Relational ProblemsNCT05194683
The Effects of Relational Letter Writing
A study testing Relational Letter Writing in people with Relational Problems and Couples, run by Universitat Oberta de Catalunya.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Relational Problems, Couples
- What is being tested?
- Relational Letter Writing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2022to 31 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Couples willing to participate in a relationship enhancing intervention
- Couples should have been living together at least for 12 months
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effects of Relational Letter Writing in Couples Wellbeing: A Mixed-Method Approach
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.
Read the detailed description
Relational letter writing is a recently developed therapeutic tool within the framework of Narrative Therapy that consists of two interviews and a letter writing task, in which a meta-conversation between the relationship itself, the couple members, and the therapists is fostered. Although this specific therapeutic technique can be used within the therapy process, in this study, it is used as a brief stand-alone narrative intervention.
The main objective of this study is to investigate the efficacy of the innovative Relational letter writing technique as a brief intervention for couples with mild to moderate levels of conflict. Also, the investigators want to explore changes in couples' narratives after experiencing the letter-writing procedure, and whether this technique can lead to reconstructing the relationship ethics and to greater relational awareness and well-being. The following objectives will be observed in this study:
- To explore the effects of Relational letter writing practice on couples' relational well-being
- To assess changes in individual psychological well-being after the Relational letter writing intervention
- To observe whether this technique can lead to reconstructing the relationship ethics and to greater relational awareness, and its relationship with the outcome
- To observe whether there is a difference between successful and unsuccessful cases in terms of the content of the letters.
- Conditions
- Relational Problems, Couples
- Being tested
- Relational Letter Writing
- Keywords
- Relational Letter Writing, Narrative Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relational Letter WritingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Letter Writing Arm | Experimental | Relational letter writing intervention Receives: Behavioral: Relational Letter Writing |
| Control Arm | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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 with CORE-OM (trujillo et al., 2016). This is a brief measure of individual well-being with 34 items with 6-point Likert-type scale ranging from 0 (Not at all) to 4 (Most or all the time). It covers four subscales: well-being (four items), problems/symptoms (12 items), life functioning (12 items), and risk to self and others (six items).
Measured: 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 relational satisfaction will be evaluated with GMRS (Byers 2005) which is a six-item self-report questionnaire that measures an individual's relationship satisfaction with his/her current partner. Questions are 7-point Likert scale ranging from 1 to 7, minimum and maximum scores are 6 and 42, respectively, and lower scores indicate lower satisfaction in the relationship.
Measured: 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)
Change of Outcome Rating Scale (ORS; Duncan et al., 2005) is an ultra-brief self-report measure that is designed to evaluate session-to-session progress made in therapy in terms of four domains. Participants will respond to how they are doing individually (personal well-being), socially (work, school, friendships), interpersonally (family, close relationships), and overall (general sense of well-being). For each item, place a mark on a 10-cm line. The mark indicates a positive feeling if it is marked to the right and it indicates a negative feeling if it is marked to the left on the line for each of the domains. The highest score possible is 40.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start15 Jun 2022 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relational ProblemsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a parallel, randomized controlled trial (RCT) comparing two arms: intervention and wait-list control.
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Oberta de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrián Montesano, Universitat Oberta de Catalunya
- Investigators
- Adrian Montesano, Principal investigator, Universitat Oberta de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05194683
- Sponsor's protocol ID
- 1005988
- Status last verified
- May 2022
- First submitted
- 14 Dec 2021
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant data for all primary and secondary outcomes, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Relational Letter Writing in Couples Wellbeing: A Mixed-Method Approach
- ClinicalTrials.gov ID
- NCT05194683
- Acronym / sponsor ID
- 1005988
- Conditions
- Relational Problems, Couples
- Keywords
- Relational Letter Writing, Narrative Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Universitat Oberta de CatalunyaUniversity, hospital or other
- Study start
- 15 Jun 2022 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 18 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Relational letter writing is a recently developed therapeutic tool within the framework of Narrative Therapy that consists of two interviews and a letter writing task, in which a meta-conversation between the relationship itself, the couple members, and the therapists is fostered. Although this specific therapeutic technique can be used within the therapy process, in this study, it is used as a brief stand-alone narrative intervention.
The main objective of this study is to investigate the efficacy of the innovative Relational letter writing technique as a brief intervention for couples with mild to moderate levels of conflict. Also, the investigators want to explore changes in couples' narratives after experiencing the letter-writing procedure, and whether this technique can lead to reconstructing the relationship ethics and to greater relational awareness and well-being. The following objectives will be observed in this study:
- To explore the effects of Relational letter writing practice on couples' relational well-being
- To assess changes in individual psychological well-being after the Relational letter writing intervention
- To observe whether this technique can lead to reconstructing the relationship ethics and to greater relational awareness, and its relationship with the outcome
- To observe whether there is a difference between successful and unsuccessful cases in terms of the content of the letters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a parallel, randomized controlled trial (RCT) comparing two arms: intervention and wait-list control.
| Arm | Type | Receives |
|---|---|---|
| Letter Writing Arm | Experimental | Behavioral: Relational Letter WritingRelational letter writing intervention |
| Control Arm | No intervention | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Couples willing to participate in a relationship enhancing intervention
- Couples should have been living together at least for 12 months
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relational Letter WritingThe 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. | Behavioural | Letter Writing Arm |
Primary outcome
Change in Dyadic Adjustment Scale (DAS)
Time frame: 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).
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.
Perceived Relational Change
Time frame: Perceived relational change will be administrated at post intervention, 2 weeks and 3 months after the intervention
Single item measure, 7-point likert scale measuring perceived change in their relationship as a result fo the intervention
3 secondary outcomes
Clinical Outcomes in Routine Evaluation - Outcome Measure Spanish version (CORE-OM)
Time frame: 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)
Time frame: 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)
Time frame: 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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Individual participant dataSharing planned: Yes. Participant data for all primary and secondary outcomes, after deidentification.
Related trials for Relational Problems
Recruiting
Grappling With Trauma: Brazilian Jiu-Jitsu for First Responders
Post-traumatic Stress Disorder (PTSD), Trauma and Stress Related Disorders
RecruitingPhase 2
Examining Intranasal Oxytocin Augmentation of Brief Couples Therapy for Veterans With PTSD
Post-Traumatic Stress Disorder (PTSD)
Not yet recruiting
Strong Couples Project: Disseminating Evidence-based Relationship Education
Relationships, Marital, Relational Problems
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrian Montesano principal investigator
Universitat Oberta de Catalunya
Questions about this trial
What is this clinical trial studying?
A study testing Relational Letter Writing in people with Relational Problems and Couples, run by Universitat Oberta de Catalunya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adrian Montesano (0034934505225, amontesano@uoc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dyadic Adjustment Scale (DAS) (time frame: 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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.