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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04824781
Other study ID # PID 15402
Secondary ID HRAIRAS
Status Completed
Phase
First received
Last updated
Start date June 9, 2021
Est. completion date February 16, 2022

Study information

Verified date March 2021
Source University of Oxford
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date February 16, 2022
Est. primary completion date July 27, 2021
Accepts healthy volunteers
Gender All
Age group 16 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Qualitative interview
Participants will be interviewed about their experiences of recovery from paranoia.

Locations

Country Name City State
United Kingdom Oxford Health NHS Foundation Trust Oxford Oxfordshire

Sponsors (1)

Lead Sponsor Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Qualitative interview accounts Semi-structured interpretative phenomenological analysis (IPA) interviews will be used. March 2021-March 2022
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