| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN28939473 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0071183793 |
| Public title | A pilot study of cognitive analytic therapy (CAT) in stressed pregnant women with underlying anxiety and depression |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Mental and Behavioural Disorders: 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. |
| Design/methodology | Pragmatic randomised controlled pilot study |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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. |
| Participants - exclusion criteria | 1.Serious active substance abuse
2. Active psychotic symptoms
3. Age under 18 years old |
| Patient information material |
|
| Anticipated start date | 01/07/2006 |
| Anticipated end date | 30/06/2009 |
| Status of trial | Ongoing |
| Target number of participants | 76 patients: 38 in both the TAU group and in the TAU plus CAT group |
| Interventions | 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). |
| Primary outcome measure(s) | 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 measure(s) | 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. |
| Sources of funding | Sheffield Health and Social Research Consortium
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Dr Ian B. Kerr |
| Contact details | Adult Mental Health/ Psychotherapy
Southern Acute Day Hospital
Sevenairs Rd
Sheffield
United Kingdom
S20 1 NZ |
| Contact telephone | +44 0114 271 6510 |
| Contact fax | +44 |
| Contact email | ian.kerr@sct.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN28939473 |
| Date last extracted from ISRCTN register | 17/04/2008 |
