UMIN-CTR Clinical Trial

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
Email	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
Email	kenichi-asano@ncnp.go.jp

Sponsor
Institute	National Center for Cognitive Behavior Therapy and Research, National Center of Neurology and Psychiatry
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050141