Partner Relational ProblemsE(f)FECTSNCT04277325
Efficacy of Emotionally Focused Therapy Among Spanish Speaking Couples
A study testing Emotionally Focused Therapy in people with Partner Relational Problems, run by Clinica Universidad de Navarra, Universidad de Navarra at 16 sites in 5 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Partner Relational Problems
- What is being tested?
- Emotionally Focused Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 16 sitesin 5 countries
- Study dates
- 1 Sep 2021to 25 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
16 sites in 5 countries.
16 sites in 5 countries
Mexico5 sites
Consulta Mónica Díaz Cayeros
Cancún, Quintana Roo, 77500
Consulta Alfonso Villareal
Mérida, Yucatán, 97128
Consulta Ali Barbosa
Mérida, Yucatán, 97128
Consulta Gerardo Vázquez
Mexico City, 03920
Consulta Cecilia Paredes
Mexico City, 11000
Argentina4 sites
Consultorio Silvia Goso
Buenos Aires, 1425
Consultorio Mariana Butty
Buenos Aires, 1602
Consultorio Esteban Azumendi
Buenos Aires, 1613
Consultorio Verónica Salem
Ciudad Autónoma de Buenos Aires, Buenos Aires, 1428
Spain4 sites
Consulta Itziar Arana
El Escorial, Madrid, 28049
Centro de Orientación y Mediación Familiar Coordenadas
Málaga, 29008
Gabinete de Terapia de Pareja de Zaragoza
Zaragoza, 50001
Centro Vitae Psicología
Zaragoza, 50005
Costa Rica2 sites
Consultorio Ileana Morera Vargas
Alajuela, 20101
Consultorio Creciendo en Pareja
San José, 10806
About this study
Official title: Efficacy of Emotionally Focused Therapy Among Spanish Speaking Couples: A Randomized Clinical Trial
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.
Read more
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.
Read the detailed description
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.
In order to ensure the therapists in this study are implementing EFT faithfully, two different procedures will be carried out. First, during the supervision meetings with participating therapists, the supervisor will review video recording segments of therapy to determine if EFT is being conducted with adherence to the model. Second, once the study ends, two independent raters will be asked to rate at least 5 sessions of each therapist's taped sessions to ensure that at least 80% of the therapists' interventions can be coded as adherent to the model.
The research team, with their relevant experience, includes the following individuals: Martiño Rodriguez-Gonzalez, Ph.D. (Principal Investigator, Certified Couple Therapist in Spain and Researcher at the Institute for Culture and Society (ICS), Universidad de Navarra, Spain), Shayne Anderson, Ph.D., (Co-Principal investigator; Associate Professor at the Brigham Young University (BYU), USA, and Psychotherapist at the BYU Comprehensive Clinic, USA), Marie-France Lafontaine, Ph.D., (Director of the Couple Research Laboratory, Full Professor at the University of Ottawa and a certified psychologist in Ontario and Quebec, Canada), Paul Greenman, Ph.D. (Full Professor and Chair of the Department of Psychoeducation and Psychology at the Université du Québec en Outaouais, and a certified psychologist in Ontario and Québec, Canada), Alfonso Osorio, Ph.D. (Associate Professor at the School of Education and Psychology and researcher at the Institute for Culture and Society, ICS, Universidad de Navarra, Spain), Jonathan Sandberg, Ph.D. (Full Professor School of Family Life at the Brigham Young University, USA), Jokin de Irala, PhD. (Associate Professor at the School of Medicine and Principal Investigator of the Research group "Educación de la afectividad y de la sexualidad humana" (EASH) at the Institute for Culture and Society, ICS, Universidad de Navarra, Spain), Patrick Steffen, Ph.D. (Full Professor in the Psychology Department at the Brigham Young University, USA), María Calatrava, Ph.D. (Researcher at the Institute for Culture and Society, ICS, Universidad de Navarra, Spain), Maria del Pilar Martínez, PhD. (Full Professor at the School of Social sciences, Department of Psychology, Universidad Pontificia Comillas, Madrid, Spain).
- Conditions
- Partner Relational Problems
- Being tested
- Emotionally Focused Therapy
- Keywords
- Emotionally Focused Therapy, Spanish Speaking couples, Couple therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotionally Focused TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Couples will receive 19-21 free sessions of Emotionally-Focused Therapy. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and up to 6 months
Secondary outcomes (10)
Change in General Health Questions (Health-4)
In this measure, respondents are asked to rate their health. Higher scores on this measure represent better health. Participants respond to these questions about general health based on a 5-point Likert scale ranging from 1 (poor) to 5 (excellent). As there are many established connections between mental health and physical health, these variables are of interest in this study so as to control for the effects of physical health or physical ailments on participant outcomes as well as an analysis of the positive effects of relationship quality increases on physical health.
Measured: Baseline and up to 6 months
Change in Patient Health Questionnaire (PHQ - 15)
The PHQ-15 is a somatic symptom subscale which stems from the original full PHQ. The PHQ has 13 somatic and 2 psychological (fatigue, sleep problems) symptoms questions. Each item is scored from 0 (not bothered at all) to 2 (bothered a lot). Items consist of symptoms such as "stomach pain" and "headaches" (Kroenke, Spitzer \& Williams, 2002).
Measured: Baseline and up to 6 months
Change in Depression Anxiety Stress Scale (DASS-21)
The DASS 21 consists of 21 negative emotional symptoms statements/questions. Respondents rate to what extent over the past week they have experienced each symptom on a 4-point scale of severity or frequency. The DASS 21 has a depression, anxiety and stress subscale. Items on the depression subscale consist of statements like "I felt that life was meaningless." and "I felt down-hearted and blue." Items on the stress subscale consist of statements like "I felt I was rather touchy." and "I found it difficult to relax." Items on the anxiety subscale consist of statements like "I felt I was close to panic." and "I felt scared without any good reason." (Antony, Bieling, Cox, Enns, \& Swinson, 1998).
Measured: Baseline and up to 6 months
Change in Sexual dissatisfaction subscale of Marital Satisfaction Inventory (SD-13)
The Revised Marital Satisfaction inventory has 150 items which measure the type and severity of relationship distress in multiple areas of marital interaction including aggression, finances, role orientation, leisure time spent together etc. Respondents choose between a true and false response to each item. The Sexual dissatisfaction (SD-13) subscale assesses the level of dissatisfaction through statements regarding the frequency and quality of the couple's sexual activity. Items consist of statements such as "My spouse sometimes shows too little enthusiasm for sex." and "My spouse has too little regard sometimes for my sexual satisfaction." (Snyder, 1979).
Measured: Baseline and up to 6 months
Change in UCLA Loneliness Scale Revised - Short version (UCLA LS-R-8)
The revised UCLA loneliness scale (UCLA LS-R) is a 8-item questionnaire designed to measure and detect variations in loneliness. Each item is ranked on a 4-point Likert scale ranging from "Never" to "Often". Items consists of statements like "I feel isolated from others" and "I lack companionship" (Hays \& DiMatteo, 1987). As loneliness can be an indicator of relationship satisfaction and/or relationship quality, data collected through this questionnaire would allow researchers to assess for an additional element of relationship satisfaction and the impact EFT has on relationship satisfaction.
Measured: Baseline and up to 6 months
Change in Reflective functioning questionnaire (RFQ-8)
The RFQ seeks to measure the capacity one has to understand one's own and other's feelings, goals and attitudes. It has an uncertainty subscale and a certainty subscale. This short version of the RFQ contains 8 items which are scored on a 7-point Likert scale ranging from "strongly disagree" to "strongly agree". Items consist of statements such as "People's thoughts are a mystery to me" and "I always know what I feel." This scale would provide data allowing researchers to control for individual's capacity for understanding their partner and how EFT might affect said capacity.
Measured: Baseline and up to 6 months
Change in Authoritative Parenting subscale (RELATE)-(AP-15)
The Authoritative Parenting subscale comes from the Parenting Style and Dimensions Questionnaire Short form (PSDQ). The PSDQ is used to measure parenting styles. The authoritative parenting subscale from the short version of the PSDQ is composed of 15 items. (Olivari, Tagliabue, \& Confalonieri, 2013; Oliveira et al., 2018). Items include phrases such as "I am responsive to our child's feelings or needs." and "I allow our child to give input into family rules." Responses are scored on a 5-point Likert scale ranging from "Never" to "Always" (Oliveira et al., 2018).
Measured: Baseline and up to 6 months
Change in Sleep quality (Sleep-8)
The PROMIS sleep disturbance short form (Sleep-8) questionnaire has 8 items. Respondents are asked to assess their sleep quality over the past 7 days by responding to statements like "I had trouble sleeping." and "My sleep was refreshing." Responses are scored on a 5-point Likert Scale ranging from "Not at all" to "Very Much."
Measured: Baseline and up to 6 months
Change in The Brief Accessibility, Responsiveness, and Engagement Scale (BARE-12)
The BARE is an instrument which measures an individual's perception of their own and their partners attachment behaviors. It measures attachment behaviors (and has 3 subscales) through assessing accessibility, responsiveness and engagement, all of which are related to secure attachment. The scale has 12 items, measuring 6 subscales (accessibility, responsiveness and engagement for both self and partner). Items are scored on a 5-point Likert scale ranging from "Never True" to "Always True." Items consist of statements such as "I am rarely available to my partner." and "I am confident my partner reaches out to me." (Sandberg, Busby, Johnson, \& Yoshida, 2012).
Measured: Baseline and up to 6 months
Change in CORE Outcome Measure short form (CORE-OM-10)
This is a client self-report questionnaire designed to be administered before and after therapy. The questionnaire is repeated after the last session of treatment; comparison of the pre-and post-therapy scores offers a measure of 'outcome' (i.e. whether or not the client's level of distress has changed, and by how much). The CORE-10 is a brief outcome measure comprising 10 items drawn from the CORE-OM which is a 34-item assessment and outcome measure. The CORE-OM has been widely adopted in the evaluation of counseling and the psychological therapies in the UK. The CORE-10 taps global distress and is, therefore, suitable for use as an initial quick screening tool and also as an outcome measure.
Measured: Baseline and up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start1 Sep 2021
- Primary completion14 Mar 2023
- Study completion25 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Partner Relational ProblemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Couples will be randomly assigned to one of two groups: intervention or waitlist.
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham Young University
- Responsible party
- Sponsor
- Investigators
- Martiño Rodríguez-González, PhD, Principal investigator, University of NavarraShayne Anderson, PhD, Principal investigator, Brigham Young University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277325
- Sponsor's protocol ID
- E(f)FECTS
- Acronym
- E(f)FECTS
- Status last verified
- Mar 2025
- First submitted
- 11 Feb 2020
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36273180
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Emotionally Focused Therapy Among Spanish Speaking Couples: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04277325
- Acronym / sponsor ID
- E(f)FECTS / E(f)FECTS
- Conditions
- Partner Relational Problems
- Keywords
- Emotionally Focused Therapy, Spanish Speaking couples, Couple therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Collaborators
- Brigham Young University
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 14 Mar 2023 (actual)
- Study completion
- 25 Mar 2025 (actual)
- First posted
- 20 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
In order to ensure the therapists in this study are implementing EFT faithfully, two different procedures will be carried out. First, during the supervision meetings with participating therapists, the supervisor will review video recording segments of therapy to determine if EFT is being conducted with adherence to the model. Second, once the study ends, two independent raters will be asked to rate at least 5 sessions of each therapist's taped sessions to ensure that at least 80% of the therapists' interventions can be coded as adherent to the model.
The research team, with their relevant experience, includes the following individuals: Martiño Rodriguez-Gonzalez, Ph.D. (Principal Investigator, Certified Couple Therapist in Spain and Researcher at the Institute for Culture and Society (ICS), Universidad de Navarra, Spain), Shayne Anderson, Ph.D., (Co-Principal investigator; Associate Professor at the Brigham Young University (BYU), USA, and Psychotherapist at the BYU Comprehensive Clinic, USA), Marie-France Lafontaine, Ph.D., (Director of the Couple Research Laboratory, Full Professor at the University of Ottawa and a certified psychologist in Ontario and Quebec, Canada), Paul Greenman, Ph.D. (Full Professor and Chair of the Department of Psychoeducation and Psychology at the Université du Québec en Outaouais, and a certified psychologist in Ontario and Québec, Canada), Alfonso Osorio, Ph.D. (Associate Professor at the School of Education and Psychology and researcher at the Institute for Culture and Society, ICS, Universidad de Navarra, Spain), Jonathan Sandberg, Ph.D. (Full Professor School of Family Life at the Brigham Young University, USA), Jokin de Irala, PhD. (Associate Professor at the School of Medicine and Principal Investigator of the Research group "Educación de la afectividad y de la sexualidad humana" (EASH) at the Institute for Culture and Society, ICS, Universidad de Navarra, Spain), Patrick Steffen, Ph.D. (Full Professor in the Psychology Department at the Brigham Young University, USA), María Calatrava, Ph.D. (Researcher at the Institute for Culture and Society, ICS, Universidad de Navarra, Spain), Maria del Pilar Martínez, PhD. (Full Professor at the School of Social sciences, Department of Psychology, Universidad Pontificia Comillas, Madrid, Spain).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Couples will be randomly assigned to one of two groups: intervention or waitlist.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Emotionally Focused TherapyCouples will receive 19-21 free sessions of 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. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emotionally Focused TherapyEmotionally 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. | Behavioural | Intervention |
Primary outcome
Change in Dyadic Adjustment Scale (DAS-32 and DAS-4)
Time frame: 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)
Time frame: 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.
Change in Experiences in Close Relationships Questionnaire (ECR-36)
Time frame: 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.
10 secondary outcomes
Change in General Health Questions (Health-4)
Time frame: Baseline and up to 6 months
Change in Patient Health Questionnaire (PHQ - 15)
Time frame: Baseline and up to 6 months
Change in Depression Anxiety Stress Scale (DASS-21)
Time frame: Baseline and up to 6 months
Change in Sexual dissatisfaction subscale of Marital Satisfaction Inventory (SD-13)
Time frame: Baseline and up to 6 months
Change in UCLA Loneliness Scale Revised - Short version (UCLA LS-R-8)
Time frame: Baseline and up to 6 months
Change in Reflective functioning questionnaire (RFQ-8)
Time frame: Baseline and up to 6 months
Change in Authoritative Parenting subscale (RELATE)-(AP-15)
Time frame: Baseline and up to 6 months
Change in Sleep quality (Sleep-8)
Time frame: Baseline and up to 6 months
Change in The Brief Accessibility, Responsiveness, and Engagement Scale (BARE-12)
Time frame: Baseline and up to 6 months
Change in CORE Outcome Measure short form (CORE-OM-10)
Time frame: Baseline and up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Derived from this study: PubMed 36273180Rodriguez-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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martiño Rodríguez-González, PhD principal investigator
University of Navarra
Shayne Anderson, PhD principal investigator
Brigham Young University
16 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotionally Focused Therapy in people with Partner Relational Problems, run by Clinica Universidad de Navarra, Universidad de Navarra at 16 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Mexico, Argentina, Spain, Costa Rica, Guatemala. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dyadic Adjustment Scale (DAS-32 and DAS-4) (time frame: Baseline and up to 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04277325, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.