UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054304 |
|---|---|
| Receipt number | R000062027 |
| Scientific Title | A single case experimental design of combined program of compassion focused therapy with family psychoeducation for depression and anxiety. |
| Date of disclosure of the study information | 2024/05/02 |
| Last modified on | 2024/05/02 01:35:32 |
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Basic information
Public title
A single case experimental design of combined program of compassion focused therapy with family psychoeducation for depression and anxiety.
Acronym
A single case experimental design of combined program of compassion focused therapy with family psychoeducation for depression and anxiety.
Scientific Title
A single case experimental design of combined program of compassion focused therapy with family psychoeducation for depression and anxiety.
Scientific Title:Acronym
A single case experimental design of combined program of compassion focused therapy with family psychoeducation for depression and anxiety.
Region
| Japan |
Condition
Condition
Major Depressive Disorder and Anxiety Disorders.
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This clinical trial will test the efficacy of a combined program for MDD and anxiety, consisting of CFT and online psychoeducation for significant others in addition to usual care, in a single-case experimental design using a randomized, multilayered baseline method for the primary endpoint of change in the PHQ-9. Safety and feasibility will also be evaluated using dropout rates, adverse events, and the Japanese version of the Client Satisfaction Questionnaire (CSQ) as measures.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Depressive symptoms as measured by PHQ-9
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Compassion Focused Therapy and Psycho-education for Family or Partner
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
1)Have major depressive disorder, panic disorder, square phobia, social anxiety, or generalized anxiety on the MINI
2)Have mild or severe depressive symptoms (more than 10 points on the PHQ-9)
3)Aged between 18 and 65 years at screening
4)Have given written consent for significant others to participate in online psychoeducation
5)Understand the purpose and content of this study and have given written consent to participate in the study of their own free will
Key exclusion criteria
5) Those with alcohol or substance dependence present within 6 months of the time of screening
6) Manic episodes, schizophrenia and other psychotic disorders at the time of pre-intervention evaluation.
5 and 6 above will be evaluated by MINI.
7) Patients with significant suicidal ideation (B. module of MINI, B10-14, 16) at the time of pre-intervention evaluation.
8)Significant others must not have a history of psychiatric disorders within the past year.
9)Persons with physical illness or severe cognitive impairment that would make it difficult to implement CFT at the time of pre-intervention evaluation.
10)Patients who are known in advance at the time of pre-intervention evaluation to have difficulty in coming to the hospital for at least 50% of the CFT implementation period.
11) Patients receiving other psychotherapy or counseling at the time of the pre-intervention evaluation.
12) Other subjects deemed inappropriate for this study by the principal investigator.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Masaya |
| Middle name | |
| Last name | Ito |
Organization
National Center of Neurology and Psychiatry
Division name
CBT Center
Zip code
187-8551
Address
4-1-1 Ogawahigashimachi, Kodaira-shi, Tokyo
TEL
042-341-2711
masayait@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
CBT Center
Zip code
187-8551
Address
4-1-1 Ogawahigashimachi, Kodaira-shi, 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 Ogawahigashimachi, Kodaira-shi, Tokyo
Tel
042-341-2711
kenichi.asano1225@gmail.com
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
| 2024 | Year | 05 | 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 | 05 | Month | 29 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | 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 | 05 | Month | 02 | Day |
Last modified on
| 2024 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062027
