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Efficacy of Emotionally Focused Therapy Among Spanish Speaking Couples (E(f)FECTS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04277325
Recruitment Status : Suspended (The study has been postponed due to mobility constrains during covid-19 crisis.)
First Posted : February 20, 2020
Last Update Posted : April 27, 2020
Sponsor:
Collaborator:
Brigham Young University
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra

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 study will start in February 2020 for Argentina and Guatemala, and in September 2020 for Costa Rica, México, and Spain. The study period for each couple will be around 6 months.


Condition or disease Intervention/treatment Phase
Partner Relational Problems Behavioral: Emotionally Focused Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Couples will be randomly assigned to one of two groups: intervention or waitlist.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Emotionally Focused Therapy Among Spanish Speaking Couples: A Randomized Clinical Trial
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : July 30, 2023

Arm Intervention/treatment
Experimental: Intervention
Couples will receive 19-21 free sessions of Emotionally-Focused Therapy.
Behavioral: Emotionally Focused Therapy
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.

No Intervention: 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.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Change in General Health Questions (Health-4) [ Time Frame: Baseline and up to 6 months ]
    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.

  2. Change in Patient Health Questionnaire (PHQ - 15) [ Time Frame: Baseline and up to 6 months ]
    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).

  3. Change in Depression Anxiety Stress Scale (DASS-21) [ Time Frame: Baseline and up to 6 months ]
    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).

  4. Change in Sexual dissatisfaction subscale of Marital Satisfaction Inventory (SD-13) [ Time Frame: Baseline and up to 6 months ]
    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).

  5. Change in UCLA Loneliness Scale Revised - Short version (UCLA LS-R-8) [ Time Frame: Baseline and up to 6 months ]
    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.

  6. Change in Reflective functioning questionnaire (RFQ-8) [ Time Frame: Baseline and up to 6 months ]
    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.

  7. Change in Authoritative Parenting subscale (RELATE)-(AP-15) [ Time Frame: Baseline and up to 6 months ]
    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).

  8. Change in Sleep quality (Sleep-8) [ Time Frame: Baseline and up to 6 months ]
    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."

  9. Change in The Brief Accessibility, Responsiveness, and Engagement Scale (BARE-12) [ Time Frame: Baseline and up to 6 months ]
    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).

  10. Change in CORE Outcome Measure short form (CORE-OM-10) [ Time Frame: Baseline and up to 6 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04277325


Locations
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Argentina
Consultorio Licenciada Natalia Gilabert
Ciudad Autónoma de Buenos Aires, Argentina, 1414
Consultorio Silvia Goso
Ciudad Autónoma de Buenos Aires, Argentina, 1425
Costa Rica
Lumiere Centro de Salud Mental y Emocional
San José, Costa Rica, 10203
Guatemala
Clínica Humanamente Guatemala
Guatemala, Guatemala, 01015
Mexico
Consultorio Monica Díaz
Cancún, Quintana Roo, Mexico, 77500
Consultorio Alfonso Villareal
Mérida, Yucatán, Mexico, 97128
Consultorio Ali Barbosa
Mérida, Yucatán, Mexico, 97128
Consultorio Gerardo Vázquez
Ciudad de México, Mexico, 04100
Consultorio Cecilia Paredes
Ciudad de México, Mexico, 11000
Spain
Consulta Itziar Arana
El Escorial, Madrid, Spain, 28049
Centro de Orientación y Mediación Familiar Coordenadas
Málaga, Spain, 29008
Gabinete de Terapia de Pareja de Zaragoza
Zaragoza, Spain, 50001
Centro Vitae Psicología
Zaragoza, Spain, 50005
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
Brigham Young University
Investigators
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Principal Investigator: Martiño Rodríguez-González, PhD University of Navarra
Principal Investigator: Shayne Anderson, PhD Brigham Young University
  Study Documents (Full-Text)

Documents provided by Clinica Universidad de Navarra, Universidad de Navarra:
Informed Consent Form  [PDF] October 15, 2019

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Responsible Party: Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT04277325    
Other Study ID Numbers: E(f)FECTS
First Posted: February 20, 2020    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra:
Emotionally Focused Therapy
Spanish Speaking couples
Couple therapy