Communal Coping Intervention for Couples With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Change in perceived stress
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will be randomly assigned to condition, and they will not be aware if they are in the intervention or control group. The control group is more than usual care, so they may also believe they are in the intervention group.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •Both persons cannot have type 2 diabetes
- •Must not have any other major comorbidities.
结局指标
主要结局
Change in perceived stress
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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.)
研究者
Melissa Zajdel
PhD Candidate Psychology
Carnegie Mellon University