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Eye Movement Desensitization and Reprocessing (EMDR) as a Treatment of Substance Use Disorders

Primary Purpose

Psychotherapy, Substance Use Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
EMDR-Therapy
Sham Intervention
Sponsored by
Center of Integrative Addiction Research, Austria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychotherapy focused on measuring EMDR, Psychotherapy, Substance Use Disorders, Eye Movement Desensitization and Reprocessing

Eligibility Criteria

18 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • male
  • SUD diagnosis
  • age between 18 and 60 years
  • patient must be stationary for at least six weeks
  • patient must be full contractual capability

Exclusion Criteria:

  • psychotic episode
  • comorbid severe dissociative symptoms
  • comorbid severe personality disorders
  • organic conditional seizure disorders, and somatic disorders (e.g., severe cardiac arrhythmias).

Sites / Locations

  • Grüner Kreis, Verein zur Rehabilitation und Integration suchtkranker MenschenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Treatment As Usual + Treatment with EMDR

Treatment As Usual + Cognitive Training

Arm Description

Outcomes

Primary Outcome Measures

Emotion Regulation Questionnaire (ERQ)
Emotion regulation is captured via 10 items on a 7-pint rating scale.

Secondary Outcome Measures

Full Information

First Posted
April 11, 2017
Last Updated
August 2, 2019
Sponsor
Center of Integrative Addiction Research, Austria
Collaborators
Medical University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT03114423
Brief Title
Eye Movement Desensitization and Reprocessing (EMDR) as a Treatment of Substance Use Disorders
Official Title
The Efficiency of Eye Movement Desensitization and Reprocessing (EMDR) for the Treatment of Substance Use Disorders: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 7, 2017 (Actual)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center of Integrative Addiction Research, Austria
Collaborators
Medical University of Graz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this clinical study is to examine the established, therapeutic EMDR intervention for patients with substance use disorders (SUD). The EMDR method is an integrative and structured therapeutic method which assumes that memories which have been dysfunctionally stored can lead to harmful behavior. The EMDR protocol used for this clinical trials has been specifically developed for patients with SUD - the results should be compared with traditional therapy. For the assessment of the EMDR treatment some questionnaires are given at several times.
Detailed Description
Substance use disorders (SUD) have been prominently described on a neuronal level as a chronic and relapsing brain disorder, which is associated with changes in emotion, motivation and cognition. Furthermore on a behavioral level, SUD have been found to be linked to an increased amount of attachment and personality pathology. More in general, SUD treatment has been demonstrated to be a complex phenomenon, with high relapse rates of 30-50% after (successful) treatment. As emotion regulation is associated with a vast amount of parameters of mental health and psychological well-being such as more satisfied employment, healthier relationships, better academic performance, and physical health, the long-term abuse of drugs on the other hand plays a detrimental role in patients' emotions and mind-sets. Research suggests that individuals who cannot regulate their emotions in an adequate way in everyday life, experience more mental turbulences or confusions. In turn this deficit might lead to substance abuse as one kind of dysfunctional method to regulate inner tensions. Specifically, an increased amount of impulsivity has been named as being predictive for addictive diseases. Accordingly, impulsivity was observed as being linked to a poorer SUD treatment outcome, especially by promoting relapse, as the emotion regulation is hindered and damaged in SUD patients. Thus the increase of capacities to moderate emotional strain becomes an important factor for the treatment of SUD. Accordingly, many SUD treatment approaches have developed specific techniques in order to address the deficient emotion regulation system. Furthermore a history of traumatic experiences may be essential for the therapeutic work, because individuals with SUD often present a history of trauma with comorbid rates of up to 75%. Consequentely, various findings suggest that traumatic experiences represent a high risk factor for the development of SUD. The method of Eye Movement Desensitization and Reprocessing (EMDR) is an integrative and well structured psychotherapeutic treatment which has received approval as an efficacious evidence-based approach for posttraumatic stress disorder (PTSD). EMDR, as a psychotherapeutic technique, accelerates the accessing and reprocessing of traumatic materials and supports the brain to release the nervous system from these traumatic experiences by means of normal handling of emotional information. Due to the fact that up to 40% of individuals with PTSD turn to substance abuse in their lifetime, EMDR is effective in the treatment of SUD especially in case of unsolved traumata, which are keeping up the vicious circle of SUD. Furthermore several studies suggest that EMDR is effective in addiction treatment by significantly reducing substance craving and thus also the rate of relapse, extending consecutive sobriety, as well as more than twice as many graduates in EMDR integrated programs. However, the evidence of the efficacy and effectiveness of EMDR on addiction treatment is still limited, because many findings are preliminary as being narratively or just case-study based or paying less attention to the role of emotions. Therefore, the purpose of this study is to further explore and determine the effectiveness of EMDR for the regulation of emotional processes in long-term addiction treatment. This study is conceptualized as a randomized controlled trial with two groups: EMDR + TAU vs. TAU + sham intervention (TAU: Treatment As Usual; the sham intervention is a cognitive training). The groups are compared pre-treatment, post-treatment, and there are two follow-up points of assessment: one month after post-treatment and three months after post-treatment. There will be a total sample of 60 clinical SUD male participants, which will be investigated during their in-patient stay at a therapeutic community center (after an initial phase of acclimatization of six weeks). One half of the sample: 30 participants will receive EMDR + TAU (experimental group; EG), the other half receives TAU + sham intervention (control group; CG).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotherapy, Substance Use Disorders
Keywords
EMDR, Psychotherapy, Substance Use Disorders, Eye Movement Desensitization and Reprocessing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment As Usual + Treatment with EMDR
Arm Type
Experimental
Arm Title
Treatment As Usual + Cognitive Training
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
EMDR-Therapy
Intervention Description
The EMDR-protocol from Hase (2008) was used
Intervention Type
Other
Intervention Name(s)
Sham Intervention
Intervention Description
For the training the COGPACK-program from Marker (2008) was used
Primary Outcome Measure Information:
Title
Emotion Regulation Questionnaire (ERQ)
Description
Emotion regulation is captured via 10 items on a 7-pint rating scale.
Time Frame
Change of baseline values in ERQ after three treatments; follow-up_1 four weeks and follow-up_2 12 weeks after treatment.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: male SUD diagnosis age between 18 and 60 years patient must be stationary for at least six weeks patient must be full contractual capability Exclusion Criteria: psychotic episode comorbid severe dissociative symptoms comorbid severe personality disorders organic conditional seizure disorders, and somatic disorders (e.g., severe cardiac arrhythmias).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rene Pilz, MSc MBA
Phone
004331638581479
Email
rene.pilz@medunigraz.at
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Human-Friedrich Unterrainer, PD DDr.
Organizational Affiliation
Center of Integrative Addiction Research, Austria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grüner Kreis, Verein zur Rehabilitation und Integration suchtkranker Menschen
City
Johnsdorf
State/Province
Styria
ZIP/Postal Code
8350
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Human-Friedrich Unterrainer, PD DDr.
Phone
0043 699 18195 990
Email
human.unterrainer@uni-graz.at

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Eye Movement Desensitization and Reprocessing (EMDR) as a Treatment of Substance Use Disorders

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