Cognitive and behavioural biomarkers in cognitive behavioural therapy (CBB4CBT): an investigation of the effect of therapist vs patient-only visibility of patient biomarkers in improving clinical outcomes for patients with mental health conditions

Ieso Digital Health0 sites235 target enrollmentApril 1, 2020

Overview

Phase: 未知
Intervention: Not specified
Conditions: Not specified
Sponsor: Ieso Digital Health
Enrollment: 235
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 1, 2020

End Date

December 31, 2021

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Ieso Digital Health

Eligibility Criteria

Inclusion Criteria

•Patients referred to the IECBT service for the treatment of depression or an anxiety disorder, who meet the eligibility criteria, will be invited to participate in the study. These criteria are as follows:
•1\. Patients must be over 18 years old at the time of recruitment and registered with a general practitioner in the geographical region of Surrey, where the service is commissioned and the study will recruit from.
•2\. Patients must have a primary diagnosis of depression or anxiety disorder
•3\. Able and willing to sign a consent form prior to the study
•4\. Patients must own an internet\-connected mobile phone, running Android version 4\.0\.3 or higher

Exclusion Criteria

•It is important that this study only seeks to recruit patients who are suitable for a primary care psychological therapy intervention and that these patients are suitable for CBT. It is also essential that patients recruited to the study are able to access and use a computer or other Internet\-enabled device. Therefore, the following groups of patients will be excluded from the study:
•1\. Patients who are not suitable for CBT, this includes patients with a comorbid diagnosis (a diagnosis of multiple disorders) of psychotic or personality disorder, autism spectrum condition or intellectual disability
•2\. Patients who display a significant risk of self\-harm, as assessed by item 9 of the PHQ\-9 questionnaire and ongoing assessment by their assigned clinician
•3\. Patients who have a poor likelihood of engagement with the therapeutic process, as assessed at triage
•4\. Patients who do not have access to an Internet\-enabled device or an Internet connection
•5\. Patients who have a low level of literacy. Patients who cannot write or read emails or texts will be excluded from this study because they will be unable to utilise the intervention
•6\. Patients who are visually impaired and are unable to write on or read from a computer and do not have access to appropriate assistive technology for the visually impaired
•7\. Patients who do not speak English
•8\. Patients who become unsuitable for treatment within an NHS primary care mental health (Improving Access to Psychological Therapy, IAPT) service. The normal NHS IAPT exclusion criteria will be applied whereby patients who become actively suicidal or present as a risk to others require a referral on to a more specialised, secondary care service. In addition, patients who are experiencing symptoms of psychosis, hyper\-mania, severe cognitive impairment, severe personality disorder or severe learning disability are also deemed as being unsuitable for an IAPT service. These patients will be excluded from this study and referred on to more specialised services.
•9\. Participants who are already involved in a different research project