UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of expressive disclosure writing on self-stigma, depression, anxiety, and stress among substance dependent clients
Title of the study (Brief title)	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	Amira M. Ali Ali
Organization	Faculty of Nursing, Alexandria University
Division name	Department of Mental Health and Psychiatric Nursing
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	Amira M. Ali Ali
Organization	Faculty of Nursing, Alexandria University
Division name	Department of Mental Health and Psychiatric Nursing
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

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 07 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	Expressive writing was not effective alleviating stigma or depression and anxie ty symptoms
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