| Study characteristics |
| Methods |
Study design: randomised controlled trial
Study grouping: parallel group
Duration of study: October 2010 to August 2012 (intervention ran from April 2011 to April 2012)
Location of study: 9 communities in South Kivu, Democratic Republic of the Congo
Randomisation method: 66 VSLA groups with 301 study women were available for randomisation in March 2011. The 66 groups were randomised into immediate start (intervention; 33 groups) and delayed start (control; 33 groups). The control groups did not receive VSLA training until year 2, when follow‐up data collection was completed.
Ethics approvals: study protocols were reviewed and approved by IRBs at the Johns Hopkins School of Public Health and Kinshasa School of Public Health. |
| Participants |
Baseline characteristics
Other psychosocial interventions (VSLAs)
Participants (select at randomisation if available): 159 Gender: 100% female participants Age, M (SD): 40.1 years (11.7 years) Ethnicity: 100% Black Disability: not given Time since trauma: not given Income: not given Education, M (SD) years: 2 (3.1) Employment: 18.9 h (16.5 h) of paid work in past 7 d Sexual violence in adulthood: 54.7% personally experienced sexual violence; 81.1% personally witnessed sexual violence Comorbid conditions: not given Baseline PTSD: not given Partnered: 54.1% Randomised (N): 159 Completed post‐treatment assessment (N): 135 Dropped out or removed prior to analysis (N): 0 Numbers analysed at final applicable time point (N): 159 Number of sessions: not given Treatment completion: not given
Wait‐list
Participants (select at randomisation if available): 142 Gender: 100% female participants Age, M (SD): 41.5 years (12.8 years) Ethnicity: 100% Black Disability: not given Time since trauma: not given Income: not given Education, M (SD) years: 1.9 (3.0) Employment: 22.5 h (19.9 h) paid work in past 7 d Sexual violence in adulthood: 68.3% personally experienced sexual violence; 85.9% personally witnessed sexual violence Comorbid conditions: not given Baseline PTSD: not given Partnered: 53.5% Randomised (N): 142 Completed post‐treatment assessment (N): 115 Dropped out or removed prior to analysis (N): 0 Numbers analysed at final applicable time point (N): 142 Number of sessions: not given Treatment completion: not given
Overall
Participants (select at randomisation if available): 301 Gender: 100% female participants Age: not given Ethnicity: 100% Black Disability: not given Time since trauma: not given Income: not given Education: not given Employment: not given Sexual violence in adulthood: 61% Comorbid conditions: not given Baseline PTSD: not given Partnered: 54% Approached (N): 695 Ineligible (N): 236 Declined (N): 2 Other (N): 156 Randomised (N): 301 Completed post‐treatment assessment (N): 250 Dropped out or removed prior to analysis (N): 0 Numbers analysed at final applicable time point (N): 301 Number of sessions: N/A Treatment completion: N/A
Inclusion criteria
Women aged 18 years of age or older Living in 1 of the 9 study sites Personally experienced or witnessed sexual violence (defined as rape locally) A score of at least 10 on the function assessment (i.e. some dysfunction on at least half of the tasks questions) A score of at least 55 on the mental health assessment (i.e. an average score of 1 for each symptom)
Exclusion criteria: severe suicidality
Pretreatment: women in the control group reported more types of traumatic events, were more ethnically diverse, worked more hours, had more people they could rely on, expressed greater group membership and spent more money on food for the household. |
| Interventions |
Intervention characteristics
Other psychosocial interventions (VSLAs)
Intensity of intervention: 10 months Mode of delivery (face‐to‐face, online, video, telephone, blend, with explanation): face‐to‐face Format (group, individual, blend): group Therapist qualifications and training appropriate (yes, no, unclear, with explanation): yes, the IRC is experienced at delivering the intervention. Research allegiance or conflict of interest (yes, no, unclear, with explanation): no, none declared Treatment fidelity (yes, no, unclear, with explanation): no, although the programme is described in detail in supplementary materials, there is no information on fidelity to the protocol. Intervention aim and theoretical basis: VSLA model was developed by CARE International, based on indigenous savings and loans groups in Africa. VSLAs provide a community‐managed mechanism for savings, loans and insurance for people who cannot access banks or microfinance institutions. It was hypothesised that participation in VSLAs would provide women who lacked access to financial services access to savings and loans in the safety of a trusted group. It was also hypothesised that for women who had experienced sexual violence, participation in the group‐based economic programme would improve their ability to care for themselves and contribute to their family's well‐being, resulting in improved self‐efficacy and a reduction in mental health symptoms; it was hypothesised that women who had experienced sexual violence would improve their social connectedness through being part of the economic group and that this, together with increased economic benefits, would reduce their experience of stigma.
Wait‐list
Intensity of intervention: N/A Mode of delivery: N/A Format: N/A Therapist qualifications and training appropriate: N/A Research allegiance or conflict of interest: N/A Treatment fidelity: N/A Intervention aim and theoretical basis: N/A
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| Outcomes |
PTSD
Outcome type: continuous outcome Scale used: Harvard Trauma Questionnaire Direction: lower is better Score range: 1 to 4 Data value: endpoint
Depression
Outcome type: continuous outcome Scale used: Hopkins Symptom Checklist Direction: lower is better Score range: 1 to 4 Data value: endpoint
Anxiety
Outcome type: continuous outcome Scale used: Hopkins Symptom Checklist Direction: lower is better Score range: 1 to 4 Data value: endpoint
Stigma
Outcome type: continuous outcome Scale used: Perceived and Internalised Stigma Direction: lower is better Score range: 1 to 4 Data value: endpoint
Global mental health
Outcome type: continuous outcome Scale used: Hopkins Symptom Checklist‐adapted Direction: lower is better Score range: 1 to 4 Data value: endpoint
|
| Identification |
Sponsorship source: United States Agency for International Development Victims of Torture Fund and the World Bank. Part of the analysis was supported by UK Aid from the UK Department for International Development for the benefit of developing countries.
Country: Democratic Republic of the Congo
Setting: women in the community who had sought support or disclosed to community‐based organisations about mental health problems due to potential trauma
Authors name: Judith K Bass
Institution: Johns Hopkins School of Public Health
Email: jbass@jhu.edu
Year: 2016
Ethics Approvals: study protocols were reviewed and approved by IRBs at the Johns Hopkins School of Public Health and Kinshasa School of Public Health. |
| Notes |
This study was included in meta‐analysis
Review team selected imputed data, but numbers per group included in analysis were not entirely clear. |
