Viewing Study NCT04588012


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Ignite Modification Date: 2025-12-26 @ 11:13 PM
Study NCT ID: NCT04588012
Status: COMPLETED
Last Update Posted: 2025-06-24
First Post: 2020-10-07
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: A Pilot Study of OurRelationship.dk, a Web-based Self-help-Program for Couples With High Levels of Conflict or Distress
Sponsor: University of Aarhus
Organization:

Study Overview

Official Title: Et Randomiseret Kontrolleret Pilotstudie af OurRelationship.dk, et Online selvhjælpsforløb Til Par Med Mange Konflikter Eller Lav Trivsel i Parforholdet.
Status: COMPLETED
Status Verified Date: 2025-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: