Relationship DistressNCT04588012
A Pilot Study of OurRelationship.dk, a Web-based Self-help-Program for Couples With High Levels of Conflict or Distress
A study testing The online self-help Program OurRelationship developed by prof. Brian Doss and prof. Andrew Christensen. and The off line self-help course "Pas på Parforholdet". in people with Relationship Distress and Marital Conflict, run by University of Aarhus at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Relationship Distress, Marital Conflict, Family Relationship
- What is being tested?
- The online self-help Program OurRelationship developed by prof. Brian Doss and prof. Andrew Christensen. and The off line self-help course "Pas på Parforholdet".
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Sep 2020to 10 Feb 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
- To detail the criteria "high level of conflict or distress", one or both of the following criteria must be fulfilled:
- One or both partners report being victim or perpetrator of at least one act of physical or psychological aggression during the past year OR
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Et Randomiseret Kontrolleret Pilotstudie af OurRelationship.dk, et Online selvhjælpsforløb Til Par Med Mange Konflikter Eller Lav Trivsel i Parforholdet.
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.
Read the 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.
- Conditions
- Relationship Distress, Marital Conflict, Family Relationship
- Being tested
- The online self-help Program OurRelationship developed by prof. Brian Doss and prof. Andrew Christensen., The off line self-help course "Pas på Parforholdet".
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The online self-help Program OurRelationship developed by prof. Brian Doss and prof. Andrew Christensen.Behavioural
The OurRelationship program is developed by prof. Brian Doss and prof. Andrew Christensen.
The off line self-help course "Pas på Parforholdet".Behavioural
The book "Pas på parforholdet" is written by Mattias Stølen Due.
| Study group | Role | What they receive |
|---|---|---|
| Online self-help the OurRelationship.dk program | Experimental | 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. Receives: Behavioral: The online self-help Program OurRelationship developed by prof. Brian Doss and prof. Andrew Christensen. |
| Off line self-help the book "Pas på Parforholdet" | Active comparator | 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. Receives: Behavioral: The off line self-help course "Pas på Parforholdet". |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-to-post (time frame spanning across 8 weeks)
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.
Measured: Pre-to-post (time frame spanning across 8 weeks)
Secondary outcomes (3)
Depressive symptoms
As measured by the Major Depression Inventory (Olsen, Jensen, Noerholm, Martiny, \& Bech, 2003). A higher score indicate more depressive symptoms.
Measured: Pre-to-post (time frame spanning across 8 weeks)
Relationship Confidence scale
Two items from the Confidence Scale (Rhoades, Stanley, \& Markman, 2009). A higher score indicate more confidence.
Measured: Pre-to-post (time frame spanning across 8 weeks)
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.
Measured: Pre-to-post (time frame spanning across 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start15 Sep 2020
- Primary completion10 Feb 2023
- Study completion10 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relationship DistressStudies 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
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- TrygFonden, Denmark, University of Miami
- Responsible party
- Sponsor
- Investigators
- Tea L. Trillingsgaard, Ph.D, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04588012
- Sponsor's protocol ID
- 72253
- Status last verified
- Mar 2025
- First submitted
- 7 Oct 2020
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Et Randomiseret Kontrolleret Pilotstudie af OurRelationship.dk, et Online selvhjælpsforløb Til Par Med Mange Konflikter Eller Lav Trivsel i Parforholdet.
- ClinicalTrials.gov ID
- NCT04588012
- Acronym / sponsor ID
- 72253
- Conditions
- Relationship Distress, Marital Conflict, Family Relationship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- TrygFonden, Denmark, University of Miami
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 10 Feb 2023 (actual)
- Study completion
- 10 Feb 2023 (actual)
- First posted
- 19 Oct 2020 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online self-help the OurRelationship.dk program | Experimental | Behavioral: The online self-help Program OurRelationship developed by prof. Brian Doss and prof. Andrew Christensen.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. |
| Off line self-help the book "Pas på Parforholdet" | Active comparator | Behavioral: The off line self-help course "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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- To detail the criteria "high level of conflict or distress", one or both of the following criteria must be fulfilled:
- One or both partners report being victim or perpetrator of at least one act of physical or psychological aggression during the past year OR
- 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).
- both partners in the couple have to be 18 or above
- been living together for at least six months
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| 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. | Behavioural | Online self-help the OurRelationship.dk program |
| The off line self-help course "Pas på Parforholdet".The book "Pas på parforholdet" is written by Mattias Stølen Due. | Behavioural | Off line self-help the book "Pas på Parforholdet" |
Primary outcome
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). A higher score indicate more relationship satisfaction.
Intimacy
Time frame: Pre-to-post (time frame spanning across 8 weeks)
"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.
3 secondary outcomes
Depressive symptoms
Time frame: Pre-to-post (time frame spanning across 8 weeks)
Relationship Confidence scale
Time frame: Pre-to-post (time frame spanning across 8 weeks)
Positive and Negative Relationship Quality
Time frame: Pre-to-post (time frame spanning across 8 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Tea L. Trillingsgaard, Ph.D principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The online self-help Program OurRelationship developed by prof. Brian Doss and prof. Andrew Christensen. and The off line self-help course "Pas på Parforholdet". in people with Relationship Distress and Marital Conflict, run by University of Aarhus at 1 site in Denmark.
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 10 inclusion and 4 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: finished, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship Satisfaction: Danish 4-item version of the Couple Satisfaction Index (time frame: Pre-to-post (time frame spanning across 8 weeks)). 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 24 Jun 2025.