UMIN-CTR Clinical Trial

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