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The Effectiveness of Couple Therapy and Relationship Support (ECoT)

19. května 2026 aktualizováno: 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.

Přehled studie

Postavení

Zápis na pozvánku

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

400

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Finsko
      • Helsinki, Finsko
        • Relationship Counselling

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Podpůrná péče
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: HUS Self-help for Couples
Behaviorální: Self-Help Program 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.
Experimentální: Peloton Parisuhde (eng Fearless Relationship) Online Course
Behaviorální: 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.
Experimentální: Manualized Short-Term EFT-Based Couple Intervention
Behaviorální: 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.
Experimentální: Standard Face-to-Face Couple Therapy (Treatment as Usual)
Behaviorální: 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.
Žádný zásah: 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 je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Relationship Satisfaction (Dyadic Adjustment Scale)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Adult Attachment (Experiences in Close Relationships - Revised
Časové okno: 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)
Časové okno: 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)
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Helsinki

Spolupracovníci

City of Helsinki

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

11. listopadu 2025

Primární dokončení (Odhadovaný)

31. prosince 2028

Dokončení studie (Odhadovaný)

30. června 2029

Termíny zápisu do studia

První předloženo

12. května 2026

První předloženo, které splnilo kritéria kontroly kvality

19. května 2026

První zveřejněno (Aktuální)

22. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

22. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

19. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • nro 20/2024

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu 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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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