NCT04277325

Brief Summary

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Longer than P75 for not_applicable

Geographic Reach
5 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
1.5 years until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2025

Completed
Last Updated

March 26, 2025

Status Verified

March 1, 2025

Enrollment Period

1.5 years

First QC Date

February 11, 2020

Last Update Submit

March 25, 2025

Conditions

Keywords

Emotionally Focused TherapySpanish Speaking couplesCouple therapy

Outcome Measures

Primary Outcomes (3)

  • Change in Dyadic Adjustment Scale (DAS-32 and DAS-4)

    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.

    Baseline and up to 6 months

  • Change in Couple Satisfaction Inventory (CSI-16)

    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.

    Baseline and up to 6 months

  • Change in Experiences in Close Relationships Questionnaire (ECR-36)

    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.

    Baseline and up to 6 months

Secondary Outcomes (10)

  • Change in General Health Questions (Health-4)

    Baseline and up to 6 months

  • Change in Patient Health Questionnaire (PHQ - 15)

    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 UCLA Loneliness Scale Revised - Short version (UCLA LS-R-8)

    Baseline and up to 6 months

  • +5 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Couples will receive 19-21 free sessions of Emotionally-Focused Therapy.

Behavioral: Emotionally Focused Therapy

Waitlist

NO INTERVENTION

Couples will receive no intervention during the trial. After the trial is ended, they will be invited to participate in a weekend intervention meeting.

Interventions

Emotionally Focused Couples Therapy (EFT) is an empirically supported, attachment-based model of couples therapy that combines experiential, systems, and attachment theories with the goal of fostering the development of safe contact, accessibility, and responsiveness in both partners.

Intervention

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Consultorio Verónica Salem

Ciudad Autónoma de Buenos Aires, Buenos Aires, 1428, Argentina

Location

Consultorio Silvia Goso

Buenos Aires, 1425, Argentina

Location

Consultorio Mariana Butty

Buenos Aires, 1602, Argentina

Location

Consultorio Esteban Azumendi

Buenos Aires, 1613, Argentina

Location

Consultorio Ileana Morera Vargas

Alajuela, 20101, Costa Rica

Location

Consultorio Creciendo en Pareja

San José, 10806, Costa Rica

Location

Clínica Humanamente Guatemala

Guatemala City, 01015, Guatemala

Location

Consulta Mónica Díaz Cayeros

Cancún, Quintana Roo, 77500, Mexico

Location

Consulta Alfonso Villareal

Mérida, Yucatán, 97128, Mexico

Location

Consulta Ali Barbosa

Mérida, Yucatán, 97128, Mexico

Location

Consulta Gerardo Vázquez

Mexico City, 03920, Mexico

Location

Consulta Cecilia Paredes

Mexico City, 11000, Mexico

Location

Consulta Itziar Arana

El Escorial, Madrid, 28049, Spain

Location

Centro de Orientación y Mediación Familiar Coordenadas

Málaga, 29008, Spain

Location

Gabinete de Terapia de Pareja de Zaragoza

Zaragoza, 50001, Spain

Location

Centro Vitae Psicología

Zaragoza, 50005, Spain

Location

Related Publications (1)

  • Rodriguez-Gonzalez M, Anderson S, Osorio A, Lafontaine MF, Greenman PS, Calatrava M, Andrade D, Lybbert R, Martinez-Diaz P, Steffen P, de Irala J, Sandberg J. Efficacy of Emotionally Focused Therapy among Spanish-speaking couples: study protocol of a randomized clinical trial in Argentina, Costa Rica, Guatemala, Mexico, and Spain. Trials. 2022 Oct 22;23(1):891. doi: 10.1186/s13063-022-06831-7.

MeSH Terms

Interventions

Emotion-Focused Therapy

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Martiño Rodríguez-González, PhD

    University of Navarra

    PRINCIPAL INVESTIGATOR
  • Shayne Anderson, PhD

    Brigham Young University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Couples will be randomly assigned to one of two groups: intervention or waitlist.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2020

First Posted

February 20, 2020

Study Start

September 1, 2021

Primary Completion

March 14, 2023

Study Completion

March 25, 2025

Last Updated

March 26, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations