UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049584 |
|---|---|
| Receipt number | R000056317 |
| Scientific Title | Efficacy of compassion focused therapy in adolescents with at risk mental state: a prospective, assessor-blind and controlled trial |
| Date of disclosure of the study information | 2022/12/01 |
| Last modified on | 2022/11/22 18:19:06 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy of compassion focused therapy in adolescents with at risk mental state: a prospective, assessor-blind and controlled trial
Acronym
Efficacy study of compassion focused therapy in adolescents with at risk mental state.
Scientific Title
Efficacy of compassion focused therapy in adolescents with at risk mental state: a prospective, assessor-blind and controlled trial
Scientific Title:Acronym
Efficacy study of compassion focused therapy in adolescents with at risk mental state.
Region
| Japan |
Condition
Condition
At Risk Mental State
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will develop Compassion Focused Therapy for adolescents at risk mental state and examine its efficacy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese version of a 12-item Self-Compassion Scale-Short Form
Key secondary outcomes
Fears of compassion scale Japanese version
Comprehensive Assessment of At Risk Mental States Four Positive Symptoms
Positive and Negative Syndrome Scale
Minnesota Multiple Personality Scale
Scale of self alienation related attributes
Beck Depression Inventory
State and Trait Anxiety Inventory
AQ Japanese version
AQ Children's version
Schizophrenia Cognition Rating Scale Japanese Version
Global Assessment Scale
Social and Occupational Functioning Assessment Scale
Quality of Life Scale
Rumination Reflection Questionnaire Japanese Version
The Pre Sleep Cognitive Activity Scale Japanese Version
The Pittsburgh Sleep Quality Index
Heart Rate Variability
Explanation of MRI Scan
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Compassion Focused Therapy (CFT) with treatment as usual (TAU)
Interventions/Control_2
Treatment as usual (TAU)
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
| 15 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
a) Outpatient for clinics of the Department of Neuropsychiatry, Toyama University Hospital
b) Patients who meet the criteria for ARMS as assessed by CAARMS prior to intervention, or who do not meet the criteria for ARMS at the time of assessment because they have had weak positive symptoms for more than 1 year, but have met them during outpatient visits and have been notified of ARMS prior to treatment
c) Have a verbal IQ of 75 or above as measured by the Japanese Adult Reading Test
d) Aged between 15 and 35 years at the time of consent
e) Subjects provide written informed consent in the participation of the study
f) When the subjects are under the age of 18 years, written consent are also obtained from the parent or guardian of a minor
Key exclusion criteria
a) Patient who had a diagnosis exceeding ARMS criteria (e.g., schizophrenia, schizoaffective disorder, acute transient psychotic disorder, delusional disorder) in the past or at baseline
b) Patient who had a diagnosis of post-traumatic stress disorder in the past or at baseline
c) Patient with significant suicidal ideation or risky behavior (CAARMS Severity Scales Score of 5 or above on Aggression/Dangerous Behaviour and/or Suicidality/Self Harm Subscales) at baseline
d) Patient who had a history of alcohol or substance dependence
e) Patient receiving other structured psychotherapy at baseline
f) Other relevant reasons decided by the investigators
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shimako |
| Middle name | |
| Last name | Nishiyama |
Organization
University of Toyama
Division name
Centre for Health Care and Human Sciences
Zip code
930-8555
Address
3190 Gofuku, Toyama, Japan
TEL
076-445-6911
nishiyas@ctg.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Shimako |
| Middle name | |
| Last name | Nishiyama |
Organization
University of Toyama
Division name
Centre for Health Care and Human Sciences
Zip code
930-8555
Address
3190 Gofuku, Toyama, Japan
TEL
076-445-6911
Homepage URL
nishiyas@ctg.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
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
Department of Neuropsychiatry, University of Toyama Graduate School of Medicine
and Pharmaceutical Sciences
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, University of Toyama
Address
2630, Sugitani, Toyama 930-0194, Japan
Tel
076-415-8857
rinri@adm.u-toyama.ac.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
富山大学附属病院（富山県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 22 | Day |
Last modified on
| 2022 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056317
