SlowMo trial: a digital therapy for people who fear harm from others
| ISRCTN | ISRCTN32448671 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32448671 |
| Integrated Research Application System (IRAS) | 206680 |
| Protocol serial number | 32154, IRAS 206680 |
| Sponsors | King's College London, South London and Maudsley NHS Foundation Trust |
| Funder | Efficacy and Mechanism Evaluation Programme |
- Submission date
- 30/01/2017
- Registration date
- 02/02/2017
- Last edited
- 18/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
Psychology, PO77, HWB
Kings College London
Institute of Psychiatry, Psychology and Neuroscience
De Crespigny Park
London
SE5 8AF
United Kingdom
| Phone | +44 (0)20 7836 5454 |
|---|---|
| thomas.ward@kcl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Treatment, Psychological & Behavioural |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomised controlled trial to evaluate the outcomes and mechanisms of a novel digital reasoning intervention for persecutory delusions |
| Study acronym | SlowMo |
| Study objectives | 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(s) | Camberwell St Giles committee, 07/12/2016, ref: 16/LO/1862 |
| Health condition(s) or problem(s) studied | Paranoia |
| 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 |
| Primary outcome measure(s) |
Paranoia is assessed using the Green Paranoid Thoughts Scale (GPTS) at screening, baseline, 12 weeks and 24 weeks. |
| Key secondary outcome measure(s) |
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 |
| Completion date | 25/10/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 360 |
| Total final enrolment | 362 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/05/2017 |
| Date of final enrolment | 14/05/2019 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Denmark Hill
London
SE5 8AZ
United Kingdom
Oxford Business Park
Oxford
OX4 2GX
United Kingdom
Arundel Road
Worthing West
BN13 3EP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/07/2021 | 08/04/2021 | Yes | No | |
| Results article | 01/07/2022 | 04/07/2022 | Yes | No | |
| Results article | 01/08/2021 | 18/03/2025 | Yes | No | |
| Protocol article | protocol | 02/11/2017 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
18/03/2025: Publication reference added.
07/06/2023: Internal review.
04/07/2022: Publication reference added.
08/04/2021: Publication reference added.
13/03/2020: The following changes were made:
1. The overall trial end date has been changed from 28/02/2020 to 25/10/2019.
2. The IRAS number was added.
12/06/2019: The total final enrolment was added.
07/05/2019: The recruitment end date was changed from 30/04/2019 to 14/05/2019.
28/03/2019: The condition has been changed from "Specialty: Mental Health, Primary sub-specialty: Psychosis - schizophrenia; UKCRC code/ Disease: Mental Health/ Schizophrenia, schizotypal and delusional disorders" to "Paranoia" following a request from the NIHR.
06/11/2018: The following changes were made:
1. The recruitment end date was updated from 31/10/2018 to 30/04/2019.
2. The overall trial end date was updated from 31/08/2019 to 28/02/2020.
3. The intention to publish date was updated from 30/09/2020 to 31/03/2021.
06/11/2017: Publication reference added.
