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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03163082
Other study ID # 15-01090
Secondary ID 1UH2DE025980-01
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2017
Est. completion date June 30, 2020

Study information

Verified date November 2020
Source NYU Langone Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 142
Est. completion date June 30, 2020
Est. primary completion date June 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
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.
Behavioral:
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.
Other:
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.
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).

Locations

Country Name City State
United States New York University School of Medicine New York New York

Sponsors (2)

Lead Sponsor Collaborator
NYU Langone Health National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 20 minutes per visit
Primary Health Behaviors Health Behaviors 10 minutes per visit
Primary 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. 20 Minutes per visit
Secondary 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. 1.5-3 hours per visit
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