Paranoia in People With Schizophrenia-spectrum Diagnosis Clinical Trial
— CITADELOfficial title:
Computerised Interventions for Thinking and Anxiety in Delusions (CITADEL) Trial
| Verified date | March 2017 |
| Source | King's College London |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 25 |
| Est. completion date | October 2016 |
| Est. primary completion date | October 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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) |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Oxleas NHS Foundation Trust | Dartford | Kent |
| United Kingdom | South London & Maudsley NHS Foundation Trust | London |
| Lead Sponsor | Collaborator |
|---|---|
| King's College London |
United Kingdom,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Green Paranoid Thoughts Scale | Change from baseline in paranoia scores at 8 weeks and 12 weeks |