- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07604740
The Effectiveness of Couple Therapy and Relationship Support (ECoT)
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:
- 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.
- 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.
- Short Manualized Emotionally Focused Couple Intervention: Five face-to-face sessions with a couple therapist.
- 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.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Helsinki, Finlandia
- Relationship Counselling
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: HUS Self-help for Couples
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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.
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Sperimentale: Peloton Parisuhde (eng Fearless Relationship) Online Course
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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.
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Sperimentale: Manualized Short-Term EFT-Based Couple Intervention
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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.
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Sperimentale: Standard Face-to-Face Couple Therapy (Treatment as Usual)
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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.
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Nessun intervento: 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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Relationship Satisfaction (Dyadic Adjustment Scale)
Lasso di tempo: Measured at enrollment before randomization, after treatment (or waitlist condition) and at a 4 months followup.
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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.
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Measured at enrollment before randomization, after treatment (or waitlist condition) and at a 4 months followup.
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Depression severity (Patient Health Questionnaire-9)
Lasso di tempo: Measured at enrollment before randomization, after treatment (or waitlist condition) and at a 4 months followup.
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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.
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Measured at enrollment before randomization, after treatment (or waitlist condition) and at a 4 months followup.
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Anxiety Severity (Generalized Anxiety Disorder-7)
Lasso di tempo: Measured at enrollment before randomization, after treatment (or waitlist condition) and at a 4 months followup.
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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.
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Measured at enrollment before randomization, after treatment (or waitlist condition) and at a 4 months followup.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Adult Attachment (Experiences in Close Relationships - Revised
Lasso di tempo: Measured at enrollment before randomization, after treatment (or waitlist condition) and at a 4 months followup.
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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.
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Measured at enrollment before randomization, after treatment (or waitlist condition) and at a 4 months followup.
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Reflective Functioning (Reflective Functioning Questionnaire)
Lasso di tempo: Measured at enrollment before randomization, after treatment (or waitlist condition) and at a 4 months followup.
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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.
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Measured at enrollment before randomization, after treatment (or waitlist condition) and at a 4 months followup.
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Communication Patterns (Communication Patterns Questionnaire)
Lasso di tempo: Masured at enrollment before randomization, after treatment (or waitlist condition) and at a 4 months followup
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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.
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Masured at enrollment before randomization, after treatment (or waitlist condition) and at a 4 months followup
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Collaboratori e investigatori
Sponsor
Collaboratori
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Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- nro 20/2024
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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