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

Depression Clinical Trial

Official title:

Psychological Intervention in Women Victims of Childhood Sexual Abuse: A Randomized Clinical Trial Comparing EMDR Psychotherapy and Trauma-Based Cognitive Therapy.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04813224
• Other study ID #: VIU-EMDR-TFCBT
• Status: Recruiting
• Phase: N/A
• Start date: April 16, 2021
• Est. completion date: December 16, 2022

Study information

• Verified date: July 2021
• Source: Universidad Internacional de Valencia
• Contact: María Teresa Mitjans Lafont, PhD
• Phone: +34600325732
• Email: mariateresa.mitjans[@]campusviu.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The experience of sexual abuse in childhood is one of the forms of interpersonal victimization most associated with the development of psychological problems since it involves a serious violation of the rights and sexual and affective freedom of children and adolescents. The different types of child abuse and neglect are, in turn, associated with moderately severe psychological sequelae in adulthood. Its effects in adult life can affect physical, psychological, and social functioning and generate psychopathological alterations, being the most frequent consequences. Women who were abused in childhood, in their adult life more frequently presented sexual dysfunction and less perceived sexual satisfaction, less trust, and more difficulties in communicating with the partner. 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 16, 2022
• Est. primary completion date: December 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Anxiety
• Conversion Disorder
• Depression
• Disease
• Dissociative Disorder
• Dissociative Disorders
• Hostility
• Obsessive-Compulsive Disorder
• Posttraumatic Stress Disorder
• Somatization
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Spain	Asociación Contra los Abusos Sexuales en la Infancia (ACASI)	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Internacional de Valencia	University of Valencia

Country where clinical trial is conducted

Spain, 

References & Publications (16)

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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;(12):CD003388. doi: 10.1002/14651858.CD003388.pub4. Review. — View Citation

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. — View Citation

Cantón-Cortés D, Cantón J, Cortés 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. — View Citation

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. — View Citation

Davidson PR, Parker KC. Eye movement desensitization and reprocessing (EMDR): a meta-analysis. J Consult Clin Psychol. 2001 Apr;69(2):305-16. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. — View Citation

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. — View Citation

Gutiérrez F, Aluja A, Peri JM, Calvo N, Ferrer M, Baillés E, Gutiérrez-Zotes JA, Gárriz 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: 10.117 — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	Increase in the scores of the Satisfaction with Life Scale (SWLS)	This instrument consists of 5 items in which the participants must indicate how much they agree with each question, with response options in Likert format from 1 (totally disagree) to 7 (totally agree) ). Scores range from a minimum of 5 to a maximum of 35, where higher scores indicate greater satisfaction with life. A clinically significant increase (P <0.05) in the global score of this scale is expected after the treatments.	4.5 months, after receiving both interventions.
Secondary	Increase in the scores of the Rosenberg Self-Esteem Scale	This instrument assesses the feeling of satisfaction that a person has about himself. The questionnaire is made up of 10 items (half of the items are positively stated and the other half negatively) whose contents focus on the general feelings of respect and acceptance towards oneself. The items are answered in a four-point Likert format (1 = Strongly agree, 2 = Agree, 3 = Disagree, 4 = Strongly disagree) depending on the degree of agreement with the statement made. The total score ranges from 10 to 40 points, distinguishing between low self-esteem (scores less than or equal to 25), medium (from 26 to 29) and high (equal to or greater than 30).; A clinically significant increase (P <0.05) in the global score of this scale is expected after the treatments.	4.5 months, after receiving both interventions.
Secondary	Increase in the scores of the Emotional Regulation Difficulties Scale (DERS)	This scale assesses different aspects of the emotional regulation process in which there may be difficulties: emotional lack of control, daily interference, emotional inattention, emotional confusion and emotional rejection. The first factor, "Emotional lack of control", includes items from two scales of the original version: "Difficulty in impulse control" and "Limited access to regulation strategies". The rest of the factors correspond to the remaining subscales of the original version, although the labels were slightly modified with respect to the originals for reasons of simplification and adaptation to Spanish: "Emotional rejection", "Everyday interference", "Emotional neglect", "Emotional confusion." A clinically significant decrease (P <0.05) is expected in the scores of the factors: "Emotional lack of control", "Emotional rejection", "Daily interference", "Emotional inattention" and "Emotional confusion"	4.5 months, after receiving both interventions.