ParanoiaNCT04824781
Recovery From Paranoia: a Qualitative Exploration
An observational study of Paranoia and Persecutory Delusion, run by University of Oxford at 1 site in United Kingdom.
Trial summary
Paranoia, the experience of undue or excessive mistrust, exists on a continuum which includes suspicious thoughts, ideas of reference, and persecutory delusions. Persecutory delusions refers to strong unfounded fears that others intend harm. These fears are very common. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Paranoia, Persecutory Delusion
- What is being tested?
- Qualitative interview
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Jun 2021to 16 Feb 2022
- Phase
- Observational
- 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 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: A sample of approximately 15 patients who have recovered from paranoia will be recruited. Participants will be recruited according to the inclusion and exclusion criteria adumbrated below.
Who may be able to join
- Participant has recovered from the paranoia. This is defined as: A.) conviction in persecution beliefs is rated as less than 10% and B.) not experiencing significant distress related to paranoia and C.) currently scoring outside the clinical range of the revised Green et al., Paranoid Thoughts Scale (R-GPTS; Freeman, 2019);
- Participants should have had experiences of paranoia in the context of non-affective psychosis. This will be determined by participant's agreement that they previously had the sort of thoughts listed in the revised Green et al. Paranoid Thoughts Scale (R-GPTS; Freeman, 2019);
- Participant is currently a patient of Oxford Health NHS Foundation Trust;
- Participant is willing and able to give informed consent for participation in the study;
- Aged 16 years or above;
- Participant has sufficient English language skills to participate in the interview.
Who cannot join
- The following exclusion criteria will apply based on concerns regarding risk and capacity to consent:
- Currently experiencing acute psychiatric symptoms which preclude ability to participate in a sustained interview;
- Diagnosis of a moderate to severe intellectual disability;
- High levels of associated risk to self or to others e.g. actively suicidal;
- Primary diagnosis of alcohol or drug misuse; personality disorder; significant forensic history;
- At the time of recruitment COVID-19 restrictions do not permit face-to-face interviews and the participant is not willing or able to conduct the interview remotely via video call.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford Health NHS Foundation Trust
Oxford, Oxfordshire, OX3 7JX
About this study
Paranoia, the experience of undue or excessive mistrust, exists on a continuum which includes suspicious thoughts, ideas of reference, and persecutory delusions. Persecutory delusions refers to strong unfounded fears that others intend harm. These fears are very common. They affect around 70% of patients with schizophrenia. They can be distressing and make day-to-day tasks difficult. However, current treatments are limited and a significant proportion of people do not benefit sufficiently. Therefore, improvements in treatment are needed. A better understanding of the experience of recovery from paranoia will help inform theoretical understanding and treatment development. Currently we do not fully understand what causes paranoia to occur, persist, or end. As such, it is critical to understand the experiences of those who have recovered, in particular what elements encourage recovery. Therefore, the aim of this study is to gain a first-person perspective on how people recover from paranoia and what psychological processes are important for recovery from paranoia. Using a qualitative approach appropriate for exploratory research, semi-structured interviews will be conducted with 12-15 patients who have recovered from paranoia. Interviews will be analysed using interpretative phenomenological analysis, a qualitative research approach which aims to provide insight on how an individual, in a particular situation, makes sense of their experience.
- Conditions
- Paranoia, Persecutory Delusion
- Being tested
- Qualitative interview
- Keywords
- Paranoia, Persecutory delusions, Recovery, NHS, Qualitative, Interpretative phenomenological analysis
- Medical subject headings
- Paranoid Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative interviewOther
Participants will be interviewed about their experiences of recovery from paranoia.
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative interview accounts
Semi-structured interpretative phenomenological analysis (IPA) interviews will be used.
Measured: March 2021-March 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start9 Jun 2021
- Primary completion27 Jul 2021
- Study completion16 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParanoiaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Felicity Waite, DClinPsy, BSc (Hons), Study director, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04824781
- Sponsor's protocol ID
- PID 15402
- Other IDs
- HRA, IRAS
- Status last verified
- Mar 2021
- First submitted
- 25 Mar 2021
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery From Paranoia: a Qualitative Exploration
- ClinicalTrials.gov ID
- NCT04824781
- Acronym / sponsor ID
- PID 15402
- Conditions
- Paranoia, Persecutory Delusion
- Keywords
- Paranoia, Persecutory delusions, Recovery, NHS, Qualitative, Interpretative phenomenological analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 27 Jul 2021 (actual)
- Study completion
- 16 Feb 2022 (actual)
- First posted
- 1 Apr 2021 (actual)
- 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.
Paranoia, the experience of undue or excessive mistrust, exists on a continuum which includes suspicious thoughts, ideas of reference, and persecutory delusions. Persecutory delusions refers to strong unfounded fears that others intend harm. These fears are very common. They affect around 70% of patients with schizophrenia. They can be distressing and make day-to-day tasks difficult. However, current treatments are limited and a significant proportion of people do not benefit sufficiently. Therefore, improvements in treatment are needed. A better understanding of the experience of recovery from paranoia will help inform theoretical understanding and treatment development. Currently we do not fully understand what causes paranoia to occur, persist, or end. As such, it is critical to understand the experiences of those who have recovered, in particular what elements encourage recovery. Therefore, the aim of this study is to gain a first-person perspective on how people recover from paranoia and what psychological processes are important for recovery from paranoia. Using a qualitative approach appropriate for exploratory research, semi-structured interviews will be conducted with 12-15 patients who have recovered from paranoia. Interviews will be analysed using interpretative phenomenological analysis, a qualitative research approach which aims to provide insight on how an individual, in a particular situation, makes sense of their experience.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- A sample of approximately 15 patients who have recovered from paranoia will be recruited. Participants will be recruited according to the inclusion and exclusion criteria adumbrated below.
Key inclusion criteria (6 listed)
- Participant has recovered from the paranoia. This is defined as: A.) conviction in persecution beliefs is rated as less than 10% and B.) not experiencing significant distress related to paranoia and C.) currently scoring outside the clinical range of the revised Green et al., Paranoid Thoughts Scale (R-GPTS; Freeman, 2019);
- Participants should have had experiences of paranoia in the context of non-affective psychosis. This will be determined by participant's agreement that they previously had the sort of thoughts listed in the revised Green et al. Paranoid Thoughts Scale (R-GPTS; Freeman, 2019);
- Participant is currently a patient of Oxford Health NHS Foundation Trust;
- Participant is willing and able to give informed consent for participation in the study;
- Aged 16 years or above;
Key exclusion criteria (6 listed)
- The following exclusion criteria will apply based on concerns regarding risk and capacity to consent:
- Currently experiencing acute psychiatric symptoms which preclude ability to participate in a sustained interview;
- Diagnosis of a moderate to severe intellectual disability;
- High levels of associated risk to self or to others e.g. actively suicidal;
- Primary diagnosis of alcohol or drug misuse; personality disorder; significant forensic history;
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 |
|---|---|---|
| Qualitative interviewParticipants will be interviewed about their experiences of recovery from paranoia. | Other | – |
Primary outcome
Qualitative interview accounts
Time frame: March 2021-March 2022
Semi-structured interpretative phenomenological analysis (IPA) interviews will be used.
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 19 May 2022.
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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.
Dr Felicity Waite, DClinPsy, BSc (Hons) study director
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paranoia and Persecutory Delusion, run by University of Oxford at 1 site 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 6 inclusion and 6 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 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Qualitative interview accounts (time frame: March 2021-March 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2022.