Construction and Preliminary Application of Mindfulness-based Emotional Regulation Intervention Scheme for Adolescents With Anxiety Disorder and Caregivers
NCT Number: NCT06550778
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anxiety|Mindfulness|Emotional Regulation
Interventions: BEHAVIORAL: Mindfulness-based emotional regulation intervention
Sponsor: Zhan Yuxin
Sex: ALL
Age: CHILD, ADULT
Enrollment: 78
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2022-06-01
Completion Date: 2024-03-01
Locations: Harbin Medical University, Daqing, Heilongjiang, China

Summary:
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.

Primary Outcome Measures: Emotion Regulation Questionnaire, 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., 10weeks|Self-rating Anxiety Scale, 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., 10weeks
Secondary Outcome Measures: Mindful Attention Awareness Scale, The questionnaire was developed by Brown and Ryan in 2003. It is used to assess people's perception of their daily life experiences, mainly including cognitive, emotional and physiological aspects. This study used the Chinese version of the Mindfulness Awareness Scale revised by Chen Siyi, Cui Hong, Zhou Renlai and Jia Yanyan \[143\]. The scale has 15 items, which are scored on a scale of 1-6 (1 = "never", 6 = "always"). The total score of the scale ranges from 15 to 90. The scoring standard is: the higher the total score of the scale, the higher the degree of mindfulness of the subject. MAAS has good internal consistency, with a Cronbach's α coefficient of 0.85 . In this study, the Cronbach's α coefficient was 0.87., 10weeks|Ruminative Responses Scale, The Ruminative Responses Scale (RRS) was developed by Nolen-Hoeksema in 1991. The scale was revised by Han Xiu and Yang Hongfei to form the Chinese version of the ruminative thinking scale \[144\]. The scale has 22 items, including three dimensions: symptom rumination, obsessive thinking, and reflective thinking. It is scored on a 1-4 scale (1 = "never", 4 = "always"), and the higher the score, the more severe the tendency of rumination. The Cronbach's α coefficient of the scale is 0.90 , and the Cronbach's α coefficient in this study is 0.88., 10weeks|Mindfulness in Parenting Questionnaire, The Mindfulness in Parenting Questionnaire (MIPQ) was developed by McCaffrey and revised in Chinese by Zhao Yaping et al. It includes two dimensions: focusing on the present and mindful parenting. It has 28 items and is scored on a 1-4 scale (1 = "occasionally", 4 = "always"). The higher the individual's mindful parenting behavior, the higher the final score. Cronbach's α coefficient is 0.90 \[144\]. In this study, Cronbach's α coefficient was 0.86., 10weeks