- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04824781
Recovery From Paranoia: a Qualitative Exploration
May 18, 2022 updated by: University of Oxford
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
15
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Oxfordshire
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Oxford, Oxfordshire, United Kingdom, OX3 7JX
- Oxford Health NHS Foundation Trust
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Qualitative interview accounts
Time Frame: March 2021-March 2022
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Semi-structured interpretative phenomenological analysis (IPA) interviews will be used.
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March 2021-March 2022
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Dr Felicity Waite, DClinPsy, BSc (Hons), University of Oxford
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 9, 2021
Primary Completion (Actual)
July 27, 2021
Study Completion (Actual)
February 16, 2022
Study Registration Dates
First Submitted
March 25, 2021
First Submitted That Met QC Criteria
March 30, 2021
First Posted (Actual)
April 1, 2021
Study Record Updates
Last Update Posted (Actual)
May 19, 2022
Last Update Submitted That Met QC Criteria
May 18, 2022
Last Verified
March 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PID 15402
- IRAS (Other Identifier: 332422)
- HRA (Other Identifier: 21/WA/0081)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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