Clinical trial NCT04588012: A Pilot Study of OurRelationship.dk, a Web-based Self-help-Program for Couples With High Levels of Conflict or Distress
Official title: Et Randomiseret Kontrolleret Pilotstudie af OurRelationship.dk, et Online selvhjælpsforløb Til Par Med Mange Konflikter Eller Lav Trivsel i Parforholdet.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Relationship Distress
Marital Conflict
Family Relationship
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: TrygFonden, Denmark
name: University of Miami
First posted: 2020-10-19
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Relationship Satisfaction: Danish 4-item version of the Couple Satisfaction Index
timeFrame: Pre-to-post (time frame spanning across 8 weeks)
measure: Intimacy
timeFrame: Pre-to-post (time frame spanning across 8 weeks)
Secondary outcomes:
measure: Depressive symptoms
timeFrame: Pre-to-post (time frame spanning across 8 weeks)
measure: Relationship Confidence scale
timeFrame: Pre-to-post (time frame spanning across 8 weeks)
measure: Positive and Negative Relationship Quality
timeFrame: Pre-to-post (time frame spanning across 8 weeks)
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University
Study officials:
affiliation: University of Aarhus
name: Tea L. Trillingsgaard, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: