Intervention Through EMDR and CBT With Women Victim of Childhood Sexual Abuse. A Randomized Controlled Trial.

NCT04813224 | Unknown DMC

• 1 other identifier: VIU-EMDR-TFCBT
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effectiveness of two types of therapy for the treatment of sexual abuse psychological impact on a sample of Spanish women. The participants will receive first Trauma-Focused Cognitive Behavioral Therapy and Eye Movement Desensitization and Reprocessing treatments in order to observe the impact on symptoms of Posttraumatic Stress Disorder, somatization, obsessive-compulsive symptoms, anxiety, aggressiveness and dissociate symptoms.

Conditions

Posttraumatic Stress Disorder; Somatization; Obsessive-Compulsive Disorder; Depression; Anxiety; Hostility; Dissociative Disorder

Outcome Measures

Primary Outcomes (3)

• Decrease in the scores of the Post-Traumatic Stress Disorder Symptom Severity Scale according to the DSM-5 (EGS-R)

  The Revised Symptom Severity Scale for Post-Traumatic Stress Disorder (PTSD) consists of 21 items, based on the DSM-5 diagnostic criteria, and is used to assess the severity of the symptoms of this clinical picture. It is a structured assessment instrument, with responses measured with a Likert-type scale from 0 to 3 according to the frequency and intensity of the symptoms. This scale has a nuclear part (EGS-R) and a complementary part. The core part consists of 21 central items (range: 0-63 points) in correspondence with the diagnostic criteria of the DSM-5 (APA, 2013): 5 refer to intrusion (range: 0-15), 3 to avoidance behavioral / cognitive (range: 0-9), 7 to cognitive disturbances and negative mood (AC / EAN) (range: 0-21) and 6 to hyperarousal (range: 0-18), as well as 4 additional ones referred to dissociation (range: 0-12). It is expected that in all these subscales they will be significantly reduced (P \<0.05) scores by patients after the treatments.

  4.5 months, after receiving both interventions.

• Decrease in the scores of the clinical symptoms measured using the Symptom Checklist-90-Revised (SCL-R)

  The SCL-90-R is a self-administered questionnaire that presents 90 elements that describe symptoms and requires the individual to indicate through a Likert-type scale graduated between 0 (not at all) and 4 (a lot or extremely) to what extent they have annoying feeling for each of the symptoms described. The questionnaire allows obtaining three global indices and 10 symptomatic dimensions: 1) Global Severity Index, 2) Total Positive Symptoms, 3) Positive Discomfort Index, 4) Somatization, 5) Obsession-compulsion, 6) Interpersonal sensitivity, 7) Depression, 8) Anxiety, 9) Hostility, 10) Phobic anxiety, 11) Paranoid ideation, 12) Psychoticism, 13) Additional scale (ADI). It collects seven symptoms that have a relevant factorial weight on different scales. A clinically significant reduction (P \<0.05) is expected in the Global Severity index, in the Total of positive symptoms, in the positive index of discomfort, in depression and anxiety.

  4.5 months, after receiving both interventions.

• Decrease in the scores on the Dissociative Symptom Scale.

  It is a 28-item self-administered scale, developed by Bernstein and Putnam (1986), designed to measure dissociative symptomatology. Items are scored, according to the frequency of each dissociative experience, in a range of 0 to 100, where 0 represents "never" and 100 "always." The center points represent 50% of the time. The global score is the sum of the score assigned to each item, divided by 28. The higher the global score, the more severe the dissociative symptoms, therefore improvement is indicated by a decrease in the DES score. A clinically significant reduction (P \<0.05) in the total score of this scale is expected after the treatments.

  4.5 months, after receiving both interventions.

Secondary Outcomes (3)

• Increase in the scores of the Satisfaction with Life Scale (SWLS)

  4.5 months, after receiving both interventions.

• Increase in the scores of the Rosenberg Self-Esteem Scale

  4.5 months, after receiving both interventions.

• Increase in the scores of the Emotional Regulation Difficulties Scale (DERS)

  4.5 months, after receiving both interventions.

Study Arms (2)

TRAUMA CENTERED EMDR-BASED TREATMENT

EXPERIMENTAL

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.

Behavioral: TRAUMA CENTERED EMDR-BASED TREATMENT and TRAUMA-FOCUSED CBT-BASED TREATMENT

TRAUMA-FOCUSED CBT-BASED TREATMENT

ACTIVE COMPARATOR

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.

Behavioral: TRAUMA CENTERED EMDR-BASED TREATMENT and TRAUMA-FOCUSED CBT-BASED TREATMENT

Interventions

TRAUMA CENTERED EMDR-BASED TREATMENT and TRAUMA-FOCUSED CBT-BASED TREATMENT BEHAVIORAL

Psychological evidence-based intervention for the reduction of the impact of childhood sexual abuse.

TRAUMA CENTERED EMDR-BASED TREATMENT; TRAUMA-FOCUSED CBT-BASED TREATMENT

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The treatment will be directed only to adult women that suffered sexual child abuse, due to the characteristics possible to access the sample in an established center that only offers treatment to women. Future studies can be conducted with both genders.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• present symptoms related to the post-traumatic sequelae of having had an experience of sexual abuse in childhood.
• 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.

You may not qualify if:

• Enfermedad mental grave.
• 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.

Sponsors & Collaborators

• Universidad Internacional de Valencia: lead
• University of Valencia: collaborator

Study Sites (1)

Asociación Contra los Abusos Sexuales en la Infancia (ACASI)

Valencia, 46200, Spain

RECRUITING

Related Publications (17)

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  PMID: 24338345 BACKGROUND

• 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.

  PMID: 22456587 BACKGROUND

• 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.

  PMID: 22749612 BACKGROUND

• 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.

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• 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.

  PMID: 32128048 BACKGROUND

• 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.

  PMID: 26701151 BACKGROUND

• 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.

  PMID: 20830695 BACKGROUND

• 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.

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• 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.

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• 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.

  PMID: 29487548 BACKGROUND

• 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.

  PMID: 28868042 BACKGROUND

• 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.

  PMID: 3783140 RESULT

• 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.

  PMID: 26606250 RESULT

• 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.

  PMID: 16367493 RESULT

• 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.

  PMID: 16281252 RESULT

• 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.

  PMID: 26391204 RESULT

• 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.

  PMID: 38868491 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Obsessive-Compulsive Disorder; Depression; Anxiety Disorders; Dissociative Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Milagros Molero Zafra, MD

  Universidad Internacional de Valencia

  STUDY CHAIR

• Alejandro Domínguez Rodríguez, PhD

  Universidad Internacional de Valencia

  STUDY CHAIR

• Marian Pérez Marín, PhD

  University of Valencia

  STUDY CHAIR

Central Study Contacts

María Teresa Mitjans Lafont, PhD

CONTACT

+34600325732; mariateresa.mitjans@campusviu.es

María Jesús Hernández Jiménez, PhD

CONTACT

+34687926591; mariajesus.hernandez@campusviu.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patients are not aware that there is another intervention and that they will receive both of them. The participants are not related and do not know each other. The conditions of the study are only known by the researcher, the therapists, and the Committee for the Evaluation and Monitoring of Research with Human Beings of the Universidad Internacional de Valencia
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full time psychology professor Universidad Internacional de Valencia

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: March 20, 2021
• First Posted: March 24, 2021
• Study Start: April 16, 2021
• Primary Completion: December 16, 2022
• Study Completion: December 16, 2022
• Last Updated: July 19, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: This data will be available approximately in December 2021 and it will be permanently available. It will be shared in the databases of the journal where the article(s) will be published.
• Access Criteria: Through the servers of the journal(s) where we will publish the articles.

Locations

ES (1)