Relationships, MaritalNCT05591261
Strong Couples Project: Disseminating Evidence-based Relationship Education
A study testing ePREP in people with Relationships, Marital and Relational Problems, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
The current research is designed to implement and evaluate the ePREP relationship intervention with couples via the Cooperative Extension system. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Relationships, Marital, Relational Problems
- What is being tested?
- ePREP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2022to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Resident of Illinois
- Married, engaged, or living with their partner for at least 6 months
- Both partners willing to participate in online relationship-focused programming
Who cannot join
- One or both partners reports sever forms of intimate partner violence occurring in the relationship
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Illinois Extension
Urbana, Illinois, 61820
Allen W. Barton, 217-244-2009, awbarton@illinois.edu
About this study
Official title: Strong Couples Project: ePREP Nationwide Dissemination
The current research is designed to implement and evaluate the ePREP relationship intervention with couples via the Cooperative Extension system.
Read the detailed description
The objective of the research is to evaluate the effectiveness of an online intervention (ePREP) for help-seeking couples designed to promote individual and couple well-being. Newly developed online intervention programs for distressed couples have shown to be efficacious, but their overall reach to the general population remains limited. The current research is designed to implement and evaluate the ePREP relationship intervention with couples throughout the nation in a manner that allows for scalable, sustainable program delivery.
- Conditions
- Relationships, Marital, Relational Problems
- Being tested
- ePREP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ePREPBehavioural
6-session online psychoeducational program with supporting coach calls
| Study group | Role | What they receive |
|---|---|---|
| ePREP condition | Experimental | The ePREP program is the online version of the Prevention and Relationship Enhancement Program. It consists of 6 self-directed online sessions and accompanying homework and brief coach calls. Receives: Behavioral: ePREP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in relationship satisfaction
Couple satisfaction index
Measured: Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
Change in relationship instability
3 item Relationship Instability measure (from Doss et al., 2020, Journal of Consulting and Clinical Psychology
Measured: Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
Change in partner support
5 item Partner Support measure (from Doss et al., 2020, Journal of Consulting and Clinical Psychology
Measured: Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
Change in communication conflict
4 item communication conflict measure (from Doss et al., 2020, Journal of Consulting and Clinical Psychology
Measured: Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
Change in relationship confidence
4 item relationship confidence measure (from Stanley et al., 1994)
Measured: Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
Change in intervention-targeted behavior
PREP 3 keys and Couple Communal Identity (new measures created for this study)
Measured: Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
Secondary outcomes (8)
Change in partner aggression
7 item partner aggression (from Doss et al., 2020, Journal of Consulting and Clinical Psychology
Measured: Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
Change in psychological distress
Kessler 6 item psychological distress
Measured: Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
Change in anger
NIH PROMIS 5 item anger measure
Measured: Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
Change in perceived stress
Cohen's 10 item perceived stress measure
Measured: Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
Change in general health
Short Form-36 4 item general health perceptions
Measured: Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
Change in insomnia
7 item insomnia severity index
Measured: Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
Change in problematic alcohol use
Patient-Reported Outcomes Measurement Information System (PROMIS) 7 item problematic alcohol use
Measured: Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
Change in exercise
1 item exercise (Behavioral Risk Factor Surveillance System 2016 adaptation)
Measured: Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study startOct 2022 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relationships, MaritalStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05591261
- Sponsor's protocol ID
- 21550
- Status last verified
- Oct 2022
- First submitted
- 18 Jul 2022
- Last updated
- 24 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strong Couples Project: ePREP Nationwide Dissemination
- ClinicalTrials.gov ID
- NCT05591261
- Acronym / sponsor ID
- 21550
- Conditions
- Relationships, Marital, Relational Problems
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 24 Oct 2022 (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 current research is designed to implement and evaluate the ePREP relationship intervention with couples via the Cooperative Extension system.
Detailed description
The objective of the research is to evaluate the effectiveness of an online intervention (ePREP) for help-seeking couples designed to promote individual and couple well-being. Newly developed online intervention programs for distressed couples have shown to be efficacious, but their overall reach to the general population remains limited. The current research is designed to implement and evaluate the ePREP relationship intervention with couples throughout the nation in a manner that allows for scalable, sustainable program delivery.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ePREP condition | Experimental | Behavioral: ePREPThe ePREP program is the online version of the Prevention and Relationship Enhancement Program. It consists of 6 self-directed online sessions and accompanying homework and brief coach calls. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Resident of Illinois
- Married, engaged, or living with their partner for at least 6 months
- Both partners willing to participate in online relationship-focused programming
Key exclusion criteria (1 listed)
- One or both partners reports sever forms of intimate partner violence occurring in the relationship
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 |
|---|---|---|
| ePREP6-session online psychoeducational program with supporting coach calls | Behavioural | ePREP condition |
Primary outcome
Change in relationship satisfaction
Time frame: Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
Couple satisfaction index
Change in relationship instability
Time frame: Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
3 item Relationship Instability measure (from Doss et al., 2020, Journal of Consulting and Clinical Psychology
Change in partner support
Time frame: Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
5 item Partner Support measure (from Doss et al., 2020, Journal of Consulting and Clinical Psychology
Change in communication conflict
Time frame: Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
4 item communication conflict measure (from Doss et al., 2020, Journal of Consulting and Clinical Psychology
Change in relationship confidence
Time frame: Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
4 item relationship confidence measure (from Stanley et al., 1994)
Change in intervention-targeted behavior
Time frame: Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
PREP 3 keys and Couple Communal Identity (new measures created for this study)
8 secondary outcomes
Change in partner aggression
Time frame: Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
Change in psychological distress
Time frame: Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
Change in anger
Time frame: Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
Change in perceived stress
Time frame: Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
Change in general health
Time frame: Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
Change in insomnia
Time frame: Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
Change in problematic alcohol use
Time frame: Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
Change in exercise
Time frame: Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ePREP in people with Relationships, Marital and Relational Problems, run by University of Illinois at Urbana-Champaign at 1 site in United States.
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 3 inclusion and 1 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: opening soon, as of the sponsor's last update on 24 Oct 2022. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in relationship satisfaction (time frame: Baseline, Within one week of program completion (~2 months post-baseline), and 6-month follow-up from baseline). The study lists 6 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 Oct 2022.