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The Effectiveness of Couple Therapy and Relationship Support (ECoT)

19 maja 2026 zaktualizowane przez: 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.

Przegląd badań

Typ studiów

Interwencyjne

Zapisy (Szacowany)

400

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

      • Helsinki, Finlandia
        • Relationship Counselling

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Eksperymentalny: 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.
Eksperymentalny: 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.
Eksperymentalny: 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.
Brak interwencji: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Relationship Satisfaction (Dyadic Adjustment Scale)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Adult Attachment (Experiences in Close Relationships - Revised
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Współpracownicy

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

11 listopada 2025

Zakończenie podstawowe (Szacowany)

31 grudnia 2028

Ukończenie studiów (Szacowany)

30 czerwca 2029

Daty rejestracji na studia

Pierwszy przesłany

12 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

19 maja 2026

Pierwszy wysłany (Rzeczywisty)

22 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

22 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

19 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu 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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Self-Help Program for Couples

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