Computerised Interventions for Thinking and Anxiety in Delusions (CITADEL) Trial

NCT01920685 | Completed

• 1 other identifier: 13/LO/0690
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief Summary

People with a schizophrenia spectrum diagnosis often experience distressing worries or beliefs about others intending to cause them harm (also known as paranoia). Paranoid beliefs are associated with significant distress and disruption to the person's life. This results in high use of services and costs to mental health providers. The National Institute of Clinical Excellence recommends that cognitive behavioural therapy for psychosis (CBTp) is offered to everybody with a schizophrenia spectrum psychosis. The latest meta analyses report improved outcomes, and reduced inpatient stays following CBTp, making it a cost effective intervention. Although improved outcomes have been obtained by therapies, CBTp has only small to moderate effects on paranoid beliefs. Further, training therapists to competently deliver CBTp is intensive, expensive and takes up to a year. CBTp is therefore not widely available to service users, resulting in inequalities in access to care. The investigators are seeking to improve outcomes and accessibility of CBTp for people with distressing, paranoid beliefs. The proposed research programme aims to conduct a feasibility study of a brief therapeutic intervention, aimed at targeting and improving anxiety processes that are causally implicated in paranoia (Freeman et al, 2015). The investigators have preliminary evidence indicating that the pilot intervention, with interactive multimedia content, reduced distressing beliefs and improved coping (Freeman et al, 2015). Participants also reported they found the therapy acceptable, enjoyable and useful. Based on these results, the investigators have further modified the intervention. The feasibility and efficacy of the therapy will be investigated in a randomised controlled design (n = 34). Please note the protocol has been been amended to exclude a pilot trial of a second brief intervention targeting reasoning styles in paranoia, as since the initial protocol was developed we have obtained data from two randomised pilot studies demonstrating its feasibility and acceptability (Garety et al, 2015; Waller et al, 2015). A further pilot trial of the reasoning styles intervention is therefore not indicated.

Conditions

Paranoia in People With Schizophrenia-spectrum Diagnosis

Keywords

Paranoia; CBT; Reasoning; Anxiety

Outcome Measures

Primary Outcomes (1)

• Green Paranoid Thoughts Scale

  Change from baseline in paranoia scores at 8 weeks and 12 weeks

Study Arms (2)

Immediate therapy

EXPERIMENTAL

6 sessions of talking therapy, targeting anxiety processes associated with paranoia, will be delivered for a period of 8 weeks immediately after randomisation.

Other: Anxiety intervention

Delayed intervention

OTHER

Therapy will be delayed until 12 weeks following randomisation, and then 6 sessions of talking therapy, targeting anxiety processes associated with paranoia, will be delivered over a period of 8 weeks.

Other: Anxiety intervention

Interventions

Anxiety intervention OTHER

Delayed intervention; Immediate therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self reported worries about being harmed or at risk from others
• Non-affective psychosis(ICD10,F20-F29)
• Age 18-65
• Symptoms stable no major relapse or crisis in last 3 months prior to consent
• Sufficient command of English to provide informed consent, complete the measures and participate in the brief interventions
• Score above the cutoff for clinically significant levels of paranoia on the Green Paranoid Thoughts Scale (Green et al, 2008)
• Paranoia is triggered by being outside

You may not qualify if:

• Lack of capacity to provide informed consent
• Primary diagnosis of drug or alcohol use with secondary psychosis
• Primary diagnosis of mood disorder or bipolar affective disorder
• Primary diagnosis of learning difficulty
• Unstable residential arrangements (making a move away during the course of participation in the research likely)

Sponsors & Collaborators

• King's College London: lead

Study Sites (2)

Oxleas NHS Foundation Trust

Dartford, Kent, DA2 7WG, United Kingdom

Location

South London & Maudsley NHS Foundation Trust

London, London, SE5 8AF, United Kingdom

Location

Related Publications (4)

• Freeman D, Emsley R, Dunn G, Fowler D, Bebbington P, Kuipers E, Jolley S, Waller H, Hardy A, Garety P. The Stress of the Street for Patients With Persecutory Delusions: A Test of the Symptomatic and Psychological Effects of Going Outside Into a Busy Urban Area. Schizophr Bull. 2015 Jul;41(4):971-9. doi: 10.1093/schbul/sbu173. Epub 2014 Dec 20.

  PMID: 25528759 BACKGROUND

• Freeman D, Waller H, Harpur-Lewis RA, Moore R, Garety P, Bebbington P, Kuipers E, Emsley R, Dunn G, Fowler D, Jolley S. Urbanicity, persecutory delusions, and clinical intervention: the development of a brief CBT module for helping patients with persecutory delusions enter social urban environments. Behav Cogn Psychother. 2015 Jan;43(1):42-51. doi: 10.1017/S1352465813000660. Epub 2013 Aug 9.

  PMID: 23930939 BACKGROUND

• Garety P, Waller H, Emsley R, Jolley S, Kuipers E, Bebbington P, Dunn G, Fowler D, Hardy A, Freeman D. Cognitive mechanisms of change in delusions: an experimental investigation targeting reasoning to effect change in paranoia. Schizophr Bull. 2015 Mar;41(2):400-10. doi: 10.1093/schbul/sbu103. Epub 2014 Jul 21.

  PMID: 25053650 BACKGROUND

• Waller H, Emsley R, Freeman D, Bebbington P, Dunn G, Fowler D, Hardy A, Kuipers E, Garety P. Thinking Well: A randomised controlled feasibility study of a new CBT therapy targeting reasoning biases in people with distressing persecutory delusional beliefs. J Behav Ther Exp Psychiatry. 2015 Sep;48:82-9. doi: 10.1016/j.jbtep.2015.02.007. Epub 2015 Feb 24.

  PMID: 25770671 BACKGROUND

MeSH Terms

Conditions

Paranoid Disorders; Anxiety Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Philippa Garety, CPsychol, MPhil, PhD, FBPsS

  King's College London

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Clinical Psychologist

Study Record Dates

• First Submitted: August 5, 2013
• First Posted: August 12, 2013
• Study Start: January 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: March 20, 2017

Record last verified: 2017-03

Locations

GB (2)