Condition category
Mental and Behavioural Disorders
Date applied
21/05/2010
Date assigned
21/05/2010
Last edited
12/12/2013
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

Mr Peter Phiri

ORCID ID

Contact details

Royal South Hants Hospital
Research & Development
1st Floor
University Dept of Psychiatry
Brintons Terrace
Southampton
SO14 0YG
United Kingdom
peter.phiri@hantspt-sw.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

7499

Study information

Scientific title

A multicentre randomised interventional treatment trial to develop culturally sensitive Cognitive Behaviour Therapy (CBT) for psychosis for ethnic minority patients

Acronym

CaCBTp

Study hypothesis

This study follows on from a recently conducted qualitative study using semi-structured interviews and focus groups to develop culturally sensitive cognitive behaviour therapy (CBT) for psychosis for ethnic minority patients by exploration and incorporation of service users' and health professionals' views and opinions.

The project has been funded by delivering race equality (Department of Health) Clinical trailblazers group. We will now conduct a pilot randomised controlled trial (RCT) with an intervention (CaCBTp) in black and ethnic minority populations. Participants will be randomised to two groups: intervention or treatment as usual.

Those in the intervention group will receive 16 sessions of CaCBTp over a 4 month period.

Ethics approval

Southampton & South West Hampshire Research Ethics Committee (B) approved on the 28th January 2009 (ref: 09/H0504/4)

Study design

Multicentre randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Mental Health Research Network; Subtopic: Schizophrenia, Psychosis; Disease: Schizophrenia, Psychosis

Intervention

Control group (TAU): Treatment as usual as provided by mental health services
Treatment group (CaCBTp): 16 sessions of CaCBTp with a trained therapist over a four month period

Follow up length: 6 months
Study entry: single randomisation only

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Reduction in overall Comprehensive Psychopathological Rating Scale (CPRS) scores post-therapy. Outcome is assessed at baseline, the end of the intervention period (4 months) and the end of the follow up period (6 months).

Secondary outcome measures

Acceptability of intervention as assessed by satisfaction, number of sessions attended and drop-out rate. Outcome is assessed at the end of the intervention period and the end of the follow up period.

Overall trial start date

01/04/2009

Overall trial end date

31/07/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosis of schizophrenia using International Classification of Disease, version 10 (ICD-10) criteria
2. Belong to an ethnic minority community
3. Willingness to participate in the interview and have notes made and/or be tape recorded
4. Have capacity to consent and understand the interview
5. Able to speak English or willing to participate with the assistance of interpreters
5. Male and female, lower age limit of 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 40; UK sample size: 40

Participant exclusion criteria

1. Severe illness which may affect capacity or markedly affect their ability to participate in the interviews
2. Lacks capacity or not giving consent
3. Those patients who in the opinion of the key worker would be thought to be distressed by the interview due to low insight

Recruitment start date

01/04/2009

Recruitment end date

31/07/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal South Hants Hospital
Southampton
SO14 0YG
United Kingdom

Sponsor information

Organisation

Hampshire Partnership NHS Foundation Trust (UK)

Sponsor details

Tatchbury Mount
Calmore
Southampton
SO40 2RZ
United Kingdom

Sponsor type

Government

Website

http://www.hampshirepartnership.nhs.uk/

Funders

Funder type

Government

Funder name

Department of Health (UK) - Delivering Race Equality Programme

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

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23231878

Publication citations

  1. Results

    Rathod S, Phiri P, Harris S, Underwood C, Thagadur M, Padmanabi U, Kingdon D, Cognitive behaviour therapy for psychosis can be adapted for minority ethnic groups: a randomised controlled trial., Schizophr. Res., 2013, 143, 2-3, 319-326, doi: 10.1016/j.schres.2012.11.007.

Additional files

Editorial Notes