Substance Use Disorders Clinical Trial
Official title:
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
Verified date | March 2021 |
Source | Parc de Salut Mar |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 142 |
Est. completion date | November 2022 |
Est. primary completion date | November 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - 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) Exclusion Criteria: - presence of organic brain diseases - presence of suicidal ideas - having received a trauma focused therapy in the last 2 years |
Country | Name | City | State |
---|---|---|---|
Spain | Parc de Salut Mar | Barcelona | |
Spain | Germanas Hospitalarias Benito Menni | Sant Boi De Llobregat | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Parc de Salut Mar |
Spain,
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. — View Citation
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. — View Citation
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. Erratum in: Alcohol Clin Exp Res. 2017 Mar;41(3):659. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Novo Navarro P, Landin-Romero R, Guardiola-Wanden-Berghe R, Moreno-Alcázar A, Valiente-Gómez A, Lupo W, García F, Fernández I, Pérez 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. Review. English, Spanish. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
Tirado-Muñoz J, Gilchrist G, Fischer G, Taylor A, Moskalewicz J, Giammarchi C, Köchl 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 cr — View Citation
* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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 | Improvement of global functioning | To measure changes with the Functioning Assessment Short Test. The global score ranges from 0 to 72. The higher the score, the poorer the functional status. | Changes from baseline to visits at 6 and 12 months. | |
Secondary | Detection of Childhood life traumatic events | To assess life events with the Childhood Trauma Questionnaire. A 5-point Likert scale is used, ranging from "Never True" to "Very Often True". | Childhood. It is administered only during the baseline visit. | |
Secondary | Detection of traumatic events in the last year | To assess events with The Holmes-Rahe Life Stress Inventory. Scores below 150 reflect low levels of stress, scores between 150 and 299 represent a 50% risk of a stress-related illness in the near future and scores above 300 represent an 80% risk. | The last year. It is administered only during the baseline visit. | |
Secondary | Making a PTSD diagnosis | To diagnose PTSD with the Global Assessment of Posttraumatic Stress Questionnaire. Higher scores indicate more severity in trauma-related symptoms. | Changes from baseline to visits at 6 and 12 months. | |
Secondary | Assessment of the severity of trauma-related symptoms. | To measure severity and changes in trauma-related symptoms with the Impact of Event Scale - Revised. Items are rated on a 5-point Likert scale ranging from 0 and 4, yielding a total score ranging from 0 to 88. | The previous 7 days. Changes from baseline to visits at 6 and 12 months. | |
Secondary | Detection of dissociative symptoms | To assess dissociative symptoms with the Dissociative Experiences Scale. An overall mean score ranging from 0 to 100. The higher score, the higher the severity of the dissociative symptoms. | Changes from baseline to visits at 6 and 12 months. |
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