Experiences of feeling exceptional: preliminary testing of a new therapy for treating harmful grandiose delusions

ISRCTN	ISRCTN82078351
DOI	https://doi.org/10.1186/ISRCTN82078351
Integrated Research Application System (IRAS)	344160
Central Portfolio Management System (CPMS)	62659
Sponsor	University of Oxford
Funder	National Institute for Health and Care Research

Submission date: 30/06/2026
Registration date: 10/07/2026
Last edited: 10/07/2026

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Experiences of Feeling Exceptional (often called grandiose delusions by mental health services) are false beliefs about having special powers, mission, wealth or identity. They are experienced by one in three patients diagnosed with severe mental health problems. These beliefs can be very meaningful but they can also come at a cost. For example:
- Stephen believed he had superpowers. He crashed his car at speed to try to demonstrate his abilities.
- Sophie believed that she was God. She stepped off heights as she expected to fly.
- Max believed he was an undercover special forces agent. He tried to conduct arrests and got into fights believing that he had back up from other agents.

Current talking therapies and medications do not work well enough for many patients with experiences of feeling exceptional. A new understanding of why these experiences persist for a person has been developed and this has been used to develop the first talking therapy specifically for the treatment of harmful experiences of feeling exceptional. The therapy aims to help people find a personally meaningful focus in life but that comes with fewer costs. The current study will conduct the very first test of this therapy. It will assess the acceptability of the therapy for patients, and provide initial evidence concerning whether the therapy is helpful.

Who can participate?
Adults aged 16+ years who are receiving care from Oxford Health NHS Foundation Trust’s mental health services for the treatment of affective or non-affective psychosis may be eligible to participate. Participants must have held a persistent experience of feeling exceptional for at least 3 months and be able to give informed consent.

What does the study involve?
Participants will all receive the talking therapy which will be delivered by a psychologist over 16 weekly one-to-one sessions.

Before therapy begins, there will be a baseline (waiting) period of 4 to 6 weeks during which participants will complete brief weekly assessments. The length of this baseline period is randomly assigned. This helps researchers understand whether any changes are due to the therapy rather than the passage of time.

Participants will complete the brief weekly measures throughout both the baseline and therapy phases. In addition there will be four more detailed assessment points: at the start of the baseline period, end of the baseline period (just before therapy begins), midway through therapy, and at the end of therapy. There will also be a short follow-up assessment after therapy ends. Participants will also be invited to take part in interview to share their experiences of therapy.

What are the possible benefits and risks of participating?
At present, since the therapy has not been evaluated before, ther eis no way to say that taking part in the study will benefit participants. It is hoped however that the therapy will help people to be able to live a meaningful and purposeful life whilst reducing difficulties associated with their experience of feeling exceptional. The therapy is not currently available outside of the study, and all participants will receive the therapy.

No major risks are anticipate any from taking part. The new therapy has been designed to minimise any risks. However, the research team will check whether there are any potential problems over the course of this research study. Everyone will have the research assessments, and if these are experienced as upsetting then it is possible to reduce the length of these or for the person to withdraw. In addition to having the support of the study therapist, participants will continue to have their usual contact with their NHS care team throughout their time in the study who can offer support if participants experience distress.

Where is the study run from?
The study is being run within Oxford Health NHS Foundation Trust, and led by a research team based in the Department of Experimental Psychology, at the University of Oxford.

When is the study starting and how long is it expected to run for?
The study is expected to begin recruitment in May 2026 and will run for approximately 13 months including recruitment, therapy delivery, and follow-up.

Who is funding the study?
The National Institute for Health and Care Research (NIHR), UK.

Who is the main contact?
Dr Louise Isham (Clinical Psychologist), louise.isham@oxfordhealth.nhs.uk

Contact information

Dr Louise Isham
Principal investigator, Scientific, Public

Department of Experimental Psychology
University of Oxford
The Life and Mind Building
South Parks Road
Oxford
OX1 3EL
United Kingdom

ORCID ID	0000-0003-1752-5236
Phone	+44 01865 283804
Email	louise.isham@psy.ox.ac.uk

Study information

Primary study design	Interventional
Allocation	N/A: single arm study
Masking	Open (masking not used)
Control	Uncontrolled
Assignment	Single
Purpose	Treatment
Scientific title	Experiences of feeling exceptional: finding meaning and balance in everyday life - a proof-of-concept multiple baseline single case experimental design series testing the feasibility, acceptability, and potential clinical benefits of treating harmful grandiose delusions
Study acronym	EOFE
Study objectives	To establish a preliminary indication of the clinical effectiveness and acceptability of a novel intervention to reduce harmful grandiose delusions in patients with psychosis attending NHS mental health services. Feedback from this study will be used to refine the therapy in preparation for a subsequent pilot RCT.
Ethics approval(s)	Approved 15/04/2026, East of England - Cambridge East Research Ethics Committee (2 Redman Place, Stratford, London, EC20 1JQ, United Kingdom; +44 0207 104 8181; CambridgeEast.REC@hra.nhs.uk), ref: 26/EE/0015
Health condition(s) or problem(s) studied	Treating persistent harmful grandiose delusions in patients attending NHS mental health services for the treatment of affective or non-affective psychosis.
Intervention	The intervention is a psychological therapy designed to precisely target the key mechanisms which drive grandiose delusions and reduce associated harm. Central to the therapy is helping patients find alternative sources of meaning in their lives so that the grandiose delusions can fade. The therapy will be provided in up to 16 sessions. The intervention will be delivered by a mental health staff member (e.g. clinical psychologist, counselling psychologist, or CBT therapist) in up to sixteen one-hour one-to-one sessions over 16 weeks.
Intervention type	Behavioural
Primary outcome measure(s)	Grandiose delusion severity measured using the Psychotic Symptom Rating Scale - Delusions subscale (PSYRATS delusions) at the start of baseline, the end of baseline, the mid therapy, and the end of therapy Grandiosity severity measured using Specific Psychotic Symptom Rating Scale - Grandiosity Subscale (SPEQ-G) at the start of baseline, the end of baseline, the mid therapy, and the end of therapy Grandiose delusion conviction measured using a 0-100% Visual Analogue Scale (VAS) at weekly timepoints throughout baseline and therapy phases and at two-week follow-up after therapy completion
Key secondary outcome measure(s)	Repetitive thinking about the grandiose delusions measured using the Thinking about Experiences of Feeling Exceptional Questionnaire (TEEQ) at the start of baseline, the end of baseline, the mid therapy, and the end of therapy Immersion Behaviours measured using Immersion Behaviours Questionnaire at the start of baseline, the end of baseline, the mid therapy, and the end of therapy Meaning in Grandiose Delusions measured using the Grandiosity Meaning Measure (gram) and Grandiosity Meaning Measure - Sources (grams) at the start of baseline, the end of baseline, the mid therapy, and the end of therapy Anomalous experiences measured using the Specific Psychotic Experiences Questionnaire - anomalous experiences (SPEQ-AE) at the start of baseline, the end of baseline, the mid therapy, and the end of therapy Mania measured using the Internal State Scale at the start of baseline, the end of baseline, the mid therapy, and the end of therapy Subjective harm from grandiose delusions measured using the Subjective Harm from Experiences of Feeling Exceptional Questionnaire (SHEEQ) at the start of baseline, the end of baseline, the mid therapy, and the end of therapy Brief idiographic measures (single item visual analogue scales) for repetitive thinking, immersion behaviours, meaning from grandiose delusions, anomalous experiences, mania, and subjective harm measured using the Brief single-item visual analogue scales at weekly timepoints throughout baseline and intervention phases and at two-week follow-up after the intervention has finished Depression measured using the Patient Health Questionnaire-9 (PHQ-9) at the start of baseline, the end of baseline, the mid therapy, and the end of therapy Anxiety measured using the Generalized Anxiety Disorder-7 (GAD-7) at the start of baseline, the end of baseline, the mid therapy, and the end of therapy Paranoia measured using the Revised Green et al Paranoid Thought Scale (RGPTS) at the start of baseline, the end of baseline, the mid therapy, and the end of therapy Patient satisfaction measured using an Adapted Client Satisfaction Questionnaire at the end of therapy Number of patients completing a dose of therapy (8 sessions is considered a dose of therapy) measured using study data collection at the end of therapy Participants' experience of therapy measured using qualitative interviews at a two-week follow up after the end of therapy
Completion date	14/07/2027

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	16 Years
Upper age limit	110 Years
Sex	All
Target sample size at registration	9
Key inclusion criteria	1. Participant is willing and able to give informed consent for participation in the study 2. Aged 16 years or older 3. Attending NHS mental health services for the treatment of affective or non-affective psychosis 4. Persistent (at least 3 months) grandiose delusion (as defined by the Schedules for Clinical Assessment in Neuropsychiatry), held with at least 60% conviction 5. No planned significant medication changes at the outset of participation
Key exclusion criteria	1. A primary diagnosis of another mental health condition (e.g. substance use disorder) that would be the first clinical priority to treat 2. Current engagement in any other intensive individual psychological therapy or a significant change in medication 3. In forensic settings or Psychiatric Intensive Care Unit (PICU) 4. Command of spoken English inadequate for engaging in the therapy 5. Significant learning difficulties that would prevent the completion of assessments or the therapy 6. A participant may also not enter the trial if there is another factor (for example, current active suicidal plans that need to be the focus of intervention), which, in the judgement of the investigator, would preclude the participant from providing informed consent or from safely engaging with the trial procedures. Reason for exclusion will be recorded
Date of first enrolment	06/07/2026
Date of final enrolment	14/02/2027

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Oxford Health NHS Foundation Trust

Littlemore Mental Health Centre
Sandford Road
Littlemore
Oxford
OX4 4XN
England

Results and Publications

Individual participant data (IPD) Intention to share	No

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol file	version 1.2	06/05/2026	01/07/2026	No	No

Additional files

49819_Protocol_V1.2_06May2026.pdf: Protocol file

Editorial Notes

30/06/2026: Study's existence confirmed by Health Research Authority (HRA) (UK).