Condition category
Mental and Behavioural Disorders
Date applied
07/03/2011
Date assigned
20/04/2011
Last edited
14/09/2015
Prospective/Retrospective
Prospectively 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

Prof Daniel Freeman

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

09/160/06

Study information

Scientific title

The effects of reducing worry in patients with persecutory delusions: An explanatory randomised controlled trial

Acronym

Worry Intervention Trial (WIT)

Study hypothesis

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

NHS Research Ethics Service Oxford REC B, application ref 11/SC/0001 - approval pending as of 09/03/2011

Study design

Single-blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

1. Penn State Worry Questionnaire (PSWQ; Meyer et al, 1990)
2. Psychotic Symptoms Rating Scale - Delusions (PSYRATS; Haddock et al, 1999)

Secondary outcome measures

1. Paranoid Thoughts Scale (Green et al, 2008)
2. Positive and Negative Symptom Scale (PANSS; Kay, 1991).
3. EQ-5D (Brooks et al, 2003)

Overall trial start date

01/09/2011

Overall trial end date

01/03/2014

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant 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)

Recruitment start date

01/09/2011

Recruitment end date

01/03/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Oxford University
Oxford
OX3 7JX
United Kingdom

Sponsor information

Organisation

The Efficacy and Mechanism Evaluation Programme (MRC/NIHR) (UK)

Sponsor details

NETSCC - Efficacy and Mechanism Evaluation
Alpha House
University of Southampton Science Park
Southampton
SO16 7NS
United Kingdom

Sponsor type

Government

Website

http://www.eme.ac.uk

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

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

1. 2010 pilot study results in: http://www.ncbi.nlm.nih.gov/pubmed/19818953
2. 2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23171601
3. 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26360083

Publication citations

  1. Protocol

    Freeman D, Dunn G, Startup H, Kingdon D, The effects of reducing worry in patients with persecutory delusions: study protocol for a randomized controlled trial., Trials, 2012, 13, 223, doi: 10.1186/1745-6215-13-223.

  2. Results

    Foster C, Startup H, Potts L, Freeman D, A randomised controlled trial of a worry intervention for individuals with persistent persecutory delusions, J Behav Ther Exp Psychiatry, 2010 , 41, 1, 45-51, doi: 10.1016/j.jbtep.2009.09.001.

  3. Results

    Freeman D, Dunn G, Startup H, Pugh K, Cordwell J, Mander H, Černis E, Wingham G, Shirvell K, Kingdon D, Effects of cognitive behaviour therapy for worry on persecutory delusions in patients with psychosis (WIT): a parallel, single-blind, randomised controlled trial with a mediation analysis, Lancet Psychiatry, 2015, 2, 4, 305-313, doi: 10.1016/S2215-0366(15)00039-5.

Additional files

Editorial Notes