UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060543 |
|---|---|
| Receipt number | R000069254 |
| Scientific Title | Effects of a Compassion-Focused Cognitive Intervention on Depressive Symptoms Among College Students: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/06/30 |
| Last modified on | 2026/02/01 04:05:06 |
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Basic information
Public title
Compassion-Focused Cognitive Intervention for Depressive Symptoms in College Students
Acronym
CFCI-D
Scientific Title
Effects of a Compassion-Focused Cognitive Intervention on Depressive Symptoms Among College Students: A Randomized Controlled Trial
Scientific Title:Acronym
CFCI-D-RCT
Region
| Asia(except Japan) |
Condition
Condition
Depressive symptoms (college students)
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the effects of a Compassion-Focused Cognitive Intervention(CFCI) on depressive symptoms among college students.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in depressive symptom scores, as measured by the PHQ-9, from baseline to post-intervention.
Key secondary outcomes
1. Change in anxiety scores (measured by GAD-7)
2. Change in self-compassion scores (measured by SCS)
3. Intervention adherence rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Compassion-Focused Cognitive Intervention (CFCI) Group: Participants will receive an 8-week, group-based compassion-focused cognitive intervention. Each weekly session lasts 120 minutes and is facilitated by a trained instructor. The intervention integrates psychoeducation with compassion-focused imagery exercises (e.g., compassion meditation directed towards self and others). Participants will be instructed to practice the techniques for approximately 20 minutes daily at home, supported by audio guides.
Interventions/Control_2
Cognitive Behavioral Therapy (CBT) Group: Participants will receive an 8-week, group-based cognitive behavioral intervention. Each weekly session lasts 120 minutes and is facilitated by a trained instructor. The intervention integrates psychoeducation with core CBT components, including identification of automatic thoughts, modification of core beliefs, cognitive restructuring, and behavioral activation. Participants will be instructed to practice the techniques for approximately 20 minutes daily at home, supported by audio guides.
Interventions/Control_3
Wait-list Control Group: Participants in this group will not receive the experimental intervention during the trial period. Instead, they will participate in a reading club. They may receive routine care as usual and will be offered the opportunity to receive the Compassion-Focused Cognitive Intervention (CFCI) after the completion of the study's post-intervention assessments.
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
| 25 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Full-time undergraduate students aged 18-25.
2. Have a score of 5 or higher on the Patient Health Questionnaire-9 (PHQ-9).
3. Provide written informed consent.
Key exclusion criteria
1. Current or history of severe mental disorders (e.g., psychosis, bipolar disorder).
2. High risk of suicide (e.g., PHQ-9 item 9 score >1).
3. Concurrent participation in other structured psychotherapy.
4. Inability to commit to the intervention schedule.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Xiaomeng |
| Middle name | |
| Last name | Zhang |
Organization
Fujian Normal University
Division name
School of Psychology
Zip code
350000
Address
No 18 Middle Wulongjiang Avenue, Shangjie town, Minhou county, Fuzhou
TEL
18254240975
xiaomengzhangzzz@163.com
Public contact
Name of contact person
| 1st name | Ting |
| Middle name | |
| Last name | Shen |
Organization
Fujian Normal University
Division name
School of Psychology
Zip code
350000
Address
No 18 Middle Wulongjiang Avenue, Shangjie town, Minhou county, Fuzhou
TEL
18266205198
Homepage URL
450255627@qq.com
Sponsor or person
Institute
Fujian Normal University
Institute
Department
Personal name
Funding Source
Organization
Fujian Normal University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
China
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board (or Ethics Committee) of Fujian Normal Universit
Address
No. 18, Wulongjiang Middle Avenue, Shangjie Town, Minhou County, Fuzhou City, Fujian Province, China
Tel
+86-0591-22867412
ethics@fjnu.edu.cn
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
| 2026 | Year | 06 | Month | 30 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 02 | Month | 01 | Day |
Last modified on
| 2026 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069254
