Couple Interaction and Health Behaviors


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Verified May 2017 by New York University School of Medicine

Sponsor:

Information provided by (Responsible Party):

New York University School of Medicine

ClinicalTrials.gov Identifier:

NCT03163082

First received: May 19, 2017

Last updated: May 19, 2017

Last verified: May 2017

This study will focus on corrosive couple coercion and its impact on behaviors and regimen adherence. Investigators will invite adult couple-dyads for a total of two visits. Couples will be randomly assigned to either a cognitive or behavioral condition. Investigators will use a within subject experimental design over 2 visits. Each couple will engage in two problem solving/conflict resolution discussions over 2 visits (10 min for each partner’s issue related to the relationship; 20 min total per visit).

Couples
Relationship, Marital
Behavioral: Problem Solving Discussion

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Within-subject design over 2 visits. Analogue procedures will be constant across the study and are detailed below.

Masking: No masking
Primary Purpose: Other

Official Title: Couple Interaction and Health Behaviors

Primary Outcome Measures:

  • Conversation Assessment Tool (CAT) [ Time Frame: 2 Days ]

    The CAT is a 36-item scale designed to capture the qualities and aspects of a relationship that one partner is unhappy with and would like the other partner to change (e.g., Please look over each item and decide if it is a problem in your relationship right now).

  • Couple Satisfaction Index-4 [ Time Frame: 2 Days ]

    The CSI-4 is a 4-item scale designed to measure one’s satisfaction in a relationship (e.g., Please indicate, all things considered, the degree of happiness of your relationship).

  • Physiological Controls Measure (PCM) [ Time Frame: 2 Days ]

    The PCM is a study specific measure that assesses factors that can affect the physiological variables being measured. It asks respondents about time since awakening, present physical illness, present medications and drug use, and several behaviors from the day of the assessment (most recent meal and snacks, smoking, caffeine and sugar intake, and physical exercise).

  • Negative Experienced Emotion Scale [ Time Frame: 2 Days ]

    This 6-item measure, adapted from the negative affect items of the Positive and Negative Affect Schedule (Watson, Clark, & Tellegen, 1988), assesses the respondent’s experience of negative emotion from “very slightly or not at all” to “extremely.” Like the PANAS, its instructions can be modified to refer to different periods of time. We will use instruction sets to refer to participants’ “typical” experience of negative emotion and that experienced during the behavior observations.

  • Emotion Regulation Questionnaire [ Time Frame: 2 Days ]

    The 10-item ERQ measures two emotion regulation constructs: reappraisal and suppression. The response range is from 1 (strong disagree) to 7 (strongly agree).

  • Couple Emotion Regulation Inventory (CERI) [ Time Frame: 2 Days ]

    This study-specific 23-item measure assesses the frequency of different behaviors individuals exhibit to manage their own emotions when they have conflicts with their partners on a 7-point scale. The items were developed based on the Emotion Regulation Questionnaire (Gross & John, 2003) and Parent Emotion Regulation Inventory 2 (Lorber, Del Vecchio, Feder, & Slep, in press). Additionally, respondents will complete a 17-item modified CERI post-interaction assessing how many times they used these strategies in during the immediately preceding observational assessment on a 4-point scale.

  • Partner cognition scale [ Time Frame: 2 Days ]

    This 11-item scale is adapted from the Parent Cognition Scale (PCS; Snarr, Slep & Grande, 2009) and assesses the degree to which partners endorse dysfunctional partner-responsible attributions for undesirable partner behavior.

Estimated Enrollment: 200
Actual Study Start Date: May 1, 2017
Estimated Study Completion Date: May 1, 2019
Estimated Primary Completion Date: May 1, 2018 (Final data collection date for primary outcome measure)
Active Comparator: Cognitive Condition Behavioral: Problem Solving Discussion

Couples will engage in two problem solving/conflict resolution discussions (10 min for each partner’s issue related to the relationship; 20 min total)that will be video recorded and later coded for relevant study variables.

Active Comparator: Behavioral Condition Behavioral: Problem Solving Discussion

Couples will engage in two problem solving/conflict resolution discussions (10 min for each partner’s issue related to the relationship; 20 min total)that will be video recorded and later coded for relevant study variables.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • At least one of the partners in the couple dyad carries a T2D diagnosis or is at risk for T2D.

Exclusion Criteria:

  • If individuals do not meet the above criteria, they will be excluded from the study.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03163082

New York University School of Medicine
New York, New York, United States, 10016
Contact: Samara Trindade    212-998-9262    st2745@nyu.edu   
Principal Investigator: Richard Heyman, MD         

New York University School of Medicine

Principal Investigator: Richard Heyman New York University School of Medicine

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT03163082     History of Changes
Other Study ID Numbers: 15-01090
Study First Received: May 19, 2017
Last Updated: May 19, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by New York University School of Medicine:

Coercion theory
Corrosive Couple Coercion

ClinicalTrials.gov processed this record on May 22, 2017