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The effect of expressive disclosure writing on self-stigma, depression, and anxiety among substance dependent clients in a governmental hospital in Egypt: A non-randomized controlled trial
Last registered on February 03, 2017

Pre-Trial

Trial Information
General Information
Title
The effect of expressive disclosure writing on self-stigma, depression, and anxiety among substance dependent clients in a governmental hospital in Egypt: A non-randomized controlled trial
RCT ID
AEARCTR-0001972
Initial registration date
February 03, 2017
Last updated
February 03, 2017 6:19 PM EST
Location(s)
Region
Primary Investigator
Affiliation
Alexandria University, Egypt
Other Primary Investigator(s)
Additional Trial Information
Status
Completed
Start date
2011-07-13
End date
2016-12-31
Secondary IDs
Abstract
Background: Among substance abusing population stigma and negative emotions are highly prevalent which can negatively hinder recovery and accelerate relapse. Aim: This study aimed to examine the effect of expressive writing intervention for improving self-stigma and depression/anxiety symptoms among drug dependent inpatients in a governmental hospital, in Alexandria. Methods: Participants (N= 165) were assigned to a 5- sessions 15 minutes expressive writing intervention or control group. Self-stigma (SSAD) and depression/anxiety (DASS-21) were measured at baseline and immediately after the intervention (posttreatment). Results: The present controlled trial found a favorable effect of EDW on the SSAD applying stigma score among drug use inpatients in the crude analysis. However the effect was unclear after adjusting for the baseline score. No group differences were found at posttreatment for other SSAD subscales neither for depression/anxiety scores. Conclusion: It is not fully clear from the study that an EDW program is effective in improving self-stigma and depression/anxiety among inpatients with drug abuse/dependence. Further research using a larger sample within a randomized and blinded context is needed.
External Link(s)
Registration Citation
Citation
Ali , Amira. 2017. "The effect of expressive disclosure writing on self-stigma, depression, and anxiety among substance dependent clients in a governmental hospital in Egypt: A non-randomized controlled trial." AEA RCT Registry. February 03. https://doi.org/10.1257/rct.1972-1.0.
Former Citation
Ali , Amira. 2017. "The effect of expressive disclosure writing on self-stigma, depression, and anxiety among substance dependent clients in a governmental hospital in Egypt: A non-randomized controlled trial." AEA RCT Registry. February 03. http://www.socialscienceregistry.org/trials/1972/history/13716.
Experimental Details
Interventions
Intervention(s)
Participants in the study group received intervention through 7 consecutive days in 2 parts. Part I: We developed a targeted CBT psycho-education component that was provided before EDW and it aimed to help participants be more able to express thoughts and feelings associated with negative and traumatic life experiences i.e. preparation for the EDW phase.
Part II comprised 15-minutes 5 consecutive sessions of expressive disclosure writing.
Intervention Start Date
2014-01-01
Intervention End Date
2015-05-26
Primary Outcomes
Primary Outcomes (end points)
Self-stigma was the primary outcome measured by Self-Stigma in Alcohol Dependence Scale (SSAD) and Secondary outcomes included levels of psychiatric distress as indicated by presence of symptoms of depression and anxiety measured by Depression Anxiety Stress Scale –21 (DASS–21).
Demographic and clinical characteristics as confounders
Primary Outcomes (explanation)
Secondary Outcomes
Secondary Outcomes (end points)
Secondary Outcomes (explanation)
Experimental Design
Experimental Design
Non-randomized controlled study examined the effect of an expressive disclosure writing (EDW) program on self-stigma, as well as depressive/anxiety symptoms compared to treatment as usual (TAU).
Experimental Design Details
This non-randomized controlled study examined the effect of an expressive disclosure writing (EDW) program on self-stigma, as well as depressive/anxiety symptoms compared to treatment as usual (TAU). Since both the intervention and control groups were derived from the same hospital unit and given the difficulty to be blinded to the intervention since the control received no placebo; there was an obvious risk of contamination of knowledge between groups. Thus, a quasi-experimental research design appeared to be a sound choice; where data were collected from members of the control group first and then the intervention was delivered for the intervention group.
Randomization Method
Non randomized historical controlled trial
Randomization Unit
Indiviuals assigned to Control group and then to Treatment when controls were over
Was the treatment clustered?
No
Experiment Characteristics
Sample size: planned number of clusters
128 participant
Sample size: planned number of observations
128 participant
Sample size (or number of clusters) by treatment arms
51 expressive writing participant and 51 control participant
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
We expected a moderate effect size so a d of .5 was used along with power of .8 and a probability of .05
IRB
INSTITUTIONAL REVIEW BOARDS (IRBs)
IRB Name
Faculty of Nursing research ethics commity
IRB Approval Date
2012-07-03
IRB Approval Number
Details not available
Analysis Plan
Analysis Plan Documents
Statistical analysis

MD5: cec3941c749c45e46ca58196433dd675

SHA1: 625890600a1a6560e384ac12363d435cbea9354c

Uploaded At: January 29, 2017

/versions/13714/docs/version/document

MD5:

SHA1:

Uploaded At: January 29, 2017

Post-Trial
Post Trial Information
Study Withdrawal
Intervention
Is the intervention completed?
Yes
Intervention Completion Date
May 28, 2015, 12:00 AM +00:00
Is data collection complete?
Yes
Data Collection Completion Date
July 29, 2015, 12:00 AM +00:00
Final Sample Size: Number of Clusters (Unit of Randomization)
165 participants
Was attrition correlated with treatment status?
No
Final Sample Size: Total Number of Observations
106 participants completed posttreatment measures
Final Sample Size (or Number of Clusters) by Treatment Arms
Complete cases 22 expressive writing participants and 23 control
Data Publication
Data Publication
Is public data available?
No

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Program Files
Program Files
No
Reports, Papers & Other Materials
Relevant Paper(s)
REPORTS & OTHER MATERIALS