Early Intervention Psychosis Communication and Engagement Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03196128
Recruitment Status : Recruiting
First Posted : June 22, 2017
Last Update Posted : October 17, 2017
Information provided by (Responsible Party):
Christina Clark, South London and Maudsley NHS Foundation Trust

Brief Summary:

This study will examine whether or not the use of digital communication methods (text messages and emails) improves patient engagement with Early Intervention Psychosis (EIP) Services, compared to standard communication methods (letters and telephone calls).

One of the biggest challenges of psychiatric services is patient disengagement. People with psychosis, are often difficult to engage in community based mental health services (CMHTs). Patient's who disengage from psychiatric care often have higher social care needs, are often more unwell and are more likely to be detained under the Mental Health Act compared to those who engage. It is important to examine the reasons for this for both research and clinical reasons to establish the effectiveness of the service to its users. Importance must be placed on the clinician's perspective of the engagement; the patient's perspective is vital.

This study is a pilot two-arm pragmatic Randomised Control Trial to examine the feasibility of assessing engagement of EIP services through different communication methods. Patients and care-coordinators will use self-reported scales to measure engagement to determine whether this improves through the use of different communication methods.

Patients will be asked to consent to being randomly allocated to one of two groups:

(i.) Receive letters, phone calls and voicemail's from their care coordinator for standard appointments.


(ii.) Receive text messages and emails from their care-coordinator for standard appointments.

Patients eligible for this study will be in their first six months of care under an EIP CMHT and who have consented to take part. They will be aged 18-35, not a hospital inpatient, have access to the Internet, a mobile phone and who are fluent in the English language.

Care-coordinators will assess the feasibility and acceptability of the design and procedures and determine an effective sample size calculation for a future large scale pragmatic Randomised Controlled Trial.

Condition or disease Intervention/treatment Phase
First Episode Psychosis Other: Digital communication Other: Non digital Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Digital Media Versus Standard Method of Communication to Examine Engagement of Patients in Community Early Intervention Psychosis (EIP) Services
Actual Study Start Date : July 18, 2017
Estimated Primary Completion Date : December 30, 2017
Estimated Study Completion Date : January 30, 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Digital Other: Digital communication
Communicating with patients via email and text message.

Active Comparator: Non Digital Other: Non digital
Communicating with patients via telephone and written appointment letters.

Primary Outcome Measures :
  1. Singh O'Brien Level of Engagement Scale [ Time Frame: Average completion time - 8-10 minutes. ]
    Self reporting scale designed to measure the level of engagement in people with psychosis. It contains 16 questions covering various aspects of engagement, each question scored in a scale ranging from 0-10.

  2. Service Engagement Scale [ Time Frame: Average completion time: 4- 6 minutes. ]
    A scale completed by clinicians to assess their perceived level of engagement of patients under their care. It is a 14 - question scale covering the same areas as the SOLES.

Secondary Outcome Measures :
  1. Care Coordinator Feasibility Questionnaire [ Time Frame: Average completion Time: 10 minutes. ]
    Self reporting scale.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • First Episode Psychosis under the care of Early Intervention Psychosis Team Community Mental Health Team.
  • Aged 18 - 65
  • Fluent in the English language
  • In first six months of service
  • Has a mobile phone and access to the internet/email

Exclusion Criteria:

  • Currently an inpatient in hospital
  • Nearing discharge from EIP services
  • Is not fluent in the English Language
  • In acute crisis at the time of participant recruitment
  • Does not have a mobile phone or access to the internet/email

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03196128

United Kingdom
Christina Clark Recruiting
London, United Kingdom, SE11 5DL
Contact: Christina Clark    02032287266   
Contact: Eduardo Iacoponi    02032287200   
Sponsors and Collaborators
South London and Maudsley NHS Foundation Trust

Responsible Party: Christina Clark, Lead Investigator, South London and Maudsley NHS Foundation Trust Identifier: NCT03196128     History of Changes
Other Study ID Numbers: 17/EM/0093
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: October 17, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders