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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000034913 |
Receipt No. | R000039805 |
Official scientific title of the study | Impacts of Cognitive-Behavioral Intervention on Anxiety and Depression Among Social Science Education Students: A Randomized Controlled Trial |
Date of disclosure of the study information | 2018/11/16 |
Last modified on | 2018/11/16 |
Basic information | ||
Official scientific title of the study | Impacts of Cognitive-Behavioral Intervention on Anxiety and Depression Among Social Science Education Students: A Randomized Controlled Trial | |
Title of the study (Brief title) | Impacts of Cognitive-Behavioral Intervention on Anxiety and Depression Among Social Science Education Students | |
Region |
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Condition | ||||
Condition | Anxiety and Depression | |||
Classification by specialty |
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Classification by malignancy | Others | |||
Genomic information | NO |
Objectives | |
Narrative objectives1 | We evaluated the impacts of cognitive-behavioral intervention on anxiety and depressive symptoms in Nigerian undergraduate social science education students population. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Others |
Trial characteristics_2 | Others |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | SMGAD-A: Time 1, Time 2, Time 3
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Key secondary outcomes | GDS: 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 |
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Interventions/Control_1 | Intervention, n=28
Treatment session: 120minutes during each meeting Cognitive-Behavioral Treatment (CBT) for Adults with Generalized Anxiety Disorder Manual Treatment Manual for Cognitive-Behavioral Therapy for Depression |
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Interventions/Control_2 | Waitlisted control group, n=27
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Interventions/Control_3 | |||
Interventions/Control_4 | |||
Interventions/Control_5 | |||
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Interventions/Control_9 | |||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Students with severe anxiety and depressive symptoms were selected as participants. Other set criteria for eligibility involved providing written, informed consent and being readily available for the study. Those participants who met the inclusion criteria were selected. | |||
Key exclusion criteria | The screened participants who did not meet any of these criteria were not invited to participate in the study. | |||
Target sample size | 55 |
Research contact person | |
Name of lead principal investigator | Dr Bernedeth Ezegbe |
Organization | University of Nigeria Nsukka |
Division name | Department of Social Science Education |
Address | Harden Building, Department of Social Science Education, University of Nigeria Nsukka |
TEL | +2348035847979 |
bernedeth.ezegbe@unn.edu.ng |
Public contact | |
Name of contact person | Chiedu Eseadi |
Organization | University of Nigeria Nsukka |
Division name | Department of Educational Foundations |
Address | Room 213, Harden Building, Department of Educational Foundations, University of Nigeria Nsukka |
TEL | +2348137258914 |
Homepage URL | |
chiedu.eseadi@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 |
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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 |
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Date of disclosure of the study information |
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Progress | |||||||
Recruitment status | Completed | ||||||
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Date analysis concluded |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
URL releasing results | |
Results | |
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Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039805 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |