NCT04824781

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

June 9, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2022

Completed
Last Updated

May 19, 2022

Status Verified

March 1, 2021

Enrollment Period

2 months

First QC Date

March 25, 2021

Last Update Submit

May 18, 2022

Conditions

Keywords

ParanoiaPersecutory delusionsRecoveryNHSQualitativeInterpretative phenomenological analysis

Outcome Measures

Primary Outcomes (1)

  • Qualitative interview accounts

    Semi-structured interpretative phenomenological analysis (IPA) interviews will be used.

    March 2021-March 2022

Interventions

Participants will be interviewed about their experiences of recovery from paranoia.

Eligibility Criteria

Age16 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oxford Health NHS Foundation Trust

Oxford, Oxfordshire, OX3 7JX, United Kingdom

Location

MeSH Terms

Conditions

Paranoid Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Dr Felicity Waite, DClinPsy, BSc (Hons)

    University of Oxford

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2021

First Posted

April 1, 2021

Study Start

June 9, 2021

Primary Completion

July 27, 2021

Study Completion

February 16, 2022

Last Updated

May 19, 2022

Record last verified: 2021-03

Locations