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

General Information

Title

RCT ID

AEARCTR-0001972

Initial registration date

February 03, 2017

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published

February 03, 2017, 6:19 PM EST

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

Country

Egypt

Region

Alexandria

Primary Investigator

Name

Amira Ali

Affiliation

Alexandria University, Egypt

Contact Primary Investigator

Other Primary Investigator(s)

Additional Trial Information

Status

Completed

Start date

2011-07-13

End date

2016-12-31

Keywords

Health

Additional Keywords

anxiety, depression, expressive disclosure writing, stress on self-stigma, substance related disorders

JEL code(s)

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

Sponsors & Partners

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

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?

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

Supporting Documents and Materials

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

Post-Trial

Post Trial Information

Study Withdrawal

There is information in this trial unavailable to the public. Use the button below to request access.

Request Information

Intervention

Is the intervention completed?

Yes

Intervention Completion Date

May 28, 2015, 12:00 +00:00

Data Collection Complete

Yes

Data Collection Completion Date

July 29, 2015, 12:00 +00:00

Final Sample Size: Number of Clusters (Unit of Randomization)

165 participants

Was attrition correlated with treatment status?

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

Is public data available?

There is information in this trial unavailable to the public. Use the button below to request access.

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

Pre-Trial

General Information

Locations

Primary Investigator

Other Primary Investigator(s)

Additional Trial Information

Registration Citation

Interventions

Primary Outcomes

Secondary Outcomes

Experimental Design

Experiment Characteristics

Institutional Review Boards (IRBs)

Analysis Plan Documents

Post-Trial

Study Withdrawal

Intervention

Data Publication

Program Files

Relevant Paper(s)

Reports & Other Materials