UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033492
Receipt number R000038191
Scientific Title 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 2018/09/04 18:31:57

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Basic information

Public title

A Stress Management Intervention for Adults Living with HIV in Nigerian Community Settings: An Effects Study

Acronym

A Stress Management Intervention for Adults Living with HIV in Nigerian Community Settings

Scientific Title

A Stress Management Intervention for Adults Living with HIV in Nigerian Community Settings: An Effects Study

Scientific Title:Acronym

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 1, 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

1st name
Middle name
Last name Uju Nwobi

Organization

University of Nigeria Nsukka

Division name

Department of Adult Education & Extra-Mural Studies

Zip code


Address

Ezeopi II street, University of Nigeria Nsukka

TEL

+2348068409177

Email

uju.nwobi@unn.edu.ng


Public contact

Name of contact person

1st name
Middle name
Last name Chiedu Eseadi

Organization

University of Nigeria Nsukka

Division name

Department of Educational Foundations

Zip code


Address

Room 213, Harden Building, University of Nigeria Nsukka

TEL

+2348137258914

Homepage URL


Email

chiedu.eseadi@unn.edu.ng


Sponsor or person

Institute

Otusum Consult Training & Services, Uyo, Nigeria

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

2017 Year 06 Month 07 Day

Date of IRB


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


Other

Other related information



Management information

Registered date

2018 Year 07 Month 24 Day

Last modified on

2018 Year 09 Month 04 Day



Link to view the page

Value
https://center6.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