The effects of reducing worry in patients with persecutory delusions: finding out if worries can be reduced by brief cognitive therapy

ISRCTN	ISRCTN23197625
DOI	https://doi.org/10.1186/ISRCTN23197625
Protocol serial number	09/160/06
Sponsor	The Efficacy and Mechanism Evaluation Programme (MRC/NIHR) (UK)
Funder	National Institute for Health Research

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Daniel Freeman
Scientific

Department of Psychiatry
Oxford University
Warneford Hospital
Oxford
OX3 7JX
United Kingdom

Primary study design	Interventional
Study design	Single-blind randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	The effects of reducing worry in patients with persecutory delusions: An explanatory randomised controlled trial
Study acronym	Worry Intervention Trial (WIT)
Study objectives	1. A worry intervention will reduce levels of worry in individuals with persecutory delusions 2. A worry intervention will reduce persecutory delusions, especially levels of distress 3. The improvements will be maintained at follow-up
Ethics approval(s)	NHS Research Ethics Service Oxford REC B, application ref 11/SC/0001 - approval pending as of 09/03/2011
Health condition(s) or problem(s) studied	Persecutory delusions in the context of schizophrenia or related diagnosis
Intervention	1. Six sessions of CBT for worry over 2 months for patients randomised to intervention arm 2. This is in addition to their standard psychiatric care 3. The control condition is standard psychiatric care
Intervention type	Other
Primary outcome measure(s)	1. Penn State Worry Questionnaire (PSWQ; Meyer et al, 1990) 2. Psychotic Symptoms Rating Scale - Delusions (PSYRATS; Haddock et al, 1999)
Key secondary outcome measure(s)	1. Paranoid Thoughts Scale (Green et al, 2008) 2. Positive and Negative Symptom Scale (PANSS; Kay, 1991). 3. EQ-5D (Brooks et al, 2003)
Completion date	01/03/2014

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	150
Key inclusion criteria	1. A current persecutory delusion as defined by Freeman and Garety (2000); scoring at least 3 on the conviction scale of the PSYRATS (Haddock et al, 1999) 2. That the delusion has persisted for at least one month 3. A clinical diagnosis of schizophrenia, schizoaffective disorder or delusional disorder (i.e. diagnosis of non-affective psychosis (F2) in the International Classification of Diseases and Diagnostic and Statistical Manual IV) 4. A clinically significant level of worry, as indicated by scores above 44 on the Penn State Worry Questionnaire (see Startup and Erickson, 2006) 5. Aged between 18 and 65 6. Where major changes in medication are being made, entry to the study would not occur until at least a month after stabilisation of dosage
Key exclusion criteria	1. A primary diagnosis of alcohol or substance dependency 2. Organic syndrome or learning disability 3. A command of spoken English inadequate for engaging in therapy 4. Currently having individual cognitive behavioural therapy (CBT) (though previous CBT experience is not an exclusion)
Date of first enrolment	01/09/2011
Date of final enrolment	01/03/2014

Oxford University

Oxford
OX3 7JX
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	pilot study results	01/03/2010		Yes	No
Results article	results	01/04/2015		Yes	No
Protocol article	protocol	21/11/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

18/12/2017: internal review.