- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02390778
Reducing Secondary Distress in Violence Researchers: a Randomised Trial of the Effectiveness of Group Debriefings.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Eligible participants were all 59 Ugandan researchers who had been employed by the GSS.
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Debrief Group
The debrief group participated in 3 consecutive face-to-face group debriefing sessions lasting 1.5-2 hrs each.
Each session started with a fun ice-breaker to create a relaxed atmosphere and group cohesion.
Session 1 focused on encouraging group participation, discussing primary trauma encountered and emotional reactions to these stories.
Session 2 connected current experiences with the group members' own trauma histories and life experiences.
The last session focussed on societal and community responses to violence, and employing personal agency to find constructive ways to address violence in communities.
|
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.
|
Placebo Comparator: Control Group
The control group was assigned to a leisure activity (film showing), for every session of debriefing undergone by the intervention group.
The films were chosen for their light-hearted uplifting content and presented as a fun and relaxing activity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline Self-Report Questionnaire-20 (SRQ-20) score at 5 weeks
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vicarious Trauma Scale (VTS) at 5 weeks
Time Frame: 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
|
Impact of Events Scale-Revised (IES-R) at 5 weeks
Time Frame: 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
|
Professional Quality of Life Scale (ProQOL) at 5 weeks
Time Frame: 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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Heidi Grundlingh, MPH, LSHTM
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LSHTM#8118
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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