UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052670 |
|---|---|
| Receipt number | R000060109 |
| Scientific Title | A single-case design to exam a compassion focused therapy for depression and anxiety program combined with psychoeducation for significant others. |
| Date of disclosure of the study information | 2023/11/02 |
| Last modified on | 2023/11/01 16:05:20 |
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Basic information
Public title
A single-case design to exam a compassion focused therapy for depression and anxiety program combined with psychoeducation for significant others.
Acronym
CFT and psychoeducation program for depression and anxiety
Scientific Title
A single-case design to exam a compassion focused therapy for depression and anxiety program combined with psychoeducation for significant others.
Scientific Title:Acronym
A single-case design to exam a compassion focused therapy for depression and anxiety program combined with psychoeducation for significant others.
Region
| Japan |
Condition
Condition
Major depression, panic disorder, agoraphobia, social anxiety disorder, or generalized anxiety disorder
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
"Examining the effectiveness and safety of a Compassion-Focused Therapy program, including psychological education for significant others, for depression and anxiety using a single-case design."
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We will evaluate changes in depressive symptoms measured by the PHQ-9 at baseline, intake interview, pre-assessment, midterm assessment, and post-assessment using visual analysis and statistical analysis with Tau-U.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Randomized
Randomization unit
Individual
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
Compassion-Focused Therapy for the patient themselves and psychological education for significant others.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals who meet the criteria for major depressive disorder, panic disorder, agoraphobia, social anxiety disorder, or generalized anxiety disorder according to MINI.
Individuals with moderate or higher levels of depressive symptoms (scoring 10 or above on the PHQ-9).
Participants aged 18 to 65 at the time of screening.
Individuals who have provided written consent for their significant others to participate in online psychological education.
Individuals who have understood the purpose and content of this study and have provided written informed consent for their voluntary participation in the research.
Key exclusion criteria
Individuals who have been identified as having alcohol or substance dependence within 6 months from the time of screening.
Individuals who have manic episodes, schizophrenia, or other psychotic disorders at the time of pre-intervention assessment, as assessed by MINI.
(Note: These criteria, 5 and 6, will be assessed using the MINI.)
Individuals who exhibit significant suicidal ideation at the time of pre-intervention assessment (those corresponding to MINI Module B, B10-14, 16).
Significant others who have no history of mental illness in the past year.
Individuals who have significant physical illnesses or severe cognitive impairments at the time of pre-intervention assessment, making the implementation of CFT difficult.
Individuals who are aware, at the time of pre-intervention assessment, that attending more than 50% of the CFT sessions during the intervention period would be difficult.
Individuals who are receiving other forms of psychotherapy or counseling at the time of pre-intervention assessment.
Other individuals whom the principal investigator has deemed unsuitable as participants for this study.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Asano |
Organization
National Center of Neurology and Psychiatry
Division name
National Center for Cognitive Behavior Therapy and Research
Zip code
187-8551
Address
4-1-1 Ogawa-Higashi, Kodaira,Tokyo
TEL
042-341-2711
kenichi-asano@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Kenichi |
| Middle name | |
| Last name | Asano |
Organization
National Center of Neurology and Psychiatry
Division name
National Center for Cognitive Behavior Therapy and Research
Zip code
187-8551
Address
4-1-1 Ogawa-Higashi, Kodaira,Tokyo
TEL
042-341-2711
Homepage URL
kenichi-asano@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center of Neurology and Psychiatry
Address
4-1-1 Ogawa-Higashi, Kodaira,Tokyo
Tel
042-341-2711
kenichi-asano@ncnp.go.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
| 2023 | Year | 11 | Month | 02 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2025 | Year | 08 | 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
| 2023 | Year | 11 | Month | 01 | Day |
Last modified on
| 2023 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060109
