Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06459596
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-05-07
Brief Title:
Pilot Brief Communal Coping Intervention for Adults With Type 2 Diabetes
Sponsor:
Carnegie Mellon University
Organization:
Carnegie Mellon University
Study Overview
Official Title:
Communal Coping Intervention for Adults With Type 2 Diabetes
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators plan to develop a communal coping intervention aimed at instilling a shared appraisal of diabetes and increasing patient-partner collaboration To that end the investigators will pilot the first randomized clinical trial of a brief communal coping intervention among couples in which one person has T12
Detailed Description:
The investigators will recruit 66 couples in which one person has type 2 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None