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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030875
Receipt No. 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

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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
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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