Optimising psychological treatment for anxiety disorders in pregnancy: a feasibility study for a trial of time-intensive CBT versus weekly CBT

ISRCTN	ISRCTN81203286
DOI	https://doi.org/10.1186/ISRCTN81203286
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	232385
Protocol serial number	CPMS 41746; IRAS 232385
Sponsor	King's College London
Funder	National Institute for Health Research

Submission date: 16/06/2019
Registration date: 27/06/2019
Last edited: 23/10/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
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 about 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. The aim of this study 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.

Who can participate?
Pregnant women over 18 with one of the anxiety disorders under investigation can take part. They must be eligible for treatment in South London and Maudsley NHS Trust (resident or referred for treatment in Lewisham, Lambeth, Southwark or Croydon) and begin the study before they are 25 weeks (updated 26/11/2019, previously: 20 weeks) pregnant.

What does the study involve?
This research is a small trial (known as a feasibility study). Women taking part receive either intensive CBT (IN-CBT) or standard CBT for their anxiety disorder. They are randomly allocated to one of these two treatments and each consists of individual treatment with a trained therapist. Interviews with women undertaking the treatments investigate the 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.

What are the possible benefits and risks of participating?
CBT is an evidence-based treatment that is routinely offered for anxiety disorders and it is expected that all women taking part could benefit. Participants will have to complete some additional questionnaires which may be a burden.

Where is the study run from?
The study will take place in primary care psychological therapy centres in the South London and Maudsley NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
April 2018 to September 2022

Who is funding the study?
National Institute of Health Research (NIHR) (UK)

Who is the main contact?
Dr Fiona Challacombe
fiona.challacombe@kcl.ac.uk

Contact information

Dr Fiona Challacombe
Scientific

PO31, Section of Women's Mental Health
De Crespigny Park, IOPPN
King's College London
London
SE5 8AF
United Kingdom

ORCID ID	0000-0002-3316-8155
Phone	+44 (0)2032283696
Email	fiona.challacombe@kcl.ac.uk

Dr Fiona Challacombe
Public

PO31, Institute of Psychiatry, Psychology & Neuroscience
De Crespigny Park
London
SE5 8AF
United Kingdom

ORCID ID	0000-0002-3316-8155
Phone	+44 (0)2032283696
Email	fiona.challacombe@kcl.ac.uk

Study information

Primary study design	Interventional
Study design	Feasibility randomized controlled trial
Secondary study design	Randomised controlled trial
Participant information sheet	ISRCTN81203286_PIS_v3_22Sept19.docx
Scientific title	Optimising psychological treatment for Anxiety DisordErs in Pregnancy: a feasibility study for a Trial of time-intensive CBT versus weekly CBT (ADEPT)
Study acronym	ADEPT
Study objectives	This is a feasibility study which aims to answer the following questions: 1. Is antenatal IN-CBT acceptable to women with anxiety disorders? 2. Is it feasible to test the effectiveness of IN-CBT compared with standard CBT in a full-scale trial?
Ethics approval(s)	Approved 29/05/2019, Surrey Borders NHS REC, Health Research Authority (Skipton House, 80 London Road, London SE1 6LH, Tel: +44 (0)20 7972 2568; Email: nrescommittee.london-surreyborders@nhs.net), ref: 19/LO/0622
Health condition(s) or problem(s) studied	Anxiety disorders (post-traumatic stress disorder, obsessive-compulsive disorder, social anxiety disorder, panic disorder) in pregnant women
Intervention	Women taking part will receive either intensive CBT (IN-CBT) or standard CBT for their anxiety disorder. They will be randomly allocated to one of these two treatments and each arm consists of individual treatment with a trained therapist. Standard CBT: This will comprise 8-10 hours (depending on the disorder) of one-to-one CBT on a one hour per week basis. This is termed ‘high intensity’ CBT in IAPT services and will be offered to all women who participate in the trial and are randomised to standard CBT. Two follow-up sessions of one hour will then be offered by the treating therapist which will include one in late pregnancy, one at 1 month postpartum. Intensively delivered CBT (IN-CBT): This will deliver the disorder-specific treatment in 4-5 sessions over 1-2 weeks, delivered at the earliest convenient point between 5 and 8 months of pregnancy, and totalling 8-10 hours. Two follow-up sessions of one hour will then be offered which will include one in late pregnancy, one at 1 month postpartum. 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. Added 17/06/2020: Treatments may take place via phone or video link using Microsoft Teams, depending on current public health restrictions.
Intervention type	Behavioural
Primary outcome measure(s)	Current primary outcome measures as of 17/06/2020: This is a feasibility study so feasibility parameters (primarily recruitment and participation) are the main outcomes and one aim is to determine the primary outcome of a full-scale trial. 1. Recruitment rate defined as the number of participants recruited/month. An acceptable recruitment rate would be at least 3 participants/month 2. Acceptability of randomisation. A take-up of >70% of eligible participants is required to be deemed feasible. 3. If the intervention is received as intended in both arms in terms of being the intended mode of treatment and treatment fidelity using a content checklist. A minimum of 70% of participants in the trial would need to complete >60% of each intervention in hours for each to be deemed feasible, i.e. 7.5 hours out of 12. For completers in the intensive arm, these treatment hours (8 out of 10 hours) will need to be completed in the two-week window for IN-CBT to be considered to be delivered as intended 4. Acceptability of both interventions to participants; this will be determined by qualitative investigation, a brief rating scale asking if the treatment was useful at the end of treatment and numbers completing treatment 5. Participation and data completion at 3-month outcome assessment; a follow-up rate of >70% is required to determine feasibility 6. Acceptability of assessment measures to participants; this will be determined by qualitative interview and brief rating scales asking if it was useful and clear Previous primary outcome measures: This is a feasibility study so feasibility parameters (primarily recruitment and participation) are the main outcomes and one aim is to determine the primary outcome of a full-scale trial. 1. Recruitment rate defined as the number of participants recruited/month. An acceptable recruitment rate would be at least 3 participants/month 2. Acceptability of randomisation. A take-up of >70% of eligible participants is required to be deemed feasible. 3. If the intervention is received as intended in both arms in terms of being the intended mode of treatment and treatment fidelity using a content checklist. A minimum of 80% of participants in the trial would need to complete >60% of each intervention in hours for each to be deemed feasible, i.e. 7.5 hours out of 12. For completers in the intensive arm, these treatment hours (8 out of 10 hours) will need to be completed in the two-week window for IN-CBT to be considered to be delivered as intended 4. Acceptability of both interventions to participants; this will be determined by qualitative investigation, a brief rating scale asking if the treatment was useful at the end of treatment and numbers completing treatment 5. Participation and data completion at 3-month outcome assessment; a follow-up rate of >80% is required to determine feasibility 6. Acceptability of assessment measures to participants; this will be determined by qualitative interview and brief rating scales asking if it was useful and clear
Key secondary outcome measure(s)	Current secondary outcome measures as of 26/11/2019: Measured at pre-treatment baseline assessment, every treatment session, after the first 2 hours of treatment, late pregnancy follow up session, 1-month postnatal follow-up session, 3 months outcome: 1. Anxiety measured using GAD-7. This is the potential primary outcome measure of a full-scale trial 2. Depression symptoms measured using PHQ-9 3. Impact of a person’s mental health difficulties on their ability to function in terms of work, home management, social leisure, private leisure and personal or family relationships measured using the Work and Social Adjustment Scale 5. Disorder specific measures: one of the following will be used depending on primary disorder. 5.1. OCD symptoms measured using the Obsessive-Compulsive Inventory-Revised (OCI) 5.2. Panic. Avoidance of a range of specific situations over the last week measured using the Mobility Inventory (alone) 5.3. PTSD symptoms measured using the Impact of Events Scale (IES) 5.4. Social Phobia severity measured by the Social Phobia Inventory (SPIN) Measured after the first 2 hours of treatment only: 6. Therapeutic alliance between participant and therapist measured using the Working Alliance Inventory – Short Revised Measured at pre-treatment baseline assessment, late pregnancy follow up session, 1-month postnatal follow-up session: 7. Pregnancy anxiety measured using the Pregnancy-Related Anxiety Questionnaire (PRAQ) Measured at 1-month postnatal follow-up session, 3 months outcome: 8. Maternal perception of her felt bonding with the infant measured using the Postpartum Bonding Questionnaire (PBQ) Measured at 3 months outcome only: 9. Mother-Infant Interactions captured in a 3-minute video clips taken during play and nappy change at home and subsequently assessed by a trained rater using the CARE Index 10. Resource use measured using the Adult Service Use Measure (AD-SUS) 11. Qualitative interview to investigate treatment experiences in women undergoing IN-CBT and those undergoing standard CBT (in a subset of participants) _____ Previous secondary outcome measures: Anxiety symptoms measured using GAD-7 pre and post treatment
Completion date	30/09/2022

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	60
Total final enrolment	59
Key inclusion criteria	Current inclusion criteria as of 26/11/2019: 1. Women over the age of 18 years 2. A current primary anxiety disorder according to DSM-V criteria OCD, PTSD, Social anxiety or panic disorder) 3. Pregnant (12 weeks – 25 weeks) 4. Eligible to be seen under Lambeth, Lewisham, Southwark, Croydon IAPT services 5. Available for either intensive or weekly treatment 6. Either not on psychotropic medication or on a stable dose of medication for at least six weeks with no plans to change this during the intervention _____ Previous inclusion criteria: 1. Women over the age of 18 2. A current primary anxiety disorder according to DSM-V criteria OCD, PTSD, Social anxiety or panic disorder) 3. Pregnant (12 weeks – 20 weeks) 4. Eligible to be seen under Lambeth, Lewisham, Southwark, Croydon IAPT services 5. Available for either intensive or weekly treatment 6. Either not on psychotropic medication or on a stable dose of medication for at least six weeks with no plans to change this during the intervention
Key exclusion criteria	Current exclusion criteria as of 26/11/2019: 1. Women with a primary DSM-V depressive disorder, affective or psychotic disorder or current problems with substance abuse 2. Women with ‘complex PTSD’ (prolonged multiple traumas affecting a number of domains) 3. Women who have high-risk conditions requiring significant additional management (e.g. Multiple Sclerosis, Lupus, Polycystic Ovary Syndrome) 4. Women who are receiving psychological therapy elsewhere 5. Unable to read English adequately to complete questionnaires _____ Previous exclusion criteria: 1. Women with a primary DSM-V depressive disorder, affective or psychotic disorder or current problems with substance abuse 2. Women with ‘complex PTSD’ (prolonged multiple traumas affecting a number of domains) 3. Women who have a medically high-risk pregnancy at the time of recruitment 4. Women who are receiving psychological therapy elsewhere 5. Unable to read English adequately to complete questionnaires
Date of first enrolment	15/07/2019
Date of final enrolment	30/09/2021

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

South London and Maudsley NHS Trust

Maudsley Hospital
London
SE5 8AZ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan	The datasets generated during and/or analysed during the current study are not expected to be made available as the numbers are small and so potentially identifiable. Data will be held at King's College London as per IG protocols.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		15/10/2023	23/10/2023	Yes	No
Protocol article		30/04/2021	13/08/2021	Yes	No
HRA research summary			28/06/2023	No	No
Other publications	Qualitative analysis	12/10/2023	12/10/2023	Yes	No
Participant information sheet	version v3	22/09/2019	26/11/2019	No	Yes
Participant information sheet	version V4	03/06/2020	17/06/2020	No	Yes
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file	version V1	06/02/2019	27/06/2019	No	No
Protocol file	version v2	19/09/2019	26/11/2019	No	No
Protocol file	version V3	03/06/2020	17/06/2020	No	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Additional files

ISRCTN81203286_PROTOCOL_V1_06Feb19.docx: Uploaded 27/06/2019
ISRCTN81203286_PIS_v3_22Sept19.docx: uploaded 26/11/2019
ISRCTN81203286_Protocol_v2_19Sept19.pdf: uploaded 26/11/2019
ISRCTN81203286_PROTOCOL_V3_03Jun20.docx: Uploaded 17/06/2020
ISRCTN81203286_PIS_V4_03Jun20.docx: Uploaded 17/06/2020

Editorial Notes

23/10/2023: Publication reference added.
12/10/2023: Publication reference added.
11/01/2022: The following changes were made to the trial record:
1. The overall trial end date was changed from 30/03/2022 to 30/09/2022.
2. The intention to publish date was changed from 01/01/2022 to 01/10/2022.
3. IPD sharing statement and total final enrolment added.
13/08/2021: Internal review.
05/05/2021: Publication reference added.
09/03/2021: The recruitment end date was changed from 31/03/2021 to 30/09/2021.
17/06/2020: The following changes were made to the trial record:
1. The protocol was uploaded as an additional file, version 3, 3 June 2020 (not peer reviewed).
2. The participant information sheet was uploaded as an additional file, version 4, 3 June 2020.
3. The interventions and primary outcome measures were updated.
26/11/2019: The following changes were made to the trial record:
1. The protocol was uploaded as an additional file, version 2, 19 September 2019 (not peer reviewed).
2. The participant information sheet was uploaded as an additional file, version 3, 22 September 2019.
3. The inclusion criteria were changed.
4. The exclusion criteria were changed.
5. The secondary outcome measures were changed.
6. The publication and dissemination plan was changed.
7. The plain English summary was updated to reflect these changes.
27/06/2019: Uploaded protocol Version 1, 6 February 2019 (not peer reviewed).
24/06/2019: Trial's existence confirmed by the NIHR.