Ethics Committee of Daqing Campus of Harbin Medical University
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Emotion Regulation Questionnaire
研究概览
简要总结
Purpose：Aiming to improve the emotional regulation abilities of adolescents with AD and caregivers, reduce anxiety levels, and play an important role in promoting the recovery of adolescents with AD and the mental and physical health of parents.
Methods：This study is divided into two parts. In Part One, a mindfulness-based emotional regulation intervention program for adolescents with anxiety disorders and their caregivers was developed. Drawing on family systems theory, the mindfulness coping model, and Gross's emotion regulation process model, a systematic literature review was conducted to extract the main contents of the intervention program. Semi-structured interviews were conducted with 11 pairs of adolescents with AD and their caregivers to identify emotional regulation issues and intervention needs, forming a preliminary draft of the mindfulness-based emotional regulation intervention program for adolescents with anxiety disorders and their caregivers. Fifteen experts were invited to participate in Delphi consultations, and based on pre-experimental feedback, the intervention program was further refined to produce a pilot intervention protocol.
In Part Two, the feasibility and effectiveness of the mindfulness-based emotional regulation intervention for adolescents with anxiety disorders and their caregivers were preliminarily assessed. Using a randomized controlled trial design, 78 pairs of adolescents with AD and their caregivers who met the inclusion criteria were selected from the Children and Adolescent Psychological Unit at the Third Hospital of Daqing City, Heilongjiang Province. They were randomly assigned to either the intervention group (n=39 pairs) receiving a 6-week mindfulness-based emotional regulation intervention or the control group (n=39 pairs) receiving routine hospital care. During the intervention period, 4 adolescents with AD and 5 caregivers withdrew from the intervention group, while 2 adolescents with AD and 3 caregivers withdrew from the control group. Assessments were conducted at baseline (T0), immediately post-intervention (T1), and one month post-intervention (T2) using the Emotion Regulation Questionnaire (ERQ), Self-Rating Anxiety Scale, Mindful Attention Awareness Scale (MAAS), Ruminative Responses Scale (RRS), and Mindfulness in Parenting Questionnaire (MIPQ) for both adolescents with AD and their caregivers. Data were analyzed using SPSS 26.0, employing descriptive statistics, t-tests, chi-square tests, Mann-Whitney U tests, and generalized estimating equations to compare the intervention effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescents aged 12-18 years who meet the diagnostic criteria of the 10th edition of the International Classification of Diseases (ICD-10) and are diagnosed with AD by clinical psychiatrists and have a score of ≥50 on the anxiety self-rating scale;
- •Adolescents are treated with benzodiazepines or 5-HT reuptake inhibitors;
- •Adolescents are in stable condition and have been hospitalized for at least 6 weeks;
- •Adolescents can communicate normally and voluntarily participate in this study;
- •The father or mother of the AD adolescent who meets the above inclusion criteria;
- •As the main fixed caregiver of the child, they are mainly responsible for daily care work, taking care of the child for ≥5 days per week and taking care of the child for more than 3 months ;
- •Informed consent and voluntarily participate in this study.
排除标准
- •The caregiver has severe cognitive impairment, mental illness, and physical illness;
- •The AD adolescent and the caregiver have participated in other psychological interventions or researchers within 6 months;
- •The AD adolescent cannot continue to cooperate with the study due to worsening of the condition;
- •Voluntarily withdraw from the study midway.
结局指标
主要结局
Emotion Regulation Questionnaire
时间窗: 10weeks
The questionnaire was compiled by Gross and John et al. in 2003 and is used to evaluate the level of emotion regulation. This study used the Chinese version translated by Wang Li et al. \[142\]. The questionnaire contains two dimensions, namely cognitive reappraisal and expressive inhibition, with a total of 10 items, and is scored on a scale of 1-7 (1 = "strongly agree", 7 = "strongly disagree"). The Cronbach's α coefficient for the cognitive reappraisal dimension of the questionnaire is 0.85, and the Cronbach's α coefficient for the expressive inhibition dimension is 0.77; in this study, the Cronbach's α coefficient for the cognitive reappraisal dimension is 0.83, and the Cronbach's α coefficient for the expressive inhibition dimension is 0.79.
Self-rating Anxiety Scale
时间窗: 10weeks
The scale was compiled by foreign scholar Zung in 1971. It aims to objectively reflect the patient's subjective emotions and assess the degree of anxiety symptoms. The scale contains 20 items, which are scored on a 1-4 scale (1 = "never or rarely"; 4 = "most or all of the time"). The standard score is the total score \* 1.25, and the sum of the scores of the 20 items is the total score. A standard score ≥ 50 indicates anxiety symptoms. In this study, the Cronbach's α coefficient was 0.87.
次要结局
- Mindfulness in Parenting Questionnaire(10weeks)
- Ruminative Responses Scale(10weeks)
- Mindful Attention Awareness Scale(10weeks)
研究者
Zhan Yuxin
researcher
Harbin Medical University