AnxietyNCT06550778
Construction and Preliminary Application of Mindfulness-based Emotional Regulation Intervention Scheme for Adolescents With Anxiety Disorder and Caregivers
A study testing Mindfulness-based emotional regulation intervention in people with Anxiety and Mindfulness, run by Zhan Yuxin at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 50 years
- Conditions the study is for
- Anxiety, Mindfulness, Emotional Regulation
- What is being tested?
- Mindfulness-based emotional regulation intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ethics Committee of Daqing Campus of Harbin Medical University
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
- Being tested
- Mindfulness-based emotional regulation intervention
- Medical subject headings
- Anxiety Disorders, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based emotional regulation interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Behavioral: Mindfulness-based emotional regulation intervention |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 10weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 10weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start1 Jun 2022
- Primary completion1 Feb 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhan Yuxin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhan Yuxin, Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550778
- Sponsor's protocol ID
- HMUDQ20230913001
- Status last verified
- Aug 2024
- First submitted
- 7 Aug 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ethics Committee of Daqing Campus of Harbin Medical University
- ClinicalTrials.gov ID
- NCT06550778
- Acronym / sponsor ID
- HMUDQ20230913001
- Conditions
- Anxiety, Mindfulness, Emotional Regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Zhan YuxinUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 13 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Mindfulness-based emotional regulation intervention |
| Control group | No intervention | – |
Who may qualify
- Ages
- 12 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-based emotional regulation interventionThe 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. | Behavioural | Intervention group |
Primary outcome
Emotion Regulation Questionnaire
Time frame: 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
Time frame: 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.
3 secondary outcomes
Mindful Attention Awareness Scale
Time frame: 10weeks
Ruminative Responses Scale
Time frame: 10weeks
Mindfulness in Parenting Questionnaire
Time frame: 10weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based emotional regulation intervention in people with Anxiety and Mindfulness, run by Zhan Yuxin at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotion Regulation Questionnaire (time frame: 10weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.