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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033492
Receipt No. R000038191
Official scientific title of the study A Stress Management Intervention for Adults Living with HIV in Nigerian Community Settings: An Effects Study
Date of disclosure of the study information 2018/07/26
Last modified on 2018/07/26

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Basic information
Official scientific title of the study A Stress Management Intervention for Adults Living with HIV in Nigerian Community Settings: An Effects Study
Title of the study (Brief title) A Stress Management Intervention for Adults Living with HIV in Nigerian Community Settings
Region
Africa

Condition
Condition HIV patients
Classification by specialty
Infectious disease Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study is to evaluate the effectiveness of a group-based cognitive-behavioral stress management intervention among community-dwelling adults living with HIV in Southeastern Nigeria.

Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes 1. Perceived Stress Scale at Time 1, Time 2, Time 3

2. Hospital Anxiety and Depression Scale at Time1, Time 2, Time 3

Key secondary outcomes
Satisfaction with Life Scale at Time 2, Time 3

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom Other
Interventions/Control_1 Intervention group

Duration: 10 weeks
Frequency: single 2- to 2.5-hour session held once weekly
Interventions/Control_2 Control group
Duration: 10 weeks
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
30 years-old <=
Age-upper limit
45 years-old >=
Gender Male and Female
Key inclusion criteria Potential participants had to meet certain inclusion criteria such as high perceived stress, severe anxiety and depression symptoms.
Key exclusion criteria Those who did not meet these criteria were excluded.
Target sample size 28

Research contact person
Name of lead principal investigator Uju Nwobi
Organization University of Nigeria Nsukka
Division name Department of Adult Education & Extra-Mural Studies
Address Ezeopi II street, University of Nigeria Nsukka
TEL +2348068409177
Email uju.nwobi@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, University of Nigeria Nsukka
TEL +2348137258914
Homepage URL
Email chiedu.eseadi@unn.edu.ng

Sponsor
Institute Otusum Consult Training & Services, Uyo, Nigeria
Institute
Department

Funding Source
Organization N/A
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Nigeria

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
2018 Year 07 Month 26 Day

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 06 Month 07 Day
Anticipated trial start date
2017 Year 06 Month 19 Day
Last follow-up date
2018 Year 07 Month 13 Day
Date of closure to data entry
2018 Year 07 Month 19 Day
Date trial data considered complete
2018 Year 07 Month 19 Day
Date analysis concluded
2018 Year 07 Month 23 Day

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 07 Month 24 Day
Last modified on
2018 Year 07 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038191

Research Plan
Registered date File name

Research case data specifications
Registered date File name
2018/08/03 HADS, Stress, Subjective Wellbeing Data.sav

Research case data
Registered date File name


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