UMIN-CTR Clinical Trial

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
Email	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
Email	danxiety2017@yahoo.co.jp

Sponsor
Institute	Faculty of Psychology, Doshisha University
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035251

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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