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

Primary Purpose

Depression, Anxiety, PTSD

Status
Completed
Phase
Not Applicable
Locations
Congo, The Democratic Republic of the
Study Type
Interventional
Intervention
Treatment as usual
Voluntary Savings/Loans Assoc
Cognitive Processing Therapy
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring mental health, gender-based violence, Africa

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Village based

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Other

Experimental

Experimental

Arm Label

Control - VSLA

Control - Mental Health

Voluntary Savings/Loans Assoc

Cognitive Processing Therapy

Arm Description

the wait control sample for the economic intervention

treatment as usual based on standard psychosocial services in the area

Outcomes

Primary Outcome Measures

Severity of mental health symptoms
Several measures of mental health problems including depression, anxiety, and post-traumatic distress, will be assessed as primary outcomes.

Secondary Outcome Measures

Economic development
A variety of economic indicators, including income, time spent working and food consumption, will be assessed for intervention impact.

Full Information

First Posted
June 22, 2011
Last Updated
June 16, 2023
Sponsor
Johns Hopkins Bloomberg School of Public Health
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1. Study Identification

Unique Protocol Identification Number
NCT01385163
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins Bloomberg School of Public Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, PTSD
Keywords
mental health, gender-based violence, Africa

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
405+
Allocation
Randomized
Enrollment
706 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control - VSLA
Arm Type
No Intervention
Arm Description
the wait control sample for the economic intervention
Arm Title
Control - Mental Health
Arm Type
Other
Arm Description
treatment as usual based on standard psychosocial services in the area
Arm Title
Voluntary Savings/Loans Assoc
Arm Type
Experimental
Arm Title
Cognitive Processing Therapy
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual
Other Intervention Name(s)
TAU
Intervention Description
Standard psychosocial counseling
Intervention Type
Behavioral
Intervention Name(s)
Voluntary Savings/Loans Assoc
Other Intervention Name(s)
economic intervention of savings and loans program
Intervention Description
economic intervention for group savings and loans
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Processing Therapy
Other Intervention Name(s)
cognitive behavioral therapy
Intervention Description
group 12 session intervention
Primary Outcome Measure Information:
Title
Severity of mental health symptoms
Description
Several measures of mental health problems including depression, anxiety, and post-traumatic distress, will be assessed as primary outcomes.
Time Frame
previous 4 weeks
Secondary Outcome Measure Information:
Title
Economic development
Description
A variety of economic indicators, including income, time spent working and food consumption, will be assessed for intervention impact.
Time Frame
prior 4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith Bass, PhD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Village based
City
Bukavu
State/Province
South Kivu Province
Country
Congo, The Democratic Republic of the

12. IPD Sharing Statement

Citations:
PubMed Identifier
29449879
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.
Results Reference
derived
PubMed Identifier
23738545
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. Erratum In: N Engl J Med. 2014 Jun 26;370(26):2547.
Results Reference
derived

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

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