Reducing Secondary Distress in Violence Researchers: a Randomised Trial of the Effectiveness of Group Debriefings.

March 19, 2015 updated by: Heidi Grundlingh, London School of Hygiene and Tropical Medicine
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
53

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
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.
Behavioral: leisure activity (film showing)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
London School of Hygiene and Tropical Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Heidi Grundlingh, MPH, LSHTM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 20, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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