Table 2 Foundation and rationale for the final intervention design
| Â | Description | Foundation and rationale |
|---|---|---|
Sample population | Nulliparous women in the second trimester of pregnancy. | Advisory group and service user group: focus on nulliparous women forpreliminary testing (facilitate data analysis and more likely to have and abilityto participate). |
Participant eligibility | Inclusion criteria: 1. Nulliparous pregnant women 2. Self- report mild-moderate anxiety Exclusion criteria: 1.Receiving treatment for a severe and enduring mentalhealth condition. 2. Complex social factors (NICE [60]). | Current clinical policy: women with severe mental health concerns andcomplex social factors have established referral pathways to specialist services. Eligibility screening method: Consider using validated anxiety measurementtools (NICE [61], Sinesi et al. [76], Nath et al. [59]). |
Inclusion screening | The anxiety measurement tool will be administered by thecommunity midwife to indicate women who meet the cut-offscore for mild to moderate. | Systematic review: rationale for inclusion screening should be discussedwithin a supportive context. Advisory group suggested: midwives may require training of anxiety tooladministration. Service user feedback: inclusion screening would be acceptable; the midwifeshould be aware of concerns women may have about disclosing symptoms. |
Intervention facilitator | The intervention will be facilitated by midwives and co-facilitatedby MSWs. They will receive training to deliver the intervention.One midwife and one support worker will facilitate each group. | Systematic review: delivered by psychiatrists, psychologists, midwives,instructors, self-help and volunteers. Advisory group suggested: women may be more willing to seek supportfrom midwives than mental health professionals. Service user feedback: supported midwife facilitation Consultations with trainers: two facilitators optimal for group interventions. Service Manager feedback: Suggestions to include support workers asco-facilitators. |
Intervention components | Delivered in three components: Component 1: one to one pre-group meeting with the midwifefacilitator. | Systematic review: some women had concerns about disclosing symptomsand feared the judgment of others (in groups). Initial meetings with facilitatorshelped women feel more confident to join the group. Advisory group: one to one meetings provide opportunity to discussconcerns and answer questions. |
Component 2: Four sessions facilitated by a midwife and MSW.Sessions will take place fortnightly and will be held in communityhealthcare centres. Each session will last for 90 min (either earlyevening or weekends). | Systematic review: group discussion sessions were highlighted as animportant and valued component Advisory group: self-help resources with discussion sessions supported asan option. CBT may not be feasible for the study due to the intensive trainingrequired for delivery. Advisory group: support for community locations Service user feedback: groups may help normalise experiences and buildsocial support. Service user feedback: offer outside daytime working hours. | |
Component 3: Choice of self-help resources for completionbetween sessions: | Systematic review: some participants reported self-help interventions aschallenging but also helpful Advisory group: self-help resources supported as an option Service user feedback: considered useful, women should be able to choosefrom different formats. |