Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01385163 |
| Other study ID # |
JHU-AMHR-IRC-2010 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 2010 |
| Est. completion date |
July 2013 |
Study information
| Verified date |
June 2023 |
| Source |
Johns Hopkins Bloomberg School of Public Health |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The Democratic Republic of the Congo (DRC) has become synonymous with sexual violence by
armed groups within the last 2 decades. Reportedly, tens of thousands of women and girls have
been raped, sexually assaulted, attacked and abducted in the Eastern Provinces including
North and South Kivu, targeted by armed groups with unparalleled levels of brutality.
Access to services in North and South Kivu-both emergency and longer term care-remains a
major challenge. Limited services as well as the potential stigma of seeking services mean
that many survivors have never received adequate care. Results of a preliminary study found
many survivors have substantially reduced ability to function, including reduced ability to
perform basic tasks and activities related to earning, self care, caring for family, and
contributing to their communities. These survivors also describe high rates of mental health
and social problems including mood disorders, anxiety, withdrawal, and stigmatization and
rejection by family and community.
While social and economic development in conflict affected areas like DRC relies on
populations who are ready and able to work, the psychological effects of conflict may mean
that a percentage of the population living in these low-resource areas are less able to
engage in economic opportunities even when they are available. However, there is little data
on the best strategy to deal with this.
This study will be run as two parallel randomized impact evaluations to investigate the
impacts of two different intervention programs to be implemented as part of standard
programming of the collaborating NGO. The first study will focus on the impact of IRC's
social-economic intervention, Village Savings and Loans Associations (VSLA) compared to a
wait-control sample. The VSLA impact evaluation study will be conducted in communities served
by 9 community-based organization (CBO) partners. The second study will focus on the impact
of a mental health intervention, Cognitive Processing Therapy (CPT) compared to a
wait-control sample. The CPT impact evaluation study will be conducted in communities
serviced by NGO partners currently providing psychosocial support. As an exploratory
investigation, the researchers will follow the CPT program with the VSLA program to look at
the effect of receiving a mental health intervention prior to the VSLA on rates of retention
and impact.
Description:
These 2 parallel randomized controlled trials will use the same inclusion criteria and same
assessments, but will have some differences in recruitment and program implementation
periods.
For the mental health study, women will be recruited and then will initiate a 12-week
treatment period when they will attend group sessions weekly with a trained counselor.
Following the treatment period, a brief qualitative assessment will be conducted followed by
a quantitative follow up of the intervention participants and wait-controls. A maintenance
period of approximately 4 months will then begin when neither the intervention nor control
participants will get any additional services from the counselors. Following the maintenance
period, the intervention and control participants will again be assessed. If the intervention
is found to be effective, the control counselors will be trained in the intervention and the
controls will begin to receive the intervention. The original intervention participants,
having successfully completed the mental health intervention, will then be invited to
participate in the social-economic intervention. That program will begin within 1-2 months
after the maintenance period is complete. The social-economic program (VSLA) will last
approximately 9 months, after which the intervention participants will again be assessed.
For the VSLA study, eligible women will be recruited and invited to form groups to
participate in the social-economic program (VSLA). Once eligibility is determined, the time
to initiation of the VSLA program will be about 1 month. The VSLA program will include 8-10
weeks of active training with weekly or bi-weekly sessions, followed by a period of program
implementation when the groups of women will save and make loans. At the end of 9 months, the
women will complete the VSLA program cycle and get the financial returns on their funds. At
that time, a brief qualitative assessment will be conducted followed by a quantitative
assessment with the VSLA participants and controls. After the assessment, the control
participants will be invited to participate in the VSLA program. All participants will then
again be assessed when the controls have completed their program, after approximately 9
months.
