Award Title: Optimising psychological treatment for Anxiety DisordErs in Pregnancy: a feasibility study for a Trial of time-intensive CBT versus weekly CBT (ADEPT)
Funder: Health Education England

Abstract: Background: There is increasing recognition that antenatal anxiety disorders are common, affecting 11-16% of women. They are by definition functionally impairing, can persist into the postpartum and can affect parenting. Antenatal anxiety has also been associated with elevated risks of behavioural problems in children. Children of parents with anxiety disorders are at increased risk of developing an anxiety disorder themselves. Therefore there is a clear need for effective treatment during pregnancy. Cognitive-behaviour therapy (CBT) is a well-evidenced treatment for anxiety disorders. Recently, time-intensive versions of CBT have been developed in non-perinatal populations, with comparable treatment effects achieved in a much shorter time for Obsessive-compulsive disorder (OCD), posttraumatic stress disorder (PTSD), panic disorder and social anxiety. Most women are in contact with services when pregnant and it is therefore a good time to intervene. Time-intensive CBT for antenatal anxiety disorders has the potential to alleviate maternal symptoms quickly and to prevent negative outcomes for parenting and children. The study will investigate whether (1) antenatal time-intensive CBT (IN-CBT) is acceptable to women with anxiety disorders and; (2) if it is feasible to test the effectiveness of IN-CBT compared with standard CBT in a full-scale trial. Plan of Investigation: The primary objective of the research is to test the feasibility of a definitive trial of antenatal IN-CBT against standard weekly antenatal CBT for anxiety disorders. This will be achieved by two sequential phases of the study: the first stage is the development and piloting of intensively delivered antenatal CBT for anxiety disorders in a case series so that it is tailored and relevant to the specific context in which it is delivered. The second stage is a feasibility study to see if it is possible to test the designed intervention in a full-scale trial with 30 women recruited into each of IN-CBT and standard weekly CBT. This will establish: (i) the best means of recruiting women (physical or mental health settings) (ii) if participants will be randomised (iii) if the intervention is delivered as intended (iv) the acceptability of the interventions (v) the properties of the primary outcome measure and (vi) follow up rates for participation in a full trial. Qualitative interviews will determine the perceived value, benefits, harms or unintended consequences of the intervention that should be measured in a full trial, the value that service providers and users place on the intervention and the outcomes it plans to deliver.This information will establish whether a full trial is appropriate and feasible. Potential benefits to patients and the NHS: In a fullscale trial, if this mode of delivery was found to be superior in terms of benefits for both mother and child, this would change practice regarding treatment of antenatal anxiety disorders. Given the recent expansions of primary care and perinatal services, there are increasing numbers of well-trained CBT therapists who could deliver IN-CBT. Evidence from this research therefore has the potential to shape their practice, focus resources and be of direct benefit to patients within a short time frame. Importantly, effective antenatal treatment could also benefit children and the wider family in terms of reduced exposure to maternal anxiety and less impact on parenting and relationships. Ultimately this could improve the burden on NHS services for adults and children.

Lay Abstract: Aims of the research: The aim of this research is to investigate if a shorter format of a well-established psychological therapy for anxiety disorders can be used with pregnant women. It will establish if pregnant women find this format acceptable and useful, and if this way of delivering the treatment can later be tested in a large trial. Background to the research: Anxiety disorders include a range of problems including panic disorder, post- traumatic stress disorder (PTSD), obsessive-compulsive disorder (OCD) and social anxiety disorder. They affect approximately 11% of pregnant women, impact on women's day to day functioning and often last into the postnatal period if untreated. In mothers, parenting, breastfeeding and mood can be affected and children are at an increased risk of developing behavioural and emotional difficulties. Anxiety during pregnancy has been linked to these effects on children and it is therefore an important time to treat maternal anxiety disorders.Cognitive behaviour therapy (CBT) is known to be an effective treatment for anxiety disorders. Many women prefer psychological treatments to medication during pregnancy and so this is often a good fit for women with these disorders. CBT is usually delivered over a period of three months. Recently, good results have been demonstrated with CBT delivered in fewer but longer sessions over two to three weeks for OCD, PTSD, panic disorder and social anxiety. However this format has not yet been tested with pregnant women. Fast, effective treatment delivered in pregnancy may be appealing to women with anxiety disorders and may be more effective than standard CBT in reducing negative effects on parenting and children. Design and methods used: This research will first develop a protocol for the delivery of time-intensive CBT (IN-CBT) for OCD, PTSD, panic disorder and social anxiety disorder. This will be tested with a small number of pregnant women with anxiety disorders and feedback will be sought from participants on outcome questionnaires and assessments for the study. The next part of the research will be a small trial (known as a feasibility study). Women taking part will receive either IN-CBT or standard CBT for their anxiety disorder. This will establish if IN-CBT is acceptable for women, the best way to reach potential participants and if enough women will take part in a trial and will complete postnatal outcome measures. Detailed interviews with women undertaking the treatments will investigate views of both versions of CBT and if the study assessments are acceptable and useful. This information will determine if a larger trial testing IN-CBT against standard weekly CBT will later be possible. If found feasible in this study, a larger trial would then examine whether IN-CBT for antenatal anxiety disorders is more effective in reducing negative outcomes for mother and child than standard weekly CBT. Ultimately, if the intensive format of delivery was found to be better in terms of benefits for both mother and child, this research would influence practice regarding treatment of antenatal anxiety disorders across the UK. Due to recent expansions of primary care and perinatal mental health services, there are increasing numbers of well-trained CBT therapists who could deliver this treatment. Evidence from this research therefore has the potential to shape practice, focus resources and be of direct benefit to patients within a short time frame. By reducing maternal anxiety it could also benefit children and partners of patients. Patient and public involvement: Service user groups have advised on the design of the study. An advisory group of service users will be set up for the study to provide input into the structure of participant interviews and interpretation of the results of the feasibility study. Service users will also be involved in publicising the results of the study. Dissemination: Results from the study will be publicised in presentations, workshops, journal articles, websites and social media. This will reach a range of audiences and national stakeholders including service users, maternity voices partnerships, clinicians and strategic clinical networks, managers, clinical directors, NHS sustainability and transformation partnerships, commissioners and researchers.

Research Activity Codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health Categories: MENTAL HEALTH;REPRODUCTIVE HEALTH AND CHILDBIRTH