Condition category
Mental and Behavioural Disorders
Date applied
30/01/2017
Date assigned
02/02/2017
Last edited
03/02/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
People often experience distressing worries about other people intentionally causing harm, also known as paranoia. Paranoia is one of the most common symptoms of severe mental health problems and is associated with marked distress and disruption to people’s lives. Paranoia tends to be associated with certain thinking habits, called “fast thinking”. Everybody thinks fast and this can be helpful in some situations. At other times, fast thinking may contribute to feeling more stressed than we need to be. SlowMo is a therapy service which has been developed by service users, designers, researchers and clinicians to support people to notice their upsetting worries and fast thinking habits, and then provides tips to help them slow down for a moment to notice new information and safer thoughts. The aim of this study is to find out whether SlowMo reduces paranoia. The study will also investigate how SlowMo works (do changes in fast thinking reduce worries about others) and whether differences in beliefs, memory, and motivation influence this.

Who can participate?
Adults who have had distressing paranoia for at least three months.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group take part in the SlowMo programme in addition to receiving usual care. This involves eight individual, face-to-face sessions with a trained therapist, which are supported by a website with interactive stories and games. The programme helps people to find out how fast thinking habits can contribute to upsetting thoughts, and try out tips to learn what helps them slow down their thinking and cope with worries. The first two sessions involve learning that worries about others and fast thinking are common, and developing an individualised understanding of the person’s thoughts and thinking habits. The remaining six sessions deal with learning and trying out tips to slow down thoughts. Those in the second group receive usual care only, as they would if they weren’t taking part in the study. At the start of the study and then after 12 and 24 weeks, participants complete a number of questionnaires to assess their paranoia and related symptoms as well as their mental wellbeing.

What are the possible benefits and risks of participating?
It is hoped that those receiving SlowMo will find it helpful. However, this cannot be guaranteed. Those who do not receive SlowMo will not be given a phone with the SlowMo app but will be reimbursed for their time. The information from all participants may help to support others with similar problems. If SlowMo is shown to work, then the plan would be for it to be more widely available in NHS services in the future. There are no anticipated risks involved with participating. However, as standard practice, the university sponsoring the research has insurance arrangements in place to provide for any harm arising from taking part if it were to occur. NHS indemnity (insurance) operates in respect of the therapy that is provided.

Where is the study run from?
1. South London and Maudsley NHS Foundation Trust (UK)
2. Oxford Health NHS Foundation Trust (UK)
3. Sussex Partnership NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
July 2015 to August 2019

Who is funding the study?
Efficacy and Mechanism Evaluation Programme (UK)

Who is the main contact?
Dr Thomas Ward
thomas.ward@kcl.ac.uk

Trial website

www.slowmotherapy.co.uk

Contact information

Type

Scientific

Primary contact

Dr Thomas Ward

ORCID ID

Contact details

Psychology
PO77
HWB
Kings College London
Institute of Psychiatry
Psychology and Neuroscience
De Crespigny Park
London
SE5 8AF
United Kingdom
+44 20 7836 5454
thomas.ward@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

32154

Study information

Scientific title

A randomised controlled trial to evaluate the outcomes and mechanisms of a novel digital reasoning intervention for persecutory delusions

Acronym

SlowMo

Study hypothesis

Research questions:
1. Is SlowMo efficacious in reducing paranoia severity over 24 weeks, when added to treatment as usual (TAU), in comparison to TAU alone?
2. Does SlowMo reduce paranoia severity by improving fast thinking (reducing belief inflexibility and jumping to conclusions)?
3. Do participant characteristics (i.e. their cognitive capacities, specifically working memory and thinking habits; and their symptoms, specifically negative symptoms) moderate the effects of the intervention?
4. Does outcome differ by adherence to the intervention and is adherence predicted by the participants’ beliefs about their illness and about the intervention?
5. Does the SlowMo digital therapy platform have acceptable rates of usability, acceptability and adherence?
6. Does SlowMo reduce worry?

Study Hypotheses:
Primary hypotheses:
1. The intervention will reduce paranoia severity over 24 weeks.
2. Fast thinking (belief inflexibility and jumping to conclusions) will improve in response to the intervention.
3. Reductions in fast thinking will mediate positive change in paranoia severity.

Secondary hypotheses:
4. Poorer working memory and more severe negative symptoms will negatively moderate treatment effects.
5. Therapy adherence will moderate the effects of treatment on outcome and adherence will be predicted by beliefs about mental health problems.
6. Worry will not mediate reductions in paranoia severity

Ethics approval

Camberwell St Giles committee, 07/12/2016, ref: 16/LO/1862

Study design

Randomised; Interventional; Design type: Treatment, Psychological & Behavioural

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

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

Condition

Specialty: Mental Health, Primary sub-specialty: Psychosis - schizophrenia; UKCRC code/ Disease: Mental Health/ Schizophrenia, schizotypal and delusional disorders

Intervention

Participants are randomised in a 1:1 ratio to one of two groups.

Intervention group: Participants receive the SlowMo intervention in addition to treatment as usual (TAU). SlowMo consists of eight individual, face-to-face sessions, delivered by trained therapists, assisted by a website with interactive stories and games. SlowMo supports people to find out how fast thinking habits can contribute to upsetting thoughts, and try out tips to learn what helps them slow down their thinking and cope with worries. Personalised session content is synchronised with a mobile app to support people to make use of strategies learnt in their daily life. The first two sessions involve learning that worries about others and fast thinking are common, and developing an individualised understanding of the person’s thoughts and thinking habits. The concepts of ‘thinking fast’ and ‘thinking slow’ are introduced. It is explained that everyone thinks fast at times, and this can be helpful although at other times thinking fast can mean we feel worried when we do not need to be. Participants learn that thinking slow can be helpful in dealing with stress and worries about other people. This key principle frames the remaining 6 sessions where people are supported to find out about and try out tips to slow down for a moment, such as the impact of mood and past experiences on paranoia.

Control group: Participants receive treatment as usual only, which involves usual care with reference to best practice guidance, specifically NICE guidance on community mental health treatment for people with psychosis and the standards of community care required by the Care Quality Commission. Participation in the study will not alter usual treatment decisions about medication and additional psychosocial interventions which remain the responsibility of the clinical team.

For participants in both groups, assessments are undertaken at baseline, after treatment at 12 weeks, and at 24-week follow-up.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Paranoia is assessed using the Green Paranoid Thoughts Scale (GPTS) at screening, baseline, 12 weeks and 24 weeks.

Secondary outcome measures

1. Frequency, severity and impact of delusional beliefs are assessed using The Psychotic Symptom Rating Scales (PSYRATS-delusions) at baseline, 12 weeks and 24 weeks
2. Positive symptoms are assessed using the Scales for Assessment of Positive Symptoms (SAPS) at baseline, 12 weeks and 24 weeks (N.B all items will be used at baseline but only the Persecutory delusions and ideas of reference items will be used at 12 and 24 weeks)
3. Belief flexibility (Possibility of being mistaken; PM) is assessed using the Maudsley Assessment of Delusional Beliefs (MADS); Wessely et al. (1993), at baseline, 12 weeks and 24 weeks
4. Belief flexibility (Presence of Alternative Explanations; AE) is assessed using Explanation for Experiences (Freeman et al., 2004) at baseline, 12 weeks and 24 weeks
5. The Jumping to conclusions (JTC) bias is assessed using the Beads Task in ratios 60:40 and 85:15 at baseline, 12 weeks and 24 week
6. Negative symptoms are assessed using Brief Negative Symptom Scale (BNSS) at baseline
7. Beliefs about problems are assessed using Beliefs about Problems Questionnaire at baseline
8. Working memory is assessed using Letter Number Sequencing (from Wechsler Adult Intelligence Scale (WAIS IV) at baseline
9. Processing speed and set-shifting are assessed using the Trail Making Task- A&B at baseline
10. Reasoning about paranoia is assessed using the Thinking about Paranoia Scale (TAPS) at baseline, 12 weeks and 24 weeks
11. Current worry is assessed using the Penn State Worry Questionnaire at baseline, 12 weeks and 24 weeks
13. Beliefs about the self and others are assessed using Brief Core Schema Scales (BCSS) at baseline, 12 weeks and 24 weeks
14. Carer criticism is assessed using Perception of carer criticism (adapted from Hooley et al., 1989) at baseline
15. Mental well-being is assessed using The Warwick-Edinburgh Mental Well-being Scale (WEMWBS) at baseline, 12 weeks and 24 weeks
16. Quality of life is assessed using the Short Assessment of Quality of Life (MANSA) at baseline, 12 weeks and 24 weeks
17. Service use (including medication, bed and crisis team days, contact with criminal justice system) will be assessed using the Client Service Receipt Inventory at baseline and 24 weeks

Overall trial start date

01/07/2015

Overall trial end date

31/08/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years and over
2. Persistent (3+ months) distressing paranoia (as assessed using clinical interview (SCAN) and score >29 on Green Paranoid Thoughts Scale (GPTS), persecutory subscale)
3. Diagnosis of schizophrenia-spectrum psychosis (F20-29, ICD 10: Present State Examination, version 10)
4. Capacity to provide informed consent
5. Sufficient grasp of English to participate in informed consent process, assessments and interventions

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 360; UK Sample Size: 360

Participant exclusion criteria

1. Lacks capacity to consent
2. Profound visual and/ or hearing impairment
3. Insufficient comprehension of English
4. Inability to engage in the assessment procedure
5. Engagement in psychological therapy for paranoia
6. Primary diagnosis of substance abuse disorder, personality disorder, organic syndrome or learning disability

Recruitment start date

01/05/2017

Recruitment end date

31/10/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

South London and Maudsley NHS Foundation Trust
Maudsley Hospital Denmark Hill
London
SE5 8AZ
United Kingdom

Trial participating centre

Oxford Health NHS Foundation Trust
4000 John Smith Drive Oxford Business Park
Oxford
OX4 2GX
United Kingdom

Trial participating centre

Sussex Partnership NHS Foundation Trust
Swandean Arundel Road
Worthing West
BN13 3EP
United Kingdom

Sponsor information

Organisation

King's College London

Sponsor details

Room 1.8 Hodgkin Building
Guy's Campus
London
SE1 4UL
United Kingdom

Sponsor type

University/education

Website

Organisation

South London and Maudsley NHS Foundation Trust

Sponsor details

R&D Department
Room W1.11
Institute of Psychiatry
Psychology & Neuroscience (IoPPN)
De Crespigny Park
London
SE5 8AF
United Kingdom
+44 20 7848 0251
jennifer.liebscher@kcl.ac.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Efficacy and Mechanism Evaluation Programme

Alternative name(s)

NIHR Efficacy and Mechanism Evaluation Programme, EME

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Trial results will be disseminated through a series of publications in high-impact peer reviewed journals.

IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Professor Philippa Garety (philippa.garety@kcl.ac.uk)

Intention to publish date

30/09/2020

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes