UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043905 |
|---|---|
| Receipt number | R000050141 |
| Scientific Title | A pilot randomized controlled trial of compassion focused therapy for depression and anxiety. |
| Date of disclosure of the study information | 2021/05/06 |
| Last modified on | 2021/05/18 11:07:22 |
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Basic information
Public title
Compassion Focused Therapy for Depression and anxiety.
Acronym
Compassion Focused Therapy for Depression and anxiety.
Scientific Title
A pilot randomized controlled trial of compassion focused therapy for depression and anxiety.
Scientific Title:Acronym
A pilot RCT of CFT for depression and anxiety.
Region
| Japan |
Condition
Condition
Major Depressive Disorder, Panic Disorder, Agoraphobia, Social Anxiety Disorder, Generalized Anxiety Disorder
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary endpoint of clinical efficacy will be the BDI-II at the end of the intervention (13 weeks), and the superiority of the intervention group over the control group will be examined using a randomized controlled trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Depressive symptoms as measured by the BDI-II at 13 weeks
Key secondary outcomes
1. severity of subjective anxiety symptoms at 13 weeks (GAD-7)
2. severity of subjective depressive symptoms at 13-week (PHQ-9)
3. quality of life at 13 weeks (EQ-5D)
4. treatment response rate at 13-week (13-week BDI-II score reduction of 50% or more compared to baseline)
5. remission rate at 13-week (BDI-II score of 13 or less at 13 weeks)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
12 weeks of Compassion Focused Therapy (60 minutes per session)
Interventions/Control_2
Treatment as usual(12 weeks)
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients with major depressive disorder, panic disorder, agoraphobia, social anxiety disorder, or generalized anxiety disorder in MINI
2) Have more than mild depressive symptoms (14 points or more on BDI-II)
3) Age between 20 and 65 years old at the time of screening
Key exclusion criteria
4) Patients with alcohol or substance dependence within last 6 months
5) Patients with manic episodes, schizophrenia and other psychotic disorders at the time of pre-intervention assessment.
6) Patients who have suicidal ideation at the time of the pre-intervention assessment.
7) Patients with severe physical illness or cognitive impairment at the time of the pre-intervention evaluation.
8) Patients who will be difficult to visit the hospital more than 50%.
9) Patients receiving other structured psychotherapy at the time of the pre-intervention evaluation.
Target sample size
24
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
National Center for Cognitive Behavior Therapy and Research
Zip code
187-8551
Address
Ogawahigashi4-1-1, Kodaira-shi, Tokyo, Japan
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 for Cognitive Behavior Therapy and Research
Division name
National Center for Cognitive Behavior Therapy and Research
Zip code
187-8551
Address
Ogawahigashi4-1-1, Kodaira-shi, Tokyo, Japan
TEL
042-341-2711
Homepage URL
kenichi-asano@ncnp.go.jp
Sponsor or person
Institute
National Center for Cognitive Behavior Therapy and Research, National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Institutional Review Board, National Center of Neurology and Psychiatry
Address
awahigashicho 4-1-1, Kodaira-shi, Tokyo, Japan
Tel
042-341-2711
ml_rinrijimu@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
| 2021 | Year | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 04 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 21 | Day |
Last follow-up date
| 2024 | 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
| 2021 | Year | 04 | Month | 13 | Day |
Last modified on
| 2021 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050141
