Table 2 Phase 2. Feasibility trial with embedded process evaluation and economic evaluation. Study assessments
Procedures | Initial screening by recruitment site worker | Final screening by study researcher | Baseline assessment by study researcher | 6-month follow up by study researcher | Measurement tool |
|---|---|---|---|---|---|
Eligibility assessment | |||||
 Age | x |  | x |  | Bespoke socio-demographic questionnaire: age, ethnicity, education, employment, marital status, children, housing, and financial situation |
 Speaking and understanding English | x |  |  |  | Recruitment site worker’s judgement |
 Diagnosed psychosis, bipolar disorder, personality disorder | x |  |  |  | Recruitment site case record |
 Current psychological therapy | x |  |  |  | Recruitment site case record |
 Readiness to start mindfulness group or alternative talking therapy on the NHS | x |  |  |  | Woman’s own judgement |
 Post-traumatic stress disorder (PTSD) |  | x |  |  | The Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) [33] |
 Current alcohol dependence |  | x |  |  | The Alcohol Use Disorders Identification Test Consumption (AUDIT-C) [34] |
 Current drug dependence |  | x |  |  | The Drug use Disorders Identification Test (DUDIT) [35] |
 Suicide history |  | x |  |  | Bespoke questions: • I made plans to end my life in the last 2 weeks • I made attempts to end my life in the last 12 months |
Trial assessments | |||||
 Live events |  |  | x |  | The Life Events Checklist for DSM-5 (LEC-5) Standard [36] |
 Clinically important symptoms of PTSD |  |  | x | x | The PTSD Checklist for DSM-V (PCL-5) [36] |
 Clinically important symptoms of complex PTSD |  |  | x | x | The International Trauma Questionnaire (ITQ) [37] |
 Depression |  |  | x | x | The Patient Health Questionnaire-9 (PHQ-9) [38] |
 Anxiety |  |  | x | x | Generalized Anxiety Disorder-7 (GAD-7) [39] |
 Adverse childhood experiences |  |  | x |  | Brief screening version of the Childhood Trauma Questionnaire [40] |
 Domestic violence and abuse |  |  | x | x | Composite Abuse Scale Revised-Short Version [41] |
 Dissociative symptoms |  |  | x | x | The Severity of Dissociative Symptoms—Adult (Brief Dissociative Experiences Scale [DES-B]—Modified) [42] |
 Self-compassion |  |  | x | x | Self-Compassion Scale–Short Form (SCS-SF) [43] |
Embedded health economic evaluation | |||||
 Health related quality of life, women |  |  | x | x | EQ-5D-5L [44] |
 Health-related quality of life, index child |  |  | x | x | KIDSCREEN-10 Index. Health Questionnaire for Children and Young People. Parent Version [45] |
 Resource use |  |  |  | x | Bespoke |
 Intervention cost |  |  |  |  | Study documentation |
Embedded process evaluation | |||||
 Qualitative semi-structured interviews with trial participants |  |  |  | x | Topic guide about experiences of the trial and interventions (Supplementary file 3) |
 Feedback form (intervention arm) |  |  |  | x | Bespoke |