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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | Social Anxiety Disorder | ||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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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 | |
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 |
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Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
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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 |
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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 | |
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Results Delay Reason | |
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Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Date analysis concluded |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |