Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06450730
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-06-05
Brief Title:
Effectiveness of a Combined mHealth-CBT Psychological Intervention to Improve Psychological Well-Being in Young Patients With T1D
Sponsor:
Maimónides Biomedical Research Institute of Córdoba
Organization:
Maimónides Biomedical Research Institute of Córdoba
Study Overview
Official Title:
Effectiveness of a Combined mHealth Cognitive Behavioral Therapy Psychological Intervention to Improve Psychological Well-being in Young Patients With Type 1 Diabetes
Status:
ACTIVE_NOT_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:
Type 1 diabetes T1D can lead to psychological adjustments that impact the acceptance and management of this health condition as well as the overall quality of life of patients especially among the young Therefore there is a need for psychological interventions aimed at enhancing the psychological well-being of children and adolescents with T1D The goal of this non-randomized controlled trial is to evaluate whether a combined intervention comprising mHealth using an app and face-to-face psychological sessions based on Barlows protocol and cognitive-behavioral therapy techniques CBT is effective in enhancing psychological well-being in children and adolescents with T1D The main hypotheses are
H1 The primary results expected to be obtained are a significant increase in psychological well-being which means a decreased diabetes distress DDS H1a an increased subjective well-being PANAS H1b and a better self-efficacy for managing their emotions RESE H1c
H2 As secondary outcomes it is also expected that the combined mHealth-CBT intervention would increase the level of positivity P-Scale H2a the self-esteem RSES H2b and the satisfaction with life SWLS H2c
H1 The primary results expected to be obtained are a significant increase in psychological well-being which means a decreased diabetes distress DDS H1a an increased subjective well-being PANAS H1b and a better self-efficacy for managing their emotions RESE H1c
H2 As secondary outcomes it is also expected that the combined mHealth-CBT intervention would increase the level of positivity P-Scale H2a the self-esteem RSES H2b and the satisfaction with life SWLS H2c
Detailed Description:
None
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