Condition category
Mental and Behavioural Disorders
Date applied
11/11/2015
Date assigned
11/11/2015
Last edited
14/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Persecutory delusions are strong unfounded fears that others intend harm. They are very common, affecting over 70% of patients with schizophrenia (a mental health problem that affects how a person thinks, feels and behaves). These fears can be very upsetting and may cause people to become so anxious that they find it hard to cope with day-to-day life. Many patients do not show enough improvement with current treatments being offered. Therefore a new, more effective treatment is needed. One theory is that persecutory delusions stem from a belief about being “unsafe”. This belief of being “unsafe” is maintained by, for example, worrying, low self-confidence, poor sleep, biases in thinking (tendencies to think in certain ways) and avoiding other people. The fear can be reduced by targeting these factors and enabling the patient to relearn that they are safe. This study will compare two treatments which both aim to help people feel safe. The first is a new treatment which has been developed by the study team called “The Feeling Safe Programme”. The second is an existing treatment called “Befriending”. Both treatments are talking therapies which aim to help people feel safe. The Feeling Safe Programme is a targeted and personalised cognitive treatment which focuses on overcoming the key factors which maintain persecutory beliefs, allowing the patient to relearn that they are safe. The Befriending treatment is a social support treatment that simulates how a good friend would respond. Through a supportive, safe relationship it aims to help reduce isolation, provide warmth and empathy, and distract from concerns. The aim of this study is to find out if the Feeling Safe Programme will be more effective in helping people to feel safer (reduced persecutory delusions), feel happier (improved psychological wellbeing) and do more of what they want in their life (increased activity levels) compared to Befriending.

Who can participate?
Patients aged 16 or over who have persistent persecutory delusions and have a diagnosis of non-affective psychosis (e.g. schizophrenia).

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive a new psychological treatment called “The Feeling Safe Programme”. Those in the second group receive an existing psychological treatment called “Befriending”. All participants continue with their usual care (e.g. taking medication). Both treatments involve around 20 meetings with a clinical psychologist over a period of 6 months. At the start of the study and then again after 6 and 12 months, participants in both groups complete assessments in order to find out if there have been any changes.

What are the possible benefits and risks of participating?
All participants will have approximately 20 meetings with a clinical psychologist. It is hoped that this will lead to an improvement in their mental well-being. There are no notable risks of taking part in this study.

Where is the study run from?
Warneford Hospital, Oxford (UK)

When is the study starting and how long is it expected to run for?
February 2016 to October 2020

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
1. Dr Felicity Waite (Public)
2. Professor Daniel Freeman (Scientific)

Trial website

Contact information

Type

Public

Primary contact

Dr Felicity Waite

ORCID ID

Contact details

Department of Psychiatry
Warneford Hospital
Warneford Lane
Headington
Oxford
OX3 7JX
United Kingdom

Type

Scientific

Additional contact

Prof Daniel Freeman

ORCID ID

Contact details

Department of Psychiatry
Warneford Hospital
Warneford Lane
Headington
Oxford
OX3 7JX
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

19657

Study information

Scientific title

Psychological support for fears about other people: A comparison of the Feeling Safe Programme to Befriending

Acronym

The Feeling Safe Study

Study hypothesis

The aim is to investigate whether the Feeling Safe Programme can lead to greater recovery in persecutory delusions, psychological well-being, and activity levels compared to befriending.

Ethics approval

South Central-Oxford B Research Ethics Committee, 28/09/2015, ref: 15/SC/0508

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Mental Health; Subtopic: Schizophrenia; Disease: Schizophrenia

Intervention

Participants are randomly allocated to receive one of two interventions: the Feeling Safe Programme (a new targeted psychological intervention for persecutory delusions) or Befriending. Both interventions are delivered by a clinical psychologist in approximately 20 sessions over 6 months.

Feeling Safe Programme: The aim of the intervention is to enable participants to relearn that they are safer than they fear. This is achieved by targeting key factors which maintain persecutory beliefs. After an assessment, the patient is offered a tailored menu of treatment modules. Typically three to four modules are completed, based upon the assessments and patient preference. These modules are delivered in a one-to-one format, with supportive telephone calls or texts between sessions.

Befriending: This will follow a protocol devised by David Kingdon (a trial investigator), which has previously been used under his supervision in two large clinical trials for patients with psychosis. Essentially the aim is to simulate how a good friend would respond, involving: a general focus on non-threatening topics (although patients are not actively dissuaded from talking about concerns); non-confrontation; empathy; and supportiveness.

Assessments, by a rater-blind to allocation, will be conducted at 0, 6 (post-treatment) and 12 months. All main analyses will be intention to treat. (A small number of qualitative interviews will also be carried out to determine views of the intervention and implementation).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Conviction in persecutory delusion will be assessed on a 0% to 100% rating scale within the Psychotic Symptoms Rating Scale - Delusions at baseline, 6 months (post-treatment) and 12 months. Both rates of recovery in the delusion (defined as conviction falling below 50%) and dimensional change in the conviction levels (0%-100%) will be tested.

Secondary outcome measures

1. Psychological well-being will be assessed by the Warwick-Edinburgh Mental Well-being Scale at baseline, 6 months and 12 months
2. Patient satisfaction will be assessed using the CHOICE (a service user-led outcome measure) at baseline, 6 months and 12 months
3. Activity levels will be assessed using actigraphy and a time-budget measure at baseline, 6 months and 12 months
4. Overall paranoia will be measured on the Green Paranoid Thoughts Scale (GPTS) at baseline, 6 months and 12 months
5. Overall delusion severity will be assessed by the Psychotic Symptoms Rating Scale – Delusions at baseline, 6 months and 12 months
6. Suicidal Ideation will be measured using the Columbia-Suicide Severity Rating Scale at baseline, 6 months and 12 months

Overall trial start date

01/02/2016

Overall trial end date

31/10/2020

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 16 years or above
2. Participant is willing and able to give informed consent for participation in the trial
3. Persistent (at least 3 months) persecutory delusion (as defined by Freeman & Garety, 2000), held with at least 60% conviction
4. Primary diagnosis of schizophrenia spectrum psychosis (nonaffective psychosis)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 150; UK Sample Size: 150; Description: The 150 refers to the patients in the main study

Participant exclusion criteria

1. Current receipt of another psychological therapy
2. Insufficient comprehension of English
3. Primary diagnosis of alcohol, drug, or personality disorder
4. In forensic settings
5. Organic syndrome
6. Learning disability

Recruitment start date

01/02/2016

Recruitment end date

31/01/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Warneford Hospital
Department of Psychiatry Warneford Lane
Oxford
OX3 7JX
United Kingdom

Sponsor information

Organisation

University of Oxford

Sponsor details

Clinical Trials Research Governance
Joint Research Office
Block 60
Churchill Hospital
Oxford
OX3 7LE
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The trial protocol will be submitted for publication early in 2016 before recruitment starts. The outcome results of the trial will later be submitted for publication.

Intention to publish date

01/06/2021

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26969128

Publication citations

Additional files

Editorial Notes

14/03/2016: Publication reference added.