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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035508
Receipt No. R000040458
Official scientific title of the study 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

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Basic information
Official scientific title of the study Randomized controlled evaluation of the effect of music therapy with cognitive-behavioral therapy on social anxiety symptoms
Title of the study (Brief title) 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 Moses Onyemaechi Ede
Organization University of Nigeria
Division name Department of Educational Foundations
Address Department of Educational Foundations (Guidance and Counselling Unit), Room 203, Faculty of Education, University of Nigeria, Nsukka
TEL +2347066725165
Email moses.ede@unn.edu.ng

Public contact
Name of contact person Moses Onyemaechi Ede
Organization University of Nigeria, Nsukka
Division name Department of Educational Foundations
Address Department of Educational Foundations (Guidance and Counselling Unit), Room 203, Faculty of Educatio
TEL +2347066725165
Homepage URL
Email moses.ede@unn.edu.ng

Sponsor
Institute Otusum Consult Training & Services
Institute
Department

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)

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

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 11 Month 03 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040458

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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