UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059104 |
|---|---|
| Receipt number | R000067573 |
| Scientific Title | The Effect of Internet-Based Compassion Focused Therapy on Psychological Distress for Women with Recurrent Pregnancy Loss:A Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/09/18 |
| Last modified on | 2025/09/17 21:44:00 |
* 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 Randomized Controlled Trial
Acronym
The Effect of Internet-Based Compassion Focused Therapy on Psychological Distress for Women with Recurrent Pregnancy Loss:A Randomized Controlled Trial (CFT-RPL)
Scientific Title
The Effect of Internet-Based Compassion Focused Therapy on Psychological Distress for Women with Recurrent Pregnancy Loss:A Randomized Controlled Trial
Scientific Title:Acronym
The Effect of Internet-Based Compassion Focused Therapy on Psychological Distress for Women with Recurrent Pregnancy Loss:A Randomized Controlled Trial (CFT-RPL)
Region
| Japan |
Condition
Condition
Recurrent pregnancy loss
Classification by specialty
| Obstetrics and Gynecology | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of a newly developed internet-based Compassion Focused Therapy (iCFT) on depressive symptoms in women with recurrent pregnancy loss.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The improvement of depression (assessed by using the Patient Health Questionnaire-9 [PHQ-9])
Key secondary outcomes
Psychological distress (assessed by using the Kessler Psychological Distress Scale-6 [K6])
Perinatal grief (assessed by using the Perinatal Grief Scale [PGS])
Rumination (assessed by using the Ruminative Response Scale [RRS])
Self-compassion (assessed by using the Self-Compassion Scale [SCS])
Worry about future pregnancies
Implementation evaluation of the program (assessed by using the Implementation Outcomes Scale for Digital Mental Health [iOSDMH] and qualitative feedback)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
This study's intervention is a psychiatrist-guided, internet-delivered Compassion-Focused Therapy (iCFT) program. The program consists of four video modules (15-25 minutes each), each covering a different component of CFT: introduction to self-compassion and mindfulness (in module 1), understanding emotional regulation and soothing practices (in module 2), developing compassionate thinking (in module 3), and expressing self-compassion through letter writing (in module 4).
Interventions/Control_2
Wait list control condition
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
First-time visitor to the study site's RPL outpatient clinic
Have experienced two or more miscarriages or stillbirths (not including abortions)
Married (including common-law marriage)
Have access to the Internet via smartphone, tablet, computer, etc
Have not received any kind of psychotherapy in the past 12 weeks, and has no plans to receive any other psychotherapy during the intervention period
Key exclusion criteria
Pregnant at study entry
Currently undergoing psychosomatic or psychiatric treatment for depression or other mental illness
Having intense suicidal ideation
Target sample size
110
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
Public Health Research Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
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
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
| 2025 | Year | 09 | Month | 18 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 18 | 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 | 09 | Month | 17 | Day |
Last modified on
| 2025 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067573
