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Table 2 Foundation and rationale for the final intervention design

From: Developing a complex intervention to support pregnant women with mild to moderate anxiety: application of the Medical Research Council framework

  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.