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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025982
Receipt No. R000029872
Scientific Title The effect of expressive disclosure writing on self-stigma, depression, anxiety, and stress among substance dependent clients
Date of disclosure of the study information 2017/02/15
Last modified on 2017/02/03

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Basic information
Public title The effect of expressive disclosure writing on self-stigma, depression, anxiety, and stress among substance dependent clients
Acronym Expressive writing for drug use stigma and psychological distress
Scientific Title The effect of expressive disclosure writing on self-stigma, depression, anxiety, and stress among substance dependent clients
Scientific Title:Acronym Expressive writing for drug use stigma and psychological distress
Region
Africa

Condition
Condition Substance related disorders
Classification by specialty
Psychiatry Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aimed to examine the effect of expressive disclosure writing (EDW)
intervention on self-stigma and depression/anxiety symptoms among
drug dependent inpatients in a governmental hospital, in Alexandria, Egypt
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Self-stigma: Self-Stigma in Alcohol Dependence Scale
Key secondary outcomes Levels of psychological distress: Depression Anxiety Stress Scale 21 items

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Single blind -participants 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 Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 The control was treatment as usual (TAU)
Interventions/Control_2 The experimental group: 2, 60-minutes CBT psycho-education group sessions plus a 5 sessions, 15 minutes expressive writing intervention
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
60 years-old >=
Gender Male and Female
Key inclusion criteria 18 years or older, detoxified and could read and write
Key exclusion criteria Having psychotic disorders and suicidal ideation
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Amira M. Ali Ali
Organization Faculty of Nursing, Alexandria University
Division name Department of Mental Health and Psychiatric Nursing
Zip code
Address Department of Mental Health, School of Health Science and Nursing, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
TEL +81-3-5841-3392
Email mercy.ofheaven2000@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Amira M. Ali Ali
Organization Faculty of Nursing, Alexandria University
Division name Department of Mental Health and Psychiatric Nursing
Zip code
Address Department of Mental Health, School of Health Science and Nursing, Graduate School of Medicine, The
TEL +81-3-5841-3392
Homepage URL
Email mercy.ofheaven2000@gmail.com

Sponsor
Institute No funding from any body but the principal investigator works for the Departm
ent of Mental Health and Psychiatric Nursing, Faculty of Nursing, Alexandria U
niversity
Institute
Department

Funding Source
Organization Amira Ali working at the Faculty of Nursing, Alexandria University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Egyptian

Other related organizations
Co-sponsor Not applicable
Name of secondary funder(s) Not applicable

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 The Substance use treatment inpatient unit, Al Maamoura Hospital for Psychiatric Medicin, Alexandria, Egypt

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 15 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 Expressive writing was not effective alleviating stigma or depression and anxie
ty symptoms
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
2011 Year 07 Month 13 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 01 Day
Last follow-up date
2015 Year 05 Month 25 Day
Date of closure to data entry
2015 Year 05 Month 26 Day
Date trial data considered complete
2015 Year 05 Month 26 Day
Date analysis concluded
2016 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 02 Month 03 Day
Last modified on
2017 Year 02 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029872

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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