Telemedicine-Delivered Unified Protocol for Cognitive Behavioral Therapy for Anxiety and Depression in Young Adults With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 94
- 试验地点
- 4
- 主要终点
- Anxiety symptom severity
研究概览
简要总结
This project will evaluate a telemedicine-delivered, Unified Protocol for Cognitive-Behavioral Therapy (UP-CBT) enhanced with continuous glucose monitor (CGM) review to target anxiety and depressive symptoms and glycemic control in adults with type 1 diabetes.
详细描述
The efficacy of the Unified Protocol for Cognitive Behavioral Therapy (UP-CBT) combined with commercial FDA-approved Continuous Glucose Monitoring (CGM) will be tested in comparison to CGM only in a randomized controlled clinical trial. The central hypothesis is that the addition of the UP-CBT intervention will yield clinically significant improvements in anxiety and depressive symptom severity and glycemic control relative to CGM alone. We will recruit 94 adults (age 18-64) with suboptimally controlled type 1 diabetes and an anxiety or depressive disorder from a national population for an entirely virtual 12-month study over five years, with targeted recruitment of racial/ethnic minorities. In addition to standard measurement of hemoglobin A1c (HbA1c) for glycemic control and validated patient-reported outcome (PRO) surveys, the study integrates momentary psychological and behavioral data via smartphone-based ecological momentary assessment (EMA) with CGM data to assess day-to-day changes in affect, self-management, and glycemia over the course of the trial.
Qualitative information will be collected from people with Type 1 Diabetes (T1D) ages 35-64 to solicit suggestions and inform future study decisions. We will create 2-4 focus groups to ask their impressions about our current study and to explore key factors like establishing adult care and attending medical appointments, disease self-management, and adjusting to chronic disease. We will compare interview responses from participant groups who have high vs. low social needs and poor vs. good glycemic control.
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)
盲法说明
Trained clinical interviewers blind to treatment assignment will administer structured clinical interviews to assess primary outcomes of anxiety and depression symptom severity at each assessment. Time in Range will be calculated from CGM data by an analyst who is blind to assignment. Hemoglobin A1c (HbA1c) will be collected via mailed kits at each assessment and analyzed by a lab blind to assignment. Anxiety and Depression severity data will be measured longitudinally throughout the trial, at baseline, immediately post-intervention, and at 9- and 12-months post-randomization by independent assessors blind to the assignment.
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes (T1D) duration ≥ 6 months
- •18-64 years old
- •English- or Spanish-speaking
- •Anxiety or depressive mood disorder as per structured diagnostic interview.
排除标准
- •Developmental or sensory disability interfering with participation
- •Current pregnancy
- •Bipolar disorders, psychotic disorders, severe eating disorders, severe substance abuse disorders, or acute suicidal risk or self-harm
- •Use of medications or recent medical procedures that would impact glycemic control or use of continuous glucose monitoring (CGM) over the study
- •Received cognitive behavioral therapy (CBT) in last year or plans to initiate CBT; (6) temporary exclusion for recent initiation of psychotropic medication - must be on a stable dose for 6 weeks prior to enrollment.
结局指标
主要结局
Anxiety symptom severity
时间窗: Baseline and midway through treatment (3 months), immediately post-treatment (5.5 months) and 9- and 12- months post-baseline
Participant ratings will be conducted via video conference by clinicians blinded to the condition, using the Structured Interview Guide for the Hamilton Anxiety Rating Scales (SIGH-A). SIGH-A measures the severity of a patient's somatic and psychic anxiety based on 14 parameters including anxious mood, tension, fears, insomnia, somatic complaints and behavior at the interview. Each item is assigned a 5-point score ranging from 0 (not present) to 4 (severe) yielding an overall possible score of 0-56. Higher SIGH-A scores denote increased severity of anxiety.
Depressive symptom severity
时间窗: Baseline and midway through treatment (3 months), immediately post-treatment (5.5 months) and 9- and 12- months post-baseline
Participant ratings will be conducted via video conference by clinicians blinded to the condition, using the Structured Interview Guide for the Hamilton Depression Rating Scales (SIGH-D). SIGH-D is a 29-item clinical interview that expands the 21-item Hamilton Depression Rating Scale for Depression (HAM-D) to include eight items assessing "atypical symptoms" of depression. Ranges for individual parameters vary but a score of 0 signifies less severity (e.g., no/absent) and incrementally higher scores represent more severe symptoms. Total SIGH-D scores can range from 0 to 90. A higher overall SIGH-D score denotes increased severity of Depression.
次要结局
- Time in Range (TIR) calculated from Continuous Glucose Monitoring (CGM)(6 months)
- Hemoglobin A1c (HbA1c)(6 months)
- Time in Range (TIR) calculated from Continuous Glucose Monitoring (CGM)(6 months)
- Hemoglobin A1c (HbA1c)(6 months)