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
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 measure
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 (if study stopped)
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
Total final enrolment
130
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
31/07/2019
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Warneford Hospital
Department of Psychiatry
Warneford Lane
Oxford
OX3 7JX
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
unknown
Funding Body Subtype
Location
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.
IPD sharing statement
Trial outcome data will be available upon reasonable request after the publication of the main report. For requests contact Prof Daniel Freeman (daniel.freeman@psych.ox.ac.uk).
Intention to publish date
31/12/2020
Participant level data
Available on request
Basic results (scientific)
Publication list
2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26969128