Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2020
INTERVENTION: This is an interventional study involving patients entering into treatment with Ieso Digital Health, a provider of Internet‐enabled cognitive behavioural therapy (IECBT), where patients communicate with a qualified CBT therapist using a real‐time text‐based system. Patients entering into the IECBT service who fulfil eligibility criteria will be invited to participate in the research study. Before commencing their course of IECBT treatment, consenting patients will be randomised to one of two groups by the patient services team. The active group will be given digitally enhanced therapy. Patients allocated to this group will receive a course of human‐delivered IECBT for mild to moderate depression or an anxiety disorder, enhanced by one of six possible digital therapeutic tools, delivered under the supervision of a clinician and used by the patient alone during the period in between therapy sessions. The control group will be given standard therapy. Patients allocated to this group will receive a standard course of human‐delivered IECBT for mild to moderate depression or an anxiety disorder, without the support of digital tools; 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, patients will be involved in the study for the duration of a course of therapy, which is typically between 8 and 12 weeks. Due to the nature of the study, it is not possible to blind therapists or patients to study group. Nevertheless, therapists will be especially trained in the study procedures and will aim to deliver the same standard of care across CONDITION: 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 PRIMARY OUTCOME: ; 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; 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 SECONDARY OUTCOME: ; 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;
Epistemonikos ID: c5e14ed67893956c460a162b5d10d940218bc17d
First added on: Aug 24, 2024