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

June 16, 2023 updated by: Johns Hopkins Bloomberg School of Public Health

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

706

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control - VSLA
the wait control sample for the economic intervention
Other: Control - Mental Health
treatment as usual based on standard psychosocial services in the area
Behavioral: Treatment as usual
Standard psychosocial counseling
Other Names:
  • TAU
Experimental: Voluntary Savings/Loans Assoc
Behavioral: Voluntary Savings/Loans Assoc
economic intervention for group savings and loans
Other Names:
  • economic intervention of savings and loans program
Experimental: Cognitive Processing Therapy
Behavioral: Cognitive Processing Therapy
group 12 session intervention
Other Names:
  • cognitive behavioral therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of mental health symptoms
Time Frame: previous 4 weeks
Several measures of mental health problems including depression, anxiety, and post-traumatic distress, will be assessed as primary outcomes.
previous 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Economic development
Time Frame: prior 4 weeks
A variety of economic indicators, including income, time spent working and food consumption, will be assessed for intervention impact.
prior 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Investigators

  • Principal Investigator: Judith Bass, PhD, Johns Hopkins Bloomberg School of Public Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

June 22, 2011

First Submitted That Met QC Criteria

June 28, 2011

First Posted (Estimated)

June 29, 2011

Study Record Updates

Last Update Posted (Estimated)

June 19, 2023

Last Update Submitted That Met QC Criteria

June 16, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JHU-AMHR-IRC-2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression

Clinical Trials on Treatment as usual

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe