UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057161 |
|---|---|
| Receipt number | R000065340 |
| Scientific Title | Clinical Trial of Antidepressant Intervention for Delaying Disease Progression and Physical Frailty among Elderly Idiopathic Pulmonary Fibrosis Patients |
| Date of disclosure of the study information | 2025/02/27 |
| Last modified on | 2025/02/27 22:37:27 |
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Basic information
Public title
Exploring Antidepressant Intervention: A New Pathway for Elderly Patients with Idiopathic Pulmonary Fibrosis to Delay the Progression of the Disease and Combat Physical Frailty
Acronym
EAI - NP - EPIPF - DPD - CPF
Scientific Title
Clinical Trial of Antidepressant Intervention for Delaying Disease Progression and Physical Frailty among Elderly Idiopathic Pulmonary Fibrosis Patients
Scientific Title:Acronym
CT - AI - DDP - PF - EIPFP
Region
| Asia(except Japan) |
Condition
Condition
Idiopathic pulmonary fibrosis
Classification by specialty
| Pneumology | Psychosomatic Internal Medicine | Geriatrics |
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Idiopathic pulmonary fibrosis is more likely to occur in the elderly population, and these patients often become depressed. This study aims to determine whether improving the depressive condition can delay the progression of Idiopathic pulmonary fibrosis and physical frailty in elderly patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
The primary outcome is the deterioration of the condition of idiopathic pulmonary fibrosis and the degree of physical frailty after 12 months of follow-up. Both at baseline and after the follow-up, the following indicators are measured: the percent predicted forced vital capacity (FVC % pred), the percent predicted diffusing capacity of the lung for carbon monoxide (DLCO % pred), the 6-minute walk test (6MWT), and the score of the Modified Medical Research Council (mMRC) Dyspnea Scale. These indicators reflect the condition of idiopathic pulmonary fibrosis. In addition, the scores of the Clinical Frailty Scale (CFS), the Total Fatigue Inventory (TFI), the St. George's Respiratory Questionnaire (SGRQ), and the King's Brief Interstitial Lung Disease (K - BILD) are also measured, which are used to assess the degree of frailty in patients. Through these indicators, the effect of the intervention on delaying the progression of idiopathic pulmonary fibrosis and physical frailty can be comprehensively evaluated.
Key secondary outcomes
The key secondary outcome measures mainly focus on assessing the status of depressive symptoms and peripheral inflammation levels, which are also measured both at baseline and after the follow-up. Specifically, they include using the score of the Beck Depression Inventory - Second Edition (BDI - II) to quantify the degree of depression in patients. This score can accurately reflect the severity of patients' depressive disorder. In addition, the levels of peripheral inflammatory factors, interleukin - 6 (IL - 6) and tumor necrosis factor - a (TNF - a), will also be measured to evaluate the inflammatory state within the patients. These indicators provide crucial data support for assessing the impact of the intervention on depression and related inflammatory responses.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
This study is divided into an intervention group and a non - intervention group. Patients in the intervention group can independently choose to receive any one of the three antidepressant intervention methods, namely Cognitive Behavioral Therapy, Music Therapy, or Meditation. The treatment courses of the three antidepressant therapies are similar, usually ranging from 8 to 20 sessions, with each session lasting approximately 45 to 60 minutes. The follow-up period is 12 months.
Interventions/Control_2
This study is divided into an intervention group and a non - intervention group. Patients in the non - intervention group do not receive any antidepressant interventions, so as to compare and evaluate the effectiveness of the treatment methods in the intervention group. The follow-up period is also 12 months.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 60 | years-old | < |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) According to the ATS/ERS/JRS/ALAT clinical practice guidelines issued in 2018, all patients were diagnosed with idiopathic pulmonary fibrosis.
(2) There was no previous history of any mental or psychological disorders, that is, there had never been any symptoms related to mental or psychological illnesses that lasted continuously for more than 24 hours, and there was no relevant medical treatment experience either.
(3) After the diagnosis of idiopathic pulmonary fibrosis, different degrees of low mood, decreased interest, and anhedonia gradually appeared (lasting for more than two weeks), and at the time of this admission, depression was present as assessed by the Beck Depression Inventory - II.
Key exclusion criteria
(1) Other types of pulmonary fibrosis, which are not idiopathic pulmonary fibrosis.
(2) There is a previous history of any mental or psychological disorder.
(3) After the diagnosis of idiopathic pulmonary fibrosis, there are no obvious depressive symptoms.
(4) The patient refuses to participate in this study.
Target sample size
213
Research contact person
Name of lead principal investigator
| 1st name | Hongyan |
| Middle name | |
| Last name | Ren |
Organization
Henan Provincial People's Hospital
Division name
Department of Respiratory and Critical Care Medicine
Zip code
450003
Address
No. 7, Weiwu Road, Jinshui District, Zhengzhou 450003, Henan Province, China
TEL
0086-0371-61621210
renhongyan19852024@163.com
Public contact
Name of contact person
| 1st name | Hongyan |
| Middle name | |
| Last name | Ren |
Organization
Henan Provincial People's Hospital
Division name
Department of Respiratory and Critical Care Medicine
Zip code
450003
Address
No. 7, Weiwu Road, Jinshui District, Zhengzhou 450003, Henan Province, China
TEL
0086-0371-61621210
Homepage URL
renhongyan19852024@163.com
Sponsor or person
Institute
Henan Provincial People's Hospital
Institute
Department
Personal name
Funding Source
Organization
Research funds sourced internally by Department of Respiratory and Critical Care Medicine, Henan Provincial People's Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
China
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Medical Ethics Committee of Henan Provincial People's Hospital
Address
No. 7, Weiwu Road, Jinshui District, Zhengzhou 450003, Henan Province, China
Tel
0086-0371-87160817
llwyh87160817@163.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 27 | Day |
Related information
URL releasing protocol
There is no URL for the releasing protocol.
Publication of results
Unpublished
Result
URL related to results and publications
There is no URL related to the released results and publications.
Number of participants that the trial has enrolled
213
Results
In the intervention group, there were no significant differences in pulmonary function, symptom burden (idiopathic pulmonary fibrosis), frailty, quality of life, and peripheral inflammation indicators before and after the follow-up.
In the non-intervention group, the above-mentioned indicators further deteriorated after the follow-up compared to before the follow-up.
Therefore, antidepressant intervention is helpful in delaying the progression of idiopathic pulmonary fibrosis and the state of frailty.
Results date posted
| 2025 | Year | 02 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 213 elderly patients with idiopathic pulmonary fibrosis were included in this study and divided into an intervention group (n = 89) and a non - intervention group (n = 124).
The baseline characteristics are as follows:
(1) There were no statistically significant differences between the intervention group and the non - intervention group in terms of gender, age, smoking history, drinking history, and body mass index.
(2) Regarding the history of chronic diseases, the proportions of patients with type 2 diabetes mellitus and coronary heart disease in the non - intervention group were significantly higher than those in the intervention group. In addition, there were no statistically significant differences in the histories of hypertension, cerebrovascular diseases, chronic obstructive pulmonary disease, and asthma.
(3) The time from the diagnosis of idiopathic pulmonary fibrosis to this admission was significantly longer in the intervention group than in the non - intervention group.
(4) There were no significant differences between the two groups of patients at baseline in terms of depressive state, lung function, clinical symptoms related to idiopathic pulmonary fibrosis, frailty, quality of life, and peripheral inflammation. Specifically, there was no statistically significant difference in the BDI - II scores for depression between the two groups. There were also no significant differences between the two groups in the FVC %pred and DLCO %pred for evaluating lung function, the 6MWT and mMRC grades for evaluating the symptoms of idiopathic pulmonary fibrosis, the CFS and TFI scores for evaluating frailty, the SGRQ and K - BILD scores for evaluating the quality of life, as well as the levels of IL - 6 and TNF - a in peripheral blood.
Overall, except for some histories of chronic diseases and the time from diagnosis to admission (which can be adjusted by multivariate logistic regression), the quality of the baseline data of the two groups of patients was satisfactory. This made the follow - up results after 12 months highly comparable and enhanced the reliability of this study.
Participant flow
A total of 213 elderly patients with idiopathic pulmonary fibrosis were consecutively included in this study from among the patients admitted to Henan Provincial People's Hospital who met specific criteria during the period from January 1, 2018, to December 31, 2022. The inclusion criteria were as follows: The patients must be elderly. They were diagnosed with idiopathic pulmonary fibrosis according to the ATS/ERS/JRS/ALAT clinical practice guidelines. They had no previous history of mental or psychological disorders. After being diagnosed with idiopathic pulmonary fibrosis, they presented with varying degrees of depressive symptoms and were determined to be depressed based on the BDI-II assessment. They survived for at least one year after the diagnosis of idiopathic pulmonary fibrosis and underwent follow - up. They had no history of malignant tumors, and the conditions of common chronic geriatric diseases were stable.
After the patients were admitted to the hospital, the attending physicians recommended that all patients receive antidepressant intervention measures. However, the patients were free to choose the intervention location, including this hospital, other hospitals, counseling institutions, or community centers. The intervention methods included cognitive behavioral therapy, music therapy, and meditation. The treatment course and specific methods were determined by the patients or the intervention institutions they chose, and the researchers only made records. Eventually, 89 patients received antidepressant interventions and were included in the intervention group, while 124 patients refused the interventions, forming the non - intervention group.
During the research process, baseline data of the patients were collected upon admission, covering indicators related to basic information, degree of depression, lung function, symptom burden of idiopathic pulmonary fibrosis, frailty status, and quality of life. Subsequently, all patients were followed up for 12 months. After the follow - up, the same methods as those used in the baseline assessment were adopted to re - evaluate the patients' degree of depression, lung function, symptom burden of idiopathic pulmonary fibrosis, frailty status, and quality of life. At the same time, blood samples were collected from the patients at baseline and after 12 months of follow - up respectively, and the levels of interleukin - 6 and tumor necrosis factor - a in the peripheral blood were detected to assess the inflammatory situation.
The above is the entire research process that the patients experienced.
Adverse events
The three intervention measures for depression in this study, including cognitive behavioral therapy, music therapy, and meditation, are very safe. Throughout the entire research process, no patient reported any form of discomfort, and there were no adverse reactions or adverse events.
Outcome measures
The outcome measures are as follows:
(1) Lung function indicators
Forced Vital Capacity Percent Predicted (FVC %pred): Used to assess pulmonary ventilation function.
Diffusing Capacity of the Lung for Carbon Monoxide Percent Predicted (DLCO %pred): Used to assess pulmonary gas exchange function.
(2) Symptom burden of idiopathic pulmonary fibrosis
6 - Minute Walk Test (6MWT): Used to assess exercise endurance and symptoms.
Modified Medical Research Council Dyspnea Scale (mMRC): Used to assess the severity of dyspnea.
(3) Frailty indicators
Clinical Frailty Scale (CFS): Used to assess an individual's frailty level.
Tilburg Frailty Indicator (TFI): Used to assess the frailty status from multiple dimensions.
(4) Quality of life
St. George's Respiratory Questionnaire (SGRQ): Used to assess the impact of respiratory diseases on the quality of life.
King's Brief Interstitial Lung Disease Questionnaire (K - BILD): Used to assess the quality of life of patients with interstitial lung disease.
(5) Peripheral inflammation
Interleukin - 6 (IL - 6): Used to assess the inflammatory status.
Tumor Necrosis Factor - a (TNF - a): Used to assess the inflammatory status.
Plan to share IPD
Yes, our research team has a plan to release personal data.
IPD sharing Plan description
The plan to share Individual Participant Data (IPD) is as follows:
(1) The research team is currently obtaining authorization from patients to release these data.
(2) The research team plans to publish the research results in the form of a paper.
(3) After completing the above two steps, all the data will be publicly released on "ScienceDB" for sharing with researchers worldwide. Depending on the smooth progress of the first and second steps, the data is expected to be released around January 2026.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 17 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 27 | Day |
Last modified on
| 2025 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065340
