The MRC described complex interventions as: 1) including several interacting components; 2) sensitive to the context in which they are delivered; 3) having a causal chain linking the intervention to outcomes; 4) having a range of possible outcomes (Craig et al. 2008). It was considered that a new intervention would need to operate within different maternity settings and be delivered to different populations of pregnant women. The choice of intervention components should include consideration of how the mechanisms of change would function within the context of maternity care structures and propose ways the mechanisms would influence women’s symptoms of anxiety. Therefore, the intervention was considered as ‘complex’ and the stages of the intervention development followed the general principles outlined by the MRC theoretical and modelling phases for complex interventions (Craig et al. 2008) (Fig. 1).
Identifying the evidence base
The MRC state that the development of a complex intervention should begin by identifying the relevant, existing evidence base (Craig et al. 2008). Existing reviews which have evaluated the effectiveness of interventions on anxiety outcomes in pregnancy have focused on depression, mind-body or pharmacological interventions or included women with severe anxiety. Therefore two systematic reviews were completed to identify the evidence base for non-pharmacological interventions delivered to women with mild to moderate anxiety in pregnancy (Evans et al. 2017, 2019). The systematic reviews asked the following questions:
How effective are non-pharmacological interventions in reducing the symptoms of mild to moderate anxiety in pregnancy?
How acceptable and beneficial are non-pharmacological interventions for reducing the symptoms of mild to moderate anxiety?
The two systematic reviews concluded that interventions, specifically designed to support pregnant women with mild to moderate anxiety have mainly been evaluated in small scale studies. Studies evaluated different intervention designs for different populations and overall results were inconclusive regarding intervention effectiveness. Although no particular design which could be directly recommended for clinical practice was identified, the synthesised review findings helped identify components likely to increase the effectiveness and acceptability of the intervention. There was some evidence of benefit for group interventions and women valued the opportunity to share experiences, reducing feelings of isolation and accessing group support. Some women were reported to feel they benefitted from having an individual discussion with their healthcare professionals (HCP). Women were motivated to self-select into intervention studies however, some had concerns about disclosing anxiety symptoms and joining groups. There was some evidence of benefit for multi-session interventions and women identified group sessions as helpful once groups became established. Studies which reported an improvement in anxiety scores included group mindfulness, mindfulness based cognitive therapy, motivational interviewing, relaxation and/or CBT interventions. Women welcomed interventions which presented options for managing their symptoms and included peer and professional support (Evans et al. 2019).
Identifying appropriate theory
The theory underpinning the potentially beneficial intervention components as identified in the two reviews were explored (Table 1). This process strengthened the rationale for the final intervention design and helped to define the process of change in relation to anxiety symptoms in pregnancy (Moore et al. 2015). The development of complex interventions requires researchers to develop an awareness of the relevant theory underpinning intervention components to increase the likelihood of the effectiveness of the intervention design (Craig et al. 2008, Garber & Weersing 2010). A description of the intervention’s underlying theoretical basis should include specific theories, theoretical positions, and frameworks as well as empirical evidence which may have been conducted in different settings or countries (Mohler et al 2015).
Summary of the findings from the systematic reviews and the theory underpinning the intervention components
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Women’s views on intervention components
Group and individual interventions
Interventions delivered to groups of pregnant women
• Able to share experiences
• Accessed group support
• Reduced feelings of isolation
• Helped to normalise women’s experiences
• Social support
o Experiential knowledge
o Social learning
o Social comparison
o Peer support
Interventions delivered to individuals
• Received support from HCPs
• Provided reassurance and guidance
• Therapeutic relationships
o Collaborative role theory
o Relational continuity
o Social influence
• Provided options and coping strategies for managing anxiety symptoms
• Learned breathing and relaxation techniques
• Learned to recognise and accept anxious thoughts
• Felt more positive about the future
• Awareness, self-regulation and acceptance
• Relaxation response
• Developed an understanding of the causes of anxiety in their lives and self-awareness of their thought patterns.
• Helped women respond in a more positive way to situations and feelings, before negative thought patterns could escalate.
• Cognitive behavioural mechanisms
Social support theory
Social support may have a positive effect on wellbeing, such as providing: 1. compassion, reassurance and a sense of self-worth; 2. access to new contacts and information to help develop problem solving skills; 3. reducing feelings of uncertainty and develop a sense of control; 4. providing instrumental support to reduce the frequency and duration of stressors; 5. influencing positive health behaviours (Heaney & Israel 2008). Social support pathways include components of experiential knowledge; social learning theory; social comparison theory and the helper-therapy principle (Salzer & Shear 2002). Individuals to resolve their problems through sharing their experiences of mental illness with others who are experiencing similar situations (Borkman 1999) and can benefit by learning from others with who have succeeded in managing their symptoms (Simoni et al. 2011).
Therapeutic relation theory
Collaborative therapeutic relationships enable pregnant women to feel physically and psychologically supported which facilitates confidence building and self-efficacy (Carolan & Hodnett 2007). Continuity of carer from a midwife known to the woman throughout pregnancy and the intrapartum period has been associated with improved health outcomes for women and babies (Sandall et al. 2016). Benefits include an increased sense of trust, choice and control. Social influence theory recognises that the HCP’s may be seen as a source of social power due to their access to information, resources and services. While this may be beneficial, it is also associated with negative outcomes if individuals are influenced or coerced into compliance to gain access to services or information. Excessive information seeking and reassurance seeking are common features of anxiety disorders and can have a negative impact on outcomes and the practitioner–service user relationship (Osborne & Williams 2013). A pregnant woman with health anxiety may continually or excessively seek reassurance about fetal growth, the progress of their pregnancy and about the birth (Bayrampour et al. 2016). HCPs need to be aware of possible service user motivations for seeking reassurance about their health and wellbeing and suggest strategies, such as CBT, to help modify negative behavioural patterns (Williams 2012).
Awareness of mind and body experiences enables an individual to direct their attention to their breathing or another object of focus, to prevent elaborative ruminative thought processing (Gard et al. 2014, NurrieStearns & NurrieStearns 2013). Acceptance involves a conscious decision to allow current thoughts, feelings and sensations with an attitude of openness and receptivity (Hayes-Skelton & Roemer 2013). It is theorised that acceptance of thought leads to a reduction in the use of cognitive and behavioural strategies used to avoid negative thoughts and reduce self-condemnation (Hayes-Skelton & Roemer 2013).
The relaxation response is thought to counteract the stress response of anxiety. Physiological mechanisms and adjustments are activated when an individual engages in repetitive mental or physical activity and is able to passively ignore anxious thoughts (Manzoni et al. 2008).
In the treatment of anxiety disorders, the aim of CBT is to reduce anxious feelings by undoing prior learning or by providing new, more adaptive learning experiences, changing cognitive and behavioural responses to anxiety (Williams & Garland 2002). Increasing an individual’s awareness of unwanted emotions and behaviours is thought to generate a number of alternative responses. This helps the individual to decide on a course of action and monitor the outcome to re-enforce positive coping strategies (Brewin 1996). CBT for anxiety disorders may include components of:
Psycho-education on the nature of fear/anxiety.
Cognitive restructuring to challenge the truth of anxious thoughts and develop alternative thoughts to better reflect their experience.
Behavioural exposure to help an individual to approach the feared stimuli and noting whether the expected disastrous result occurs (Brewin 1996).
Many of the interventions identified in the systematic reviews had multiple components: psycho-education; relaxation; peer support; and professional support. This multi-component approach was reflected in the interconnected theoretical approaches which underpinned existing intervention components. For example, CBT techniques are often incorporated within therapeutic relationship approaches and can be accessed as a resource within peer support models.
A theoretical model was developed to map the potential mechanisms and their usefulness in meeting the needs of pregnant women with symptoms of mild to moderate anxiety (Fig. 2). Exploring the theoretical base highlighted that positive change can occur though: 1. developing collaborative relationships with women which aim to promote women’s choice and control over their care. 2. receiving support from HCPs who both understand women’s individual needs and can also help them access services; 3. accessing support and learning from other women who have experienced / are experiencing similar feelings or situations; 4. developing strategies to help women develop an awareness of their thought processes and learn techniques to improve the way they cope with anxiety. Mind-body and/or CBT approaches were considered as appropriate components of the intervention design.
Additional considerations and motivations informing the intervention design
In response to the increased focus on the role of the midwife to support the psychological and emotional wellbeing of women in pregnancy (MMHA 2013), the development work explored ways in which women could be supported by midwives within midwives current scope of practice (Nursing & Midwifery Council 2013). It was considered that a midwife could facilitate peer groups, acting as a resource to the women. Midwife facilitation may be more appropriate when groups are establishing, until women feel confident to contribute and lead the group themselves (Brown & Lucksted 2010). Women who feel isolated in pregnancy or have poor social support may benefit from peer group approaches, however some women may not feel confident to share their situations or feelings within a group. Women may have additional pregnancy related or mental health concerns which they would prefer to discuss individually with a midwife who can provide maternity expertise and support referrals or signposting to other specialist services such as Increasing Access to Psychological Therapies (IAPT). The options for the delivery of the intervention components, considering the feasibility of employing midwife facilitators and facilitator training requirements were mapped (Fig. 3).
It was considered that the therapeutic intervention components (mind body and cognitive behavioural approaches) could be delivered through supported use of self-help resources. Guided self-help has been reported as an effective intervention for depression and anxiety in general populations (Seekles et al. 2011) and has been used as a stand-alone intervention or alongside group interventions for pregnant women with anxiety, stress and depression (Evans et al. 2017). Potential self-help resources were identified evaluated using IAPT criteria (IAPT 2010) .
Modelling process and outcomes
For this study, potential intervention components and processes were tested through consultations with a study advisory group and a maternity research public involvement group. The advisory group consisted of the head of nursing and midwifery research at the local NHS trust, a community psychiatric nurse, a midwife manager, a service user, consultant clinical psychologist and mental health training providers. Service users provided insight into how the intervention would be accessed and used and ensured the intervention was relevant to the needs of pregnant women (INVOLVE 2012, Moss et al 2016). Both groups supported the proposed intervention components and helped to identify methods of delivery for the intervention which considered: the context and methods for introducing the intervention, assessing eligibility, method of delivery and facilitation of peer groups; and delivery of the therapeutic components. Rather than having two midwife facilitators, service managers identified that a midwifery support worker (MSW) could provide support to the midwife during the groups and co-facilitate the intervention. A bespoke training framework was developed for midwives and MSWs which referred to existing perinatal competency frameworks (NHS Education for Scotland 2006, NHS England & The Tavistock and Portman NHS Foundation Trust 2016). Experienced mental health training providers developed a three day training workshop which included a range of educational and learning approaches e.g. role play, lectures and the completion of an information and reflective workbook.
Following the evaluation of the evidence base, exploring the theoretical base and consultations with stakeholder groups, a protocol was developed for the intervention (Mohler et al. 2015, Fig. 4 & Table 2).
Foundation and rationale for the final intervention design
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Foundation and rationale
Nulliparous women in the second trimester of pregnancy.
Advisory group and service user group: focus on nulliparous women for preliminary testing (facilitate data analysis and more likely to have and ability to participate).
1. Nulliparous pregnant women
2. Self- report mild-moderate anxiety
1.Receiving treatment for a severe and enduring mental health condition.
2. Complex social factors (NICE 2010).
Current clinical policy: women with severe mental health concerns and complex social factors have established referral pathways to specialist services.
Eligibility screening method: Consider using validated anxiety measurement tools (NICE 2014, Sinesi et al. 2019, Nath et al. 2018).
The anxiety measurement tool will be administered by the community midwife to indicate women who meet the cut-off score for mild to moderate.
Systematic review: rationale for inclusion screening should be discussed within a supportive context.
Advisory group suggested: midwives may require training of anxiety tool administration.
Service user feedback: inclusion screening would be acceptable; the midwife should be aware of concerns women may have about disclosing symptoms.
The intervention will be facilitated by midwives and co-facilitated by 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 support from 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 as co-facilitators.
Delivered in three components:
Component 1: one to one pre-group meeting with the midwife facilitator.
Systematic review: some women had concerns about disclosing symptoms and feared the judgment of others (in groups). Initial meetings with facilitators helped women feel more confident to join the group.
Advisory group: one to one meetings provide opportunity to discuss concerns and answer questions.
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Component 2: Four sessions facilitated by a midwife and MSW. Sessions will take place fortnightly and will be held in community healthcare centres. Each session will last for 90 minutes (either early evening or weekends).
Systematic review: group discussion sessions were highlighted as an important and valued component
Advisory group: self-help resources with discussion sessions supported as an option. CBT may not be feasible for the study due to the intensive training required for delivery.
Advisory group: support for community locations
Service user feedback: groups may help normalise experiences and build social support.
Service user feedback: offer outside daytime working hours.
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Component 3: Choice of self-help resources for completion between sessions:
Systematic review: some participants reported self-help interventions as challenging but also helpful
Advisory group: self-help resources supported as an option
Service user feedback: considered useful, women should be able to choose from different formats.
Key assumptions, process interventions and indicators relating to the Theory of Change for the proposed intervention
1. Midwives and midwifery support workers are motivated to apply to be trained and participate as intervention facilitators; Maternity mangers are willing to release midwives and midwifery supporters time to complete training and facilitate the intervention; Intervention facilitators are supported by specialist PMH teams and professional midwifery advocates
2. Community midwives are confident and competent to delivery anxiety screening tools; Community midwives feel confident to discuss perinatal mental health with women and create the right context for women to disclose their symptoms and access supportive services
3. Specialist perinatal mental health teams and psychological services support the intervention as a service for women with sub-threshold symptoms of anxiety
Specialist perinatal mental health teams and psychological services are willing to support intervention facilitators by providing training in supporting women with anxiety and provide advice and referral pathways for women who are identified as having more severe symptoms or requiring more specialist support
4. Women are willing to disclose their symptoms and women with mild to moderate symptoms of anxiety are willing to attend and engage with the intervention
Women who develop more severe symptoms or are identified by intervention facilitators are requiring specialist support are willing to be accept a referral to specialist PMH services for assessment and treatment
2. Recruitment and training of facilitators
1. Intervention co-ordinator trained to monitor the intervention fidelity, measure outcomes and support facilitators across maternity systems
3. Training of community midwives to effectively screen for symptoms of anxiety and refer women with mild to moderate anxiety to intervention facilitators
Intervention facilitators to raise awareness of the intervention in local community teams
4. Establish a multi-disciplinary stakeholder team to support the implementation of the intervention
5. Women who develop more severe symptoms or are identified by intervention facilitators are requiring specialist support are referred to specialist PMH services for assessment and treatment
2. Facilitators assessment of the usefulness of training and preparedness to facilitate the intervention
3. 80% of community midwives are aware of the intervention and know how to refer women to intervention facilitators; 80% of women who are identified with mild to moderate symptoms of anxiety and are eligible for participation are referred to intervention facilitators
1. Intervention fidelity assessment reaches pre-agreed standards; Facilitators feel well supported in their roles; The intervention is implemented across maternity care systems
4. Women attend 75% of intervention sessions; Rates of appropriate referrals to specialist services
5. Women report an improvement in anxiety scores (pre-agreed % in improvement); Women’s evaluation of the acceptability and usefulness of the intervention; Improvement in infant outcomes; Improvement in perinatal mental health in the postnatal period (3, 6 and 12 months)
The MRC (Craig et al. 2008) state that the future implementation of the intervention needs to be considered at an early stage of development. This should ask questions about whether implementation would be possible, who the key stakeholders are and what information they may need to implement changes in practice. De Silva et al. (2014) proposed that the current MRC guidance could be strengthened by incorporating Theory of Change (TOC) into the design and evaluation of complex interventions To help identify the intervention processes and success indicators a TOC map was developed (Fig. 5). TOC defines how and why an initiative works, providing a pragmatic framework to describe how the intervention affects change (Weiss 1995, de Silva et al 2014). Each pre-condition for the intervention is evidence based and measured through an indicator. The TOC can help reduce future implementation failures as weak links in the causal pathway can be tested, revised and strengthened. The TOC map set out to answer a series of questions which asked how the intervention could be integrated into routine practice and identifying how the intervention could be empirically tested in future definitive research (Bonell et al. 2012, de Silva et al. 2014).