Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Ian B. Kerr


Contact details

Adult Mental Health/ Psychotherapy
Southern Acute Day Hospital
Sevenairs Rd
S20 1 NZ
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

A pilot study of cognitive analytic therapy (CAT) in stressed pregnant women with underlying anxiety and depression


Study hypothesis

It is hypothesised primarily that treatment with CAT for a group of pregnant women with stressful anxiety, either alone or in conjunction with, depressive disorders will:
1. Result in a reduction of psychological distress and disability as measured by standard psychometric instruments and also
2. In a biological marker of stress as measured by salivary cortisol levels when compared to an untreated control group with similar disorders

Ethics approval

Not provided at time of registration

Study design

Pragmatic randomised controlled pilot study

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet


Mental and Behavioural Disorders: Depression


We propose to conduct an essentially pragmatic, randomised, controlled pilot aiming to evaluate the treatment effects of a brief (16-session) treatment with CAT in addition to treatment as usual in two maternal mental health outpatient settings (Sheffield Care Trust and St Thomas’ Hospital, London). This intervention would be compared to treatment as usual provided by primary care (e.g. GPs, midwives, health visitors) and secondary mental health services (e.g. community mental health teams, peri-natal psychiatric services).

Intervention type



Not Specified

Drug names

Primary outcome measure

The principal screening and outcome measure will be the Spielberger State/Trait Anxiety Measure which has been used in previous studies in this patient group as indicator of stress (Glover 2002).

Secondary outcome measures

Secondary standard outcome measures will include the Edinburgh Post Natal Depression Questionnaire (EPDS - a measure specifically validated for use in pregnancy as well as post-partum), the ‘CORE’ brief routine outcome battery (an increasingly widely used general baseline indicator of subjective well being, risk of self harm, symptoms and functioning (Barkham et al 1998)) and the SF 36 short form of the Duke social support questionnaire. The latter will also be used in the economic evaluation. Use of self-report measures will minimise interviewer bias. In addition, sequential salivary cortisol levels will be used as secondary biological outcome measure. These will be sampled at the time points described above. They will be collected by obtaining samples of saliva 4 times per day (waking, after 30 minutes, after 3 hours, after 12 hours), on 2 days running in order to minimise day to day and diurnal variation. These samples will be collected on Salivette dental rolls, stored in a fridge and posted on to the laboratory (VG) at Imperial College. It is well established that cortisol is stable under such conditions.

Data on the prevalence of mother-infant interaction difficulties using a 5 minute video recording of mother-infant interaction (Murray et al 1996) will also be collected as well as any reductions observed in such difficulties in the treatment group. This will generate data on their prevalence initially and also enable future more extended studies to be planned if indicated. Similarly data will be collected on the incidence of subsequent post-natal psychiatric morbidity in these patient groups along with any change observed in the treatment group. This would similarly inform for further extended study of interventions aimed at reducing such morbidity.

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

Patients between 18 and 65 being referred from adult health services to perinatal psychiatric services (e.g. by midwives, obstetricians, GPs or mental health professionals) who appear at clinical diagnostic interview to be suffering from stress in the context of underlying anxiety, with or without associated depressive disorders will be offered entry into the trial at initial assessment.

Participant type


Age group




Target number of participants

76 patients: 38 in both the TAU group and in the TAU plus CAT group

Participant exclusion criteria

1. Serious active substance abuse
2. Active psychotic symptoms
3. Age under 18 years old

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Adult Mental Health/ Psychotherapy
S20 1 NZ
United Kingdom

Sponsor information


Record Provided by the NHSTCT Register - 2007 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
United Kingdom
+44 (0)20 7307 2622

Sponsor type




Funder type


Funder name

Sheffield Health and Social Research Consortium

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

29/06/2016: No publications found, verifying study status with principal investigator