Condition category
Mental and Behavioural Disorders
Date applied
16/06/2019
Date assigned
27/06/2019
Last edited
27/06/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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 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 March 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

Trial website

https://www.adeptstudy.co.uk/

Contact information

Type

Scientific

Primary contact

Dr Fiona Challacombe

ORCID ID

http://orcid.org/0000-0002-3316-8155

Contact details

PO31
Section of Women's Mental Health
De Crespigny Park
IOPPN
King's College London
London
SE5 8AF
United Kingdom
+44 (0)2032283696
fiona.challacombe@kcl.ac.uk

Type

Public

Additional contact

Dr Fiona Challacombe

ORCID ID

http://orcid.org/0000-0002-3316-8155

Contact details

PO31
Institute of Psychiatry
Psychology & Neuroscience
De Crespigny Park
London
SE5 8AF
United Kingdom
+44 (0)2032283696
fiona.challacombe@kcl.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

41746

Study information

Scientific title

Optimising psychological treatment for Anxiety DisordErs in Pregnancy: a feasibility study for a Trial of time-intensive CBT versus weekly CBT (ADEPT)

Acronym

ADEPT

Study hypothesis

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

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

Study design

Feasibility randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

https://www.adeptstudy.co.uk/

Condition

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.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

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, ie. 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 measures

Anxiety symptoms measured using GAD-7 pre and post treatment

Overall trial start date

01/04/2018

Overall trial end date

30/03/2022

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

60

Participant 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

Recruitment start date

15/07/2019

Recruitment end date

31/03/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

King's College London

Sponsor details

R&D Office
Institute of Psychiatry
De Crespigny Park
London
SE5 8AZ
United Kingdom
+44 (0)2032283696
slam-ioppn.research@kcl.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

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 statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/01/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

27/06/2019: Uploaded protocol Version 1, 6 February 2019 (not peer reviewed). 24/06/2019: Trial's existence confirmed by the NIHR.