UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000031442
Receipt No. R000034137
Scientific Title Effect of cognitive behavior therapy for antiretroviral therapy adherence and depression among people living with HIV and depressive symptoms: A randomized controlled trial
Date of disclosure of the study information 2018/02/23
Last modified on 2019/02/25

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effect of cognitive behavior therapy for antiretroviral therapy adherence and depression among people living with HIV and depressive symptoms: A randomized controlled trial
Acronym Effect of cognitive behavior therapy for antiretroviral therapy adherence and depression among people living with HIV and depressive symptoms: A randomized controlled trial
Scientific Title Effect of cognitive behavior therapy for antiretroviral therapy adherence and depression among people living with HIV and depressive symptoms: A randomized controlled trial
Scientific Title:Acronym Effect of cognitive behavior therapy for antiretroviral therapy adherence and depression among people living with HIV and depressive symptoms: A randomized controlled trial
Region
Asia(except Japan)

Condition
Condition People living with HIV, depressive episode, ART non-adherence
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine the effectiveness of cognitive behavioral therapy (CBT) for ART adherence and depression among living with HIV and depressive symptoms in comparison with treatment as usual (TAU).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes 1) ART Adherence measured by multi-method tool (four method) at the baseline, after intervention, 3 months and 6 months follow-up
Key secondary outcomes 1) Severity of depression by mBDI-II
2) Severity of depression by 19-item mental health questionnaire
3) Viral load

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 A weekly, 8-session group-based program which provide the psychoeducation of ART adherence and depression based on cognitive behavioral therapy technique
Interventions/Control_2 Treatment as usual which include the counseling session of HIV, adverse reaction of ART
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
18 years-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) being HIV positive
2) Beck depression inventory II index > 11 at the baseline study (pre-threshold depression)
3) no suicidal thought and experience (questionnaire)
4) having sufficient knowledge of Myanmar language
5) available for the next 10 weeks to work on intervention
Key exclusion criteria 1) declined to participate in this study
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norito Kawakami
Organization Graduate School of Medicine, University of Tokyo
Division name Mental Health
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL +81-3-5841-3521
Email nkawakami@m.u-tokyo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Khine Lae Win
Organization Graduate School of Medicine, University of Tokyo
Division name Mental Health
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL +81-3-5841-3521
Homepage URL
Email khinelaewin@gmail.com

Sponsor
Institute Department of Mental Health, Graduate School of Medicine, University of Tokyo
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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 02 Month 23 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 Enrolling by invitation
Date of protocol fixation
2018 Year 02 Month 23 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 28 Day
Last follow-up date
2019 Year 01 Month 15 Day
Date of closure to data entry
2019 Year 02 Month 28 Day
Date trial data considered complete
2019 Year 02 Month 28 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 02 Month 23 Day
Last modified on
2019 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034137

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.