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| Name | Class |
|---|---|
| Juvenile Diabetes Research Foundation | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Communal Coping Intervention | Experimental | 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:
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| Diabetes Education Attention Control | No Intervention | These participants will receive diabetes education via a 15-20 minute videotape (as well the intervention group) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Communal Coping Intervention | Behavioral | The components of the intervention were described in the experimental arm. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | diabetes distress | baseline, abbreviated for ecological momentary assessment, 6-week followup |
| 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 | self-management | baseline, abbreviated for ecological momentary assessment, 6-week followup |
| Measure | Description | Time Frame |
|---|---|---|
| change in hemoglobin a1c from baseline to 6 weeks; higher numbers = poorer outcome | test kit | baseline, 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 |
| Measure | Description | Time Frame |
|---|---|---|
| change in communal coping from baseline to 6 weeks; higher = more communal copingl; range = 0 to 10; also change over ecological momentary assessment period | self-reports of communal coping, raters coding of communal coping from videotapes, we-talk from brief interview | baseline, abbreviated for ecological momentary assessment, 6-week followup |
Inclusion Criteria:
diagnosis of type 1 diabetes for at least one year
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vicki Helgeson, Ph.D. | Carnegie Mellon University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carnegie Mellon University | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42095850 | Derived | Helgeson VS. Communal coping in type 1 diabetes: Randomized trial of a couple-focused intervention. Health Psychol. 2026 May 7. doi: 10.1037/hea0001614. Online ahead of print. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 21, 2026 | |
| Reset | Apr 8, 2026 | |
| Release | Apr 27, 2026 | |
| Reset | May 18, 2026 | |
| Release | May 27, 2026 | |
| Reset | Jun 22, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 21, 2026 | Apr 8, 2026 | |||
| Apr 27, 2026 |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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data downloaded from continuous glucose monitors |
| baseline (from past 2 weeks), end of 2-week ecological momentary assessment (from past 2 weeks), 6-week followup (past 2 weeks) |
| 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 | depressive symptoms | 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 | life satisfaction | baseline, abbreviated for ecological momentary assessment, 6-week followup |
| 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 | relationship quality | baseline, abbreviated for ecological momentary assessment, 6-week followup |
| change in social support and negative social interactions from baseline to 6 weeks; higher numbers = more support or more negative interactions; range = 1-7; also change over ecological momentary assessment period |
emotional, instrumental, informational support, criticism, overprotective behavior |
| baseline, abbreviated for for ecological momentary assessment, 6-week followup |
| change in diabetes communication from baseline to 6 weeks; higher numbers = more communication; range = 0 to 10; also change over ecological momentary assessment period | self-report of diabetes communication, videotaped observations | baseline, abbreviated for for ecological momentary assessment, 6-week followup |
| change in self-efficacy subscale from Multidimensional Diabetes Questionnaire from baseline to 6 weeks; higher numbers = greater efficacy; range = 0 to 100%; also change over ecological momentary assessment period | self-efficacy with diabetes management | baseline, abbreviated for for ecological momentary assessment, 6-week followup |
| May 18, 2026 |
| May 27, 2026 | Jun 22, 2026 |
| Jun 25, 2026 |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |