Clinical trial NCT06550778: Construction and Preliminary Application of Mindfulness-based Emotional Regulation Intervention Scheme for Adolescents With Anxiety Disorder and Caregivers
Official title: Ethics Committee of Daqing Campus of Harbin Medical University
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Mindfulness
Emotional Regulation
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 78
Sex: ALL
Minimum age (years): 12
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: Inclusion Criteria:

1. 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;
2. Adolescents are treated with benzodiazepines or 5-HT reuptake inhibitors;
3. Adolescents are in stable condition and have been hospitalized for at least 6 weeks;
4. Adolescents can communicate normally and voluntarily participate in this study;
5. The father or mother of the AD adolescent who meets the above inclusion criteria;
6. 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 ;
7. Informed consent and voluntarily participate in this study.

Exclusion Criteria:

1. The caregiver has severe cognitive impairment, mental illness, and physical illness;
2. The AD adolescent and the caregiver have participated in other psychological interventions or researchers within 6 months;
3. The AD adolescent cannot continue to cooperate with the study due to worsening of the condition;
4. Voluntarily withdraw from the study midway.

Primary outcomes:
measure: Emotion Regulation Questionnaire
timeFrame: 10weeks
measure: Self-rating Anxiety Scale
timeFrame: 10weeks
Secondary outcomes:
measure: Mindful Attention Awareness Scale
timeFrame: 10weeks
measure: Ruminative Responses Scale
timeFrame: 10weeks
measure: Mindfulness in Parenting Questionnaire
timeFrame: 10weeks
Other outcomes:
Locations:
city: Daqing
country: China
facility: Harbin Medical University
state: Heilongjiang
Study officials:
References: