Paranoia in People With Schizophrenia-spectrum DiagnosisCITADELNCT01920685
Computerised Interventions for Thinking and Anxiety in Delusions (CITADEL) Trial
A study testing Anxiety intervention in people with Paranoia in People With Schizophrenia-spectrum Diagnosis, run by King's College London at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Paranoia in People With Schizophrenia-spectrum Diagnosis
- What is being tested?
- Anxiety intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jan 2014to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Oxleas NHS Foundation Trust
Dartford, Kent, DA2 7WG
South London & Maudsley NHS Foundation Trust
London, London, SE5 8AF
About this study
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.
Read more
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.
- Being tested
- Anxiety intervention
- Keywords
- Paranoia, CBT, Reasoning, Anxiety
- Medical subject headings
- Paranoid Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anxiety interventionOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Anxiety intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Green Paranoid Thoughts Scale
Measured: Change from baseline in paranoia scores at 8 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2013 (estimated)
- Study startJan 2014
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Paranoia in People With Schizophrenia-spectrum DiagnosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Amy Hardy, King's College London
- Investigators
- Philippa Garety, CPsychol, MPhil, PhD, FBPsS, Study chair, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920685
- Sponsor's protocol ID
- 13/LO/0690
- Acronym
- CITADEL
- Status last verified
- Mar 2017
- First submitted
- 5 Aug 2013
- Last updated
- 20 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25528759Freeman 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.
PubMed 23930939Garety 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.
PubMed 25053650Waller 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.
PubMed 25770671
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerised Interventions for Thinking and Anxiety in Delusions (CITADEL) Trial
- ClinicalTrials.gov ID
- NCT01920685
- Acronym / sponsor ID
- CITADEL / 13/LO/0690
- Keywords
- Paranoia, CBT, Reasoning, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 12 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate therapy | Experimental | Other: Anxiety intervention6 sessions of talking therapy, targeting anxiety processes associated with paranoia, will be delivered for a period of 8 weeks immediately after randomisation. |
| Delayed intervention | Other | Other: Anxiety interventionTherapy 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anxiety intervention | Other | Delayed intervention, Immediate therapy |
Primary outcome
Green Paranoid Thoughts Scale
Time frame: Change from baseline in paranoia scores at 8 weeks and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2017.
- Background: PubMed 25528759Freeman 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.
- Background: PubMed 23930939Freeman 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.
- Background: PubMed 25053650Garety 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.
- Background: PubMed 25770671Waller 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippa Garety, CPsychol, MPhil, PhD, FBPsS study chair
King's College London
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anxiety intervention in people with Paranoia in People With Schizophrenia-spectrum Diagnosis, run by King's College London at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Green Paranoid Thoughts Scale (time frame: Change from baseline in paranoia scores at 8 weeks and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01920685, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2017.