Clinical trial NCT04014582: Taking Action: a Care for Type 2 Diabetes Intervention for Couples
Official title: Communal Coping Intervention for Couples With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: communal coping
couples coping
adjustment
Lead sponsor: Carnegie Mellon University
Sponsor class: OTHER
First posted: 2019-07-10
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to one of two groups, either the intervention or the control (diabetes education) condition
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in depressive symptoms
timeFrame: Depressive symptoms will be measured at baseline and 1 month after the intervention.
measure: Change in life satisfaction
timeFrame: Life satisfaction will be measured at baseline and 1 month after the intervention.
measure: Change in perceived stress
timeFrame: Perceived stress will be measured at baseline and 1 month after the intervention.
measure: Change in relationship satisfaction--QMI
timeFrame: Relationship satisfaction--QMI will be measured at baseline and 1 month after the intervention.
measure: Change in relationship satisfaction--PAIR
timeFrame: Relationship satisfaction will be measured at baseline and 1 month after the intervention.
measure: Change in diabetes self-care
timeFrame: Diabetes self-care will be measured at baseline and 1 month after the intervention.
Secondary outcomes:
measure: Change in perceived emotional responsiveness
timeFrame: Perceived emotional responsiveness will be measured at measured at baseline and 1 month after the intervention.
measure: Change in generalized self-efficacy
timeFrame: Self-efficacy will be measured at baseline and 1 month after the intervention.
measure: Change in diabetes specific self-efficacy
timeFrame: Self-efficacy will be measured at baseline and 1 month after the intervention.
Other outcomes:
measure: Daily mood
timeFrame: Daily mood will be measured over a 7 day daily diary period.
measure: Daily self-care behaviors.
timeFrame: Daily mood will be measured over a 7 day daily diary period.
measure: Daily relationship satisfaction
timeFrame: Daily relationship satisfaction will be measured over a 7 day daily diary period.
measure: Daily diabetes self-efficacy
timeFrame: Daily diabetes self efficacy will be measured over a 7 day daily diary period.
measure: Daily self-efficacy
timeFrame: Daily self efficacy will be measured over a 7 day daily diary period.
Locations:
city: Pittsburgh
country: United States
facility: Carnegie Mellon Universityl
state: Pennsylvania
Study officials:
References: