Effectiveness of a Combined mHealth Cognitive Behavioral Therapy Psychological Intervention to Improve Psychological Well-being in Young Patients With Type 1 Diabetes.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Diabetes Distress
研究概览
简要总结
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 Barlow's 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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Girls and Boys with a diagnosis of T1D 6 - 18
- •Having a smartphone compatible with the APP created used for the mHealth intervention and daily access to internet
- •Having the required digital skills to follow the mHealth intervention
- •Not currently participating in another clinical trial involving a psychological intervention
排除标准
- •Girls and Boys with a diagnosis of T1D >18 years
- •Not Having a smartphone compatible with the APP created used for the mHealth intervention and daily access to internet
- •Currently participating in another clinical trial involving a psychological intervention
研究组 & 干预措施
CBT face-to-face + app
Combines face-to-face CBT sessions with online activities and resources trough a mobile app
干预措施: Cognitive-Behavioral Therapy: face-to-face + app (Behavioral)
TAU Group
TAU Group Patients of the control group continued their usual treatment.
结局指标
主要结局
Diabetes Distress
时间窗: Baseline, immediately after intervention and four months later (follow-up)
Diabetes Distress Scale (DDS; Polonsky et al., 2005) is a Likert-type scale of 17 items that measures the level of emotional distress related to diabetes in individuals living with this chronic condition and how it impacts their quality of life. Scores ranges from 1 "not a problem" to 5 "very serious problem".
Positive Affect and Negative Affect
时间窗: Baseline, immediately after intervention and four months later (follow-up)
Positive Affect and Negative Affect Scale (PANAS; Watson et al., 1988) It is a Likert-type scale of 20-item (10 items for positive and 10 items for negative affect, that assesses the extent to which the participants experienced positive affect in the last 2 weeks. Rated on a 5-point scale from 1 "not at all" to 5 "very much". It has been validated in Spanish (López-Gomez, et al., 2015)
Regulatory Emotional Self-Efficacy
时间窗: Baseline, immediately after intervention and four months later (follow-up)
Regulatory Emotional Self-Efficacy scale (RESE; Caprara \& Gervino, 2001).It is designed to assess an individual's perceived self-efficacy in managing negative and expressing positive emotions. It is a five-point scale (1 = not capable at all; 5 = completely capable) to 12 items distributed across two factors: positive affect expression (4 items) and negative affect expression, further divided into handling dejection and distress (4 items), and handling anger and irritation (4 items).
次要结局
- Positivity(Baseline, immediately after intervention and four months later (follow-up))
- Self-esteem(Baseline, immediately after intervention and four months later (follow-up))
- Satisfaction with Life(Baseline, immediately after intervention and four months later (follow-up))
研究者
Rosario Castillo-Mayén
Dr
Maimónides Biomedical Research Institute of Córdoba