NCT07604740

Brief Summary

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. 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. 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. 3.Short Manualized Emotionally Focused Couple Intervention: Five face-to-face sessions with a couple therapist.
  4. 4.Face-to-Face Couple Therapy (Treatment As Usual): 1 to 10 sessions, with the therapeutic approach varying depending on the therapist's training.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
38mo left

Started Nov 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress15%
Nov 2025Jun 2029

Study Start

First participant enrolled

November 11, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

3.1 years

First QC Date

May 12, 2026

Last Update Submit

May 19, 2026

Conditions

Keywords

relationship supportrelationship counsellingrandomized controlled trialcouplescouple therapyrelationship satisfaction

Outcome Measures

Primary Outcomes (3)

  • Relationship Satisfaction (Dyadic Adjustment Scale)

    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)

    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)

    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.

Secondary Outcomes (3)

  • Adult Attachment (Experiences in Close Relationships - Revised

    Measured at enrollment before randomization, after treatment (or waitlist condition) and at a 4 months followup.

  • Reflective Functioning (Reflective Functioning Questionnaire)

    Measured at enrollment before randomization, after treatment (or waitlist condition) and at a 4 months followup.

  • Communication Patterns (Communication Patterns Questionnaire)

    Masured at enrollment before randomization, after treatment (or waitlist condition) and at a 4 months followup

Study Arms (5)

HUS Self-help for Couples

EXPERIMENTAL
Behavioral: Self-Help Program for Couples

Peloton Parisuhde (eng Fearless Relationship) Online Course

EXPERIMENTAL
Behavioral: Peloton Parisuhde (eng Fearless Relationship) Online Course

Manualized Short-Term EFT-Based Couple Intervention

EXPERIMENTAL
Behavioral: Manualized Short-Term EFT-Based Couple Intervention

Standard Face-to-Face Couple Therapy (Treatment as Usual)

EXPERIMENTAL
Behavioral: Standard Face-to-Face Couple Therapy (Treatment as Usual)

Waitlist (control group)

NO INTERVENTION

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.

Interventions

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.

HUS Self-help for Couples

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.

Peloton Parisuhde (eng Fearless Relationship) Online Course

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.

Manualized Short-Term EFT-Based Couple Intervention

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.

Standard Face-to-Face Couple Therapy (Treatment as Usual)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Relationship Counselling

Helsinki, Finland

Location

MeSH Terms

Interventions

Family CharacteristicsTherapeutics

Intervention Hierarchy (Ancestors)

DemographyPopulation CharacteristicsSocioeconomic FactorsEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 4 intervention groups and 1 waitlist control group. Waitlist control group gets TAU after waitlist time is finished.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Clinical lecturer

Study Record Dates

First Submitted

May 12, 2026

First Posted

May 22, 2026

Study Start

November 11, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

June 30, 2029

Last Updated

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

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.

Locations