UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045369 |
|---|---|
| Receipt number | R000051794 |
| Scientific Title | Effectiveness of animal therapy as a complementary intervention for exposure to social anxiety. |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2021/09/03 14:36:03 |
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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
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
snagamine2000@gmail.com
Sponsor or person
Institute
University of the Ryukyus
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051794
