UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055170 |
|---|---|
| Receipt number | R000063026 |
| Scientific Title | The Effect of Internet-Based Compassion Focused Therapy on Psychological Distress for Women with Recurrent Pregnancy Loss: A Pilot Study |
| Date of disclosure of the study information | 2024/08/06 |
| Last modified on | 2025/08/10 07:47:26 |
* 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
The Effect of Internet-Based Compassion Focused Therapy on Psychological Distress for Women with Recurrent Pregnancy Loss: A Pilot Study
Acronym
The Effect of Internet-Based Compassion Focused Therapy on Psychological Distress for Women with Recurrent Pregnancy Loss: A Pilot Study (CFT-RPL)
Scientific Title
The Effect of Internet-Based Compassion Focused Therapy on Psychological Distress for Women with Recurrent Pregnancy Loss: A Pilot Study
Scientific Title:Acronym
The Effect of Internet-Based Compassion Focused Therapy on Psychological Distress for Women with Recurrent Pregnancy Loss: A Pilot Study (CFT-RPL)
Region
| Japan |
Condition
Condition
Recurrent Pregnancy Loss
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the appropriateness and usefulness of a newly developed Internet-based Compassion Focused Therapy Program (iCFT) for women with recurrent pregnancy loss.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Appropriateness and usefulness of program content (evaluated in semi-structured interviews)
Evaluation timings: after intervention
Key secondary outcomes
Patient Health Questionnaire-9
Kessler Psychological Distress Scale-6
Self-Compassion Scale
Perinatal Grief Scale
Ruminative Responses Scale
Rosenberg Self-Esteem Scale
Original questions regarding concerns about future pregnancies
Evaluation timings: after intervention
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
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Videos of the four iCFT contents (15-25 minutes each) will be distributed once a week for four weeks by the Line app (or by E-mail).
The details of each content are as follows:1.The concept of compassion/Tricky brain/Mindfulness, 2.The three regulatory affect systems/Imagery of a relieving place/Exercises for caring for the body, 3.Imagery of others with compassion/Compassionate thinking, 4.Compassionate letter writing
During the program intervention period, participants can send a message on the Line app (or E-mail) to research office with questions and comments about the program to receive answers.
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
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
a new patient
Have experienced two or more miscarriages and stillbirths (not including abortions)
Without live births
Married (including common-law marriage)
Have access to the Internet via smartphone, tablet, computer, etc
No plans to receive any other psychotherapy during the intervention period
Key exclusion criteria
Intense suicidal ideation (having thought nearly every day for the past two weeks that I would be better off dead, or thoughts of hurting myself)
Currently undergoing psychosomatic or psychiatric treatment for depression or other mental illness
Pregnant on the date of inclusion
Have undergone any kind of psychotherapy within the past 12 weeks
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Nishi |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Mental Health
Zip code
1130033
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3364
d-nishi@m.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Ito |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Mental Health
Zip code
1130033
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-5841-3364
Homepage URL
ito-yuka232@g.ecc.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Office for Human Research Studies(OHRS) Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033 JAPAN
Tel
03-5841-0818
ethics@m.u-tokyo.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
東京大学医学部附属病院（東京都）、茗荷谷レディースクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 06 | 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
Completed
Date of protocol fixation
| 2024 | Year | 06 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 06 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 08 | Month | 06 | Day |
Last modified on
| 2025 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063026
