UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness of animal therapy as a complementary intervention for exposure to social anxiety.
Acronym	Effectiveness of animal therapy as a complementary intervention for exposure to social anxiety.
Scientific Title	Effectiveness of animal therapy as a complementary intervention for exposure to social anxiety.
Scientific Title:Acronym	Effectiveness of animal therapy as a complementary intervention for exposure to social anxiety.
Region	Japan

Condition
Condition	Undergraduate students with high social anxiety tendencies.
Classification by specialty	Psychiatry Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to examine the effect of conducting AAT before exposure on the treatment effect. Specifically, we hypothesize that (1) the confidence in expectation will decrease in the AAT group after the exposure compared to before the exposure, and (2) the confidence in expectation will be lower in the AAT group after the exposure compared to the control group, and we will examine the confidence in expectation as an effect indicator.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	(1) Social Avoidance and Distress Scale (2) Difficulty with speech situations (0-100) (3) State anxiety (0-100) (4) Confidence in anticipation (0-100) (5) Anxiety during exposure (0-100) (6) Degree to which anticipation occurred (0-100) (7) Degree of self-attention (Check-list) (8) Degree of use of SB (0-100)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Factorial
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Intervention condition (exposure therapy with or without AAT)
Interventions/Control_2	Measurement phase (pre-test, post-test)
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	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) University students with a tendency toward social anxiety (those who are in the top 15% of SADS scores and experience difficulty in speech situations) 2) Those who can participate in face-to-face experiments.
Key exclusion criteria	(1) those who are allergic to animals or resist contact with animals, (2) those who are currently experiencing significant psychological distress or extreme traumatic experiences immediately prior to participation in the experiment, (3) those who have a history of mental illness, (4) those who are currently visiting a hospital or taking medication for any illness, (5) those who have participated in psychological experiments before (6) those who are currently ill or injured in any way.
Target sample size	32

Research contact person
Name of lead principal investigator	1st name Yoshinori Middle name Last name Ito
Organization	University of the Ryukyus
Division name	Faculty of Humanity and Social Science
Zip code	903-0213
Address	1 Senbaru, Nishihara, Okinawa, 903-0213, Japan
TEL	098-895-8423
Email	gitoku@hs.u-ryukyu.ac.jp

Public contact
Name of contact person	1st name Saya Middle name Last name Nagamine
Organization	University of the Ryukyus
Division name	Faculty of Humanity and Social Science
Zip code	903-0213
Address	1Senbaru, Nishihara, Okinwa, 903-0213, Japan
TEL	098-895-8423
Homepage URL
Email	snagamine2000@gmail.com

Sponsor
Institute	University of the Ryukyus
Institute
Department

Funding Source
Organization	University of the Ryukyus
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	University of the Ryukyus
Address	1Senbaru, Nishihara, Okinwa, 903-0213, Japan
Tel	098-895-8423
Email	gitoku@hs.u-ryukyu.ac.jp

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	2021 Year 10 Month 01 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
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	Preinitiation
Date of protocol fixation	2021 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date	2021 Year 10 Month 01 Day
Last follow-up date	2021 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 09 Month 03 Day
Last modified on	2021 Year 09 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051794