EMDR Versus Treatment As Usual in Patients With Substance Use Disorder

NCT03517592 | Unknown

• 1 other identifier: 2017/7615/I
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 2

Brief Summary

The main objective of this project is to test whether EMDR therapy is effective in reducing substance use and improving clinical and trauma-related symptoms in SUD patients with a history of psychological trauma.

Conditions

Substance Use Disorders

Outcome Measures

Primary Outcomes (6)

• Reduction in severity of consumption

  To measure changes in the Severity of Dependence Scale. 4-point Likert scale (0 - 3). The higher score indicate greater dependence.

  Changes from baseline to visits at 3, 6 and 12 months.

• Reduction in level of consumption

  To measure changes in the Visual Analog Scale. It ranges from 0 to 10: the higher the score, the greater the craving severity.

  Changes from baseline to visits at 3, 6 and 12 months.

• Reduction in the number of relapses

  To measure relapses with the Timeline Followback Questionnaire. It is a retrospective calendar-based measure of daily substance use.

  Change of relapses from baseline to visits at 3, 6 and 12 months.

• Reduction of (hypo) manic symptoms associated with a comorbid psychiatric disorder

  To measure changes in the Young Mania Rating Scale. It ranges from 0 to 130: the higher the score, the worse the manic symptoms.

  Changes from baseline to visits at 6 and 12 months.

• Reduction of general psychopathological symptoms associated with psychiatric comorbidity

  To measure changes in the Brief Psychiatric Rating Scale. It ranges from 18 to 126: the higher the score, the worse the general psychopathology symptoms.

  Change from baseline to visits at 6 and 12 months.

• Reduction in depressive symptoms associated with a comorbid psychiatric disorder

  To measure changes in the Hamilton Depression Rating Scale. Total scores range from 0 to 52: the higher the score, the worse the depressive symptoms.

  Changes from baseline to visits at 6 and 12 months.

Secondary Outcomes (6)

• Improvement of global functioning

  Changes from baseline to visits at 6 and 12 months.

• Detection of Childhood life traumatic events

  Childhood. It is administered only during the baseline visit.

• Detection of traumatic events in the last year

  The last year. It is administered only during the baseline visit.

• Making a PTSD diagnosis

  Changes from baseline to visits at 6 and 12 months.

• Assessment of the severity of trauma-related symptoms.

  The previous 7 days. Changes from baseline to visits at 6 and 12 months.

Study Arms (2)

EMDR Therapy

EXPERIMENTAL

EMDR: 20 individual sessions 60 minutes each for 6 months

Other: EMDR

Treatment as Usual

OTHER

The TAU condition includes follow-up visits with the psychiatry, psychology and with the nursing service. Visits with the psychiatrist consist to evaluate clinical status and readjust the pharmacological treatment if necessary while visits with the psychologist consist to assess and detect risk situations and to prevent relapses using a cognitive behavioral approach. Finally, the nursing service will provide health and care habits and will carry out the abstinence controls.

Other: Treatment as Usual

Interventions

EMDR OTHER

The EMDR SUD Protocol consists of a detailed interview with respect to traumatic events, the treatment of those with the EMDR standard protocol and a further specific protocol for SUD that is focused on the concept of addiction memory.

EMDR Therapy

Treatment as Usual OTHER

The TAU condition includes follow-up visits with the psychiatry, psychology and with the nursing service. Visits with the psychiatrist consist to evaluate clinical status and readjust the pharmacological treatment if necessary while visits with the psychologist consist to assess and detect risk situations and to prevent relapses using a cognitive behavioral approach. Finally, the nursing service will provide health and care habits and will carry out the abstinence controls.

Treatment as Usual

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 18 and 65 years
• outpatients
• presence of one or more traumatic events, which causes currently trauma associated symptoms (Scale of the impact of the event-reviewed, IES-R\> 0) and subjective Disability Unit (SUD)\>5)

You may not qualify if:

• presence of organic brain diseases
• presence of suicidal ideas
• having received a trauma focused therapy in the last 2 years

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (2)

Germanas Hospitalarias Benito Menni

Sant Boi de Llobregat, Barcelona, 08830, Spain

Location

Parc de Salut Mar

Barcelona, 08019, Spain

Location

Related Publications (16)

• Driessen M, Schulte S, Luedecke C, Schaefer I, Sutmann F, Ohlmeier M, Kemper U, Koesters G, Chodzinski C, Schneider U, Broese T, Dette C, Havemann-Reinecke U; TRAUMAB-Study Group. Trauma and PTSD in patients with alcohol, drug, or dual dependence: a multi-center study. Alcohol Clin Exp Res. 2008 Mar;32(3):481-8. doi: 10.1111/j.1530-0277.2007.00591.x. Epub 2008 Jan 22.

  PMID: 18215214 BACKGROUND

• Mauritz MW, Goossens PJ, Draijer N, van Achterberg T. Prevalence of interpersonal trauma exposure and trauma-related disorders in severe mental illness. Eur J Psychotraumatol. 2013;4. doi: 10.3402/ejpt.v4i0.19985. Epub 2013 Apr 8.

  PMID: 23577228 BACKGROUND

• Gradus JL. Prevalence and prognosis of stress disorders: a review of the epidemiologic literature. Clin Epidemiol. 2017 May 3;9:251-260. doi: 10.2147/CLEP.S106250. eCollection 2017.

  PMID: 28496365 BACKGROUND

• Kok T, de Haan H, van der Meer M, Najavits L, de Jong C. Assessing traumatic experiences in screening for PTSD in substance use disorder patients: what is the gain in addition to PTSD symptoms? Psychiatry Res. 2015 Mar 30;226(1):328-32. doi: 10.1016/j.psychres.2015.01.014. Epub 2015 Jan 28.

  PMID: 25687377 BACKGROUND

• Novo P, Landin-Romero R, Radua J, Vicens V, Fernandez I, Garcia F, Pomarol-Clotet E, McKenna PJ, Shapiro F, Amann BL. Eye movement desensitization and reprocessing therapy in subsyndromal bipolar patients with a history of traumatic events: a randomized, controlled pilot-study. Psychiatry Res. 2014 Sep 30;219(1):122-8. doi: 10.1016/j.psychres.2014.05.012. Epub 2014 May 15.

  PMID: 24880581 BACKGROUND

• Shapiro F. The role of eye movement desensitization and reprocessing (EMDR) therapy in medicine: addressing the psychological and physical symptoms stemming from adverse life experiences. Perm J. 2014 Winter;18(1):71-7. doi: 10.7812/TPP/13-098.

  PMID: 24626074 BACKGROUND

• Novo Navarro P, Landin-Romero R, Guardiola-Wanden-Berghe R, Moreno-Alcazar A, Valiente-Gomez A, Lupo W, Garcia F, Fernandez I, Perez V, Amann BL. 25 years of Eye Movement Desensitization and Reprocessing (EMDR): The EMDR therapy protocol, hypotheses of its mechanism of action and a systematic review of its efficacy in the treatment of post-traumatic stress disorder. Rev Psiquiatr Salud Ment (Engl Ed). 2018 Apr-Jun;11(2):101-114. doi: 10.1016/j.rpsm.2015.12.002. Epub 2016 Feb 11. English, Spanish.

  PMID: 26877093 BACKGROUND

• Hase M, Balmaceda UM, Hase A, Lehnung M, Tumani V, Huchzermeier C, Hofmann A. Eye movement desensitization and reprocessing (EMDR) therapy in the treatment of depression: a matched pairs study in an inpatient setting. Brain Behav. 2015 Jun;5(6):e00342. doi: 10.1002/brb3.342. Epub 2015 Apr 30.

  PMID: 26085967 BACKGROUND

• Behnammoghadam M, Alamdari AK, Behnammoghadam A, Darban F. Effect of Eye Movement Desensitization and Reprocessing (EMDR) on Depression in Patients With Myocardial Infarction (MI). Glob J Health Sci. 2015 Apr 19;7(6):258-62. doi: 10.5539/gjhs.v7n6p258.

  PMID: 26153191 BACKGROUND

• Feske U, Goldstein AJ. Eye movement desensitization and reprocessing treatment for panic disorder: a controlled outcome and partial dismantling study. J Consult Clin Psychol. 1997 Dec;65(6):1026-35. doi: 10.1037//0022-006x.65.6.1026.

  PMID: 9420364 BACKGROUND

• Doering S, Ohlmeier MC, de Jongh A, Hofmann A, Bisping V. Efficacy of a trauma-focused treatment approach for dental phobia: a randomized clinical trial. Eur J Oral Sci. 2013 Dec;121(6):584-93. doi: 10.1111/eos.12090. Epub 2013 Sep 23.

  PMID: 24206075 BACKGROUND

• Nazari H, Momeni N, Jariani M, Tarrahi MJ. Comparison of eye movement desensitization and reprocessing with citalopram in treatment of obsessive-compulsive disorder. Int J Psychiatry Clin Pract. 2011 Nov;15(4):270-4. doi: 10.3109/13651501.2011.590210. Epub 2011 Aug 3.

  PMID: 22122001 BACKGROUND

• Gerhardt A, Leisner S, Hartmann M, Janke S, Seidler GH, Eich W, Tesarz J. Eye Movement Desensitization and Reprocessing vs. Treatment-as-Usual for Non-Specific Chronic Back Pain Patients with Psychological Trauma: A Randomized Controlled Pilot Study. Front Psychiatry. 2016 Dec 20;7:201. doi: 10.3389/fpsyt.2016.00201. eCollection 2016.

  PMID: 28066274 BACKGROUND

• Perez-Dandieu B, Tapia G. Treating Trauma in Addiction with EMDR: A Pilot Study. J Psychoactive Drugs. 2014 Oct-Dec;46(4):303-9. doi: 10.1080/02791072.2014.921744.

  PMID: 25188700 BACKGROUND

• Tirado-Munoz J, Gilchrist G, Fischer G, Taylor A, Moskalewicz J, Giammarchi C, Kochl B, Munro A, Dabrowska K, Shaw A, Di Furia L, Leeb I, Hopf C, Torrens M. Psychiatric comorbidity and intimate partner violence among women who inject drugs in Europe: a cross-sectional study. Arch Womens Ment Health. 2018 Jun;21(3):259-269. doi: 10.1007/s00737-017-0800-3. Epub 2017 Dec 11.

  PMID: 29230558 RESULT

• Valiente-Gomez A, Moreno-Alcazar A, Radua J, Hogg B, Blanco L, Lupo W, Perez V, Robles-Martinez M, Torrens M, Amann BL. A Multicenter Phase II Rater-Blinded Randomized Controlled Trial to Compare the Effectiveness of Eye Movement Desensitization Reprocessing Therapy vs. Treatment as Usual in Patients With Substance Use Disorder and History of Psychological Trauma: A Study Design and Protocol. Front Psychiatry. 2019 Mar 15;10:108. doi: 10.3389/fpsyt.2019.00108. eCollection 2019.

  PMID: 30930801 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Eye Movement Desensitization Reprocessing; Therapeutics

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Benedikt L Amann, PhD, MD

  Parc de Salut Mar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: May 7, 2018
• Study Start: September 1, 2018
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: March 31, 2022

Record last verified: 2021-03

Locations

ES (2)