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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02390778
Other study ID # LSHTM#8118
Secondary ID
Status Completed
Phase N/A
First received March 11, 2015
Last updated March 19, 2015
Start date June 2014
Est. completion date July 2014

Study information

Verified date March 2015
Source London School of Hygiene and Tropical Medicine
Contact n/a
Is FDA regulated No
Health authority United Kingdom: LSHTM Research Ethics Committee
Study type Interventional

Clinical Trial Summary

The objectives of the study were: To (1) describe the epidemiology of emotional distress experienced by Ugandan violence researchers; to (2) assess the effectiveness of group debriefings in mitigating secondary distress; to (3) assess risk and protective factors. Eligible participants were 59 Ugandan researchers employed by the Good Schools Study (GSS, NCT01678846) to interview children and adults who experienced violence. Recruited participants were randomly assigned to group debriefings (intervention) or film viewing (control). The primary outcome was change in levels of emotional distress.


Description:

Background: Secondary distress including emotional distress, vicarious trauma (VT) and secondary traumatic stress (STS) due to exposure to primary trauma victims have been described in helping professionals and in violence researchers. To our knowledge, there are few prevalence studies, and no tailored interventions have been tested to reduce secondary distress in violence researchers.

Objective: To (1) describe the epidemiology of emotional distress experienced by Ugandan violence researchers; to (2) assess the effectiveness of group debriefings in mitigating secondary distress; to (3) assess risk and protective factors.

Methods: An unblinded, individually randomised trial with parallel assignment was conducted. Eligible participants were 59 Ugandan researchers employed by the Good Schools Study (GSS, NCT01678846) to interview children and adults who experienced violence in the district of Luwero, Uganda. 53 researchers agreed to participate and were randomly allocated. The intervention group (n=26) participated in three group debriefings and the control group (n=27) participated in three leisure sessions (film viewing).The primary outcome was change in levels of emotional distress (SRQ-20); secondary outcomes were levels of VT and STS at end-line.


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Eligible participants were all 59 Ugandan researchers who had been employed by the GSS.

Exclusion Criteria:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Group Debriefing
Group Debriefing involves story-telling, identifying emotional responses to these stories, psycho-education and practical information to normalize group member reactions to a distressing event.
leisure activity (film showing)


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
London School of Hygiene and Tropical Medicine

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline Self-Report Questionnaire-20 (SRQ-20) score at 5 weeks The SRQ-20 is a 20 item measure which require simple 'yes' or 'no' responses and was designed as a screening tool for psychological symptoms/emotional distress. It has been widely used and validated in low and middle-income countries as a measure of mental health and wellbeing. The SRQ-20 was modelled as a continuous variable but also a binary variable were the top 33% of the overall distribution was deemed as having a 'high' score indicative of probable emotional distress, consistent with previous research. 5 weeks No
Secondary Vicarious Trauma Scale (VTS) at 5 weeks The Vicarious Trauma Scale (VTS), an 8 item measure with a 7 point Likert-type scale, has recently been developed and shown to have good psychometric properties for use as a screening tool for vicarious trauma in low resource settings. It is the only publically available screening measure of VT. 5 weeks No
Secondary Impact of Events Scale-Revised (IES-R) at 5 weeks The Impact of Events Scale-Revised (IES-R)consists of 22 items with a 4 point Likert-type scale widely validated and used to screen for post-traumatic stress disorder (PTSD). It has been used by several studies to measure STS as the theoretical symptomology is similar. 5 weeks No
Secondary Professional Quality of Life Scale (ProQOL) at 5 weeks The Professional Quality of Life Scale (ProQOL) was developed to screen mental health and other professionals who may experience positive or negative impacts as they help others. Versions of the screening tool have good construct validity with over 200 published papers and it is widely used in research as a measure for STS and related constructs. 5 weeks No
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