Intervention Effectiveness in Improving Psychosocial and Economic Well-being of Sexual Violence Survivors in DRC

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Johns Hopkins Bloomberg School of Public Health.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT01385163
First received: June 22, 2011
Last updated: July 15, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Depression
Anxiety
PTSD
Behavioral: Treatment as usual
Behavioral: Voluntary Savings/Loans Assoc
Behavioral: Cognitive Processing Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Intervention Effectiveness in Improving Psychosocial and Economic Well-being of Sexual Violence Survivors in DRC

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • Severity of mental health symptoms [ Time Frame: previous 4 weeks ] [ Designated as safety issue: No ]
    Several measures of mental health problems including depression, anxiety, and post-traumatic distress, will be assessed as primary outcomes.


Secondary Outcome Measures:
  • Economic development [ Time Frame: prior 4 weeks ] [ Designated as safety issue: No ]
    A variety of economic indicators, including income, time spent working and food consumption, will be assessed for intervention impact.


Estimated Enrollment: 1000
Study Start Date: October 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control - VSLA
the wait control sample for the economic intervention
Control - Mental Health
treatment as usual based on standard psychosocial services in the area
Behavioral: Treatment as usual
Standard psychosocial counseling
Other Name: TAU
Experimental: Voluntary Savings/Loans Assoc Behavioral: Voluntary Savings/Loans Assoc
economic intervention for group savings and loans
Other Name: economic intervention of savings and loans program
Experimental: Cognitive Processing Therapy Behavioral: Cognitive Processing Therapy
group 12 session intervention
Other Name: cognitive behavioral therapy

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01385163

Locations
Congo
Village based Recruiting
Bakavu, South Kivu Province, Congo
Contact: Judith Bass, PhD    410-502-9840    jbass@jhsph.edu   
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Investigators
Principal Investigator: Judith Bass, PhD Johns Hopkins Bloomberg School of Public Health
  More Information

No publications provided by Johns Hopkins Bloomberg School of Public Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Judith Bass, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01385163     History of Changes
Other Study ID Numbers: JHU-AMHR-IRC-2010
Study First Received: June 22, 2011
Last Updated: July 15, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
mental health
gender-based violence
Africa

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Mental Disorders
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on April 17, 2014