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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19361782
Publication citations
-
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.