Communal Coping Intervention for Adults With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- change in Type 1 Diabetes Distress Scale (Fisher et al., 2015) from baseline to 6 weeks; higher scores = more distress; range 1-6; also change over ecological momentary assessment period
研究概览
简要总结
We plan to develop a communal coping intervention aimed at instilling a shared appraisal of diabetes and increasing patient-partner collaboration. To that end, we will pilot the first randomized clinical trial of a brief communal coping intervention among couples in which one person has T1D
详细描述
We will recruit 66 couples in which one person has type 1 diabetes. Power is based on effect sizes from previous couple intervention studies and meta-analyses on primary outcomes. Couples will be randomly assigned to either a communal coping intervention or an attention (diabetes education) control group. All couples will come to the laboratory or meet via zoom, complete a baseline questionnaire assessment (primary and secondary outcomes, mediators) and have a videotaped conversation about how they cope with diabetes. The intervention group will receive the communal coping intervention. Couples in the intervention group will identify 5 collaborative implementation intentions, whereas controls will identify 5 individual implementation intentions. After the in-person session, couples will individually complete a daily diary at the end of the day for 14 consecutive days which focuses on daily communication, mood, and patient self-care. During the first 7 days, the intervention group will receive two text messages per day (morning focus on shared appraisal, evening focus on one of collaborative implementation intentions identified during in-person session). An in-person follow-up interview will take place 6 weeks after the initial session, during which primary outcomes, secondary outcomes, and mediators will be assessed and the videotaped conversation repeated.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of type 1 diabetes for at least one year
- •married or living with someone for at least one year who is willing to participate in the study as the study partner
- •age 18 and over
- •reliable access to the internet at home
排除标准
- •Non-English speakers
- •Patient has a major chronic illness that affects daily life more than diabetes (e.g., currently undergoing treatment for cancer)
- •Partner does not consent to participate in study
- •Partner has diabetes
研究组 & 干预措施
Diabetes Education Attention Control
These participants will receive diabetes education via a 15-20 minute videotape (as well the intervention group)
Communal Coping Intervention
The intervention consists of a single session brief communal coping intervention followed by 7 days of intervention prompts delivered via text message to help couples generalize what they have learned into their daily life. There are 9 components to the intervention:
- establishment of rapport
- shared stressor recollection
- communal coping education
- application of appraisal to diabetes
- we-statements to reframe diabetes as shared
- facilitated discussion between couple members to identify each person's needs with active listening
- collaborative implementation intentions
- EMI text messaging for 7 days following intervention
干预措施: Communal Coping Intervention (Behavioral)
结局指标
主要结局
change in Type 1 Diabetes Distress Scale (Fisher et al., 2015) from baseline to 6 weeks; higher scores = more distress; range 1-6; also change over ecological momentary assessment period
时间窗: baseline, abbreviated for ecological momentary assessment, 6-week followup
diabetes distress
change in Self-Care Inventory from baseline to 6 weeks; higher score = better self-care; range 1-5; also change over ecological momentary assessment period
时间窗: baseline, abbreviated for ecological momentary assessment, 6-week followup
self-management
次要结局
- change in hemoglobin a1c from baseline to 6 weeks; higher numbers = poorer outcome(baseline, 6 week followup)
- change in Center for Epidemiological Depression Scale from baseline to 6 weeks; higher numbers = more depressive symptoms; range = 0 to 30; also change over ecological momentary assessment period(baseline, abbreviated for ecological momentary assessment, 6-week followup)
- change in Diener's life satisfaction scale from baseline to 6 weeks; higher numbers= more life satisfaction; range = 1-7; also change over ecological momentary assessment period(baseline, abbreviated for ecological momentary assessment, 6-week followup)
- change in time in range from baseline to 6 weeks; higher numbers = better outcome; range 0 to 100%; also change over ecological momentary assessment period(baseline (from past 2 weeks), end of 2-week ecological momentary assessment (from past 2 weeks), 6-week followup (past 2 weeks))
- change in Quality of Marriage Index and intimacy subscale from Personal Assessment of Intimacy in Relationships from baseline to 6 weeks; higher numbers = better; range = 1 to 7; also change over ecological momentary assessment period(baseline, abbreviated for ecological momentary assessment, 6-week followup)
研究者
Vicki Helgeson
Professor
Carnegie Mellon University