Time intensive v weekly CBT for antenatal anxiety disorders (ADEPT) v1
Research type
Research Study
Full title
Optimising psychological treatment for Anxiety DisordErs in Pregnancy: a feasibility study for a Trial of time-intensive CBT versus weekly CBT (ADEPT)
IRAS ID
232385
Contact name
Fiona Challacombe
Contact email
Sponsor organisation
King's College London
ISRCTN Number
ISRCTN81203286
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
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.
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. 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 intensive CBT (IN-CBT) delivered in fewer but longer sessions over one to two weeks for OCD, PTSD, panic disorder and social anxiety. However this format has not yet been tested with pregnant women.
This research is a small trial (known as a feasibility study). Pregnant women suitable for treatment in primary care psychological therapy services (IAPT) will be identified. Participants will be randomly allocated to receive either IN-CBT or standard CBT for their anxiety disorder. This will establish if IN-CBT is acceptable for pregnant 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.Lay Summary of Results:
Background: Anxiety disorders are very common in pregnant women. The ADEPT study aimed to gain initial information on whether a time-intensive version of a routine treatment, cognitive-behaviour therapy (CBT) was acceptable for pregnant women experiencing anxiety disorders. Therapy is usually in the form of one hour per week; time intensive therapy means having a burst of longer sessions in the first few weeks of treatment. This way of doing treatment has been shown to be useful for people with OCD, Social anxiety, panic disorder and post-traumatic stress disorder, but had not been researched in pregnant women. Therefore, if a time intensive version of this therapy was helpful, it could be a useful treatment option for some pregnant women. This feasibility study aimed to understand (1) if women would take part in a trial and (2) what participants thought about the two treatments on offer.
People with lived experience of perinatal depression and anxiety advised on all aspects of the study. The study was a randomised trial design, meaning that half of participants received the intensive version (INT-CBT), while the other half had standard weekly treatment (W-CBT). Everyone was offered the same number of hours of treatment in total and were treated in the NHS. The sessions mostly took part in pregnancy with some sessions postnatally. The final outcome point for the research was measured at 3 months postnatal in the form of questionnaires and an interview with a researcher who did not know which type of treatment the person received. COVID happened at the start of the trial which meant things slowed down a lot, there were many challenges for participants and researchers alike to navigate and that most of the treatments were then conducted online, or a mixture of online and in person sessions.
Summary of results
Question 1: Would women take part in the trial?
59 women took part in total (we had aimed to recruit 60 for the project). About a third of the women referred to the study ended up taking part, which is high for this sort of trial. Recruitment happened by people seeing a poster or by midwives or talking therapies services therapists referring; self-referral was by far the most popular method for referral to the project.Question 2: Was the treatment on offer acceptable?
There were very few dropouts (3.3%) from therapy in the project which indicates that both forms of the therapy were useful to people overall. There were of course variations – some people got a lot of benefit and others not as much. 81% of participants gave feedback at three months. We asked people to rate how useful they found the therapy for anxiety (57.6% - very, 20.3% quite, 6.8% not at all), for supporting during pregnancy and birth (57.6% very, 15.3 – quite, 11.9% not at all). This was similar for INT-CBT and W-CBT. The anxiety questionnaire scores shown in the graph below indicated that both types of CBT led to improvement for most people, with steeper change in the intensive version at first.
In the feedback interviews, many women also spoke of challenges undertaking therapy, most frequently fitting treatment around work and other responsibilities. This was true of participants in both arms.
Participants tended to like the treatment arm that they had been allocated to (but not always). There were comments about the benefit of increased momentum in the intensive group but also that it was very demanding. Women in the weekly group noted the benefit of being able to bring up a variety of problems each week as pregnancy threw up new challenges.
Women spoke about the importance of active treatment as well as talking (the behavioural experiments and exposure exercises) and the great importance of the relationship with their therapist to facilitate this (and it not going as well when that relationship was not as strong). For some women, further sessions were needed after pregnancy. Finally online therapy has some challenges in terms of engagement but is also a very useful option in pregnancy. A hybrid option mixing face to face and online sessions is probably best option. COVID caused a lot of problems for pregnant women, there was additional stress and accessing and using therapy was difficult.Next steps: The study has suggested that CBT is acceptable for anxiety disorders in pregnancy and should be offered to women that would like it. It has also shown that a larger trial could be really useful in testing out the different forms of treatments in terms of their effectiveness for women in pregnancy and in the postnatal period.
Has the registry been updated to include summary results?: No
If yes - please enter the URL to summary results:
If no – why not?: Results submitted so should be updated in coming weeks (by 15/8/25)
Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Yes
If yes, describe or provide URLs to disseminated materials: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fpubmed.ncbi.nlm.nih.gov%252F37822231%252F%2FNBTI%2FORK-AQ%2FAQ%2F38190156-0a62-4b3e-8df0-6d877e581015%2F2%2F2s5fFc6NOG&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7Caad02e696ef84d36859108ddd11c6943%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638896642132472403%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=e1F9zVhm%2BfXIj2WKNlqfJzMpgderHgB%2BxhbEmpm6hsY%3D&reserved=0
https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fpubmed.ncbi.nlm.nih.gov%252F37848088%252F%2FNBTI%2FORK-AQ%2FAQ%2F38190156-0a62-4b3e-8df0-6d877e581015%2F3%2F_znp9iqgzf&data=05%7C02%7Csurreyborders.rec%40hra.nhs.uk%7Caad02e696ef84d36859108ddd11c6943%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638896642132487409%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=mrnsO1gUv6Gn%2B0LVU2DAHXHnWvAESbHGzaSO7c0vG6k%3D&reserved=0Research disseminated in presentations at academic and practitioner conferences.
If pending, date when dissemination is expected:
If no, explain why you didn't follow it:
Have participants been informed of the results of the study?: Yes
If yes, describe and/or provide URLs to materials shared and how they were shared: Lay summary was emailed to participants.
If pending, date when feedback is expected:
If no, explain why they haven't:
Have you enabled sharing of study data with others?: No
If yes, describe or provide URLs to how it has been shared:
If no, explain why sharing hasn't been enabled: Data is small n and potentially identifiable.
Have you enabled sharing of tissue samples and associated data with others?: No
If yes, describe or provide a URL:
If no, explain why: Not applicable.
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London - Surrey Borders Research Ethics Committee
REC reference
19/LO/0622
Date of REC Opinion
29 May 2019
REC opinion
Further Information Favourable Opinion