UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035508 |
|---|---|
| Receipt number | R000040458 |
| Scientific Title | Randomized controlled evaluation of the effect of music therapy with cognitive-behavioral therapy on social anxiety symptoms |
| Date of disclosure of the study information | 2019/01/12 |
| Last modified on | 2019/01/10 20:12:22 |
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Basic information
Public title
Randomized controlled evaluation of the effect of music therapy with cognitive-behavioral therapy on social anxiety symptoms
Acronym
Music therapy with cognitive-behavioral therapy for social anxiety symptoms
Scientific Title
Randomized controlled evaluation of the effect of music therapy with cognitive-behavioral therapy on social anxiety symptoms
Scientific Title:Acronym
Music therapy with cognitive-behavioral therapy for social anxiety symptoms
Region
| Africa |
Condition
Condition
social anxiety
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examined the effects of music therapy with cognitive behavioural therapy on social anxiety in a sample of schooling adolescents in south-east Nigeria.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
SMGAD-C: Time 1, Time 2, Time 3
Key secondary outcomes
SAS-A: Time 1, Time 2, Time 3
LSAS-CA-SR: Time 1, Time 2, Time 3
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Intervention, n=78
Music Therapy with Cognitive Behavioral Program (MTCBP manual)
Treatment session: 12 sessions (12 weeks), one session per week
Interventions/Control_2
Waitlist Control group, N=77
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
| 11 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Must be in public secondary school, Age 11-18,
Participants must have social anxiety symptoms.
Key exclusion criteria
Participants that did not meet the specific inclusion were excluded.
Target sample size
155
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Moses Onyemaechi Ede |
Organization
University of Nigeria
Division name
Department of Educational Foundations
Zip code
Address
Department of Educational Foundations (Guidance and Counselling Unit), Room 203, Faculty of Education, University of Nigeria, Nsukka
TEL
+2347066725165
moses.ede@unn.edu.ng
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Moses Onyemaechi Ede |
Organization
University of Nigeria, Nsukka
Division name
Department of Educational Foundations
Zip code
Address
Department of Educational Foundations (Guidance and Counselling Unit), Room 203, Faculty of Educatio
TEL
+2347066725165
Homepage URL
moses.ede@unn.edu.ng
Sponsor or person
Institute
Otusum Consult Training & Services
Institute
Department
Personal name
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2019 | Year | 01 | Month | 12 | 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
Completed
Date of protocol fixation
| 2016 | Year | 11 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 04 | Day |
Date of closure to data entry
| 2018 | Year | 05 | Month | 08 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 14 | Day |
Date analysis concluded
| 2018 | Year | 06 | Month | 19 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 10 | Day |
Last modified on
| 2019 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040458
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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