NCT05194683

Brief Summary

The main objective of this research is to explore the relational letter writing technique as an intervention for improving couples' relational well-being. This is a two-arm superiority randomized clinical trial. Sixty-eight couples will be monitored before, during, and after the intervention. To observe the effect of the relational letter, scores of couples who are in the intervention arm and control arm will be compared (between groups) as well as pre-post scores (within-group). The content of the letter writing will be qualitatively analyzed to explore the reconstruction of their ethical values. Results from both methods will be integrated in order to get an in-depth perspective of the newly developed intervention. It is expected to increase the array of available techniques to help couples improve their individual and relational well-being.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Status
unknown

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

First Submitted

Initial submission to the registry

December 14, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 18, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

June 15, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

7 months

First QC Date

December 14, 2021

Last Update Submit

May 17, 2022

Conditions

Keywords

Relational Letter WritingNarrative Therapy

Outcome Measures

Primary Outcomes (2)

  • Change in Dyadic Adjustment Scale (DAS)

    The change of relational well-being will be evaluated with DAS (Spanier 1976, 2001), which is developed to provide a global measure of relational satisfaction of each member, has 32 items with 5-point, 6-point, 7-point Likert scales as well as two dichotomous items. Scores range from 0 to 151, higher scores indicating more dyadic adjustment.

    The change of relational wellbeing will be evaluated for a week before the intervention (baseline), after the first session of the interview, and with follow-ups (right after the intervention, 2 weeks, and 3 months after the intervention).

  • Perceived Relational Change

    Single item measure, 7-point likert scale measuring perceived change in their relationship as a result fo the intervention

    Perceived relational change will be administrated at post intervention, 2 weeks and 3 months after the intervention

Secondary Outcomes (3)

  • Clinical Outcomes in Routine Evaluation - Outcome Measure Spanish version (CORE-OM)

    Individual wellbeing will be evaluated for a week before the intervention (baseline), after the first session of the interview, and with follow-ups (right after the intervention, 2 weeks, and 3 months after the intervention).

  • Change in Global Measure of Relational Satisfaction (GMRS)

    The change of relationship satisfaction will be evaluated a week before the intervention (baseline), after the first and second session of the interview, and with follow-ups (right after the intervention, 2 weeks, and 3 months after the intervention)

  • Change in Outcome Rating Scale (ORS)

    Chance of session to session progress will be evaluated a week before the intervention (baseline), after the first and second session of the interview, and with follow-ups (right after the intervention, 2 weeks, and 3 months after the intervention).

Study Arms (2)

Letter Writing Arm

EXPERIMENTAL

Relational letter writing intervention

Behavioral: Relational Letter Writing

Control Arm

NO INTERVENTION

No intervention

Interventions

The intervention consists of two interviews and a between-session writing task. In the first session, couples will be interviewed regarding their relationship story and preferences. Between the two sessions, each couple member will write a letter from their relationship point of view. In the second interview, the task is reviewed and paths for relationship improvement are outlined.

Letter Writing Arm

Eligibility Criteria

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

You may qualify if:

  • Couples willing to participate in a relationship enhancing intervention
  • Couples should have been living together at least for 12 months

You may not qualify if:

  • Couples who are currently receiving any kind of psychotherapy
  • Participants presenting severe psychological disorders (Psychosis, substance abuse, major depression)
  • Presence of intimate partner violence or abuse
  • Participants presenting cognitive impairment or disability impeding them from writing or answering written information
  • High-conflicted couples as measured by the DAS (Scores below 70)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Adrian Montesano

    Universitat Oberta de Catalunya

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adrian Montesano

CONTACT

Kevser Cakmak

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Blinding of the participants will not be valid for the nature of the study and for therapists, on the other hand, they will be blinded to the hypothesis and research questions of the study.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a parallel, randomized controlled trial (RCT) comparing two arms: intervention and wait-list control.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Adrian Montesano

Study Record Dates

First Submitted

December 14, 2021

First Posted

January 18, 2022

Study Start

June 15, 2022

Primary Completion

December 31, 2022

Study Completion

May 31, 2023

Last Updated

May 18, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

Participant data for all primary and secondary outcomes, after deidentification.

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available after six months of study completion
Access Criteria
Researchers who provide a methodologically sound proposal whose proposed use of the data has been approved by an independent review committee