Condition category
Mental and Behavioural Disorders
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
28/01/2010
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 Chris Jackson

ORCID ID

Contact details

North Birmingham Mental Health NHS Trust
Harry Waton House
97 Church Lane
Aston
Birmingham
B6 5UG
United Kingdom
+44 (0)121 685 6479
chris.jackson@bsmht.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RGC00447

Study information

Scientific title

Acronym

Study hypothesis

The objective of the study is to evaluate whether a form of cognitive therapy (recovery intervention) is an effective intervention to promote personal adjustment to psychosis and reduce depression, trauma and other characteristic negative consequences of psychosis.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Schizophrenia and other psychoses

Intervention

1. The intervention group will receive cognitive therapy over a 6 month period
2. The control group will receive treatment as usual

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Post-psychotic depression, suicidal ideation (Calgary scale)
2. Symptoms of Post Traumatic Stress Disorder (Impact of Events scale)
3. Adaptation to psychosis
4. Particularly perceived control over psychosis

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/05/2001

Overall trial end date

01/05/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Patients conforming to International Statistical Classification of Diseases and Related Health Problems, Tenth revision (ICD-10) schizophrenia or related disorder

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

66 (added 28/01/10; see publication)

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/05/2001

Recruitment end date

01/05/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

North Birmingham Mental Health NHS Trust
Birmingham
B6 5UG
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

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.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive West Midlands (UK)

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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19361782

Publication citations

  1. Results

    Jackson C, Trower P, Reid I, Smith J, Hall M, Townend M, Barton K, Jones J, Ross K, Russell R, Newton E, Dunn G, Birchwood M, Improving psychological adjustment following a first episode of psychosis: a randomised controlled trial of cognitive therapy to reduce post psychotic trauma symptoms., Behav Res Ther, 2009, 47, 6, 454-462, doi: 10.1016/j.brat.2009.02.009.

Additional files

Editorial Notes