UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025982 |
|---|---|
| Receipt number | 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 11:31:48 |
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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
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
mercy.ofheaven2000@gmail.com
Sponsor or person
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
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029872
