Construction and Preliminary Application of Mindfulness-based Emotional Regulation Intervention Scheme for Adolescents With Anxiety Disorder and Caregivers

NCT06550778 | Completed

• 1 other identifier: HMUDQ20230913001
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety; Mindfulness; Emotional Regulation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Mindful Attention Awareness Scale

  10weeks

• Ruminative Responses Scale

  10weeks

• Mindfulness in Parenting Questionnaire

  10weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

Behavioral: Mindfulness-based emotional regulation intervention

Control group

NO INTERVENTION

Interventions

Mindfulness-based emotional regulation intervention BEHAVIORAL

The intervention was conducted once a week for 6 weeks, with each session lasting 90-120 minutes, including a 30-minute parenting course each week. The intervention program was divided into 6 themes, including "Entering mindfulness, feeling the connection between emotions and the body", "Dealing with negative emotions", "Moderate emotional expression", "Mindfulness to relieve anxiety", "Learning to be grateful" and "Embrace future life". The intervention content integrates mindfulness training, parental mindful parenting exercises and emotion regulation skills. For details, refer to Greenland's "Mindfulness Games", Bögels' "Mindful Parenting Manual", mindful breathing and meditation in MBSR and MBCT, as well as emotion regulation skills. The intervention location was the activity room of the child and adolescent psychology unit of the hospital.

Intervention group

Eligibility Criteria

• Age: 12 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhan Yuxin: lead

Study Sites (1)

Harbin Medical University

Daqing, Heilongjiang, China

Location

MeSH Terms

Conditions

Anxiety Disorders; Emotional Regulation

Condition Hierarchy (Ancestors)

Mental Disorders; Self-Control; Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: researcher

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: August 13, 2024
• Study Start: June 1, 2022
• Primary Completion: February 1, 2024
• Study Completion: March 1, 2024
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)