UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056888 |
|---|---|
| Receipt number | R000065019 |
| Scientific Title | Supporting lifestyle improvement in the workplace through the introduction of short-term psychotherapy: A pilot intervention study |
| Date of disclosure of the study information | 2025/02/01 |
| Last modified on | 2025/08/31 17:45:28 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Supporting lifestyle improvement in the workplace through the introduction of short-term psychotherapy: A pilot intervention study
Acronym
Pilot study to support lifestyle improvement
Scientific Title
Supporting lifestyle improvement in the workplace through the introduction of short-term psychotherapy: A pilot intervention study
Scientific Title:Acronym
Pilot study to support lifestyle improvement
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Lifestyle habits such as smoking, drinking, body weight, exercise and sleep are widely known to be risk factors for cancer. However, it is not uncommon for people to wish to improve these habits, but be unable to do so. This study will examine the "lifestyle improvement effects of psychotherapy concluded with one to three interviews" for such cases in the workplace. When lifestyle habits improve after receiving psychotherapy, it is important to understand the mechanisms that influenced this improvement. Multifaceted measures such as stress in the work environment, quality of sleep and autonomic nervous system state will be obtained, and a preliminary and detailed study will be conducted on a small number of cases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of one or more lifestyle habits including smoking, drinking, weight, exercise, and sleep
Key secondary outcomes
Psychosocial stress, autonomic nervous function, quality and quantity of sleep
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Short-term Psychotherapy "Autonomy Training"
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. University employee
2. Age 20 to 59 y
3. Has at least one lifestyle habit that needs improvement and wants to improve but is unable to achieve it
4. Able to answer self-administered web questionnaire without assistance
5. Able to receive psychotherapy in Japanese
Key exclusion criteria
1. Diagnosed with chronic atrial fibrillation
2. Chronic disease causing autonomic nervous system dysfunction
3. Taking medication that affects autonomic nervous system function
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Nagano |
Organization
Kyushu University
Division name
Center for Health Sciences and Counseling
Zip code
819-0395
Address
Motooka 744, Nishi-ku, Fukuoka
TEL
092-802-5881
nagano@chc.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Nagano |
Organization
Kyushu University
Division name
Center for Health Sciences and Counseling
Zip code
819-0395
Address
Motooka 744, Nishi-ku, Fukuoka
TEL
092-802-5881
Homepage URL
nagano@chc.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Kyushu University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Joint Ethics Committee of the Faculty of Arts and Science and the Center for Health Sciences and Counseling
Address
Motooka 744, Nishi-ku, Fukuoka
Tel
092-802-5881
kishimoto@artsci.kyushu-u.ac.jp
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 | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 17 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 31 | Day |
Last modified on
| 2025 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065019
