Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06618027
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
Pragmatic Clinic-Based Trial of a Mindfulness Based Intervention for Mood Concerns in Youth With Type 1 Diabetes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pragmatic Clinic-Based Trial of a Mindfulness Based Intervention for Mood Concerns in Youth With Type 1 Diabetes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BREATHE-T1D
Brief Summary:
Type 1 diabetes T1D is a common chronic illness among children requiring a high degree of self-management for good glycemic control Adolescents are at risk for poor disease management and health outcomes due to a number of factors including high rates of depression anxiety and stress Accessing support for these challenges can be a barrier to care so the current study BRinging Empowerment and Attention to Teen HEalth-T1D evaluates the efficacy of a virtual group-based mindfulness based intervention and a virtual group-based diabetes education intervention on improving symptoms of depression and anxiety and diabetes self management in teens with T1D The study also aims to study how these interventions might be implemented in diabetes clinic settings
Detailed Description:
Type 1 diabetes T1D is one of the most common chronic illnesses of childhood affecting around 200000 youth in the US Youth with T1D are at heightened risk for serious adverse health consequences as compared to their peers without T1D but treatment adherence markedly reduces this risk Adolescence is a critical period for determining the course of T1D as treatment adherence and glycemic target achievements deteriorate in adolescence with 80 failing to meet glycemic targets Adolescents failure to adhere to standards of treatment can result in poor glycemic control HbA1c gt70 which if unaddressed increases the risk of serious adverse health consequences Effective intervention to address glycemic control in adolescents with T1D remains elusive Negative affect-including depression and anxiety-increases during adolescence and is a key contributor to treatment non-adherence and glycemic control above targets As many as 40 of adolescents with T1D have elevated depression and anxiety symptoms which likely impact adherence and glycemia through stress-related behavior eg disordered eating avoidant coping Trials of effective interventions to decrease negative affect and downstream stress-related behaviors are critical to improve the health of adolescents with T1D
Our pilot study adapted a brief group mindfulness-based intervention MBI for teens with T1D utilizing stakeholder input and designed with an iterative approach BREATHE-T1D Our R34 demonstrated that BREATHE-T1D was highly feasible 100 of eligible teens approached enrolled with a 93 retention rate and demonstrated outstanding acceptability with teens participating in 98 of sessions and reporting high value of participation Those randomized to BREATHE-T1D had evidence of more clinical improvement for depression and HbA1c while those in the health education comparison had stability or worsening of symptoms Improvements over time were seen in anxiety diabetes distress and disordered eating for participants Existing data from randomized controlled trials RCT support the efficacy of MBI for decreasing negative affect and stress-related behavior in adolescents without T1D The next step is to evaluate the efficacy of BREATHE-T1D in a 2-site study as compared to our health education attention control HealthEd-T1D In our R34 providers noted that many adolescents have psychosocial concerns yet there are grossly inadequate referral sources and a need for integration of efficacious programs into clinic settings Therefore it is critical to design interventions for implementation and sustainability and evaluate how the intervention is aligned with infrastructure in real world settings
The current study is a partnership with Childrens National and the University of Colorado to conduct an RCT comparing BREATHE-T1D and HealthEd-T1D in N200 adolescents 13-17y with gt1 year duration of T1D and elevated negative affect This study is a pragmatic trial to evaluate the efficacy of BREATHE-T1D and methods of implementation of this program into the clinic setting for which it is designed Given the positive response to the pilot trial the value of evaluating screening and referral in clinic increased emphasis on in-clinic screening for mood anxiety and disordered eating and evaluating outcomes relevant to the clinic setting enables both evaluation of efficacy as well as feasibility of clinic implementation The intervention will be conducted virtually and the trial will employ multi-method assessment of outcomes including self-report parent-report and indica-tors of diabetes management ie blood glucose variability via Continuous Glucose Monitors or blood glucose meters and glycemic control via HbA1c N200 adolescents will be randomized 11 to BREATHE-T1D or HealthEd-T1D and have a baseline assessment 7 weeks of groups and follow-ups 3 months and 1 year following baseline
Our pilot study adapted a brief group mindfulness-based intervention MBI for teens with T1D utilizing stakeholder input and designed with an iterative approach BREATHE-T1D Our R34 demonstrated that BREATHE-T1D was highly feasible 100 of eligible teens approached enrolled with a 93 retention rate and demonstrated outstanding acceptability with teens participating in 98 of sessions and reporting high value of participation Those randomized to BREATHE-T1D had evidence of more clinical improvement for depression and HbA1c while those in the health education comparison had stability or worsening of symptoms Improvements over time were seen in anxiety diabetes distress and disordered eating for participants Existing data from randomized controlled trials RCT support the efficacy of MBI for decreasing negative affect and stress-related behavior in adolescents without T1D The next step is to evaluate the efficacy of BREATHE-T1D in a 2-site study as compared to our health education attention control HealthEd-T1D In our R34 providers noted that many adolescents have psychosocial concerns yet there are grossly inadequate referral sources and a need for integration of efficacious programs into clinic settings Therefore it is critical to design interventions for implementation and sustainability and evaluate how the intervention is aligned with infrastructure in real world settings
The current study is a partnership with Childrens National and the University of Colorado to conduct an RCT comparing BREATHE-T1D and HealthEd-T1D in N200 adolescents 13-17y with gt1 year duration of T1D and elevated negative affect This study is a pragmatic trial to evaluate the efficacy of BREATHE-T1D and methods of implementation of this program into the clinic setting for which it is designed Given the positive response to the pilot trial the value of evaluating screening and referral in clinic increased emphasis on in-clinic screening for mood anxiety and disordered eating and evaluating outcomes relevant to the clinic setting enables both evaluation of efficacy as well as feasibility of clinic implementation The intervention will be conducted virtually and the trial will employ multi-method assessment of outcomes including self-report parent-report and indica-tors of diabetes management ie blood glucose variability via Continuous Glucose Monitors or blood glucose meters and glycemic control via HbA1c N200 adolescents will be randomized 11 to BREATHE-T1D or HealthEd-T1D and have a baseline assessment 7 weeks of groups and follow-ups 3 months and 1 year following baseline
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None