UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008322 |
|---|---|
| Receipt number | R000009800 |
| Scientific Title | Feasibility Study of Unified Protocol for Anxiety and Depressive Disorders |
| Date of disclosure of the study information | 2012/07/12 |
| Last modified on | 2022/01/11 18:01:51 |
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Basic information
Public title
Feasibility Study of Unified Protocol for Anxiety and Depressive Disorders
Acronym
Open label study of Unified Protocol for Emotional Disorders
Scientific Title
Feasibility Study of Unified Protocol for Anxiety and Depressive Disorders
Scientific Title:Acronym
Open label study of Unified Protocol for Emotional Disorders
Region
| Japan |
Condition
Condition
Anxiety Disorders, Depressive Disorders
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the feasibility of Unified Protocol for anxiety and depressive disorders in Japanese setting
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Severity of anxiety symptoms assessed by the SIGH-A (0 week vs 1 week after the completion of intervention)
Key secondary outcomes
1. Diagnoses assessed by the M.I.N.I.
2. Objective severity of depressive symptoms (GRID-HAM-D)
3. Subjective severity of depressive symptoms (BDI-II)
4. Quality of Life (EuroQol etc)
5. Subjective symptoms for primary diagnosis (self-report scale)
6. Emotion Regulation (ERQ)
7. Experienced Emotion (PANAS)
8. Drop Out rates
9. Adverse Events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
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
| Maneuver |
Interventions/Control_1
CBT (Unified Protocol)
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Subjects with current DSM-IV Panic disorder with/without Agoraphobia, Agoraphobia without history of Panic Disorder, Specific Phobia, Social Phobia (Social Anxiety Disorder), Obsessive-Compulsive Disorder, Post-Traumatic Stress Disorder, Generalized Anxiety Disorder, Anxiety Disorder Not Otherwise Specified, Major Depressive Disorder, Depressive Disorder Not Otherwise Specified
2. HAM-D Anxiety Factor >= 7
3. Age 20 years or older, and 65 years or younger at screening.
4. Subjects who give full consent in the participation of the study
Key exclusion criteria
1. No alcohol or substance use disorder in 6 months prior to the screening.
2. No history or concurrent manic or psychotic episode.
3. No other primary DSM-IV Axis I Disorders in six months prior to the screening.
4. No comorbid of antisocial personality disorder.
5. No serious suicidal ideation at screening.
6. Evidence of unable to participate half or more of the intervention phase.
7. No past treatment of CBT.
8. No structured psychotherapy (except supportive therapy) during the intervention.
9. No major cognitive deficits at screening.
10. No life-threatening, severe or unstable physical disorders at screening.
11. Other relevant reason decided by the investigators.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaya Ito, Ph.D. |
Organization
National Center of Neurology and Psychiatry
Division name
National Center for Cognitive Behavior Therapy and Research, Department of Clinical Training
Zip code
Address
Ogawahigashi 4-1-1, Kodaira-shi, Tokyo, Japan
TEL
042-341-2712(3605)
masayait@ncnp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriko Kato |
Organization
National Center of Neurology and Psychiatry
Division name
National Center for Cognitive Behavior Therapy and Research
Zip code
Address
Ogawahigashi 4-1-1, Kodaira-shi, Tokyo, Japan
TEL
042-341-2712(3605)
Homepage URL
norikokato@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry, National Center for Cognitive Behavior Therapy and Research
Institute
Department
Personal name
Funding Source
Organization
Intramural Research Grant (24-4) for Neurological and Psychiatric Disorders of NCNP
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Disaster Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
国立精神・神経医療研究センター(東京都)
国立病院機構 災害医療センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 07 | Month | 12 | Day |
Related information
URL releasing protocol
not available
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.beth.2016.02.005
Number of participants that the trial has enrolled
17
Results
The severity of anxiety symptoms decreased significantly after the intervention and remained low for 3 months.
Results date posted
| 2022 | Year | 01 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2016 | Year | 02 | Month | 24 | Day |
Baseline Characteristics
10 female (59%)
Mean age=35.18(SD=10.8)
Participant flow
Referred for study, baseline assessment, enrolled, intervention, post-assessment, 3-month follow-up assessment.
Adverse events
No severe adverse event occurred.
Outcome measures
Structured Interview Guide for the Hamilton Anxiety Rating Scale
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 03 | Day |
Last modified on
| 2022 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009800
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