- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03163082
Couple Interaction and Health Behaviors
Targeting Couple Coercion to Impact Health Behaviors and Regimen Adherence
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- New York University School of Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
-If individuals do not meet the above criteria, they will be excluded from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Cognitive Intervention
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.
|
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.
|
Active Comparator: Behavioral Intervention
The behavioral intervention has partners develop an if-then plan for dealing with conflict and negativity, using strategies to downregulate their own negative emotions.
|
The behavioral intervention has partners develop an if-then plan for dealing with conflict and negativity, using strategies to downregulate their own negative emotions.
|
Active Comparator: Interpretation Bias
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.
|
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.
|
Active Comparator: Evaluative Conditioning
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).
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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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
20 minutes per visit
|
Health Behaviors
Time Frame: 10 minutes per visit
|
Health Behaviors
|
10 minutes per visit
|
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.
|
20 Minutes per visit
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psychophysiological Measures
Time Frame: 1.5-3 hours per visit
|
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.
|
1.5-3 hours per visit
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Richard Heyman, NYU Langone Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 15-01090
- 1UH2DE025980-01 (NIH)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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