Condition category
Mental and Behavioural Disorders
Date applied
21/10/2010
Date assigned
21/10/2010
Last edited
30/09/2016
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 Ruth Turner

ORCID ID

Contact details

Norfolk and Waveney Mental Health NHS Foundation Trust
80 St Stephens Road
Norwich
NR1 3RE
United Kingdom
-
ruth.turner@nwmhp.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

7261

Study information

Scientific title

Social Anxiety Research Clinic: an exploratory randomised controlled trial of standard versus enhanced cognitive behavioural therapy for social anxiety in early psychosis

Acronym

SARC

Study hypothesis

Small pilot randomised therapy trial for people recovering from psychosis who are experiencing social anxiety.

Ethics approval

MREC, ref: 09/H0310/4

Study design

Single-centre randomised interventional treatment pilot/feasibility study

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 contact details to request a participant information sheet

Condition

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

Intervention

Cognitive behavioural intervention provided by graduate mental health workers.
Follow up length: 6 months

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Social Anxiety Interaction Scale

Secondary outcome measures

1. Paranoia Scale
2. Brief Core Schema Scale

Overall trial start date

13/05/2009

Overall trial end date

30/04/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Score above 30 on the Social Interaction Anxiety Scale (SIAS)
2. Early Intervention Service user
3. Aged 14 years and above, either sex

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

Planned sample size: 48; UK sample size: 48

Participant exclusion criteria

Current acute psychotic episode

Recruitment start date

13/05/2009

Recruitment end date

30/04/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Norfolk and Waveney Mental Health NHS Foundation Trust
Norwich
NR1 3RE
United Kingdom

Sponsor information

Organisation

Norfolk and Waveney Mental Health NHS Foundation Trust (UK)

Sponsor details

80 St Stephens Road
Norwich
NR1 3RE
United Kingdom

Sponsor type

Government

Website

http://www.nmhct.nhs.uk

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Research for Innovation, Speculation and Creativity (RISC) 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

Publication citations

Additional files

Editorial Notes

30/09/2016: No publications found, verifying study status with principal investigator.