Emotional DistressNCT02390778
Reducing Secondary Distress in Violence Researchers: a Randomised Trial of the Effectiveness of Group Debriefings.
A study testing Group Debriefing and leisure activity (film showing) in people with Emotional Distress, run by London School of Hygiene and Tropical Medicine.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Emotional Distress
- What is being tested?
- Group Debriefing and leisure activity (film showing)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Eligible participants were all 59 Ugandan researchers who had been employed by the GSS.
Who cannot join
- none
About this study
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.
Read the 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.
- Conditions
- Emotional Distress
- Being tested
- Group Debriefing, leisure activity (film showing)
- Keywords
- secondary traumatic stress, vicarious trauma, secondary distress
- Medical subject headings
- Compassion Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group DebriefingBehavioural
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)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Debrief Group | Experimental | 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. Receives: Behavioral: Group Debriefing |
| Control Group | Placebo comparator | 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. Receives: Behavioral: leisure activity (film showing) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 weeks
Secondary outcomes (3)
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.
Measured: 5 weeks
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.
Measured: 5 weeks
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.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startJun 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emotional DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heidi Grundlingh, London School of Hygiene and Tropical Medicine
- Investigators
- Heidi Grundlingh, MPH, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02390778
- Sponsor's protocol ID
- LSHTM#8118
- Status last verified
- Mar 2015
- First submitted
- 11 Mar 2015
- Last updated
- 20 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Grundlingh H, Knight L, Naker D, Devries K. Secondary distress in violence researchers: a randomised trial of the effectiveness of group debriefings. BMC Psychiatry. 2017 Jun 2;17(1):204. doi: 10.1186/s12888-017-1327-x.
PubMed 28578682
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Secondary Distress in Violence Researchers: a Randomised Trial of the Effectiveness of Group Debriefings.
- ClinicalTrials.gov ID
- NCT02390778
- Acronym / sponsor ID
- LSHTM#8118
- Conditions
- Emotional Distress
- Keywords
- secondary traumatic stress, vicarious trauma, secondary distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 18 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Debrief Group | Experimental | Behavioral: Group DebriefingThe 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. |
| Control Group | Placebo comparator | Behavioral: leisure activity (film showing)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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible participants were all 59 Ugandan researchers who had been employed by the GSS.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group DebriefingGroup Debriefing involves story-telling, identifying emotional responses to these stories, psycho-education and practical information to normalize group member reactions to a distressing event. | Behavioural | Debrief Group |
| leisure activity (film showing) | Behavioural | Control Group |
Primary outcome
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.
3 secondary outcomes
Vicarious Trauma Scale (VTS) at 5 weeks
Time frame: 5 weeks
Impact of Events Scale-Revised (IES-R) at 5 weeks
Time frame: 5 weeks
Professional Quality of Life Scale (ProQOL) at 5 weeks
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2015.
- Derived from this study: PubMed 28578682Grundlingh H, Knight L, Naker D, Devries K. Secondary distress in violence researchers: a randomised trial of the effectiveness of group debriefings. BMC Psychiatry. 2017 Jun 2;17(1):204. doi: 10.1186/s12888-017-1327-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heidi Grundlingh, MPH principal investigator
London School of Hygiene and Tropical Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Group Debriefing and leisure activity (film showing) in people with Emotional Distress, run by London School of Hygiene and Tropical Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Self-Report Questionnaire-20 (SRQ-20) score at 5 weeks (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02390778, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2015.