Clinical trial NCT03114423: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Psychotherapy
Substance Use Disorders
Keywords: EMDR
Psychotherapy
Substance Use Disorders
Eye Movement Desensitization and Reprocessing
Lead sponsor: Center of Integrative Addiction Research, Austria
Sponsor class: OTHER
Collaborators: name: Medical University of Graz
First posted: 2017-04-14
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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).

Primary outcomes:
measure: Emotion Regulation Questionnaire (ERQ)
timeFrame: Change of baseline values in ERQ after three treatments; follow-up_1 four weeks and follow-up_2 12 weeks after treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Johnsdorf
country: Austria
facility: Grüner Kreis, Verein zur Rehabilitation und Integration suchtkranker Menschen
state: Styria
Study officials:
affiliation: Center of Integrative Addiction Research, Austria
name: Human-Friedrich Unterrainer, PD DDr.
role: PRINCIPAL_INVESTIGATOR
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