Clinical trial NCT01385163: Intervention Effectiveness in Improving Psychosocial and Economic Well-being of Sexual Violence Survivors in DRC
Official title: Study of Intervention Effectiveness in Improving Psychosocial and Economic Well-being of Sexual Violence Survivors in DRC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
PTSD
Keywords: mental health
gender-based violence
Africa
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
First posted: 2011-06-29
Enrollment: 706
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* survivor of sexual violence
* mental health symptom severity cut-off
* functional impairment cut-off

Exclusion Criteria:

* active suicidality
* not living in the study site

Primary outcomes:
measure: Severity of mental health symptoms
timeFrame: previous 4 weeks
Secondary outcomes:
measure: Economic development
timeFrame: prior 4 weeks
Other outcomes:
Locations:
city: Bukavu
country: Congo, The Democratic Republic of the
facility: Village based
state: South Kivu Province
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Judith Bass, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Murray SM, Augustinavicius J, Kaysen D, Rao D, Murray LK, Wachter K, Annan J, Falb K, Bolton P, Bass JK. The impact of Cognitive Processing Therapy on stigma among survivors of sexual violence in eastern Democratic Republic of Congo: results from a cluster randomized controlled trial. Confl Health. 2018 Feb 12;12:1. doi: 10.1186/s13031-018-0142-4. eCollection 2018.
citation: Bass JK, Annan J, McIvor Murray S, Kaysen D, Griffiths S, Cetinoglu T, Wachter K, Murray LK, Bolton PA. Controlled trial of psychotherapy for Congolese survivors of sexual violence. N Engl J Med. 2013 Jun 6;368(23):2182-91. doi: 10.1056/NEJMoa1211853.