DepressionNCT01385163
Intervention Effectiveness in Improving Psychosocial and Economic Well-being of Sexual Violence Survivors in DRC
A study testing Treatment as usual, Voluntary Savings/Loans Assoc and Cognitive Processing Therapy in people with Depression and Anxiety, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Democratic Republic of the Congo.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Depression, Anxiety, PTSD
- What is being tested?
- Treatment as usual, Voluntary Savings/Loans Assoc and Cognitive Processing Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 706 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- Oct 2010to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- survivor of sexual violence
- mental health symptom severity cut-off
- functional impairment cut-off
Who cannot join
- active suicidality
- not living in the study site
Trial locations and contacts
1 site in 1 country.
Democratic Republic of the Congo1 site
Village based
Bukavu, South Kivu
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Depression, Anxiety, PTSD
- Being tested
- Treatment as usual, Voluntary Savings/Loans Assoc, Cognitive Processing Therapy
- Keywords
- mental health, gender-based violence, Africa
- Medical subject headings
- Depression, Anxiety Disorders, Stress Disorders, Post-Traumatic, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment as usualBehavioural
Also called TAU
Standard psychosocial counseling
Voluntary Savings/Loans AssocBehavioural
Also called economic intervention of savings and loans program
economic intervention for group savings and loans
Cognitive Processing TherapyBehavioural
Also called cognitive behavioral therapy
group 12 session intervention
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Treatment as usual |
| Voluntary Savings/Loans Assoc | Experimental | Not described Receives: Behavioral: Voluntary Savings/Loans Assoc |
| Cognitive Processing Therapy | Experimental | Not described Receives: Behavioral: Cognitive Processing Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of mental health symptoms
Several measures of mental health problems including depression, anxiety, and post-traumatic distress, will be assessed as primary outcomes.
Measured: previous 4 weeks
Secondary outcomes (1)
Economic development
A variety of economic indicators, including income, time spent working and food consumption, will be assessed for intervention impact.
Measured: prior 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2011 (estimated)
- Study startOct 2010
- Primary completionAug 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 706 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Judith Bass, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01385163
- Sponsor's protocol ID
- JHU-AMHR-IRC-2010
- Status last verified
- Jun 2023
- First submitted
- 22 Jun 2011
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 37795783Murray 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.
PubMed 29449879Bass 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.
PubMed 23738545
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Intervention Effectiveness in Improving Psychosocial and Economic Well-being of Sexual Violence Survivors in DRC
- ClinicalTrials.gov ID
- NCT01385163
- Acronym / sponsor ID
- JHU-AMHR-IRC-2010
- Conditions
- Depression, Anxiety, PTSD
- Keywords
- mental health, gender-based violence, Africa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 706 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 29 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control - VSLA | No intervention | –the wait control sample for the economic intervention |
| Control - Mental Health | Other | Behavioral: Treatment as usualtreatment as usual based on standard psychosocial services in the area |
| Voluntary Savings/Loans Assoc | Experimental | Behavioral: Voluntary Savings/Loans Assoc |
| Cognitive Processing Therapy | Experimental | Behavioral: Cognitive Processing Therapy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- survivor of sexual violence
- mental health symptom severity cut-off
- functional impairment cut-off
Key exclusion criteria (2 listed)
- active suicidality
- not living in the study site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment as usualAlso: TAUStandard psychosocial counseling | Behavioural | Control - Mental Health |
| Voluntary Savings/Loans AssocAlso: economic intervention of savings and loans programeconomic intervention for group savings and loans | Behavioural | Voluntary Savings/Loans Assoc |
| Cognitive Processing TherapyAlso: cognitive behavioral therapygroup 12 session intervention | Behavioural | Cognitive Processing Therapy |
Primary outcome
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.
1 secondary outcome
Economic development
Time frame: prior 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Derived from this study: PubMed 37795783O'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.
- Derived from this study: PubMed 29449879Murray 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.
- Derived from this study: PubMed 23738545Bass 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith Bass, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment as usual, Voluntary Savings/Loans Assoc and Cognitive Processing Therapy in people with Depression and Anxiety, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Democratic Republic of the Congo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of mental health symptoms (time frame: previous 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01385163, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.