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

U

Universidad Internacional de Valencia

Status

Unknown

Conditions

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

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04813224
VIU-EMDR-TFCBT

Details and patient eligibility

About

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.

Full 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

Enrollment

50 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

50 participants in 2 patient groups

TRAUMA CENTERED EMDR-BASED TREATMENT
Experimental group
Description:
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.
Treatment:
Behavioral: TRAUMA CENTERED EMDR-BASED TREATMENT and TRAUMA-FOCUSED CBT-BASED TREATMENT
TRAUMA-FOCUSED CBT-BASED TREATMENT
Active Comparator group
Description:
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.
Treatment:
Behavioral: TRAUMA CENTERED EMDR-BASED TREATMENT and TRAUMA-FOCUSED CBT-BASED TREATMENT

Trial documents
1

Trial contacts and locations

1

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Central trial contact

María Teresa Mitjans Lafont, PhD; María Jesús Hernández Jiménez, PhD

Data sourced from clinicaltrials.gov

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