ISRCTN ISRCTN82628699
DOI https://doi.org/10.1186/ISRCTN82628699
Protocol serial number Nro20/2024
Sponsor University of Helsinki
Funders Valtion tutkimusrahoitus (Finnish State Research Funding), Helsingin Kaupunki
Submission date
13/11/2025
Registration date
18/11/2025
Last edited
18/11/2025
Recruitment status
Recruiting
Overall study status
Ongoing
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
A romantic relationship is, for many, the most important interpersonal relationship in life. However, various relationship problems, such as conflicts and difficulties in communication, are common. Relationship issues have a significant impact on both partners' mental and physical health. In addition to the partners' own health, parental relationship satisfaction is strongly associated with better mental health in children, whereas conflicts between parents increase both behavioral problems and symptoms of depression and anxiety in children.

This study, conducted at the Relationship Counselling unit of the City of Helsinki, aims to evaluate the effectiveness of different forms of relationship support, including two online self-help programs, one in-person manualized short-term intervention, and couple therapy as usual, by comparing four intervention groups with each other and with a waitlist control group.

Who can participate?
Parents of children under 7 years old, of whom one of the parents lives in Helsinki. The couple experiences serious distress in their relationship or a threat of separation or divorce.

What does the study involve?
The study is a randomly allocated study in which participants are allocated to a couple (cluster), with a parallel-group design comparing four intervention groups, both with each other and with a waitlist control group. The interventions include two online self-help interventions: (1) HUS Self-Help for Couples, (2) Fearless Relationship Course, and two face-to-face interventions: (3) Short Manualized Emotionally Focused Intervention, (4) Couple Therapy (Treatment As Usual).

Participants complete questionnaires at the beginning and end of the service, and at a 4-month follow-up. The questionnaires measure relationship satisfaction and mental health, experiences in close relationships and reflective functioning. In addition, feedback-informed treatment is collected at the face-to-face interventions.

The study is run from the Relationship Counselling Unit of the City of Helsinki’s social services, 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.

What are the possible benefits and risks of participating?
Participants may benefit from addressing relationship challenges, potentially improving relationship satisfaction and overall family well-being. Risks include being assigned to an intervention that may not fully meet the couple’s needs. However, after completing the research treatment, all participants in the self-help and waitlist groups will have access to the unit’s standard treatment-as-usual services.

Where is the study run from?
The Relationship Counselling Unit of the City of Helsinki’s social services, Finland.

When is the study starting and how long is it expected to run for?
The study enrolment starts in November 2025 to November 2027.

Who is funding the study?
1. Valtion tutkimusrahoitus (Finnish State Research Funding), Finland.
2. City of Helsinki, Finland.

Who is the main contact?
1. Clinical Senior Lecturer, PhD Petra Nyman-Salonen, petra.nyman-salonen@helsinki.fi
2. PhD, Docent Marjo Flykt, marjo.flykt@helsinki.fi

Contact information

Dr Petra Nyman-Salonen
Principal investigator, Public, Scientific

University of Helsinki, Haartmaninkatu 3
Helsinki
00014
Finland

ORCiD logoORCID ID 0000-0002-4532-3159
Phone +358504794405
Email petra.nyman-salonen@helsinki.fi
Dr Marjo Flykt
Principal investigator, Scientific

University of Helsinki, Haartmaninkatu 3
Helsinki
00014
Finland

ORCiD logoORCID ID 0000-0003-0874-4357
Phone +358503015679
Email marjo.flykt@helsinki.fi

Study information

Primary study designInterventional
AllocationRandomized controlled trial
MaskingBlinded (masking used)
ControlActive
AssignmentParallel
PurposeSupportive care, Treatment
Scientific titleThe effectiveness of couple therapy and relationship support: a randomized controlled trial
Study acronymECot
Study objectivesThis study investigates the effectiveness of four different interventions for couples: two online self-help relationship support programs (HUS Mielenterveystalo and ‘Fearless Relationship’ course) and two face-to-face interventions (a manualized short-term intervention based on the Emotionally Focused Couple therapy and Couple Therapy ‘Treatment as Usual’) on Relationship Satisfaction and Mental Health, and interventions are compared to the waitlist condition.
Ethics approval(s)

Approved 06/11/2024, Research Ethics Committee of the Faculty of Medicine (University of Helsinki) (Faculty Office, P.O:Box 3 (Haartmaninkatu 8), Helsinki, FI-00014, Finland; +35829 41911; eettinen-toimikunta@helsinki.fi), ref: 20/2024

Health condition(s) or problem(s) studiedRelationship satisfaction and mental health
InterventionThe couples are randomly assigned to the five arms based on their relationship satisfaction, mental health symptoms, and family form.

Four interventions:
1) Self-help program for Couples (Mielenterveystalo.fi) developed by HUS (Helsinki University Hospital): couples receive psychoeducational content and practical exercises to enhance their well-being
2) The Fearless Relationship -course is designed based on Emotionally Focused Couple therapy principles.
3) Manualized Short-Term EFT-Based Couple Intervention is a structured program consisting of five weekly face-to-face sessions with a trained couple therapist.
4) Treatment as Usual consists of 1 to 10 in-person sessions with a couples therapist.

Control group: Waitlist control (2 months).
Intervention typeBehavioural
Primary outcome measure(s)

1. Relationship satisfaction measured using the Relationship satisfaction (R-DAS) before randomization, post-intervention and at 4-month follow-up
2. Mental health: depression measured using the Patient Health Questionnaire-9 (PHQ-9) before randomization, post-intervention and at 4-month follow-up
3. Anxiety measured using the Generalized Anxiety Disorder 7-item questionnaire (GAD-7) before randomization, post-intervention and at 4-month follow-up

Key secondary outcome measure(s)

1. Adult attachment measured using the Experience in Close Relationships– Short Form (ECR-12) before randomization, post-intervention and at 4-month follow-up
2. Communication styles during arguments measured using the Communication Patterns Questionnaire Short Form (CPQ-SF) before randomization, post-intervention and at 4-month follow-up
3. Reflective capacities measured using the Reflective Functioning Questionnaire (RFQ8) before randomization, post-intervention and at 4-month follow-up
4. Therapeutic alliance is measured using the Session Rating Scale (SRS) and the well-being of the participants with the Outcome Rating Scale (ORS) during the Feedback-Informed-Treatment used in the face-to-face interventions at the Relationship Counselling Unit of the City of Helsinki

Completion date31/12/2027

Eligibility

Participant type(s)Resident, Service user
Age groupMixed
Lower age limit18 Years
Upper age limit100 Years
SexAll
Target sample size at registration200
Key inclusion criteriaParticipants include couples (including blended families or those expecting their first child) in which at least one partner is a resident of Helsinki.
The couple must be 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 must be eligible for treatment at the Relationship Counselling Unit of the City of Helsinki, Finland.
Key exclusion criteria1. Inadequate Finnish written language skills (the questionnaires are only available in Finnish)
2. If both spouses do not complete the baseline questionnaires within the given deadline
Date of first enrolment18/11/2025
Date of final enrolment31/12/2027

Locations

Countries of recruitment

  • Finland

Study participating centre

Relationship Counselling, City of Helsinki
Vironkatu 2
Helsinki
00170
Finland

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
IPD sharing plan

Editorial Notes

18/11/2025: Study’s existence confirmed by the Research Ethics Committee of the Faculty of Medicine (University of Helsinki), Finland.