Condition category
Mental and Behavioural Disorders
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
29/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ian B. Kerr

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0071183793

Study information

Scientific title

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

Acronym

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

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Mental and Behavioural Disorders: Depression

Intervention

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

Other

Phase

Not Specified

Drug names

Primary outcome measures

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

01/07/2006

Overall trial end date

30/06/2009

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Female

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

01/07/2006

Recruitment end date

30/06/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Adult Mental Health/ Psychotherapy
Sheffield
S20 1 NZ
United Kingdom

Sponsor information

Organisation

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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Sheffield Health and Social Research Consortium

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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