- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상태
정황
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Helsinki, 핀란드
- Relationship Counselling
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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실험적: 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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실험적: 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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실험적: 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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간섭 없음: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Relationship Satisfaction (Dyadic Adjustment Scale)
기간: 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)
기간: 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)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Adult Attachment (Experiences in Close Relationships - Revised
기간: 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)
기간: 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)
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- nro 20/2024
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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