UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030875 |
|---|---|
| Receipt number | R000035251 |
| Scientific Title | Safety Aid Elimination Intervention: Randomized Controlled Trial for college students |
| Date of disclosure of the study information | 2018/01/18 |
| Last modified on | 2019/05/17 13:28:57 |
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Basic information
Public title
Safety Aid Elimination Intervention: Randomized Controlled Trial for college students
Acronym
Efficacy of SAFE
Scientific Title
Safety Aid Elimination Intervention: Randomized Controlled Trial for college students
Scientific Title:Acronym
Efficacy of SAFE
Region
| Japan |
Condition
Condition
Social Anxiety Disorder
Classification by specialty
| Psychosomatic Internal Medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary goal of the present study is to adapt the brief CBT intervention to Japanese college students with subclinical anxiety.
Korte et al. (2015) developed a brief CBT approach for the subclinical anxiety disorders called, Safety Aid Elimination Intervention (SAFE). SAFE was designed to treat anxiety disorders through the identification and elimination of avoidance and coping strategies utilized by anxiety patients. These strategies, called safety aids, are ubiquitous across anxiety conditions and play a central role in the maintenance of anxiety conditions. A major strength of SAFE is the straightforward nature of the intervention, which focuses on the identification and elimination of safety aids that tend to be similar across anxiety disorders. To examine the efficacy of the SAFE preventative intervention, we conducted a randomized controlled (RCT) trial examining the efficacy of the intervention in those with subclinical social anxiety symptoms.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Japanese version of Social Interaction Anxiety Scale.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Intervention:Cognitive Behavior Therapy
Interventions/Control_2
Control: Health Education and Adaptive Living
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)Those with high social anxiety symptoms.
Key exclusion criteria
2) Those who get treatment in psychosomatic/psychiatric hospitals
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shin-ichi Ishikawa |
Organization
Doshisha University
Division name
Faculty of Psychology
Zip code
Address
1-3 Tatara Miyakodani, Kyotanabe-shi, Kyoto-fu
TEL
0774-65-8220
ekq1001@mail2.doshisha.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Honami Arai |
Organization
Graduate school of Doshisha University
Division name
Department of psychology
Zip code
Address
Faculty of Psychology
TEL
0774-65-8220
Homepage URL
danxiety2017@yahoo.co.jp
Sponsor or person
Institute
Faculty of Psychology, Doshisha University
Institute
Department
Personal name
Funding Source
Organization
Faculty of Psychology, Doshisha University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 18 | 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
59
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
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 18 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 18 | Day |
Last modified on
| 2019 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035251
