NCT03114423

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 7, 2017

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 11, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 14, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

August 5, 2019

Status Verified

August 1, 2019

Enrollment Period

3.4 years

First QC Date

April 11, 2017

Last Update Submit

August 2, 2019

Conditions

Keywords

EMDRPsychotherapySubstance Use DisordersEye Movement Desensitization and Reprocessing

Outcome Measures

Primary Outcomes (1)

  • Emotion Regulation Questionnaire (ERQ)

    Emotion regulation is captured via 10 items on a 7-pint rating scale.

    Change of baseline values in ERQ after three treatments; follow-up_1 four weeks and follow-up_2 12 weeks after treatment.

Study Arms (2)

Treatment As Usual + Treatment with EMDR

EXPERIMENTAL
Other: EMDR-Therapy

Treatment As Usual + Cognitive Training

SHAM COMPARATOR
Other: Sham Intervention

Interventions

The EMDR-protocol from Hase (2008) was used

Treatment As Usual + Treatment with EMDR

For the training the COGPACK-program from Marker (2008) was used

Treatment As Usual + Cognitive Training

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grüner Kreis, Verein zur Rehabilitation und Integration suchtkranker Menschen

Johnsdorf, Styria, 8350, Austria

RECRUITING

Related Publications (28)

  • Abel, N. J., & O'Brien, J. M. (2010). EMDR Treatment of Comorbid PTSD and Alcohol Dependence: A Case Example. Journal of EMDR Practice and Research, 4(2), 50-59. http://doi.org/10.1891/1933-3196.4.2.50.

    BACKGROUND
  • Abler, B., & Kessler, H. (2009). Emotion Regulation Questionnaire - Eine Deutschsprachige Fassung des ERQ von Gross und John. Diagnostica, 55(3), 144-152. http://doi.org/10.1026/0012-1924.55.3.144.

    BACKGROUND
  • Aldao A, Nolen-Hoeksema S, Schweizer S. Emotion-regulation strategies across psychopathology: A meta-analytic review. Clin Psychol Rev. 2010 Mar;30(2):217-37. doi: 10.1016/j.cpr.2009.11.004. Epub 2009 Nov 20.

    PMID: 20015584BACKGROUND
  • Ursano RJ, Bell C, Eth S, Friedman M, Norwood A, Pfefferbaum B, Pynoos JD, Zatzick DF, Benedek DM, McIntyre JS, Charles SC, Altshuler K, Cook I, Cross CD, Mellman L, Moench LA, Norquist G, Twemlow SW, Woods S, Yager J; Work Group on ASD and PTSD; Steering Committee on Practice Guidelines. Practice guideline for the treatment of patients with acute stress disorder and posttraumatic stress disorder. Am J Psychiatry. 2004 Nov;161(11 Suppl):3-31. No abstract available.

    PMID: 15617511BACKGROUND
  • Brown, S. H., Gilman, S. G., Goodman, E. G., Adler-Tapia, R., & Freng, S. (2015). Integrated Trauma Treatment in Drug Court: Combining EMDR Therapy and Seeking Safety. Journal of EMDR Practice and Research, 9(3), 123-136. http://dx.doi.org/10.1891/1933-3196.9.3.123

    BACKGROUND
  • Ersche KD, Sahakian BJ. The neuropsychology of amphetamine and opiate dependence: implications for treatment. Neuropsychol Rev. 2007 Sep;17(3):317-36. doi: 10.1007/s11065-007-9033-y. Epub 2007 Aug 10.

    PMID: 17690986BACKGROUND
  • Flores, J. P., 2004. Addiction as an Attachment Disorder. Maryland: Jason Aronson Inc. Publishers. Franke, G. H. (2000). Brief Symptom Inventory (BSI). Göttingen: Beltz.

    BACKGROUND
  • Hase, M., Schallmayer, S., & Sack, M. (2008). EMDR Reprocessing of the Addiction Memory: Pretreatment, Posttreatment, and 1-Month Follow-Up. Journal of EMDR Practice and Research, 2(3), 170-179. http://doi.org/10.1891/1933-3196.2.3.170.

    BACKGROUND
  • Homer BD, Solomon TM, Moeller RW, Mascia A, DeRaleau L, Halkitis PN. Methamphetamine abuse and impairment of social functioning: a review of the underlying neurophysiological causes and behavioral implications. Psychol Bull. 2008 Mar;134(2):301-10. doi: 10.1037/0033-2909.134.2.301.

    PMID: 18298273BACKGROUND
  • Jacobsen LK, Southwick SM, Kosten TR. Substance use disorders in patients with posttraumatic stress disorder: a review of the literature. Am J Psychiatry. 2001 Aug;158(8):1184-90. doi: 10.1176/appi.ajp.158.8.1184.

    PMID: 11481147BACKGROUND
  • Klinitzke G, Romppel M, Hauser W, Brahler E, Glaesmer H. [The German Version of the Childhood Trauma Questionnaire (CTQ): psychometric characteristics in a representative sample of the general population]. Psychother Psychosom Med Psychol. 2012 Feb;62(2):47-51. doi: 10.1055/s-0031-1295495. Epub 2011 Dec 27. German.

    PMID: 22203470BACKGROUND
  • Lee, C. W., Taylor, G., & Drummond, P. D. (2006). The active ingredient in EMDR: Is it traditional exposure or dual focus of attention? Clinical Psychology and Psychotherapy, 13(2), 97-107. http://doi.org/10.1002/cpp.479.

    BACKGROUND
  • Loree AM, Lundahl LH, Ledgerwood DM. Impulsivity as a predictor of treatment outcome in substance use disorders: review and synthesis. Drug Alcohol Rev. 2015 Mar;34(2):119-34. doi: 10.1111/dar.12132. Epub 2014 Mar 31.

    PMID: 24684591BACKGROUND
  • Marich J. Eye movement desensitization and reprocessing in addiction continuing care: a phenomenological study of women in recovery. Psychol Addict Behav. 2010 Sep;24(3):498-507. doi: 10.1037/a0018574.

    PMID: 20853935BACKGROUND
  • Marissen MA, Franken IH, Blanken P, van den Brink W, Hendriks VM. Cue exposure therapy for the treatment of opiate addiction: results of a randomized controlled clinical trial. Psychother Psychosom. 2007;76(2):97-105. doi: 10.1159/000097968.

    PMID: 17230050BACKGROUND
  • Meysami-Bonab, S., Abolghasemi, A., Sheikhian, M., Barahmand, U., & Rasooliazad, M. (2012). The Effectiveness of Eye Movement Desensitization and Reprocessing Therapy on the Emotion Regulation and Emotion Recognition of Addicted Individuals. Zahedan Journal of Research in Medical Sciences, 14(10), 33-37.

    BACKGROUND
  • Moos RH, Moos BS. Rates and predictors of relapse after natural and treated remission from alcohol use disorders. Addiction. 2006 Feb;101(2):212-22. doi: 10.1111/j.1360-0443.2006.01310.x.

    PMID: 16445550BACKGROUND
  • Ouimette P, Coolhart D, Funderburk JS, Wade M, Brown PJ. Precipitants of first substance use in recently abstinent substance use disorder patients with PTSD. Addict Behav. 2007 Aug;32(8):1719-27. doi: 10.1016/j.addbeh.2006.11.020. Epub 2006 Dec 22.

    PMID: 17188816BACKGROUND
  • Parker, J. D. A., Taylor, R. N., Eastabrook, J. M., Schell, S. L., & Wood, L. M. (2008). Problem gambling in adolescence: Relationships with internet misuse, gaming abuse and emotional intelligence. Personality and Individual Differences, 45(2), 174-180. http://doi.org/10.1016/j.paid.2008.03.018

    BACKGROUND
  • Schmidt S, Strauss B, Hoger D, Brahler E. [The Adult Attachment Scale (AAS) - psychometric evaluation and normation of the German version]. Psychother Psychosom Med Psychol. 2004 Sep-Oct;54(9-10):375-82. doi: 10.1055/s-2003-815000. German.

    PMID: 15343479BACKGROUND
  • Schulz, H., Lang, K., Nübling, R., & Koch, U. (2003). Psychometrische Überprüfung einer Kurzform des Fragebogens zur Psychotherapiemotivation - FPTM-23. Diagnostica, 49(2), 83-93. http://doi.org/10.1026//0012-1924.49.2.83

    BACKGROUND
  • Solomon, R., & Shapiro, F. (2008). EMDR and the adaptive information processing model: Potential mechanisms of change. Journal of EMDR Practice and Research, 2(4), 315-325. http://doi.org/10.1891/1933-3196.2.4.315

    BACKGROUND
  • Swendsen J, Conway KP, Degenhardt L, Glantz M, Jin R, Merikangas KR, Sampson N, Kessler RC. Mental disorders as risk factors for substance use, abuse and dependence: results from the 10-year follow-up of the National Comorbidity Survey. Addiction. 2010 Jun;105(6):1117-28. doi: 10.1111/j.1360-0443.2010.02902.x. Epub 2010 Mar 10.

    PMID: 20331554BACKGROUND
  • Torchalla I, Nosen L, Rostam H, Allen P. Integrated treatment programs for individuals with concurrent substance use disorders and trauma experiences: a systematic review and meta-analysis. J Subst Abuse Treat. 2012 Jan;42(1):65-77. doi: 10.1016/j.jsat.2011.09.001. Epub 2011 Oct 27.

    PMID: 22035700BACKGROUND
  • Trinidad, D. R., Unger, J. B., Chou, C. P., & Anderson Johnson, C. (2004). The protective association of emotional intelligence with psychosocial smoking risk factors for adolescents. Personality and Individual Differences, 36(4), 945-954. http://doi.org/10.1016/S0191-8869(03)00163-6

    BACKGROUND
  • Verdejo-Garcia A, Lawrence AJ, Clark L. Impulsivity as a vulnerability marker for substance-use disorders: review of findings from high-risk research, problem gamblers and genetic association studies. Neurosci Biobehav Rev. 2008;32(4):777-810. doi: 10.1016/j.neubiorev.2007.11.003. Epub 2008 Jan 17.

    PMID: 18295884BACKGROUND
  • Verdejo-Garcia A, Lopez-Torrecillas F, Gimenez CO, Perez-Garcia M. Clinical implications and methodological challenges in the study of the neuropsychological correlates of cannabis, stimulant, and opioid abuse. Neuropsychol Rev. 2004 Mar;14(1):1-41. doi: 10.1023/b:nerv.0000026647.71528.83.

    PMID: 15260137BACKGROUND
  • Xie H, McHugo GJ, Fox MB, Drake RE. Substance abuse relapse in a ten-year prospective follow-up of clients with mental and substance use disorders. Psychiatr Serv. 2005 Oct;56(10):1282-7. doi: 10.1176/appi.ps.56.10.1282.

    PMID: 16215196BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Human-Friedrich Unterrainer, PD DDr.

    Center of Integrative Addiction Research, Austria

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2017

First Posted

April 14, 2017

Study Start

April 7, 2017

Primary Completion

September 1, 2020

Study Completion

July 1, 2021

Last Updated

August 5, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations