Post-traumatic Stress SymptomsPhase 2NCT01483261
An RCT of Trauma Focused-Cognitive Behavioral Therapy With Sexually Exploited, War-affected Girls in the DRC
A Phase 2 study testing Trauma-Focused Cognitive Behavioral Therapy in people with Post-traumatic Stress Symptoms and Psychosocial Distress, run by Queen's University, Belfast at 1 site in Republic of the Congo.
Trial summary
To date, no RCT has examined the efficacy of Trauma-Focused Cognitive Behavioral Therapy with Sexually Exploited, War Affected Adolescent Girls in the Democratic Republic of Congo. Read more about this study
- Who is it for?
- Ages 10 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-traumatic Stress Symptoms, Psychosocial Distress
- What is being tested?
- Trauma-Focused Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteRepublic of the Congo
- Study dates
- May 2011to Nov 2011
- Phase
- Phase 2
- 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 10 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- -Suicidal ideation (irrespective of score on any other measure)
Who cannot join
- psychosis
- mental retardation
- inability to understand Swahili
- one standard deviation below the mean on every measure
Trial locations and contacts
1 site in 1 country.
Republic of the Congo1 site
World Vision Rebound Centre
Beni, South Kivu
About this study
Official title: Is Trauma-Focused Cognitive Behavioral Therapy Effective in Reducing Post-traumatic Stress and Psychosocial Distress Among Sexually Exploited, War-affected Girls in the Democratic Republic of Congo.
To date, no RCT has examined the efficacy of Trauma-Focused Cognitive Behavioral Therapy with Sexually Exploited, War Affected Adolescent Girls in the Democratic Republic of Congo. This study seeks to fill this gap by designing, implementing and testing such an intervention using both an intervention and waiting list control group.
- Being tested
- Trauma-Focused Cognitive Behavioral Therapy
- Keywords
- Trauma-Focused Cognitive Behavior Therapy, Sexually Exploited Girls, Post-traumatic Stress Symptoms, Psychosocial Distress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma-Focused Cognitive Behavioral TherapyBehavioural
15 sessions of manualised, culturally modified trauma-focused cognitive behavior therapy
| Study group | Role | What they receive |
|---|---|---|
| Trauma-Focused Cognitive Behavioral Therapy | Experimental | Not described Receives: Behavioral: Trauma-Focused Cognitive Behavioral Therapy |
| Waiting List Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Post-traumatic Stress Symptoms as measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index
Measured: baseline, post-intervention and 3-months
Secondary outcomes (1)
Change in Psychosocial Distress as measured by the African Youth Psychosocial Assessment Instrument
Measured: baseline post-intervention and 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startMay 2011
- Primary completionSep 2011
- Study completionNov 2011
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 Post-traumatic Stress SymptomsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Collaborators
- World Vision
- Responsible party
- Principal investigator, Paul O'Callaghan, Queen's University, Belfast
- Investigators
- Dr Ciaran Shannon, BA, MA, DClin, Study director, Chartered Clinical Psychologist (British Psychological Society)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01483261
- Sponsor's protocol ID
- PREC23-2011
- Status last verified
- Dec 2011
- First submitted
- 29 Nov 2011
- Last updated
- 2 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
O'Callaghan P, McMullen J, Shannon C, Rafferty H, Black A. A randomized controlled trial of trauma-focused cognitive behavioral therapy for sexually exploited, war-affected Congolese girls. J Am Acad Child Adolesc Psychiatry. 2013 Apr;52(4):359-69. doi: 10.1016/j.jaac.2013.01.013. Epub 2013 Mar 6.
PubMed 23582867
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Trauma-Focused Cognitive Behavioral Therapy Effective in Reducing Post-traumatic Stress and Psychosocial Distress Among Sexually Exploited, War-affected Girls in the Democratic Republic of Congo.
- ClinicalTrials.gov ID
- NCT01483261
- Acronym / sponsor ID
- PREC23-2011
- Keywords
- Trauma-Focused Cognitive Behavior Therapy, Sexually Exploited Girls, Post-traumatic Stress Symptoms, Psychosocial Distress
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Collaborators
- World Vision
- Study start
- May 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 1 Dec 2011 (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.
To date, no RCT has examined the efficacy of Trauma-Focused Cognitive Behavioral Therapy with Sexually Exploited, War Affected Adolescent Girls in the Democratic Republic of Congo. This study seeks to fill this gap by designing, implementing and testing such an intervention using both an intervention and waiting list control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trauma-Focused Cognitive Behavioral Therapy | Experimental | Behavioral: Trauma-Focused Cognitive Behavioral Therapy |
| Waiting List Control | No intervention | – |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- -Suicidal ideation (irrespective of score on any other measure)
Key exclusion criteria (4 listed)
- psychosis
- mental retardation
- inability to understand Swahili
- one standard deviation below the mean on every measure
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 |
|---|---|---|
| Trauma-Focused Cognitive Behavioral Therapy15 sessions of manualised, culturally modified trauma-focused cognitive behavior therapy | Behavioural | Trauma-Focused Cognitive Behavioral Therapy |
Primary outcome
Change in Post-traumatic Stress Symptoms as measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index
Time frame: baseline, post-intervention and 3-months
1 secondary outcome
Change in Psychosocial Distress as measured by the African Youth Psychosocial Assessment Instrument
Time frame: baseline post-intervention and 3-months
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 2 Dec 2011.
- Derived from this study: PubMed 23582867O'Callaghan P, McMullen J, Shannon C, Rafferty H, Black A. A randomized controlled trial of trauma-focused cognitive behavioral therapy for sexually exploited, war-affected Congolese girls. J Am Acad Child Adolesc Psychiatry. 2013 Apr;52(4):359-69. doi: 10.1016/j.jaac.2013.01.013. Epub 2013 Mar 6.
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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.
Dr Ciaran Shannon, BA, MA, DClin study director
Chartered Clinical Psychologist (British Psychological Society)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trauma-Focused Cognitive Behavioral Therapy in people with Post-traumatic Stress Symptoms and Psychosocial Distress, run by Queen's University, Belfast at 1 site in Republic of the Congo.
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 4 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 2 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 in Post-traumatic Stress Symptoms as measured by the University of California Los Angelus Post Traumatic Stress Disorder -Reaction Index (time frame: baseline, post-intervention and 3-months). 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 NCT01483261, 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 2 Dec 2011.