The Effects of Reducing Worry in Patients with Persecutory Delusions: Study Protocol for a Randomized Controlled Trial

Overview

Journal Trials

Publisher Biomed Central

Specialties General Medicine
Pharmacology

Date 2012 Nov 23

PMID 23171601

Citations 5

Authors

Daniel Freeman

Graham Dunn

Helen Startup

David Kingdon

Affiliations

Soon will be listed here.

Abstract

Background: Our approach to advancing the treatment of psychosis is to focus on key single symptoms and develop interventions that target the mechanisms that maintain them. In our theoretical research we have found worry to be an important factor in the development and maintenance of persecutory delusions. Worry brings implausible ideas to mind, keeps them there, and makes the experience distressing. Therefore the aim of the trial is to test the clinical efficacy of a cognitive-behavioral intervention for worry for patients with persecutory delusions and determine how the worry treatment might reduce delusions.

Methods/design: An explanatory randomized controlled trial--called the Worry Intervention Trial (WIT)--with 150 patients with persecutory delusions will be carried out. Patients will be randomized to the worry intervention in addition to standard care or to standard care. Randomization will be carried out independently, assessments carried out single-blind, and therapy competence and adherence monitored. The study population will be individuals with persecutory delusions and worry in the context of a schizophrenia spectrum diagnosis. They will not have responded adequately to previous treatment. The intervention is a six-session cognitive-behavioral treatment provided over eight weeks. The control condition will be treatment as usual, which is typically antipsychotic medication and regular appointments. The principal hypotheses are that a worry intervention will reduce levels of worry and that it will also reduce the persecutory delusions. Assessments will be carried out at 0 weeks (baseline), 8 weeks (post treatment) and 24 weeks (follow-up). The statistical analysis strategy will follow the intention-to-treat principle and involve the use of linear mixed models to evaluate and estimate the relevant between- and within-subjects effects (allowing for the possibility of missing data). Both traditional regression and newer instrumental variables analyses will examine mediation. The trial is funded by the UK Medical Research Council (MRC)/NHS National Institute of Health Research (NIHR) Efficacy and Mechanism Evaluation (EME) Programme.

Discussion: This will be the first large randomized controlled trial specifically focused upon persecutory delusions. The project will produce a brief, easily administered intervention that can be readily used in mental health services.

Trial Registration: Current Controlled Trials ISRCTN23197625.

Citing Articles

Worry and metacognitions as predictors of the development of anxiety and paranoia.

Sun X, So S, Chan R, Chiu C, Leung P Sci Rep. 2019; 9(1):14723.

PMID: 31605005 PMC: 6789003. DOI: 10.1038/s41598-019-51280-z.

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.

Freeman D, Dunn G, Startup H, Pugh K, Cordwell J, Mander H Lancet Psychiatry. 2015; 2(4):305-13.

PMID: 26360083 PMC: 4698664. DOI: 10.1016/S2215-0366(15)00039-5.

Orbitofrontal cortex, emotional decision-making and response to cognitive behavioural therapy for psychosis.

Premkumar P, Fannon D, Sapara A, Peters E, Anilkumar A, Simmons A Psychiatry Res. 2015; 231(3):298-307.

PMID: 25659473 PMC: 4834460. DOI: 10.1016/j.pscychresns.2015.01.013.

Persecutory delusions and psychological well-being.

Freeman D, Startup H, Dunn G, Wingham G, cernis E, Evans N Soc Psychiatry Psychiatr Epidemiol. 2013; 49(7):1045-50.

PMID: 24297621 DOI: 10.1007/s00127-013-0803-y.

The interaction of affective with psychotic processes: a test of the effects of worrying on working memory, jumping to conclusions, and anomalies of experience in patients with persecutory delusions.

Freeman D, Startup H, Dunn G, cernis E, Wingham G, Pugh K J Psychiatr Res. 2013; 47(12):1837-42.

PMID: 23871449 PMC: 3905189. DOI: 10.1016/j.jpsychires.2013.06.016.

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