AsthmaMBCTNCT06617143
Effect of MBCT Applied to Asthma Patients on Anxiety, Depressıon and Dyspnea
A study testing mindfulness-based cognitive therapy and routine treatment and care in people with Asthma and Mindfulness, run by Ardahan University at 1 site in Turkey (Türkiye).
Trial summary
In this study, short-term MBCT will be applied to asthmatic patients receiving hospital treatment and its effects on anxiety, depression and dyspnea will be determined. A quasi-experimental study was planned for this purpose. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma, Mindfulness
- What is being tested?
- mindfulness-based cognitive therapy and routine treatment and care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2025to 15 Aug 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 18 years old, Inpatient treatment in the chest ward volunteer participants with no communication problems
Who cannot join
- Under 18 years old, with communication problems, not willing to participate hospitalized with diseases other than asthma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Short-Term Conscious Awareness-Based Cognitıve Therapy Applied to Asthma Patients on Anxiety, Depression and Dyspnea
In this study, short-term MBCT will be applied to asthmatic patients receiving hospital treatment and its effects on anxiety, depression and dyspnea will be determined. A quasi-experimental study was planned for this purpose.
Read the detailed description
In the study, cognitive behavioral therapy will be applied to the intervention group, which is determined as the experimental group, and a group of asthma patients who did not receive any application during the same periods will be included and the dyspnea, anxiety and depression levels of the patients in these two groups will be compared.
- Conditions
- Asthma, Mindfulness
- Being tested
- mindfulness-based cognitive therapy, routine treatment and care
- Keywords
- asthma, mindfulness-based cognitive therapy, anxiety, depression, dyspnea
- Medical subject headings
- Asthma, Anxiety Disorders, Depression, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulness-based cognitive therapyOther
In this study, it is planned to apply MBCT to asthmatic inpatients in the patient room in groups of 2 or 3. This application is planned to continue for one hour.
routine treatment and careOther
routine treatment and care
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | In this study, it is planned to apply MBCT to asthmatic inpatients in the patient room in groups of 2 or 3. This application is planned to continue for one hour. Receives: Other: mindfulness-based cognitive therapy |
| Control group | Active comparator | No application will be made to the patients in the control group. Receives: Other: routine treatment and care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
It will be evaluated with the Hospital Anxiety and Depression Scale.
Measured: Average of 1 week after completion of the intervention
Depression
It will be evaluated with the Hospital Anxiety and Depression Scale.
Measured: Average of 1 week after completion of the intervention
Dyspnea
It will be assessed with the Modified Medical Research Council (mMRC) Dyspnoea Questionnaire.
Measured: Average of 1 week after completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start1 Apr 2025
- Primary completion31 Jul 2025
- Study completion15 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- pre-test post-test quasi-experimental design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ardahan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Derya ŞİMŞEKLİ, PhD, Principal investigator, Ardahan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06617143
- Sponsor's protocol ID
- ArdahanU-Şimsekli-DS-03
- Acronym
- MBCT
- Status last verified
- Aug 2025
- First submitted
- 25 Sep 2024
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
FLETCHER CM. The clinical diagnosis of pulmonary emphysema; an experimental study. Proc R Soc Med. 1952 Sep;45(9):577-84. No abstract available.
PubMed 13003946Mahler DA, Weinberg DH, Wells CK, Feinstein AR. The measurement of dyspnea. Contents, interobserver agreement, and physiologic correlates of two new clinical indexes. Chest. 1984 Jun;85(6):751-8. doi: 10.1378/chest.85.6.751.
PubMed 6723384Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
PubMed 6880820
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Short-Term Conscious Awareness-Based Cognitıve Therapy Applied to Asthma Patients on Anxiety, Depression and Dyspnea
- ClinicalTrials.gov ID
- NCT06617143
- Acronym / sponsor ID
- MBCT / ArdahanU-Şimsekli-DS-03
- Conditions
- Asthma, Mindfulness
- Keywords
- asthma, mindfulness-based cognitive therapy, anxiety, depression, dyspnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Ardahan UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 15 Aug 2025 (actual)
- First posted
- 27 Sep 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.
In this study, short-term MBCT will be applied to asthmatic patients receiving hospital treatment and its effects on anxiety, depression and dyspnea will be determined. A quasi-experimental study was planned for this purpose.
Detailed description
In the study, cognitive behavioral therapy will be applied to the intervention group, which is determined as the experimental group, and a group of asthma patients who did not receive any application during the same periods will be included and the dyspnea, anxiety and depression levels of the patients in these two groups will be compared.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- pre-test post-test quasi-experimental design
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: mindfulness-based cognitive therapyIn this study, it is planned to apply MBCT to asthmatic inpatients in the patient room in groups of 2 or 3. This application is planned to continue for one hour. |
| Control group | Active comparator | Other: routine treatment and careNo application will be made to the patients in the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Over 18 years old, Inpatient treatment in the chest ward volunteer participants with no communication problems
Key exclusion criteria (1 listed)
- Under 18 years old, with communication problems, not willing to participate hospitalized with diseases other than asthma
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 cognitive therapyIn this study, it is planned to apply MBCT to asthmatic inpatients in the patient room in groups of 2 or 3. This application is planned to continue for one hour. | Other | Experimental group |
| routine treatment and careroutine treatment and care | Other | Control group |
Primary outcome
Anxiety
Time frame: Average of 1 week after completion of the intervention
It will be evaluated with the Hospital Anxiety and Depression Scale.
Depression
Time frame: Average of 1 week after completion of the intervention
It will be evaluated with the Hospital Anxiety and Depression Scale.
Dyspnea
Time frame: Average of 1 week after completion of the intervention
It will be assessed with the Modified Medical Research Council (mMRC) Dyspnoea Questionnaire.
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 27 Aug 2025.
- Background: PubMed 13003946FLETCHER CM. The clinical diagnosis of pulmonary emphysema; an experimental study. Proc R Soc Med. 1952 Sep;45(9):577-84. No abstract available.
- Background: PubMed 6723384Mahler DA, Weinberg DH, Wells CK, Feinstein AR. The measurement of dyspnea. Contents, interobserver agreement, and physiologic correlates of two new clinical indexes. Chest. 1984 Jun;85(6):751-8. doi: 10.1378/chest.85.6.751.
- Background: PubMed 6880820Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
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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.
Derya ŞİMŞEKLİ, PhD principal investigator
Ardahan University
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 cognitive therapy and routine treatment and care in people with Asthma and Mindfulness, run by Ardahan University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 27 Aug 2025. 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 Turkey (Türkiye). 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?
Anxiety (time frame: Average of 1 week after completion of the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06617143, which also lists 3 linked publications.
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 27 Aug 2025.