NCT06617143

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
Last Updated

August 27, 2025

Status Verified

August 1, 2025

Enrollment Period

4 months

First QC Date

September 25, 2024

Last Update Submit

August 21, 2025

Conditions

AsthmaMindfulness

Keywords

asthmamindfulness-based cognitive therapyanxietydepressiondyspnea

Outcome Measures

Primary Outcomes (3)

  • Anxiety

    It will be evaluated with the Hospital Anxiety and Depression Scale.

    Average of 1 week after completion of the intervention

  • Depression

    It will be evaluated with the Hospital Anxiety and Depression Scale.

    Average of 1 week after completion of the intervention

  • Dyspnea

    It will be assessed with the Modified Medical Research Council (mMRC) Dyspnoea Questionnaire.

    Average of 1 week after completion of the intervention

Study Arms (2)

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.

Other: mindfulness-based cognitive therapy

Control group

ACTIVE COMPARATOR

No application will be made to the patients in the control group.

Other: routine treatment and care

Interventions

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.

Experimental group
routine treatment and careOTHER

routine treatment and care

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 18 years old, Inpatient treatment in the chest ward volunteer participants with no communication problems

You may not qualify if:

  • Under 18 years old, with communication problems, not willing to participate hospitalized with diseases other than asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ardahan University

Ardahan, Ardahan, 75100, Turkey (Türkiye)

Location

Related Publications (3)

  • FLETCHER CM. The clinical diagnosis of pulmonary emphysema; an experimental study. Proc R Soc Med. 1952 Sep;45(9):577-84. No abstract available.

    PMID: 13003946BACKGROUND

  • Mahler 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.

    PMID: 6723384BACKGROUND

  • Zigmond 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.

    PMID: 6880820BACKGROUND

MeSH Terms

Conditions

AsthmaAnxiety DisordersDepressionDyspnea

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesMental DisordersBehavioral SymptomsBehaviorRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Derya ŞİMŞEKLİ, PhD

    Ardahan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Participants and researchers could not be blinded due to the natural course of the study and only the statistician was blinded.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: pre-test post-test quasi-experimental design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2024

First Posted

September 27, 2024

Study Start

April 1, 2025

Primary Completion

July 31, 2025

Study Completion

August 15, 2025

Last Updated

August 27, 2025

Record last verified: 2025-08

Locations

TU(1)