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
IRAS number 232385
Secondary identifying numbers CPMS 41746; IRAS 232385
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

Study website

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

Study information

Study designFeasibility randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet ISRCTN81203286_PIS_v3_22Sept19.docx
Scientific titleOptimising psychological treatment for Anxiety DisordErs in Pregnancy: a feasibility study for a Trial of time-intensive CBT versus weekly CBT (ADEPT)
Study acronymADEPT
Study objectivesThis 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) studiedAnxiety disorders (post-traumatic stress disorder, obsessive-compulsive disorder, social anxiety disorder, panic disorder) in pregnant women
InterventionWomen 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 typeBehavioural
Primary outcome measureCurrent 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
Secondary outcome measuresCurrent 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
Overall study start date01/04/2018
Completion date30/09/2022

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participants60
Total final enrolment59
Key inclusion criteriaCurrent 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 criteriaCurrent 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 enrolment15/07/2019
Date of final enrolment30/09/2021

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

South London and Maudsley NHS Trust
Maudsley Hospital
London
SE5 8AZ
United Kingdom

Sponsor information

King's College London
University/education

R&D Office
Institute of Psychiatry
De Crespigny Park
London
SE5 8AZ
England
United Kingdom

Phone +44 (0)2032283696
Email slam-ioppn.research@kcl.ac.uk
ROR logo "ROR" https://ror.org/0220mzb33

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location
United Kingdom

Results and Publications

Intention to publish date01/10/2022
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planCurrent publication and dissemination plan as of 26/11/2019:
1. Results of the trial will be fed back to participants via a newsletter
2. Findings from the study will be published in a series of high quality peer reviewed papers. These wil include journals targeted at academics, CBT practitioners, perinatal specialists and health service managers
3. Study results will be presented at academic and service user led conferences as well as conferences for managers. Examples would be the BABCP conference, Marce conference, Maternal Mental Health Alliance conference
4. Findings from the study will be disseminated to service user groups in perinatal mental health and for anxiety disorders and umbrella organisations such as the maternal mental health alliance
5. Clinical approaches developed from the study would be disseminated in clinical skills workshops and training for existing and new CBT therapists. These would take place in IAPT and specialist perinatal settings
_____
Previous publication and dissemination plan:
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.
_____
IPD sharing planThe 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?
Protocol file version V1 06/02/2019 27/06/2019 No No
Participant information sheet version v3 22/09/2019 26/11/2019 No Yes
Protocol file version v2 19/09/2019 26/11/2019 No No
Participant information sheet version V4 03/06/2020 17/06/2020 No Yes
Protocol file version V3 03/06/2020 17/06/2020 No 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
Results article 15/10/2023 23/10/2023 Yes No

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.