Efficacy of Emotionally Focused Therapy Among Spanish Speaking Couples: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 16
- 主要终点
- Change in Experiences in Close Relationships Questionnaire (ECR-36)
研究概览
简要总结
70 couples (married or cohabiting) will be recruited across 5 countries (12-18 in each country: Argentina, Costa Rica, Guatemala, México, and Spain). After their entry into the study is confirmed, couples will be randomly allocated into one of two groups: intervention or control (no intervention). In each country, both groups will have equal number of couples.
Couples in the intervention group will receive 20 sessions of Emotionally Focused couple Therapy (EFT). Couples in the control group will receive no intervention during the study period (they will receive a shorter intervention after the trial is over). Participants of both groups will fill questionnaires before allocation, during the intervention period and after the intervention period.
The main outcomes will be couple attachment, couple satisfaction and dyadic adjustment.
The original timeline for the study was to start in Argentina and Guatemala in February 2020, and the remaining countries in September 2020. The study started in February 2020 for Argentina and Guatemala, but in April 2020 the process was postponed due to mobility constrains during covid-19 crisis. During these two months, the process remained in the recruitment phase. Therefore, couples were not randomly assigned. Due to an improvement in the pandemic situation, the study started in Spain in September 2021.We expect the remaining countries will start during 2022.
The study period for each couple will be around 6 months.
详细描述
A detailed description about the procedure of this clinical trial will be available on an open access study protocol document or paper upon request.
Some more details about therapists, supervision during treatment phase, implementation checking and research team, is offered below.
Participating therapists were chosen based on a rigorous criterion focused on excellence in the adherence to the EFT model. There therapists also had to meet the following prerequisites: (1) Meet all legal requirements necessary to practice therapy in the country and region in which the therapist is located (licensure, insurance, etc.); (2) Have a video recording device; (3) Have completed the Externship, Core Skills and at least 10 hours of EFT supervision by the 1st of June, 2019; (4) Have experience applying the EFT model in couples therapy; and (5) be a licensed therapist or actively participating in case supervision. Additionally, candidates for participating therapists must send a video of at least 20 minutes of a session of actual couples therapy recorded in the last three months, to the principal investigator (MR-G) with their application. The couple in the recording was asked for their consent to have this video be reviewed by two supervisors who are participating in the study. Each video was shared through a secure channel with Martiño Rodríguez, who then sent said video to two EFT certified therapists and/or supervisors from a list of six therapists provided by Samuel Jinich, PhD and Certified EFT Trainer. Each evaluator submitted their evaluation independently to the principle investigator. In the event that a discrepancy arose, a third evaluation was sought from a separate evaluator. In some cases, a second video was requested to resolve doubts regarding a candidate's suitability. A total of 26 therapists sent in an application to participate, of those 11 applications were considered insufficient, and 15 met the requirements of the evaluation. This application and evaluation process took place between January and September, 2019.
All sessions will be videotaped and/or audio-taped for supervision and research purposes.
Supervision of the therapy process will be offered biweekly, in an individual meeting (one therapist, one supervisor) of one hour. Participating supervisors are required to speak Spanish and to certified as a supervisor by the International Center for Excellence in Emotionally Focused Therapy; Ottawa, Canada (ICEEFT), or to be certified by ICEEFT as a therapist and actively be in the process of becoming an ICEEFT certified supervisor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Each couple has to be exclusive in their courtship and been living together for at least 1 year. Participants must be willing to participate in all of the study components (questionnaires, videotaping, therapy, and follow-up once therapy is finished). Each member of the relationship must speak Spanish as a native language and have lived in the country where the study is going to be conducted (Argentina, Costa Rica, Guatemala, Mexico, Spain) for at least 5 years. Couple's average score on the Dyadic Adjustment Scale (DAS; Spanier, 1976) must classify the relationship as mildly to moderately distressed (80-100).
排除标准
- •Either partner of the couple is receiving current psychotherapeutic (psychological or psychiatric) treatment or anticipates receiving this type of treatment (not directly involved with this study) within the next 6 months.
- •Either member has been previously diagnosed with any psychotic, somatoform or dissociative disorder.
- •Either partner is currently taking any medication known to treat psychosis, somatoform, dissociative or psychotic disorders or is taking any psychotropic medication, has a diagnosis of a neurodevelopmental (e. g., autism spectrum disorder), neurocognitive, personality or paraphilic disorder.
- •Either partner reports having been arrested or in prison in the past 3 months due to driving drunk or any other legal problem related to alcohol or other drugs, reports having been fired from her/his job due to alcohol or substance use/abuse, reports an episode (as a victim and/or perpetrator) of a sexual assault during the past 2 years, reports current physical or sexual violence in their relationship, or is currently involved in an affair which he/she will not end or requests that the affair remains secret.
- •Either partner has a condition or anticipates having a condition that may make attending therapy sessions unlikely (e.g., major surgery expected in the next 3 months, or moving to a new area in the near future, etc.), is misusing/abusing drugs or alcohol, is a psychotherapist active in clinical practice and/or has a direct knowledge of the model because he/she is in training or trained in EFT.
研究组 & 干预措施
Intervention
Couples will receive 19-21 free sessions of Emotionally-Focused Therapy.
干预措施: Emotionally Focused Therapy (Behavioral)
Waitlist
Couples will receive no intervention during the trial. After the trial is ended, they will be invited to participate in a weekend intervention meeting.
结局指标
主要结局
Change in Experiences in Close Relationships Questionnaire (ECR-36)
时间窗: Baseline and up to 6 months
This measure contains 36 items and yields continuous scores on two attachment domains: attachment anxiety and attachment avoidance. The data collected through the ECR would contribute to this study as it would allow researchers to analyze the effect of EFT therapy on the attachment styles of clients living in Spanish speaking countries.
Change in Dyadic Adjustment Scale (DAS-32 and DAS-4)
时间窗: Baseline and up to 6 months
The Dyadic Adjustment Scale (DAS; Spanier, 1976) is a 32- item measure which measures romantic relationship adjustment. Partners are asked to rate the occurrence of both relationship disagreements and positive relationship exchanges on a Likert scale from 1-5 or 1-6. Higher scores on this measure are indicative of better relationship adjustment or higher relationship satisfaction. A short version of the DAS called the DAS-4 (Sabourin, Valois, \& Lussier, 2005), composed of 4 items, will also be used. The DAS-4 measure was chosen to decrease the time spent by couples completing questionnaires coinciding with their therapy sessions.
Change in Couple Satisfaction Inventory (CSI-16)
时间窗: Baseline and up to 6 months
The CSI-16 (Funk \& Rogge, 2007) is a 16-item measure of relationship satisfaction. One global item uses a 7-point scale, whereas the other 15 items use a variety of response anchors, all with 6-point scales. The CSI represents the only measure of relationship satisfaction described here which was developed using item response theory. Higher scores indicate higher levels of relationship satisfaction.
次要结局
- Change in Reflective functioning questionnaire (RFQ-8)(Baseline and up to 6 months)
- Change in Patient Health Questionnaire (PHQ - 15)(Baseline and up to 6 months)
- Change in UCLA Loneliness Scale Revised - Short version (UCLA LS-R-8)(Baseline and up to 6 months)
- Change in Authoritative Parenting subscale (RELATE)-(AP-15)(Baseline and up to 6 months)
- Change in Sleep quality (Sleep-8)(Baseline and up to 6 months)
- Change in General Health Questions (Health-4)(Baseline and up to 6 months)
- Change in Depression Anxiety Stress Scale (DASS-21)(Baseline and up to 6 months)
- Change in Sexual dissatisfaction subscale of Marital Satisfaction Inventory (SD-13)(Baseline and up to 6 months)
- Change in The Brief Accessibility, Responsiveness, and Engagement Scale (BARE-12)(Baseline and up to 6 months)
- Change in CORE Outcome Measure short form (CORE-OM-10)(Baseline and up to 6 months)