Condition category
Mental and Behavioural Disorders
Date applied
22/09/2018
Date assigned
28/09/2018
Last edited
01/10/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Sponsor information

Organisation

Queen Mary University of London

Sponsor details

Joint Research Management Office
5 Walden Street
London
E1 2EF
United Kingdom

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes