Heart Rate Variability, Biofeedback, Nicotine Dependence, Nicotine Withdrawal, Anxiety, Depression, InsomniaNCT04679636
Effects of HRV Biofeedback on Autonomic Function and Nicotine Withdrawal Symptoms and Dependence in Smoking Cessation Adults
A study testing heart rate variability biofeedback in people with Heart Rate Variability, Biofeedback, Nicotine Dependence, Nicotine Withdrawal, Anxiety, Depression, Insomnia, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
Trial summary
This study is a randomized controlled trial. It is estimated that 80 quitters will be recruited, and they will be randomly included in the experimental group and 40 in the control group. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Heart Rate Variability, Biofeedback, Nicotine Dependence, Nicotine Withdrawal, Anxiety, Depression, Insomnia
- What is being tested?
- heart rate variability biofeedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Nov 2020to 31 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to quit smoking
- Clear consciousness
- Able to communicate in Mandarin or Taiwanese
Who cannot join
- Diagnosed with asthma or chronic obstructive pulmonary disease
- Diagnosed with nervous system
- Diagnosis of mental illness
- Arrhythmia, use of cardiac pacemakers, and atrioventricular conduction disorders
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Tri-Service Medical Center
Taipei
Yu-Ju Chen, Ph.D., 886-2-87923100 ext. 18762, judychen37@gmail.com
About this study
Official title: Effects of Heart Rate Variability Biofeedback on Promoting Autonomic Function and Decreasing Nicotine Withdrawal Symptoms and Dependence in Smoking Cessation Adults
This study is a randomized controlled trial. It is estimated that 80 quitters will be recruited, and they will be randomly included in the experimental group and 40 in the control group. The experimental group will be involved in heart rate variability biological feedback training for eight weeks, and the control group will receive conventional treatment. Use the scale to assess the symptoms of nicotine withdrawal-anxiety, depression and insomnia, as well as the degree of nicotine dependence before and after the intervention; the autonomic nervous function of the participants was measured by heart rhythm variation before and after the intervention; in addition, the cessation of smoking was tracked by telephone once a month for six Months. Discuss interventional biological feedback training and evaluate its effectiveness in improving heart rate variability, which represents autonomic nervous function, and alleviating nicotine withdrawal anxiety, insomnia, and depression symptoms, as well as nicotine dependence.
Read the detailed description
Smoking cessation has been one of the priorities in public health for many years, because the severity of the disease and the social and economic losses caused by smoking cannot be ignored. Among them, nicotine dependence is one of the important issues in quitting smoking. Nicotine withdrawal symptoms often make the quitters' actions fail, especially anxiety, insomnia, and depression, which further affect the lives of quitters. If an intervention can be provided to improve the nicotine withdrawal symptoms of quitters and reduce nicotine dependence, it should be able to improve the effectiveness of smoking cessation.This study is a randomized controlled trial to facilitate sampling. It is expected that 80 quitters will be recruited at the smoking cessation clinic of the medical center through the referral of the attending physician, and 40 will be randomly included in the experimental group and the control group. The experimental group will receive biofeedback training for heart rate variability for eight weeks, while the control group will receive conventional treatment. Use the scale to assess nicotine withdrawal symptoms before and after intervention-the degree of anxiety (Beck Anxiety Inventory), depression (Beck Depression Inventory) and insomnia (Pittsburgh Sleep Quality Index), And the degree of nicotine dependence (Nicotine Dependence Scale; Fagerstrom Test for Nicotine Dependence); the autonomic nerve function of the participants was measured by heart rhythm variability before and after the intervention; in addition, the cessation of smoking was tracked by telephone once a month for six months. This study is mainly to explore interventional biological feedback training to evaluate its effectiveness in improving the representative autonomic nervous function-heart rate variability and alleviating nicotine withdrawal anxiety, insomnia and depression symptoms and nicotine dependence.
- Being tested
- heart rate variability biofeedback
- Medical subject headings
- Tobacco Use Disorder, Anxiety Disorders, Depression, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heart rate variability biofeedbackBehavioural
receive biofeedback training for heart rate variability for eight weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | receive biofeedback training for heart rate variability for eight weeks Receives: Behavioral: heart rate variability biofeedback |
| Control group | No intervention | receive conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
autonomic nerve function
heart rate variability index
Measured: baseline
autonomic nerve function
heart rate variability index
Measured: 1 month
autonomic nerve function
heart rate variability index
Measured: 2 month
autonomic nerve function
heart rate variability index
Measured: 6 month
Secondary outcomes (16)
symptom distress(Anxiety)
Beck Anxiety Inventory
Measured: baseline
symptom distress(Anxiety)
Beck Anxiety Inventory
Measured: 1 month
symptom distress(Anxiety)
Beck Anxiety Inventory
Measured: 2 month
symptom distress(Anxiety)
Beck Anxiety Inventory
Measured: 6 month
symptom distress(Depression)
Beck Depression Inventory-II
Measured: baseline
symptom distress(Depression)
Beck Depression Inventory-II
Measured: 1 month
symptom distress(Depression)
Beck Depression Inventory-II
Measured: 2 month
symptom distress(Depression)
Beck Depression Inventory-II
Measured: 6 month
symptom distress(Sleep)
Pittsburgh Sleep Quality Index
Measured: baseline
symptom distress(Sleep)
Pittsburgh Sleep Quality Index
Measured: 1 month
symptom distress(Sleep)
Pittsburgh Sleep Quality Index
Measured: 2 month
symptom distress(Sleep)
Pittsburgh Sleep Quality Index
Measured: 6 month
Cigarette Dependence
Short-Form Cigarette Dependence Questionnaire
Measured: baseline
Cigarette Dependence
Short-Form Cigarette Dependence Questionnaire
Measured: 1 month
Cigarette Dependence
Short-Form Cigarette Dependence Questionnaire
Measured: 2 month
Cigarette Dependence
Short-Form Cigarette Dependence Questionnaire
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start26 Nov 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Rate Variability, Biofeedback, Nicotine Dependence, Nicotine Withdrawal, Anxiety, Depression, InsomniaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Ju Chen, National Defense Medical Center, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04679636
- Sponsor's protocol ID
- 2-2020-1204
- Status last verified
- Mar 2023
- First submitted
- 18 Dec 2020
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Heart Rate Variability Biofeedback on Promoting Autonomic Function and Decreasing Nicotine Withdrawal Symptoms and Dependence in Smoking Cessation Adults
- ClinicalTrials.gov ID
- NCT04679636
- Acronym / sponsor ID
- 2-2020-1204
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Study start
- 26 Nov 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 22 Dec 2020 (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.
This study is a randomized controlled trial. It is estimated that 80 quitters will be recruited, and they will be randomly included in the experimental group and 40 in the control group. The experimental group will be involved in heart rate variability biological feedback training for eight weeks, and the control group will receive conventional treatment. Use the scale to assess the symptoms of nicotine withdrawal-anxiety, depression and insomnia, as well as the degree of nicotine dependence before and after the intervention; the autonomic nervous function of the participants was measured by heart rhythm variation before and after the intervention; in addition, the cessation of smoking was tracked by telephone once a month for six Months. Discuss interventional biological feedback training and evaluate its effectiveness in improving heart rate variability, which represents autonomic nervous function, and alleviating nicotine withdrawal anxiety, insomnia, and depression symptoms, as well as nicotine dependence.
Detailed description
Smoking cessation has been one of the priorities in public health for many years, because the severity of the disease and the social and economic losses caused by smoking cannot be ignored. Among them, nicotine dependence is one of the important issues in quitting smoking. Nicotine withdrawal symptoms often make the quitters' actions fail, especially anxiety, insomnia, and depression, which further affect the lives of quitters. If an intervention can be provided to improve the nicotine withdrawal symptoms of quitters and reduce nicotine dependence, it should be able to improve the effectiveness of smoking cessation.This study is a randomized controlled trial to facilitate sampling. It is expected that 80 quitters will be recruited at the smoking cessation clinic of the medical center through the referral of the attending physician, and 40 will be randomly included in the experimental group and the control group. The experimental group will receive biofeedback training for heart rate variability for eight weeks, while the control group will receive conventional treatment. Use the scale to assess nicotine withdrawal symptoms before and after intervention-the degree of anxiety (Beck Anxiety Inventory), depression (Beck Depression Inventory) and insomnia (Pittsburgh Sleep Quality Index), And the degree of nicotine dependence (Nicotine Dependence Scale; Fagerstrom Test for Nicotine Dependence); the autonomic nerve function of the participants was measured by heart rhythm variability before and after the intervention; in addition, the cessation of smoking was tracked by telephone once a month for six months. This study is mainly to explore interventional biological feedback training to evaluate its effectiveness in improving the representative autonomic nervous function-heart rate variability and alleviating nicotine withdrawal anxiety, insomnia and depression symptoms and nicotine dependence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: heart rate variability biofeedbackreceive biofeedback training for heart rate variability for eight weeks |
| Control group | No intervention | –receive conventional treatment |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Willing to quit smoking
- Clear consciousness
- Able to communicate in Mandarin or Taiwanese
Key exclusion criteria (4 listed)
- Diagnosed with asthma or chronic obstructive pulmonary disease
- Diagnosed with nervous system
- Diagnosis of mental illness
- Arrhythmia, use of cardiac pacemakers, and atrioventricular conduction disorders
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 |
|---|---|---|
| heart rate variability biofeedbackreceive biofeedback training for heart rate variability for eight weeks | Behavioural | Experimental group |
Primary outcome
autonomic nerve function
Time frame: baseline
heart rate variability index
autonomic nerve function
Time frame: 1 month
heart rate variability index
autonomic nerve function
Time frame: 2 month
heart rate variability index
autonomic nerve function
Time frame: 6 month
heart rate variability index
16 secondary outcomes
symptom distress(Anxiety)
Time frame: baseline
symptom distress(Anxiety)
Time frame: 1 month
symptom distress(Anxiety)
Time frame: 2 month
symptom distress(Anxiety)
Time frame: 6 month
symptom distress(Depression)
Time frame: baseline
symptom distress(Depression)
Time frame: 1 month
symptom distress(Depression)
Time frame: 2 month
symptom distress(Depression)
Time frame: 6 month
symptom distress(Sleep)
Time frame: baseline
symptom distress(Sleep)
Time frame: 1 month
symptom distress(Sleep)
Time frame: 2 month
symptom distress(Sleep)
Time frame: 6 month
Cigarette Dependence
Time frame: baseline
Cigarette Dependence
Time frame: 1 month
Cigarette Dependence
Time frame: 2 month
Cigarette Dependence
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing heart rate variability biofeedback in people with Heart Rate Variability, Biofeedback, Nicotine Dependence, Nicotine Withdrawal, Anxiety, Depression, Insomnia, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
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 3 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: status not confirmed, as of the sponsor's last update on 23 Mar 2023. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
autonomic nerve function (time frame: baseline). The study lists 4 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 23 Mar 2023.