Intervention Through EMDR and CBT With Women Victim of Childhood Sexual Abuse. A Randomized Controlled Trial.
NCT ID: NCT04813224
Last Updated: 2021-07-19
Study Results
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Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2021-04-16
2022-12-16
Brief Summary
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Detailed Description
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Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) is an evidence-based treatment model designed to help patients (children, adolescents, youth) and their families overcome the symptoms resulting from exposure to a traumatic experience. Numerous investigations that support it, today it is considered a well-established intervention for the treatment of post-traumatic stress and associated symptoms.
Desensitization and reprocessing psychotherapy using eye movements. It is one of the transdiagnostic psychotherapeutic models of choice in international guidelines for dealing with the sequelae of traumatic life experiences. Trauma-focused treatment carried out with the EMDR therapeutic approach is feasible and safe for patients with PTSD derived from childhood sexual abuse.
A Randomized Clinical Trial is proposed, without a control group, and assignment to two types of treatment 1) TF -CBT, 2) EMDR.
After the initial evaluation, the participants will be randomly assigned to one of the two treatments. Subsequently, and after allowing the same time period that the intervention protocols will last, they will be evaluated again to measure changes without having received treatment. After this second evaluation, they will receive the treatment protocol to which they have been assigned after randomization. After receiving the first treatment, they will be evaluated again. After this evaluation, they will receive the other protocol of the intervention. Finally, after finishing the second intervention, they will be evaluated again. Thus, for example, participants who first received TF-CBT will subsequently receive the EMDR intervention, and participants who first received the EMDR intervention will subsequently receive the TF-CBT intervention. In this way, it will be possible to evaluate both the effectiveness of each of the protocols separately (intragroup comparison of each treatment condition), as well as the level of effectiveness obtained by comparing both treatment groups (intergroup comparison, after the application of each type of intervention ).
The subjective measures will include the following Psychometrics:
Satisfaction with life scale Rosenberg Self-Esteem Scale Symptom Checklist-90-Revised Post-Traumatic Stress Disorder Symptom Severity Scale according to DSM-5 (EGS-R) DSM-5 Personality Inventory - Short Version (PID-5-BF) Adults Scale of emotional regulation difficulties Dissociative Symptom Scale Satisfaction scale with received treatment Satisfaction scale with received treatment
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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TRAUMA CENTERED EMDR-BASED TREATMENT
Phase 1) Client history before session 1 Phase 2) Preparation for the treatment of the traumatic event, with psycho education and regulation strategies.
Phases 3 to 6) Gives the sense of Safety (safe place, past resource, desired future-PC, timeline) control structure, order, differentiation of past \& present (move concretely between past danger to present safety) EMD strategy gives containment boundaries to current T-Episode.
Phase 7) Session closure A group debriefing of the experience will take place, and some of the stabilization exercises Phase 8) Re-Evaluation This phase will take place immediately after the group intervention. It assesses which participants may need individual attention and which may need further evaluation to identify the nature and extent of their symptoms.
TRAUMA CENTERED EMDR-BASED TREATMENT and TRAUMA-FOCUSED CBT-BASED TREATMENT
Psychological evidence-based intervention for the reduction of the impact of childhood sexual abuse.
TRAUMA-FOCUSED CBT-BASED TREATMENT
TF-CBT is an evidence-based therapeutic approach to improve symptoms of PTSD as well as affective or cognitive and behavioral problems. The treatment will consist of three phases that will include: Psychoeducation, Relaxation-Mindfulness, Emotional regulation skills, Cognitive coping skills, Narration and processing of trauma, Exposure / Desensitization of memories of the trauma, Self-esteem and future goals. The treatment is composed by 3 phases: 1) Phase 1: TF-CBT Coping Skills for Complex Traumas. Phase 2: Narration of trauma and processing of complicated trauma. Phase 3: Consolidation and closure of the treatment. Each case is delivered to the participants in a maximum of 3 sessions per phase.
TRAUMA CENTERED EMDR-BASED TREATMENT and TRAUMA-FOCUSED CBT-BASED TREATMENT
Psychological evidence-based intervention for the reduction of the impact of childhood sexual abuse.
Interventions
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TRAUMA CENTERED EMDR-BASED TREATMENT and TRAUMA-FOCUSED CBT-BASED TREATMENT
Psychological evidence-based intervention for the reduction of the impact of childhood sexual abuse.
Eligibility Criteria
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Inclusion Criteria
* The traumatic experience is accessible to explicit memory.
* The participant has shared her experience at least in a context of containment and is able to talk about it.
Exclusion Criteria
* Extreme scores on both the personality questionnaire and the Psychopathology questionnaire in the indicator of global severity, paranoid ideation, and psychoticism.
* Any problem of addiction to alcohol or other substances at the time of the evaluation, etc. that may interfere with adherence to treatment and group dynamics.
* Being currently in treatment to treat the traumatic experience.
* Present severe dissociative symptoms, beyond those typical of the PTSD diagnosis.
* Extreme scores on the dissociation scale in the pathological ideation items.
18 Years
FEMALE
Yes
Sponsors
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University of Valencia
OTHER
Universidad Internacional de Valencia
OTHER
Responsible Party
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María Teresa Mitjans Lafont
Full time psychology professor Universidad Internacional de Valencia
Principal Investigators
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Milagros Molero Zafra, MD
Role: STUDY_CHAIR
Universidad Internacional de Valencia
Alejandro Domínguez Rodríguez, PhD
Role: STUDY_CHAIR
Universidad Internacional de Valencia
Marian Pérez Marín, PhD
Role: STUDY_CHAIR
University of Valencia
Locations
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Asociación Contra los Abusos Sexuales en la Infancia (ACASI)
Valencia, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Bisson JI, Roberts NP, Andrew M, Cooper R, Lewis C. Psychological therapies for chronic post-traumatic stress disorder (PTSD) in adults. Cochrane Database Syst Rev. 2013 Dec 13;2013(12):CD003388. doi: 10.1002/14651858.CD003388.pub4.
Canton-Cortes D, Canton J, Cortes MR. The interactive effect of blame attribution with characteristics of child sexual abuse on posttraumatic stress disorder. J Nerv Ment Dis. 2012 Apr;200(4):329-35. doi: 10.1097/NMD.0b013e31824cc078.
Cohen JA, Mannarino AP, Kliethermes M, Murray LA. Trauma-focused CBT for youth with complex trauma. Child Abuse Negl. 2012 Jun;36(6):528-41. doi: 10.1016/j.chiabu.2012.03.007. Epub 2012 Jun 30.
Davidson PR, Parker KC. Eye movement desensitization and reprocessing (EMDR): a meta-analysis. J Consult Clin Psychol. 2001 Apr;69(2):305-16. doi: 10.1037//0022-006x.69.2.305.
De Jongh A, Groenland GN, Sanches S, Bongaerts H, Voorendonk EM, Van Minnen A. The impact of brief intensive trauma-focused treatment for PTSD on symptoms of borderline personality disorder. Eur J Psychotraumatol. 2020 Feb 14;11(1):1721142. doi: 10.1080/20008198.2020.1721142. eCollection 2020.
Deblinger E, Pollio E, Dorsey S. Applying Trauma-Focused Cognitive-Behavioral Therapy in Group Format. Child Maltreat. 2016 Feb;21(1):59-73. doi: 10.1177/1077559515620668. Epub 2015 Dec 23.
Deblinger E, Mannarino AP, Cohen JA, Runyon MK, Steer RA. Trauma-focused cognitive behavioral therapy for children: impact of the trauma narrative and treatment length. Depress Anxiety. 2011 Jan;28(1):67-75. doi: 10.1002/da.20744. Epub 2010 Sep 9.
Karadag M, Gokcen C, Sarp AS. EMDR therapy in children and adolescents who have post-traumatic stress disorder: a six-week follow-up study. Int J Psychiatry Clin Pract. 2020 Mar;24(1):77-82. doi: 10.1080/13651501.2019.1682171. Epub 2019 Oct 30.
Lee CW, Cuijpers P. A meta-analysis of the contribution of eye movements in processing emotional memories. J Behav Ther Exp Psychiatry. 2013 Jun;44(2):231-9. doi: 10.1016/j.jbtep.2012.11.001. Epub 2012 Nov 20.
Ostacoli L, Carletto S, Cavallo M, Baldomir-Gago P, Di Lorenzo G, Fernandez I, Hase M, Justo-Alonso A, Lehnung M, Migliaretti G, Oliva F, Pagani M, Recarey-Eiris S, Torta R, Tumani V, Gonzalez-Vazquez AI, Hofmann A. Comparison of Eye Movement Desensitization Reprocessing and Cognitive Behavioral Therapy as Adjunctive Treatments for Recurrent Depression: The European Depression EMDR Network (EDEN) Randomized Controlled Trial. Front Psychol. 2018 Feb 13;9:74. doi: 10.3389/fpsyg.2018.00074. eCollection 2018.
Horst F, Den Oudsten B, Zijlstra W, de Jongh A, Lobbestael J, De Vries J. Cognitive Behavioral Therapy vs. Eye Movement Desensitization and Reprocessing for Treating Panic Disorder: A Randomized Controlled Trial. Front Psychol. 2017 Aug 18;8:1409. doi: 10.3389/fpsyg.2017.01409. eCollection 2017.
Bernstein EM, Putnam FW. Development, reliability, and validity of a dissociation scale. J Nerv Ment Dis. 1986 Dec;174(12):727-35. doi: 10.1097/00005053-198612000-00004.
Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015 Dec;28(6):489-98. doi: 10.1002/jts.22059. Epub 2015 Nov 25.
Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.
Elhai JD, Gray MJ, Kashdan TB, Franklin CL. Which instruments are most commonly used to assess traumatic event exposure and posttraumatic effects?: A survey of traumatic stress professionals. J Trauma Stress. 2005 Oct;18(5):541-5. doi: 10.1002/jts.20062.
Gutierrez F, Aluja A, Peri JM, Calvo N, Ferrer M, Bailles E, Gutierrez-Zotes JA, Garriz M, Caseras X, Markon KE, Krueger RF. Psychometric Properties of the Spanish PID-5 in a Clinical and a Community Sample. Assessment. 2017 Apr;24(3):326-336. doi: 10.1177/1073191115606518. Epub 2016 Jul 28.
Molero-Zafra M, Fernandez-Garcia O, Mitjans-Lafont MT, Perez-Marin M, Hernandez-Jimenez MJ. Psychological intervention in women victims of childhood sexual abuse: a randomized controlled clinical trial comparing EMDR psychotherapy and trauma-focused cognitive behavioral therapy. Front Psychiatry. 2024 May 29;15:1360388. doi: 10.3389/fpsyt.2024.1360388. eCollection 2024.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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VIU-EMDR-TFCBT
Identifier Type: -
Identifier Source: org_study_id
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