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Digital therapeutic tools in the treatment of mild to moderate depression and anxiety disorders

Digitising paper-based tools in common use for the treatment of mild to moderate depression and anxiety disorders: an investigation of efficacy and acceptability

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN87336732
Enrollment
300
Registered
2020-05-12
Start date
2021-12-03
Completion date
Unknown
Last updated
2024-02-27

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 and anxiety disorders (including generalized anxiety disorder, obsessive-compulsive disorder, phobias, post-traumatic stress disorder, and social anxiety) Mental and Behavioural Disorders

Interventions

but they will be given standard non-interactive therapy tools, delivered through from the platform as pdf documents. Patients’ clinical outcomes and response to therapy will be monitored. Therefore,

Sponsors

Ieso Digital Health
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Current participant inclusion criteria as of 11/02/2022: 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 where the service is commissioned (over 50 CCGs in the UK) 2. Patients must have a diagnosis of an anxiety disorder or depression in the mild to moderate range, i.e. GAD-7 score at assessment between 8 and 17 points, PHQ-9 scores at assessment below 14 points 3. Patients must be able and willing to sign a consent form prior to the study Previous participant 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 where the service is commissioned (over 50 CCGs in the UK) 2. Patients must have a diagnosis of an anxiety disorder or depression in the mild to moderate range, i.e. GAD-7 score at assessment between 8 and 14 points, PHQ-9 scores at assessment between 10 and 14 points, inclusive 3. Patients must be able and willing to sign a consent form prior to the study

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 have started a course of psychotropic medication or changed medication within the last 3 months (currently being prescribed medication is not an exclusion criteria) 3. Patients at a significant risk of self-harm, as assessed by item 9 of the PHQ-9 questionnaire and ongoing assessment by their assigned clinician. 4. Patients undergoing any other psychological therapy 5. People who do not have access to an internet-enabled device or have access to internet connection 6. People who have a low level of literacy; those who cannot write or read emails or texts will be excluded from this study because they will be unable to utilise the intervention 7. People 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 8. People who are not suitable for CBT, e.g. patients with cognitive deficits from brain damage or dementia, and patients who do not wish to engage with the process e.g. by completing homework 9. Patients who do not speak English

Design outcomes

Primary

MeasureTime frame
1. Symptoms of depression measured using the Patient Health Questionnaire (PHQ-9), completed by the participant at initial assessment and before every treatment session 2. Symptoms of anxiety measured using the Generalised Anxiety Disorder Questionnaire (GAD-7), completed by the participant at initial assessment and before every treatment session

Secondary

MeasureTime frame
1. Drop-out rates measured by observing the number of patients who cease therapy either before clinical recovery or before being discharged by the therapist 2. Engagement rates measured by observing the number of patients who fail to attend at least two treatment sessions (after completing an initial assessment session) 3. Acceptability of digital tools measured by responses to an acceptability questionnaire devised at Ieso Digital Health (only to be given to the active group) which patients will complete once, after completion of the homework task 4. Treatment duration measured by the number of treatment sessions needed to reduce symptoms of anxiety and depression, measured from the first treatment session to the last

Countries

England, United Kingdom

Contacts

Public ContactMichael Ewbank
m.ewbank@iesohealth.com+44 (0)800 074 5560

Outcome results

None listed

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