The University of Southampton
University of Southampton Institutional Repository

The efficacy of a new translational treatment for persecutory delusions: study protocol for a randomised controlled trial (The Feeling Safe Study)

The efficacy of a new translational treatment for persecutory delusions: study protocol for a randomised controlled trial (The Feeling Safe Study)
The efficacy of a new translational treatment for persecutory delusions: study protocol for a randomised controlled trial (The Feeling Safe Study)

BACKGROUND: Persecutory delusions (strong unfounded fears that others intend harm to the person) occur in more than 70 % of the patients diagnosed with schizophrenia. This major psychotic experience is a key clinical target, for which substantial improvement in treatment is needed. Our aim is to use advances in theoretical understanding to develop a much more efficacious treatment that leads to recovery in at least 50 % of people with persistent persecutory delusions. Our cognitive conceptualisation is that persecutory delusions are threat beliefs, developed in the context of genetic and environmental risk, maintained by a number of psychological processes including excessive worry, low self-confidence, intolerance of anxious affect and other internal anomalous experiences, reasoning biases, and safety-seeking strategies. The clinical implication is that safety has to be relearned, by entering the feared situations after reduction of the influence of the maintenance factors. We have been individually evaluating modules targeting causal factors. These will now be tested together as a full treatment, called The Feeling Safe Programme. The treatment is modular, personalised, and includes patient preference. We will test whether the new treatment leads to greater recovery in persistent persecutory delusions, psychological well-being, and activity levels compared to befriending (that is, controlling for therapist attention).

METHODS/DESIGN: The Feeling Safe Study is a parallel group randomised controlled trial for 150 patients who have persecutory delusions despite previous treatment in mental health services. Patients will be randomised (1:1 ratio) to The Feeling Safe Programme or befriending (both provided in 20 sessions over 6 months). Standard care will continue as usual. Online randomisation will use a permuted blocks algorithm, with randomly varying block size, stratified by therapist. Assessments, by a rater blind to allocation, will be conducted at 0, 6 (post treatment), and 12 months. The primary outcome is the level of delusional conviction at 6 months. Secondary outcomes include levels of psychological well-being, suicidal ideation, and activity. All main analyses will be intention-to-treat. The trial is funded by the NHS National Institute for Health Research.

DISCUSSION: The Feeling Safe study will provide a Phase II evaluation of a new targeted translational psychological treatment for persecutory delusions.

TRIAL REGISTRATION: Current Controlled Trials ISRCTN18705064 (registered 11 November 2015).

Clinical Protocols, Cognitive Therapy, England, Humans, Intention to Treat Analysis, Mental Health, Paranoid Disorders, Psychiatric Status Rating Scales, Research Design, Schizophrenia, Paranoid, Schizophrenic Psychology, Suicidal Ideation, Time Factors, Translational Medical Research, Treatment Outcome, Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
1745-6215
134
Freeman, Daniel
b90a2f85-f05c-40e8-a592-e1545fae654c
Waite, Felicity
2049f85c-0b07-468d-b254-ac8cd04e90c9
Emsley, Richard
befe7b94-728c-47aa-84db-4f066d5f4836
Kingdon, David
14cdc422-10b4-4b2d-88ec-24fde5f4329b
Davies, Linda
5cb5a68e-ff0a-4519-a773-dafb313e2e70
Fitzpatrick, Ray
e8a93c39-1f5e-4a7d-bfc2-77cf6dd7435f
Dunn, Graham
ffc12c0e-b002-43fd-bdf7-60e17f4b4871
Freeman, Daniel
b90a2f85-f05c-40e8-a592-e1545fae654c
Waite, Felicity
2049f85c-0b07-468d-b254-ac8cd04e90c9
Emsley, Richard
befe7b94-728c-47aa-84db-4f066d5f4836
Kingdon, David
14cdc422-10b4-4b2d-88ec-24fde5f4329b
Davies, Linda
5cb5a68e-ff0a-4519-a773-dafb313e2e70
Fitzpatrick, Ray
e8a93c39-1f5e-4a7d-bfc2-77cf6dd7435f
Dunn, Graham
ffc12c0e-b002-43fd-bdf7-60e17f4b4871

Freeman, Daniel, Waite, Felicity, Emsley, Richard, Kingdon, David, Davies, Linda, Fitzpatrick, Ray and Dunn, Graham (2016) The efficacy of a new translational treatment for persecutory delusions: study protocol for a randomised controlled trial (The Feeling Safe Study). Trials, 17 (1), 134. (doi:10.1186/s13063-016-1245-0).

Record type: Article

Abstract

BACKGROUND: Persecutory delusions (strong unfounded fears that others intend harm to the person) occur in more than 70 % of the patients diagnosed with schizophrenia. This major psychotic experience is a key clinical target, for which substantial improvement in treatment is needed. Our aim is to use advances in theoretical understanding to develop a much more efficacious treatment that leads to recovery in at least 50 % of people with persistent persecutory delusions. Our cognitive conceptualisation is that persecutory delusions are threat beliefs, developed in the context of genetic and environmental risk, maintained by a number of psychological processes including excessive worry, low self-confidence, intolerance of anxious affect and other internal anomalous experiences, reasoning biases, and safety-seeking strategies. The clinical implication is that safety has to be relearned, by entering the feared situations after reduction of the influence of the maintenance factors. We have been individually evaluating modules targeting causal factors. These will now be tested together as a full treatment, called The Feeling Safe Programme. The treatment is modular, personalised, and includes patient preference. We will test whether the new treatment leads to greater recovery in persistent persecutory delusions, psychological well-being, and activity levels compared to befriending (that is, controlling for therapist attention).

METHODS/DESIGN: The Feeling Safe Study is a parallel group randomised controlled trial for 150 patients who have persecutory delusions despite previous treatment in mental health services. Patients will be randomised (1:1 ratio) to The Feeling Safe Programme or befriending (both provided in 20 sessions over 6 months). Standard care will continue as usual. Online randomisation will use a permuted blocks algorithm, with randomly varying block size, stratified by therapist. Assessments, by a rater blind to allocation, will be conducted at 0, 6 (post treatment), and 12 months. The primary outcome is the level of delusional conviction at 6 months. Secondary outcomes include levels of psychological well-being, suicidal ideation, and activity. All main analyses will be intention-to-treat. The trial is funded by the NHS National Institute for Health Research.

DISCUSSION: The Feeling Safe study will provide a Phase II evaluation of a new targeted translational psychological treatment for persecutory delusions.

TRIAL REGISTRATION: Current Controlled Trials ISRCTN18705064 (registered 11 November 2015).

Full text not available from this repository.

More information

Accepted/In Press date: 2015
Published date: 11 March 2016
Keywords: Clinical Protocols, Cognitive Therapy, England, Humans, Intention to Treat Analysis, Mental Health, Paranoid Disorders, Psychiatric Status Rating Scales, Research Design, Schizophrenia, Paranoid, Schizophrenic Psychology, Suicidal Ideation, Time Factors, Translational Medical Research, Treatment Outcome, Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't

Identifiers

Local EPrints ID: 413706
URI: https://eprints.soton.ac.uk/id/eprint/413706
ISSN: 1745-6215
PURE UUID: 8df0a7b6-e0fe-4376-80eb-98478abee99f

Catalogue record

Date deposited: 31 Aug 2017 16:32
Last modified: 13 Mar 2019 20:03

Export record

Altmetrics

Download statistics

Downloads from ePrints over the past year. Other digital versions may also be available to download e.g. from the publisher's website.

View more statistics

Atom RSS 1.0 RSS 2.0

Contact ePrints Soton: eprints@soton.ac.uk

ePrints Soton supports OAI 2.0 with a base URL of https://eprints.soton.ac.uk/cgi/oai2

This repository has been built using EPrints software, developed at the University of Southampton, but available to everyone to use.

We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we will assume that you are happy to receive cookies on the University of Southampton website.

×