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Cognitive and behavioural biomarkers for the treatment of mental health conditions: an investigation of acceptability and efficacy when used as a therapeutic tool

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11004397
Enrollment
200
Registered
2020-04-01
Start date
2020-07-01
Completion date
Unknown
Last updated
2022-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Common mental health disorders including depression, anxiety, obsessive-compulsive disorder (OCD), phobias, post-traumatic stress disorder (PTSD) and social anxiety Mental and Behavioural Disorders

Interventions

Sponsors

Ieso Digital Health
Lead Sponsor
Biotaware Ltd
Collaborator

Eligibility

Sex/Gender
All

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
1. Depressive symptoms measured using the PHQ-9 at initial assessment and before every therapy session 2. Anxiety symptoms measured using the GAD-7 at initial assessment and before every therapy session

Secondary

MeasureTime frame
1. Mood ratings using a single scale question, every day throughout the course of treatment 2. Active minutes measured through a Fitibit, every day throughout the course of treatment 3. Cardio minutes measured through a Fitibit, every day throughout the course of treatment 4. Peak activity minutes measured through a Fitbit, every day throughout the course of treatment 5. Total time asleep measured through a Fitibit, every day throughout the course of treatment 6. Total time awake measured through a Fitibit, every day throughout the course of treatment 7. Total distance travelled measured by the mobile phone, every day throughout the course of treatment 8. Number of locations visited measured by the mobile phone, every day throughout the course of treatment 9. Time spent at home measured by the mobile phone, every day throughout the course of treatment 10. Maximum distance from home measured by the mobile phone, every day throughout the course of treatment 11. Time with phone screen on measured by the mobile phone, every day throughout the course of treatment 12. Time spent on social media apps measured by the mobile phone, every day throughout the course of treatment 13. Time spent on messaging apps measured by the mobile phone, every day throughout the course of treatment 14. Number of calls made, received, and missed, measured by the mobile phone, every day throughout the course of treatment 15. Total duration of calls made, received, and missed measured by the mobile phone, every day throughout the course of treatment

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026