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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04588012
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Collaborators:
TrygFonden, Denmark
University of Miami
Information provided by (Responsible Party):
University of Aarhus

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. 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.

Condition or disease Intervention/treatment Phase
Relationship Distress Marital Conflict Behavioral: The online self-help Program OurRelationship developed by prof. Brian Doss and prof. Andrew Christensen. Behavioral: The off line self-help course "Pas på Parforholdet". Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Et Randomiseret Kontrolleret Pilotstudie af OurRelationship.dk, et Online selvhjælpsforløb Til Par Med Mange Konflikter Eller Lav Trivsel i Parforholdet.
Actual Study Start Date : September 15, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : April 15, 2022

Arm Intervention/treatment
Experimental: Online self-help the OurRelationship.dk program
Couples in the intervention condition will receive the full OurRelationship program including the three modules, the Observe, the Understand, and the Respond module. The program takes 6-8 hours to complete the program after the randomization. The second coach call will take place after the Observe phase. The third coach call will take place after the Understand phase. The fourth coach call will take place after the Respond phase.
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.

Active Comparator: Off line self-help the book "Pas på Parforholdet"
Couples in the active control group receive two copies of the book "Pas på parforholdet, når kærligheden er kommet for at blive" [Take care of your relationship when love is here to stay] by Mattias Stølen Due (2016). This book includes general research based knowledge on maintaining a healthy relationship as well as questions and exercises for couples to do on their own. To support couples in an activate self-help approach, a sheet with guidelines on using the book will help couples plan their reading and couple conversations. Regular questionnaires will be sent to couples in the control group (matched timely to the questionnaires received by the intervention group). As such, the active control condition will mirror the benefit that couples are likely to get from using well-chosen, solid literature with the addition of any benefit that the research participation (filling in questionnaire) will generate.
Behavioral: The off line self-help course "Pas på Parforholdet".
The book "Pas på parforholdet" is written by Mattias Stølen Due.




Primary Outcome Measures :
  1. Relationship Satisfaction: Danish 4 item version of the Couple Satisfaction Index [ Time Frame: Pre-to-post (time frame spanning across 8 weeks) ]
    As measured by the Danish 4 item version of the Couple Satisfaction Index (CSI; Funk & Rogge, 2007)

  2. Intimacy [ Time Frame: Pre-to-post (time frame spanning across 8 weeks) ]
    Feeling cared for, understood, validated, as measured by the four-Item scale "psychological intimacy" (Debrot et al, 2013)


Secondary Outcome Measures :
  1. Depressive symptoms [ Time Frame: Pre-to-post (time frame spanning across 8 weeks) ]
    As measured by the Major Depression Inventory (Olsen, Jensen, Noerholm, Martiny, & Bech, 2003)

  2. Relationship positives and negatives [ Time Frame: Pre-to-post (time frame spanning across 8 weeks) ]
    Two items from the Confidence Scale (Rhoades, Stanley, & Markman, 2009)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   heterosexual couples are eligible for the study
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04588012


Contacts
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Contact: Hanne Nørr Fentz, Ph.D +4587165817 hanneno@psy.au.dk
Contact: Tea L Trillingsgaard, Ph.D +4587165843 teatri@psy.au.dk

Locations
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Denmark
Aarhus University Recruiting
Aarhus, Denmark, 8000
Contact: Hanne Fentz, Ph.D    +4587165817    hanneno@psy.au.dk   
Principal Investigator: Tea L Trillingsgaard, Ph.D         
Sponsors and Collaborators
University of Aarhus
TrygFonden, Denmark
University of Miami
Investigators
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Principal Investigator: Tea L Trillingsgaard, Ph.D University of Aarhus
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT04588012    
Other Study ID Numbers: 72253
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No