Abstract
BACKGROUND: Experience of domestic violence and abuse (DVA) is associated with mental illness. Advocacy has little effect on mental health outcomes of female DVA survivors and there is uncertainty about the effectiveness of psychological interventions for this population. OBJECTIVE: To test effectiveness of a psychological intervention delivered by advocates to DVA survivors. DESIGN, MASKING, SETTING, PARTICIPANTS: Pragmatic parallel group individually randomized controlled trial of normal DVA advocacy vs. advocacy + psychological intervention. Statistician and researchers blinded to group assignment. Setting: specialist DVA agencies; two UK cities. Participants: Women aged 16 years and older accessing DVA services. INTERVENTION: Eight specialist psychological advocacy (SPA) sessions with two follow up sessions. MEASUREMENTS: Primary outcomes at 12 months: depression symptoms (PHQ-9) and psychological distress (CORE-OM). Primary analysis: intention to treat linear (logistic) regression model for continuous (binary) outcomes. RESULTS: 263 women recruited (78 in shelter/refuge, 185 in community), 2 withdrew (1 community, control group; 1 intervention, refuge group), 1 was excluded from the study for protocol violation (community, control group), 130 in intervention and 130 in control groups. Recruitment ended June 2013. 12-month follow up: 64%. At 12-month follow up greater improvement in mental health of women in the intervention group. Difference in average CORE-OM score between intervention and control groups: -3.3 points (95% CI -5.5 to -1.2). Difference in average PHQ-9 score between intervention and control group: -2.2 (95% CI -4.1 to -0.3). At 12 months, 35% of the intervention group and 55% of the control group were above the CORE-OM -2clinical threshold (OR 0.32, 95% CI 0.16 to 0.64); 29% of the intervention group and 46% of the control group were above the PHQ-9 clinical threshold (OR 0.41, 95% CI 0.21 to 0.81). LIMITATIONS: 64% retention at 12 months. CONCLUSIONS: An eight-session psychological intervention delivered by DVA advocates produced clinically relevant improvement in mental health outcomes compared with normal advocacy care. TRIAL REGISTRATION: ISRCTN registry ISRCTN58561170 Original Research 3675/3750.