Taking Action: a Care for Type 2 Diabetes Intervention for Couples

NCT ID: NCT04014582

Last Updated: 2020-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-20
• Study Completion Date: 2020-04-14

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Communal Coping Intervention

This group will participate in diabetes education + a communal coping based intervention.

Group Type: EXPERIMENTAL

Communal Coping Intervention

Intervention Type: BEHAVIORAL

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. 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. These couples will also receive a brief diabetes education.

Control

This group will participate in diabetes education and an individual intervention.

Group Type: ACTIVE_COMPARATOR

Diabetes Education

Intervention Type: BEHAVIORAL

Couples in the diabetes education group will receive a brief diabetes education and complete individual implementation intentions. Patients will create implementation intentions related to diabetes and partners will create implementation intentions that are not related to health.

Interventions

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. 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. These couples will also receive a brief diabetes education.

Intervention Type: BEHAVIORAL

Diabetes Education

Couples in the diabetes education group will receive a brief diabetes education and complete individual implementation intentions. Patients will create implementation intentions related to diabetes and partners will create implementation intentions that are not related to health.

Intervention Type: BEHAVIORAL

Other Intervention Names

Control

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carnegie Mellon University

OTHER

Sponsor Role: lead

Responsible Party

Melissa Zajdel

PhD Candidate Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Carnegie Mellon Universityl

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

STUDY2019_00000227

Identifier Type: -

Identifier Source: org_study_id