Plain English Summary
Background and study aims
People with psychosis are commonly socially isolated, both due to their own condition, but also due to the stigma towards them. Although several volunteering programmes exist in the community that could potentially help patients, many expect in person meetings, requiring a greater effort of availability and commitment from participants, which may be difficult for them to fulfil. Therefore, there is a need for more flexible, easily accessible support for people with psychosis.
This study aims to find out the acceptability and the feasibility of remote digital volunteering over a smart-phone for people with psychosis, exploring its potential impact in participants (patients and volunteers).
Who can participate?
Patient participants: Adults with psychosis, receiving care in secondary NHS mental health services, who have sufficient command of English to complete the measures and have capacity to provide informed consent.
Volunteer participants: Adult volunteers, who have sufficient command of English to complete the measures and have capacity to provide informed consent.
What does the study involve?
A patient participant will be matched with a volunteer participant. Each patient-volunteer pair will be encouraged to communicate during 12 weeks with each other through a smart-phone that they will receive. Participants are encouraged to send texts, WhatsApp messages, e-mails, make audio or video phone-calls, according to their preference, once per week.
What are the possible benefits and risks of participating?
Participants may benefit from getting in contact with their match over smart-phone. Participants will be reimbursed for their time spent completing the baseline and follow-up measures. We will provide training at the beginning of the study, and support throughout whenever required. There are no known risks to participants taking part in this study.
Where is the study run from?
East London NHS Foundation Trust (UK)
When is study starting and how long is it expected to run for?
May 2018 to October 2019
Who is funding the study?
East London NHS Foundation Trust (UK)
Who is the main contact?
Dr Mariana Pinto da Costa
mariana.pintodacosta@qmul.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Mariana Pinto da Costa
ORCID ID
http://orcid.org/0000-0002-5966-5723
Contact details
Unit for Social and Community Psychiatry (WHO Collaborating Centre for Mental Health Services Development)
London
E138SP
United Kingdom
07423219017
mariana.pintodacosta@qmul.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
012393
Study information
Scientific title
Phone Pal: a mixed methods exploratory study of an intervention for people with psychosis to get in contact with a volunteer via smart-phone
Acronym
Phone Pal
Study hypothesis
The overall aim of this study is to assess the acceptability and the feasibility of remote digital volunteering over smart-phone for people with psychosis, exploring its potential impact.
Ethics approval
Cambridgeshire and Hertfordshire Research Ethics Committee, 22/08/2018, ref. 18/EE/0196
Study design
Interventional single-centre pre-post feasibility study with an internal pilot
Primary study design
Interventional
Secondary study design
Feasibility study
Trial setting
Community
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Psychosis
Intervention
A patient participant will be matched with a volunteer participant. Each patient-volunteer pair will be encouraged to communicate during 12 weeks with each other, through a smart-phone, once per week, conducting informal conversation. Participants can send texts, WhatsApp messages, e-mails, and make audio or video phone-calls, according to their preference. Follow-up assessments will be done within 2 weeks of the end of the intervention.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Feasibility and acceptability of the intervention will be evaluated by assessing the patterns of smart-phone usage (texts, WhatsApp messages, e-mails, make audio or video phone-calls) within each patient-volunteer pair, and interviewing participants at the end of the study.
Secondary outcome measures
The following are assessed at the baseline and at the end of the study for both patients and volunteers.
For patient participants:
1. Smart-phone preferences usage, assessed by self-reported smart-phone usage
2. Step count, assessed by the smart-phone
3. Quality of life, assessed using the Manchester Short Assessment of Quality of Life (MANSA)
4. Physical activity, assessed using the International physical activity questionnaire (IPAQ)
5. Self-esteem, assessed using the Self-Esteem Rating Scale – Short Form
6. Social comparison, assessed using the Social Comparison Scale
7. Attachment, assessed using the Revised Adult Attachment Scale (RAAS)
8. Strength of social network, assessed using the 7-days Social Contacts Assessment
9. Psychiatric symptoms, assessed using the Brief Psychiatric Rating Scale (BPRS)
10. Therapeutic relationship, assessed using the Scale to Assess Therapeutic Relationships – Patient Version (STAR-P)
For volunteer participants:
1. Smart-phone preferences usage, assessed by self-reported smart-phone usage
2. Step count, assessed by the smart-phone
3. Quality of life, assessed using the Manchester Short Assessment of Quality of Life (MANSA)
4. Physical activity, assessed using the International physical activity questionnaire (IPAQ)
5. Self-esteem, assessed using the Self-Esteem Rating Scale – Short Form
6. Social comparison, assessed using the Social Comparison Scale
7. Social distance, assessed using the Social Distance Questionnaire (SDQ)
8. Therapeutic relationship, assessed using the Scale to Assess Therapeutic Relationships – Volunteer Version (STAR-V)
Overall trial start date
01/05/2018
Overall trial end date
01/12/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients:
1. Aged 18 years or over
2. Clinical diagnosis of schizophrenia or a related psychotic disorder (ICD 10: F20- 29)
3. Interested in having a volunteer with whom they would be in contact through a smart-phone for 12 weeks
4. Receiving care in secondary NHS mental health services
5. Capacity to provide informed consent
6. Sufficient command of English to complete the measures
Volunteers:
1. Aged 18 years or over
2. Interested in having a patient with whom they would be in contact through a smart-phone for 12 weeks
3. Capacity to provide informed consent
4. Sufficient command of English to complete the measures
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
36 (18 patients and 18 volunteers)
Participant exclusion criteria
Patients and volunteers:
1. Unable to use smart-phones, even if provided with appropriate assistive technology
Recruitment start date
01/10/2018
Recruitment end date
01/10/2019
Locations
Countries of recruitment
United Kingdom
Trial participating centre
East London NHS Foundation Trust
Trust Heardquarters 9 Alie Street
London
E18DE
United Kingdom
Funders
Funder type
Not defined
Funder name
East London NHS Foundation Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The results of this research study will be used in a doctoral thesis submitted to Queen Mary University of London. It is hoped the results will be published in scientific journals and will be shared widely via open access publications.
Participants in the study will receive a summary of findings if they wish.
IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
31/12/2019
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list