A Pilot Study of OurRelationship.dk, a Web-based Self-help-Program for Couples With High Levels of Conflict or Distress

Marital Conflict Clinical Trial

Official title:

Et Randomiseret Kontrolleret Pilotstudie af OurRelationship.dk, et Online selvhjælpsforløb Til Par Med Mange Konflikter Eller Lav Trivsel i Parforholdet.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04588012
• Other study ID #: 72253
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 15, 2020
• Est. completion date: February 10, 2023

Study information

• Verified date: June 2022
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is twofold 1) to conduct a pilot test of methods for a larger scale RCT study evaluating the efficacy of OurRelationship offered to couples with high levels of conflict or distress and at least one child at the address, and 2) to test if the OurRelationship program meets predefined feasibility criteria when implemented in a real-world setting. If study results on these two aims are convincing, a full scale RCT of the intervention will be pursued.

Description:

A cost-effective online self-help program for distressed couples could help serve more couples, in particular those with limited access to traditional couple therapy. The OurRelationship program, a web-based, primarily self-help program for couples developed in the US, has previously shown medium to large effects sizes on relationship functioning for a diverse sample of couples and these effects were maintained over 12 months (Doss et al., 2016; 2020). These findings promise a large potential in online self-help for couples, if findings replicate in independent research.

For the pilot, 80 couples experiencing high levels of conflict or distress in their relationship and who had at least one child at the address were recruited through a study website (www.ourelationship.dk) build for the pilot. Couples were randomized to receive either the Danish version of the program including 4 coach calls, or an active control condition receiving two copies of a self-help book and a plan for 4 x 30 min couple conversations. In this pilot, research methods in terms of recruitment, randomization, completion of program, test of measures, and data collection are evaluated.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 182
• Est. completion date: February 10, 2023
• Est. primary completion date: February 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

To detail the criteria "high level of conflict or distress", one or both of the following criteria must be fulfilled:

1. One or both partners report being victim or perpetrator of at least one act of physical or psychological aggression during the past year OR

2. One partner score at least 1 standard deviation (SD) (indicating severe relationship distress) or both partners 0.5 SD below the Danish population mean on a measure for relationship satisfaction (Couple Satisfaction Index; Funk & Rogge, 2007).

In addition:

• both partners in the couple have to be 18 or above

• been living together for at least six months

• have at least one child below 18 years living at home

• be able to read and understand Danish

• have access to the Internet, a tablet, computer, or telephone

• willing to refrain from couple therapy (or other couple interventions) within the period of the project.

Exclusion Criteria:

• Plans on divorcing, breaking up or having an ongoing affair

• Moderate to severe levels of suicidal ideation (>=7 on the Suicidal Behavioral Questionnaire-Revised, Osman et al., 2001)

• Victimization of intimate partner violence resulting in injury or fear within the last three months (using screener items developed by Beach, Whisman, Snyder, & Heyman, 2013).

• Taking psychotropic drugs.

Related Conditions & MeSH terms

• Family Relationship
• Marital Conflict
• Relationship Distress

Intervention

Behavioral:
• The online self-help Program OurRelationship developed by prof. Brian Doss and prof. Andrew Christensen.
The OurRelationship program is developed by prof. Brian Doss and prof. Andrew Christensen.
• The off line self-help course "Pas på Parforholdet".
The book "Pas på parforholdet" is written by Mattias Stølen Due.

Locations

Country	Name	City	State
Denmark	Aarhus University	Aarhus

Sponsors (3)

Lead Sponsor	Collaborator
University of Aarhus	TrygFonden, Denmark, University of Miami

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship Satisfaction: Danish 4-item version of the Couple Satisfaction Index	As measured by the Danish 4-item version of the Couple Satisfaction Index (CSI; Funk & Rogge, 2007). A higher score indicate more relationship satisfaction.	Pre-to-post (time frame spanning across 8 weeks)
Primary	Intimacy	"Psychological" intimacy was assessed by four items on 5-point scales. Items were: I felt close to, secure with, cared for, and understood (Debrot et al, 2013). A higher score indicate more intimacy between partners.	Pre-to-post (time frame spanning across 8 weeks)
Secondary	Depressive symptoms	As measured by the Major Depression Inventory (Olsen, Jensen, Noerholm, Martiny, & Bech, 2003). A higher score indicate more depressive symptoms.	Pre-to-post (time frame spanning across 8 weeks)
Secondary	Relationship Confidence scale	Two items from the Confidence Scale (Rhoades, Stanley, & Markman, 2009). A higher score indicate more confidence.	Pre-to-post (time frame spanning across 8 weeks)
Secondary	Positive and Negative Relationship Quality	As measured by the eight-item Positive and Negative Relationship Quality scale (Fincham, & Rogge, 2010). Participants were asked to separately rate four positive (e.g., enjoyable, alive) and four negative (e.g., bad, lifeless) dimensions of their relationship. Higher scores on the positive and lower scores on the negative scale indicate more relationship quality.	Pre-to-post (time frame spanning across 8 weeks)