UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031442
Receipt number 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 2019/12/05 12:40:56

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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 depression and ART adherence among people 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-month and 6-month follow-up
2) Severity of depression by mBDI-II
3) Severity of depression by 19-item mental health questionnaire

Key secondary outcomes

1) CD4 count
2) 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 > 10 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 Norito
Middle name
Last name Kawakami

Organization

Graduate School of Medicine, University of Tokyo

Division name

Mental Health

Zip code

113-0033

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 Khine Lae
Middle name
Last name Win

Organization

University of Tokyo

Division name

Mental Health

Zip code

113-0033

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8654, JAPAN

TEL

+81-3-5841-3521

Homepage URL


Email

khinelaewin@gmail.com


Sponsor or person

Institute

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

Institute

Department

Personal name



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

University of Tokyo

Address

7-3-1, Hongo, Bunkyo-ku, Tokyo, 113-8654, JAPAN, Tokyo

Tel

+81 3 5841 0818

Email

ethics@m.u-tokyo.ac.jp


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

2018 Year 04 Month 18 Day

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 03 Month 12 Day

Date analysis concluded

2019 Year 10 Month 31 Day


Other

Other related information



Management information

Registered date

2018 Year 02 Month 23 Day

Last modified on

2019 Year 12 Month 05 Day



Link to view the page

Value
https://center6.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