Clinical trial NCT04813224: Intervention Through EMDR and CBT With Women Victim of Childhood Sexual Abuse. A Randomized Controlled Trial.
Official title: Psychological Intervention in Women Victims of Childhood Sexual Abuse: A Randomized Clinical Trial Comparing EMDR Psychotherapy and Trauma-Based Cognitive Therapy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Posttraumatic Stress Disorder
Somatization
Obsessive-Compulsive Disorder
Depression
Anxiety
Hostility
Dissociative Disorder
Lead sponsor: Universidad Internacional de Valencia
Sponsor class: OTHER
Collaborators: name: University of Valencia
First posted: 2021-03-24
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

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.

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Decrease in the scores of the Post-Traumatic Stress Disorder Symptom Severity Scale according to the DSM-5 (EGS-R)
timeFrame: 4.5 months, after receiving both interventions.
measure: Decrease in the scores of the clinical symptoms measured using the Symptom Checklist-90-Revised (SCL-R)
timeFrame: 4.5 months, after receiving both interventions.
measure: Decrease in the scores on the Dissociative Symptom Scale.
timeFrame: 4.5 months, after receiving both interventions.
Secondary outcomes:
measure: Increase in the scores of the Satisfaction with Life Scale (SWLS)
timeFrame: 4.5 months, after receiving both interventions.
measure: Increase in the scores of the Rosenberg Self-Esteem Scale
timeFrame: 4.5 months, after receiving both interventions.
measure: Increase in the scores of the Emotional Regulation Difficulties Scale (DERS)
timeFrame: 4.5 months, after receiving both interventions.
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Asociación Contra los Abusos Sexuales en la Infancia (ACASI)
Study officials:
affiliation: Universidad Internacional de Valencia
name: Milagros Molero Zafra, MD
role: STUDY_CHAIR
affiliation: Universidad Internacional de Valencia
name: Alejandro Domínguez Rodríguez, PhD
role: STUDY_CHAIR
affiliation: University of Valencia
name: Marian Pérez Marín, PhD
role: STUDY_CHAIR
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