe SUD, assessed by a clinical interview.
- No active drug consumption.
- Having experienced one or more traumatic events, assessed by the Life Event Checklist DSM-5 (LEC-5) and the Childhood Trauma Questionnaire (CTQ).
- Current posttraumatic symptoms, evaluated with the Impact Event Scale-Revised (IES-R).
- Aged from 18 to 65 years old.
- Sign an informed consent to participate in the study.
- Capable of speaking and comprehending Catalan or Spanish.
Exclusion Criteria:
- Having received a trauma-focused therapy within the last 5 years.
- Severe dissociative symptoms according to the Dissociative Experience Scale (DES).
- Presence of acute suicidal ideation.
- Acute episode of a comorbid psychiatric disorder.
- Severe cognitive impairments.
- Medical illness that compromises the HPA-axis.
- Long-term exposure to corticoids.
- Claustrophobia.
- Subjects with pacemakers.
- Presence of metallic objects within the body.
- Pregnancy
Sites / Locations
- Hospital Clínic de BarcelonaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Eye Movement Desensitization and Reprocessing therapy
Treatment as usual
Arm Description
8 to 10 individual 60-minutes sessions over 2 months.
Same periodicity as the experimental group and at the same time range.
Outcomes
Primary Outcome Measures
time to relapse
Relapse is defined as a return to the addictive behavior, different from a punctual consumption, which is considered as a lapse. This will bee measured by the Time Line Follow Back self-report (TLFB)
Secondary Outcome Measures
changes in functional connectivity
measured by resting-state fMRI
percentage of conditioned eyeblink responses (CR)
measured by the Eyeblink Conditioning System
CR latency, CR onset, and CR amplitude.
measured by the Eyeblink Conditioning System
Hair and salivary cortisol levels
Comparison of the Area Under the Curve pre and post treatment
Craving
Self-report measurement
Total amount of substance consumed during the previous month
measured by the TLFB
Changes in depressive symptomatology
measured by Beck's Depression Inventory (BDI)
Changes in anxious symptomatology
measured by The State-Trait Anxiety Inventory (STAI)
Changes in posttraumatic symptomatology
measured by Clinician-Administered PTSD Scale (CAPS)
Changes in global functioning
measured by Functioning Assessment Short Test (FAST)
Full Information
NCT ID
NCT05488691
First Posted
June 2, 2022
Last Updated
September 27, 2023
Sponsor
Hospital Clinic of Barcelona
1. Study Identification
Unique Protocol Identification Number
NCT05488691
Brief Title
Eye Movement Desensitization and Reprocessing as a Treatment for Substance Use Disorders
Official Title
What Works and Why? Eye Movement Desensitization and Reprocessing as a Potential Treatment for Substance Use Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Clinic of Barcelona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Substance Use Disorders (SUD) are often comorbid with psychological trauma, however, the complex interaction between the two is not yet fully understood. Most addiction-specialized professionals do not engage in exploring past traumatic experiences of the patients due to personal, professional, and educational barriers. Therefore, psychological trauma remains highly undetected and its contribution to the development and maintenance of SUD is neglected. This compromises the therapeutic results of most interventions, with relapse rates in SUD still remaining impressively high. EMDR is one of the most effective interventions for Post-Traumatic Stress Disorder (PTSD), and has been applied to other disorders that are often comorbid with trauma, such as psychosis and depression, with promising results. Nevertheless, its application in SUD is still limited. Taken altogether, there is a need to clarify the efficacy of Eye Movement Desensitization and Reprocessing (EMDR) therapy in SUD, as well as the mechanisms of action that mediate its potential therapeutic effects.
The aim of this study is to 1) determine the efficacy of EMDR therapy in patients with SUD comorbid with psychological trauma, as well as whether changes in these clinical variables correspond to changes in salivary cortisol levels- a robust marker of the Hypothalamic-Pituitary-Adrenal (HPA) axis; 2) investigate the mechanisms of action of EMDR therapy, paying special attention to the key role that the cerebellum might play in mediating its therapeutic effects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Eye Movement Desensitization and Reprocessing therapy
Arm Type
Experimental
Arm Description
8 to 10 individual 60-minutes sessions over 2 months.
Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm Description
Same periodicity as the experimental group and at the same time range.
Intervention Type
Behavioral
Intervention Name(s)
EMDR
Intervention Description
The first session consists of recording the patient's history. In the second session the therapist evaluates the presence of coping mechanisms of the patient and, if necessary, suggests extra coping techniques. The following sessions are devoted to the reprocessing process. During these sessions, a target memory is identified and processed using EMDR. After a total of 8-10 sessions, it is expected that the patient will have achieved physiological reconciliation, relieved distress, and the ability to reformulate negative beliefs.
Intervention Type
Behavioral
Intervention Name(s)
TAU
Intervention Description
treatment as usual for substance use disorders
Primary Outcome Measure Information:
Title
time to relapse
Description
Relapse is defined as a return to the addictive behavior, different from a punctual consumption, which is considered as a lapse. This will bee measured by the Time Line Follow Back self-report (TLFB)
Time Frame
2 months
Secondary Outcome Measure Information:
Title
changes in functional connectivity
Description
measured by resting-state fMRI
Time Frame
2 months
Title
percentage of conditioned eyeblink responses (CR)
Description
measured by the Eyeblink Conditioning System
Time Frame
2 months
Title
CR latency, CR onset, and CR amplitude.
Description
measured by the Eyeblink Conditioning System
Time Frame
2 months
Title
Hair and salivary cortisol levels
Description
Comparison of the Area Under the Curve pre and post treatment
Time Frame
2 months
Title
Craving
Description
Self-report measurement
Time Frame
2 months 3 months and 5 months
Title
Total amount of substance consumed during the previous month
Description
measured by the TLFB
Time Frame
2 months, 3 months and 5 months
Title
Changes in depressive symptomatology
Description
measured by Beck's Depression Inventory (BDI)
Time Frame
2 months, 3 months and 5 months
Title
Changes in anxious symptomatology
Description
measured by The State-Trait Anxiety Inventory (STAI)
Time Frame
2 months, 3 months and 5 months
Title
Changes in posttraumatic symptomatology
Description
measured by Clinician-Administered PTSD Scale (CAPS)
Time Frame
2 months, 3 months and 5 months
Title
Changes in global functioning
Description
measured by Functioning Assessment Short Test (FAST)
Time Frame
2 months, 3 months and 5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A primary DSM-5 diagnosis of moderate to severe SUD, assessed by a clinical interview.
No active drug consumption.
Having experienced one or more traumatic events, assessed by the Life Event Checklist DSM-5 (LEC-5) and the Childhood Trauma Questionnaire (CTQ).
Current posttraumatic symptoms, evaluated with the Impact Event Scale-Revised (IES-R).
Aged from 18 to 65 years old.
Sign an informed consent to participate in the study.
Capable of speaking and comprehending Catalan or Spanish.
Exclusion Criteria:
Having received a trauma-focused therapy within the last 5 years.
Severe dissociative symptoms according to the Dissociative Experience Scale (DES).
Presence of acute suicidal ideation.
Acute episode of a comorbid psychiatric disorder.
Severe cognitive impairments.
Medical illness that compromises the HPA-axis.
Long-term exposure to corticoids.
Claustrophobia.
Subjects with pacemakers.
Presence of metallic objects within the body.
Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laia Miquel de Montagut
Phone
+34932275400
Ext
1719
Email
miquel@clinic.cat
Facility Information:
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laia Miquel, MD
Phone
+34932275400
Ext
1719
Email
MIQUEL@clinic.cat
12. IPD Sharing Statement
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Eye Movement Desensitization and Reprocessing as a Treatment for Substance Use Disorders
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