Skip to main content
Clinical Trials/NCT04014582
NCT04014582
Completed
Not Applicable

Communal Coping Intervention for Couples With Type 2 Diabetes

Carnegie Mellon University1 site in 1 country42 target enrollmentJuly 20, 2019
ConditionsType 2 Diabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 2 Diabetes
Sponsor
Carnegie Mellon University
Enrollment
42
Locations
1
Primary Endpoint
Change in perceived stress
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Communal coping consists of the appraisal of a problem as shared and collaboration to manage the problem. Among individuals with type 2 diabetes, self-report, daily diary, and observational measures of communal coping have been linked to better relationship and health outcomes. While communal coping has been linked to positive adjustment outcomes, there are no interventions that incorporate both components of communal coping theory; interventions often focus on collaborative strategies but do not emphasize a shared appraisal. However, focusing on the shared appraisal component of communal coping may be the critical component to affect change. The primary goal of this study will be to design an intervention that fosters both a shared appraisal and collaboration in individuals with type 2 diabetes. The second goal is to explore two potential mechanisms that may drive the links of the intervention to outcomes-perceived emotional responsiveness and self-efficacy.

Detailed Description

Participants will be 60 couples recruited from a previous research study in which one person has type 2 diabetes. We will recruit 60 couples based on power analyses of collaboration based interventions. The design will be a two-group pretest-posttest design in which couples will be randomly assigned to one of two conditions: communal coping or diabetes education. All couples will engage in 1) an in-person session, 2) a 7-day daily diary protocol, and 3) a phone call follow-up 1 month later. All participants will come into the laboratory at Carnegie Mellon University to complete a baseline questionnaire and listen to a brief diabetes education from the American Association of Diabetes Educators. Couples in the intervention group will then participate in the communal coping intervention. This intervention aims to foster a shared appraisal and collaboration through: the discussion of past joint coping, education about communal coping (e.g. what it is and why it is beneficial), and discussions to foster the perception of diabetes as shared. Participants in the intervention group will also create collaborative action plans to increase collaboration-collaborative intentions have been shown to successfully impact health outcomes for patients with type 2 diabetes. Couples in the intervention group will also receive two daily text messages-one a general reminder to engage in communal coping and the other one of the collaborative intentions they created during the in-person session. There will be two follow-up periods after this in-person session. First, all couples will answer daily questionnaires over a 7-day period starting the day after the in-person session. The second follow-up will be one month after the daily diary period, when couples will receive a follow up phone call to assess how the primary outcomes of interest changed over a longer period of time.

Registry
clinicaltrials.gov
Start Date
July 20, 2019
End Date
April 14, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Melissa Zajdel

PhD Candidate Psychology

Carnegie Mellon University

Eligibility Criteria

Inclusion Criteria

  • One person must have type 2 diabetes.
  • Must be married or cohabitating for at least 1 year with a partner
  • Must have access to internet to participate (required for daily diary component).

Exclusion Criteria

  • Both persons cannot have type 2 diabetes
  • Must not have any other major comorbidities.

Outcomes

Primary Outcomes

Change in perceived stress

Time Frame: Perceived stress will be measured at baseline and 1 month after the intervention.

Perceived stress will be measured via the 4 item Perceived Stress Scale which ranges from 1 never to 5 very often. Both patients and spouses will complete this self-report questionnaire.

Change in diabetes self-care

Time Frame: Diabetes self-care will be measured at baseline and 1 month after the intervention.

Diabetes self-care will be measured via the summary of diabetes self care activities. Patients will report on their own self care and spouses will report on their perceptions of the patient's self-care. The items in the SDSCA have varying scales based on the question, but higher numbers reflect greater self-care.

Change in relationship satisfaction--PAIR

Time Frame: Relationship satisfaction will be measured at baseline and 1 month after the intervention.

Relationship satisfaction will also be measured via the Personal Assessment of Intimacy in Relationships scale. This scale will be assessed from 1 strongly disagree to 7 strongly agree. Both patients and spouses will complete this questionnaire.

Change in depressive symptoms

Time Frame: Depressive symptoms will be measured at baseline and 1 month after the intervention.

Depressive symptoms will be measured via the 10 item CESD scale which range from 1 none of the time to 4 most of the time. This self-report questionnaire will be assessed for both patient and spouse. Higher numbers represent more depressive symptoms.

Change in life satisfaction

Time Frame: Life satisfaction will be measured at baseline and 1 month after the intervention.

Life satisfaction will be measured via the Satisfaction with Life scale which range from 1 strongly disagree to 7 strongly agree. Higher numbers represent more life satisfaction. Both patients and spouses will report on life satisfaction.

Change in relationship satisfaction--QMI

Time Frame: Relationship satisfaction--QMI will be measured at baseline and 1 month after the intervention.

Relationship satisfaction will be measured via the Quality of Marriage Index. This self-report scale ranges from 1 strongly disagree to 7 strongly agree. Both patients and spouses will complete this self-report questionnaire.

Secondary Outcomes

  • Change in generalized self-efficacy(Self-efficacy will be measured at baseline and 1 month after the intervention.)
  • Change in perceived emotional responsiveness(Perceived emotional responsiveness will be measured at measured at baseline and 1 month after the intervention.)
  • Change in diabetes specific self-efficacy(Self-efficacy will be measured at baseline and 1 month after the intervention.)

Study Sites (1)

Loading locations...

Similar Trials

Completed
Not Applicable
Pilot Brief Communal Coping Intervention for Adults With Type 2 DiabetesDiabetes Mellitus, Type 2
NCT06459596Carnegie Mellon University62
Completed
Not Applicable
Pilot Brief Communal Coping Intervention for Adults With Type 1 DiabetesDiabetes Mellitus, Type 1
NCT05925556Carnegie Mellon University80
Completed
Not Applicable
Acceptance and Commitment Therapy in Improving Well-Being in Patients With Stage III-IV Cancer and Their PartnersMalignant Female Reproductive System NeoplasmMalignant Hepatobiliary NeoplasmPartnerStage III Breast CancerStage III Cervical CancerStage III Colorectal CancerStage III Lung CancerStage III Prostate CancerStage III Skin MelanomaStage III Uterine Corpus CancerStage IIIA Breast CancerStage IIIA Cervical CancerStage IIIA Colorectal CancerStage IIIA Lung CarcinomaStage IIIA Skin MelanomaStage IIIA Uterine Corpus CancerStage IIIB Breast CancerStage IIIB Cervical CancerStage IIIB Colorectal CancerStage IIIB Lung CarcinomaStage IIIB Skin MelanomaStage IIIB Uterine Corpus CancerStage IIIC Breast CancerStage IIIC Colorectal CancerStage IIIC Skin MelanomaStage IIIC Uterine Corpus CancerStage IV Breast CancerStage IV Cervical CancerStage IV Colorectal CancerStage IV Lung CancerStage IV Prostate CancerStage IV Skin MelanomaStage IV Uterine Corpus CancerStage IVA Cervical CancerStage IVA Colorectal CancerStage IVA Uterine Corpus CancerStage IVB Cervical CancerStage IVB Colorectal CancerStage IVB Uterine Corpus Cancer
NCT03112668Rutgers, The State University of New Jersey14
Completed
Phase 2
Dyadic, Skills-Based Primary Prevention for Partner Violence in Perinatal ParentsIntimate Partner Violence
NCT02009111New York University706
Completed
Not Applicable
Community-based Intervention to Prevent Intimate Partner Violence in Rural Southwest, NigeriaViolenceDomestic ViolenceAttitude
NCT06119984Funmilola OlaOlorun2,650