Psychological Intervention in Women Victims of Childhood Sexual Abuse: A Randomized Clinical Trial Comparing EMDR Psychotherapy and Trauma-Based Cognitive Therapy.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Decrease in the scores on the Dissociative Symptom Scale.
研究概览
简要总结
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.
详细描述
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 ).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Decrease in the scores on the Dissociative Symptom Scale.
时间窗: 4.5 months, after receiving both interventions.
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.
Decrease in the scores of the clinical symptoms measured using the Symptom Checklist-90-Revised (SCL-R)
时间窗: 4.5 months, after receiving both interventions.
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.
Decrease in the scores of the Post-Traumatic Stress Disorder Symptom Severity Scale according to the DSM-5 (EGS-R)
时间窗: 4.5 months, after receiving both interventions.
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.
次要结局
- 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.)
研究者
María Teresa Mitjans Lafont
Full time psychology professor Universidad Internacional de Valencia
Universidad Internacional de Valencia