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

NCT01385163 | Completed

• 1 other identifier: JHU-AMHR-IRC-2010
• Study Type: interventional
• Target: 706
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Anxiety; PTSD

Keywords

mental health; gender-based violence; Africa

Outcome Measures

Primary Outcomes (1)

• Severity of mental health symptoms

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

  previous 4 weeks

Secondary Outcomes (1)

• Economic development

  prior 4 weeks

Study Arms (4)

Control - VSLA

NO INTERVENTION

the wait control sample for the economic intervention

Control - Mental Health

OTHER

treatment as usual based on standard psychosocial services in the area

Behavioral: Treatment as usual

Voluntary Savings/Loans Assoc

EXPERIMENTAL

Behavioral: Voluntary Savings/Loans Assoc

Cognitive Processing Therapy

EXPERIMENTAL

Behavioral: Cognitive Processing Therapy

Interventions

Treatment as usual BEHAVIORAL

Standard psychosocial counseling

Also known as: TAU

Control - Mental Health

Voluntary Savings/Loans Assoc BEHAVIORAL

economic intervention for group savings and loans

Also known as: economic intervention of savings and loans program

Voluntary Savings/Loans Assoc

Cognitive Processing Therapy BEHAVIORAL

group 12 session intervention

Also known as: cognitive behavioral therapy

Cognitive Processing Therapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• active suicidality
• not living in the study site

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead

Study Sites (1)

Village based

Bukavu, South Kivu, Democratic Republic of the Congo

Location

Related Publications (3)

• O'Doherty L, Whelan M, Carter GJ, Brown K, Tarzia L, Hegarty K, Feder G, Brown SJ. Psychosocial interventions for survivors of rape and sexual assault experienced during adulthood. Cochrane Database Syst Rev. 2023 Oct 5;10(10):CD013456. doi: 10.1002/14651858.CD013456.pub2.

  PMID: 37795783 DERIVED

• 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.

  PMID: 29449879 DERIVED

• 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.

  PMID: 23738545 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders; Stress Disorders, Post-Traumatic; Psychological Well-Being

Interventions

Therapeutics; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Judith Bass, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 405+
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2011
• First Posted: June 29, 2011
• Study Start: October 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: July 1, 2013
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

DE (1)