CouplesNCT03163082
Couple Interaction and Health Behaviors
A study testing Cognitive Intervention, Behavioral Intervention and Interpretation Bias in people with Couples and Relationship, Marital, run by NYU Langone Health at 1 site in United States.
Trial summary
The investigators are interested in typical couple interactions and health behaviors. In particular, the investigators are interested in different ways that each partner in a coupled relationship reacts to and understand each other's behavior, and in their health behaviors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Couples, Relationship, Marital
- What is being tested?
- Cognitive Intervention, Behavioral Intervention and Interpretation Bias
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 30 Jun 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both partners must be 18 years of age or older
- At least one of the partners in the couple dyad carries a Type 2 Diabetes (T2D) diagnosis or is at risk for T2D.
- The couple must qualify on relationship characteristics
- The couple must be married or have lived together for at least 6 months
Who cannot join
- -If individuals do not meet the above criteria, they will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Targeting Couple Coercion to Impact Health Behaviors and Regimen Adherence
The investigators are interested in typical couple interactions and health behaviors. In particular, the investigators are interested in different ways that each partner in a coupled relationship reacts to and understand each other's behavior, and in their health behaviors.
Read the detailed description
If couples decide to participate in this study, they will come visit the laboratory at a time that is convenient for them.
Couples will be asked to participate in the following activities. These activities will be video recorded and recordings will be kept digitally on a secure password-protected server. Video recordings will be assigned a number, and names and identifying information will not be associated in any way with the video recordings. If couples do not want to be video recorded, they can not participate in this research.
- Upon arrival at the laboratory during both visits, the subject runners will explain the tasks to participants. The subject runners also will measure participants' heart rates and skin moisture. To do so the subject runners will place 9 sensors on each person's body: on the collar bones, the lower left rib cage, the upper and mid-chest, the upper and mid-back, and the palm of their nondominant hand. The sensors will be connected to small machines that participants will carry. Participants will still be able to move freely around the room.
- Partners will be asked to sit separately while they complete a questionnaire that asks about their relationship.
- There will either be:
- A short discussion where the subject runners will discuss their responses to their partner's behavior or the intentions behind their partner's behavior. A quarter of the research subjects in this study will complete a task where their responses to their partner's behaviors are discussed and another quarter of the subjects will complete a task where the reasons for their partner's behavior are discussed. Which type of discussion they have will be "randomly assigned", which means that a computer will generate this decision before they arrive for their visit.
- Or a short computerized activity where partners will look at a series of images and descriptions or will be asked to rate a series of images with facial expressions. A quarter of the research subjects in this study will complete a computerized activity where they will look at a series of images and descriptions and another quarter of the subjects will complete a computerized activity where they will rate a series of images with facial expressions. Which type of activity participants have will be "randomly assigned", which means that a computer will generate this decision before they arrive for their visit.
- Couples will complete a video-recorded problem-solving task, where they discuss some of the things that they would like each other to do, do different, or change.
- There will either be:
- A 10-minute break. Drinks and snacks will be provided during the break.
- Or a task where partners will rate what they felt and thought during their conversation with their partner while watching a video of their conversation.
- At the end of these activities, the subject runners will provide couples with the opportunity to discuss the visit and any other questions or concerns they may have. They will not be asked to participate in any additional visits or questionnaires after their second visit.
- Conditions
- Couples, Relationship, Marital
- Being tested
- Cognitive Intervention, Behavioral Intervention, Interpretation Bias, Evaluative Conditioning
- Keywords
- Coercion theory, Corrosive Couple Coercion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive InterventionOther
The cognitive intervention has partners come up with reasons why their partners do things they don't like, until they come up with benign attributions for those behaviors.
Behavioral InterventionBehavioural
The behavioral intervention has partners develop an if-then plan for dealing with conflict and negativity, using strategies to downregulate their own negative emotions.
Interpretation BiasOther
The Interpretation Bias intervention has partners look at "morphed" facial expressions and determine whether the face is happy or angry. Positive feedback is given for rating the faces as happy and negative feedback is given for rating the faces as angry.
Evaluative ConditioningOther
The Evaluative Conditioning intervention presents partners with pictures of ambiguous adult faces (conditioned stimuli) and pairs them with positive word descriptors (unconditioned stimuli; e.g., generous; loving).
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Intervention | Active comparator | The cognitive intervention has partners come up with reasons why their partners do things they don't like, until they come up with benign attributions for those behaviors. Receives: Other: Cognitive Intervention |
| Behavioral Intervention | Active comparator | The behavioral intervention has partners develop an if-then plan for dealing with conflict and negativity, using strategies to downregulate their own negative emotions. Receives: Behavioral: Behavioral Intervention |
| Interpretation Bias | Active comparator | The Interpretation Bias intervention has partners look at "morphed" facial expressions and determine whether the face is happy or angry. Positive feedback is given for rating the faces as happy and negative feedback is given for rating the faces as angry. Receives: Other: Interpretation Bias |
| Evaluative Conditioning | Active comparator | The Evaluative Conditioning intervention presents partners with pictures of ambiguous adult faces (conditioned stimuli) and pairs them with positive word descriptors (unconditioned stimuli; e.g., generous; loving). Receives: Other: Evaluative Conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Problem-Solving Task
Couples will complete a video-recorded problem-solving task, where they discuss some of the things that they would like each other to do, do different, or change.
Measured: 20 minutes per visit
Health Behaviors
Health Behaviors
Measured: 10 minutes per visit
Video-Mediated Emotion Recall
The video-mediated recall procedure (Gottman \& Levenson, 1985; Lorber, 2007) is a procedure by which parents and/or a member of a couple view a videotape of their interaction with their partner or child. While watching the video, they use a dial to rate their experienced emotion and/or cognitions moment-by-moment during the interaction task. Partners assigned to the interpretation bias and evaluative conditioning interventions will be given this task.
Measured: 20 Minutes per visit
Secondary outcomes (1)
Psychophysiological Measures
The investigators also will measure participants' heart rates and skin moisture. To do so the subject runners will place 9 sensors on each person's body: on the collar bones, the lower left rib cage, the upper and mid-chest, the upper and mid-back, and the palm of their nondominant hand. The sensors will be connected to small machines that participants will carry. Participants will still be able to move freely around the room.
Measured: 1.5-3 hours per visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start1 May 2017
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CouplesStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Within-subject design over 2 visits.
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- Richard Heyman, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03163082
- Sponsor's protocol ID
- 15-01090
- Other IDs
- 1UH2DE025980-01
- Status last verified
- Nov 2020
- First submitted
- 19 May 2017
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Smith Slep AM, Heyman RE, Mitnick DA, Lorber MF, Rhoades KA, Daly KA, Nichols SR, Eddy JM. Do Brief Lab-Based Interventions Decrease Coercive Conflict Within Couples and Parent-Child Dyads? Behav Ther. 2023 Jul;54(4):666-681. doi: 10.1016/j.beth.2023.01.006. Epub 2023 Feb 2.
PubMed 37330256
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Couple Coercion to Impact Health Behaviors and Regimen Adherence
- ClinicalTrials.gov ID
- NCT03163082
- Acronym / sponsor ID
- 15-01090
- Conditions
- Couples, Relationship, Marital
- Keywords
- Coercion theory, Corrosive Couple Coercion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 22 May 2017 (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 investigators are interested in typical couple interactions and health behaviors. In particular, the investigators are interested in different ways that each partner in a coupled relationship reacts to and understand each other's behavior, and in their health behaviors.
Detailed description
If couples decide to participate in this study, they will come visit the laboratory at a time that is convenient for them.
Couples will be asked to participate in the following activities. These activities will be video recorded and recordings will be kept digitally on a secure password-protected server. Video recordings will be assigned a number, and names and identifying information will not be associated in any way with the video recordings. If couples do not want to be video recorded, they can not participate in this research.
- Upon arrival at the laboratory during both visits, the subject runners will explain the tasks to participants. The subject runners also will measure participants' heart rates and skin moisture. To do so the subject runners will place 9 sensors on each person's body: on the collar bones, the lower left rib cage, the upper and mid-chest, the upper and mid-back, and the palm of their nondominant hand. The sensors will be connected to small machines that participants will carry. Participants will still be able to move freely around the room.
- Partners will be asked to sit separately while they complete a questionnaire that asks about their relationship.
- There will either be:
- A short discussion where the subject runners will discuss their responses to their partner's behavior or the intentions behind their partner's behavior. A quarter of the research subjects in this study will complete a task where their responses to their partner's behaviors are discussed and another quarter of the subjects will complete a task where the reasons for their partner's behavior are discussed. Which type of discussion they have will be "randomly assigned", which means that a computer will generate this decision before they arrive for their visit.
- Or a short computerized activity where partners will look at a series of images and descriptions or will be asked to rate a series of images with facial expressions. A quarter of the research subjects in this study will complete a computerized activity where they will look at a series of images and descriptions and another quarter of the subjects will complete a computerized activity where they will rate a series of images with facial expressions. Which type of activity participants have will be "randomly assigned", which means that a computer will generate this decision before they arrive for their visit.
- Couples will complete a video-recorded problem-solving task, where they discuss some of the things that they would like each other to do, do different, or change.
- There will either be:
- A 10-minute break. Drinks and snacks will be provided during the break.
- Or a task where partners will rate what they felt and thought during their conversation with their partner while watching a video of their conversation.
- At the end of these activities, the subject runners will provide couples with the opportunity to discuss the visit and any other questions or concerns they may have. They will not be asked to participate in any additional visits or questionnaires after their second visit.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Within-subject design over 2 visits.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Intervention | Active comparator | Other: Cognitive InterventionThe cognitive intervention has partners come up with reasons why their partners do things they don't like, until they come up with benign attributions for those behaviors. |
| Behavioral Intervention | Active comparator | Behavioral: Behavioral InterventionThe behavioral intervention has partners develop an if-then plan for dealing with conflict and negativity, using strategies to downregulate their own negative emotions. |
| Interpretation Bias | Active comparator | Other: Interpretation BiasThe Interpretation Bias intervention has partners look at "morphed" facial expressions and determine whether the face is happy or angry. Positive feedback is given for rating the faces as happy and negative feedback is given for rating the faces as angry. |
| Evaluative Conditioning | Active comparator | Other: Evaluative ConditioningThe Evaluative Conditioning intervention presents partners with pictures of ambiguous adult faces (conditioned stimuli) and pairs them with positive word descriptors (unconditioned stimuli; e.g., generous; loving). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Both partners must be 18 years of age or older
- At least one of the partners in the couple dyad carries a Type 2 Diabetes (T2D) diagnosis or is at risk for T2D.
- The couple must qualify on relationship characteristics
- The couple must be married or have lived together for at least 6 months
Key exclusion criteria (1 listed)
- -If individuals do not meet the above criteria, they will be excluded from the study.
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 |
|---|---|---|
| Cognitive InterventionThe cognitive intervention has partners come up with reasons why their partners do things they don't like, until they come up with benign attributions for those behaviors. | Other | Cognitive Intervention |
| Behavioral InterventionThe behavioral intervention has partners develop an if-then plan for dealing with conflict and negativity, using strategies to downregulate their own negative emotions. | Behavioural | Behavioral Intervention |
| Interpretation BiasThe Interpretation Bias intervention has partners look at "morphed" facial expressions and determine whether the face is happy or angry. Positive feedback is given for rating the faces as happy and negative feedback is given for rating the faces as angry. | Other | Interpretation Bias |
| Evaluative ConditioningThe Evaluative Conditioning intervention presents partners with pictures of ambiguous adult faces (conditioned stimuli) and pairs them with positive word descriptors (unconditioned stimuli; e.g., generous; loving). | Other | Evaluative Conditioning |
Primary outcome
Problem-Solving Task
Time frame: 20 minutes per visit
Couples will complete a video-recorded problem-solving task, where they discuss some of the things that they would like each other to do, do different, or change.
Health Behaviors
Time frame: 10 minutes per visit
Health Behaviors
Video-Mediated Emotion Recall
Time frame: 20 Minutes per visit
The video-mediated recall procedure (Gottman \& Levenson, 1985; Lorber, 2007) is a procedure by which parents and/or a member of a couple view a videotape of their interaction with their partner or child. While watching the video, they use a dial to rate their experienced emotion and/or cognitions moment-by-moment during the interaction task. Partners assigned to the interpretation bias and evaluative conditioning interventions will be given this task.
1 secondary outcome
Psychophysiological Measures
Time frame: 1.5-3 hours per visit
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 13 Nov 2020.
- Derived from this study: PubMed 37330256Smith Slep AM, Heyman RE, Mitnick DA, Lorber MF, Rhoades KA, Daly KA, Nichols SR, Eddy JM. Do Brief Lab-Based Interventions Decrease Coercive Conflict Within Couples and Parent-Child Dyads? Behav Ther. 2023 Jul;54(4):666-681. doi: 10.1016/j.beth.2023.01.006. Epub 2023 Feb 2.
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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.
Richard Heyman principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Intervention, Behavioral Intervention and Interpretation Bias in people with Couples and Relationship, Marital, run by NYU Langone Health 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 4 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: finished, as of the sponsor's last update on 13 Nov 2020. 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?
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?
Problem-Solving Task (time frame: 20 minutes per visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03163082, which also lists 1 linked publication.
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 13 Nov 2020; AzTrials last refreshed its copy on 29 Oct 2026.