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The Effectiveness of Couple Therapy and Relationship Support (ECoT)

19 de mayo de 2026 actualizado por: Petra Nyman-Salonen, University of Helsinki

The Effectiveness of Couple Therapy and Relationship Support: a Randomized Controlled Trial

This randomized and controlled study investigates the effectiveness of relationship counselling and couple therapy in improving couples' relationship satisfaction and overall well-being. It compares four intervention groups both with each other and with a waitlist control group. The groups are:

  1. HUS Self-Help (Mielenterveystalo.fi): Participants independently complete online self-help tasks based on couple therapy, developed by Helsinki University Hospital (HUS) Psychiatry and Väestöliitto.
  2. Peloton Parisuhde (eng. Fearless Relationship) Online Course: Based on Emotionally Focused Couple Therapy (EFCT), this course by EFCT trainers Eklund-Mikola & Pinomaa uses online lectures and exercises to help couples identify negative interaction patterns and strengthen their emotional connection.
  3. Short Manualized Emotionally Focused Couple Intervention: Five face-to-face sessions with a couple therapist.
  4. Face-to-Face Couple Therapy (Treatment As Usual): 1 to 10 sessions, with the therapeutic approach varying depending on the therapist's training.

The study is conducted at the Relationship Counselling Unit of the City of Helsinki's Social Services in Finland, which provides counselling and family guidance under Section 26 of the Social Welfare Act to couples with children living in Helsinki. A total of 200 couples from the unit's treatment queue will be invited to participate and randomly assigned to one of the interventions or the control group, with 40 couples in each group.

Participants will complete questionnaires at the beginning and end of the service, and at a 4-month follow-up. The questionnaires measure relationship satisfaction and well-being, among other things. The study also examines how individual, couple-level, and treatment-related background factors influence and mediate the effectiveness of the interventions.

In addition to the questionnaires, registry data, therapist assessments, and ongoing treatment feedback collected within the unit is utilized. The results will provide new scientific insights into the effectiveness of short interventions and their suitable target groups and can be used to develop relationship counselling work both within the unit and nationally.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Estimado)

400

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Helsinki, Finlandia
        • Relationship Counselling

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Descripción

Inclusion Criteria:

  • Parents (couple) and blended families, and at least one of the parents is resident of Helsinki
  • Couples expecting their first child. The couple is experiencing one or more of the following (1) severe relationship conflict, (2) a serious threat of separation, (3) significant challenges in forming a family or navigating a blended family relationship.
  • couples eligible for treatment at the couple counselling faculty of Helsinki

Exclusion Criteria:

  • Inadequate Finnish written language skills (the questionnaires are only available in Finnish)
  • if both spouses do not complete the baseline questionnaires within the given deadline.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: HUS Self-help for Couples
Self-Help Program for Couples (Mielenterveystalo.fi) developed by HUS, this online self-help program provides couples with psychoeducational content and practical exercises designed to enhance relationship well-being. Partners can complete the tasks together or individually. The materials aim to strengthen emotional connection and improve communication.
Experimental: Peloton Parisuhde (eng Fearless Relationship) Online Course
Based on Emotionally Focused Couple Therapy, this course by Eira Eklund-Mikola and Hanna Pinomaa uses online lectures and exercises to help couples identify negative interaction patterns and strengthen their emotional connection.
Experimental: Manualized Short-Term EFT-Based Couple Intervention
Manualized Short-Term EFT-Based Couple Intervention is a structured program consisting of five face-to-face sessions with a trained couple therapist. Based on Emotionally Focused Therapy (EFT), the intervention helps partners explore emotional patterns, improve communication, and strengthen their bond through guided therapeutic exercises.
Experimental: Standard Face-to-Face Couple Therapy (Treatment as Usual)
This intervention consists of 1 to 10 in-person sessions with a couple therapist. The therapeutic approach varies depending on the therapist's professional background and training. It reflects typical clinical practice and is not standardized, allowing for flexibility in addressing the couple's specific needs.
Sin intervención: Waitlist (control group)
Participants in this group do not receive any intervention during the initial two-month study period. After the waiting period, they are offered Treatment as Usual. This group serves as a comparison to assess the effectiveness of the active treatments.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Relationship Satisfaction (Dyadic Adjustment Scale)
Periodo de tiempo: Measured at enrollment before randomization, after treatment (or waitlist condition) and at a 4 months followup.
The Dyadic Adjustment Scale (DAS) is a self-report questionnaire assessing relationship satisfaction and adjustment between romantic partners. The scale measures consensus, satisfaction, cohesion, and affectional expression. Total scores range from 0 to 151, with higher scores indicating better relationship adjustment and satisfaction.
Measured at enrollment before randomization, after treatment (or waitlist condition) and at a 4 months followup.
Depression severity (Patient Health Questionnaire-9)
Periodo de tiempo: Measured at enrollment before randomization, after treatment (or waitlist condition) and at a 4 months followup.
The Patient Health Questionnaire-9 (PHQ-9) is a validated self-report measure assessing the severity of depressive symptoms over the past two weeks. Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.
Measured at enrollment before randomization, after treatment (or waitlist condition) and at a 4 months followup.
Anxiety Severity (Generalized Anxiety Disorder-7)
Periodo de tiempo: Measured at enrollment before randomization, after treatment (or waitlist condition) and at a 4 months followup.
The Generalized Anxiety Disorder-7 (GAD-7) is a validated self-report measure assessing the severity of generalized anxiety symptoms over the past two weeks. Total scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms.
Measured at enrollment before randomization, after treatment (or waitlist condition) and at a 4 months followup.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Adult Attachment (Experiences in Close Relationships - Revised
Periodo de tiempo: Measured at enrollment before randomization, after treatment (or waitlist condition) and at a 4 months followup.
The Experiences in Close Relationships - Revised (ECR-R) is a widely used self-report questionnaire that assesses adult attachment styles in romantic relationships. The instrument measures two dimensions: attachment anxiety and attachment avoidance, reflecting how individuals experience closeness, trust, and emotional connection with their partner. Scores on each subscale typically range from 1 to 7, with higher scores indicating greater attachment anxiety or greater attachment avoidance.
Measured at enrollment before randomization, after treatment (or waitlist condition) and at a 4 months followup.
Reflective Functioning (Reflective Functioning Questionnaire)
Periodo de tiempo: Measured at enrollment before randomization, after treatment (or waitlist condition) and at a 4 months followup.
The Reflective Functioning Questionnaire - RFQ-8 is a brief self-report measure developed by Fonagy and colleagues to assess reflective functioning, or mentalizing-the ability to understand one's own and others' thoughts, feelings, and intentions. In couple research, it helps evaluate how well partners can interpret each other's behavior in emotionally meaningful ways, which is essential for healthy communication and emotional connection.
Measured at enrollment before randomization, after treatment (or waitlist condition) and at a 4 months followup.
Communication Patterns (Communication Patterns Questionnaire)
Periodo de tiempo: Masured at enrollment before randomization, after treatment (or waitlist condition) and at a 4 months followup
Communication Patterns Questionnaire - Short Form (CPQ-SF) Developed by Christensen and Sullaway, the CPQ-SF is a self-report measure that assesses how couples communicate during conflict. It focuses on typical interaction styles-such as constructive communication, avoidance, and demand-withdraw patterns-providing insight into how partners argue and resolve disagreements in their relationship.
Masured at enrollment before randomization, after treatment (or waitlist condition) and at a 4 months followup

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Colaboradores

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

11 de noviembre de 2025

Finalización primaria (Estimado)

31 de diciembre de 2028

Finalización del estudio (Estimado)

30 de junio de 2029

Fechas de registro del estudio

Enviado por primera vez

12 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

19 de mayo de 2026

Publicado por primera vez (Actual)

22 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

19 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Individual participant data cannot be shared due to strict confidentiality and data protection regulations. These data contain sensitive health-related information and personal identifiers, and sharing them could compromise participants' privacy. All data are handled in accordance with ethical guidelines and legal standards to ensure the protection of participants' rights and well-being.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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