Anxiety symptoms in adults Mental and Behavioural Disorders
Conditions
Interventions
The intervention consists of a 6-week digital programme that follows a pre-defined set of psychoeducational activities with a clinical oversight wrap-around model. These activities will be made availa
Sponsors
ieso Digital Health
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 26/04/2024: 1. Individuals must be over 18 years old at the time of recruitment 2. Anxiety must be the primary presenting issue that individuals are seeking help for (i.e. with a GAD-7 score >7), with symptoms of anxiety and worry typically associated with Generalised Anxiety Disorder (GAD) 3. If depressive symptoms are present at screening, these are not within the severe range (i.e., participants must have a PHQ-9 score 7), with symptoms of anxiety and worry typically associated with Generalised Anxiety Disorder (GAD) 3. If depressive symptoms are present, these are not within the severe range (i.e., participants must have a PHQ-9 score <16) 4. Individuals must be able and willing to sign a consent form prior to the study 5. Individuals must be registered with a GP in the UK 6. Individuals must have access to a smartphone with an internet connection
Exclusion criteria
Exclusion criteria: 1. Individuals currently receiving psychological therapy 2. Individuals who are not suitable for CBT, this includes individuals with a comorbid diagnosis (a diagnosis of multiple disorders) of psychotic or personality disorder, autism spectrum condition or intellectual disability 3. Individuals who have a formal diagnosis of an untreated mental health condition including substance misuse (except for GAD, MDD or Mixed Anxiety and Depression) 4. Individuals who have Post Traumatic Stress Disorder (PTSD), Obsessive Compulsive Disorder (OCD) or Panic Disorder 5. Individuals who have had a change in psychiatric medication in the past 3 months 6. Individuals who display a significant risk of harm to self, to others or from others 7. Individuals who do not have access to an Internet-enabled device or an Internet connection 8. Individuals who have a low level of literacy in the English language. People who cannot write or read emails or texts will be excluded from this study because they will be unable to utilise the intervention 9. Individuals who have an impairment that will prevent them from using a phone app and/or who usually rely on accessibility features (note: this app has not yet gone through accessibility evaluation) 10. Individuals who become unsuitable for treatment within an NHS primary care mental health service. The normal NHS Talking Therapies for Anxiety and Depression (TTAD) exclusion criteria will be applied whereby people who become actively suicidal or present as a risk to or from others require a referral on to a more specialised, secondary care service. In addition, people 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 a TTAD service. These people will be excluded from this study and referred on to more specialised services. 11. People who are already involved in or who have previously participated in our user research relating to this digital programme
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 26/04/2024: 1. Passive usage metrics are measured throughout the programme and during the follow-up period: 1.1. Mean and distribution of time spent in the device across participants 1.2. Proportion of participants successfully engaged with the programme (defined as completing session 1 of week 2 in the device) 1.3. Proportion of participants completing the 6-week digital programme 1.4. Number of activities completed per week vs expected number of activities per week (defined weekly dose) 2. How likely a participant is to recommend the programme to a friend is measured by the Net Promoter Score post intervention 3. User engagement is measured using the User Engagement Scale (UES) post intervention 4. Proportion of participants requiring technical support recorded during the programme 5. Usability of the device is measured using the System Usability Scale (SUS) post intervention 6. Acceptability of the programme is measured using the Service User Technology Acceptability Questionnaire (SUTAQ) post intervention 7. Qualitative analysis of acceptability of the programme for participants as assessed using a semi-structured interview in sub-sample 8. Sub-group analysis of quantitative primary engagement and adherence endpoints across anxiety severity at baseline (measured by GAD-7 questionnaire) Previous primary outcome measures: 1. Passive usage metrics are measured throughout the programme and during the follow-up period: 1.1. Mean and distribution of time spent in the device across participants 1.2. Proportion of screens in the programme not accessed 1.3. Proportion of participants successfully engaged with the programme (defined as completing 2 full weeks worth of activities in the device) 1.4. Proportion of participants completing the 6-week digital programme 1.5. Number of activities completed per week vs expected number of activities per week (defined weekly dose) 2. How likely a participant is to recommend the programme to | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Recruitment rate across different recruitment methods and referral avenues 2. Clinician and research coordinator total time spent and cost recorded across the study period 3. Number of off-schedule check-ins required recorded across the study period 4. Overall attrition rate and attrition rate recorded at follow-up assessment 5. Adverse event reporting across the study period 6. Number of cases withdrawn and referred on due to safety concerns (compared with expected number receiving first-line intervention in TTAD) recorded across the study period 7. Number of times clinical risk escalation protocols were initiated and time spent by clinician responding recorded across the study period 8. Qualitative analysis of safety assessment from a semi-structured interview in sub-sample post intervention Exploratory endpoints: Clinical effectiveness determined by: 1. Symptoms of anxiety measured using the GAD-7 questionnaire from baseline to programme completion 2. Symptoms of anxiety measured using the GAD-7 questionnaire across all time points (baseline, weekly during the intervention, at programme completion and 1-month follow-up) 3. Sub-group analysis stratified by symptom severity at baseline measuring symptoms of anxiety using the GAD-7 questionnaire in severity from baseline to follow-up and across all time points (baseline, weekly during intervention, at programme completion and 1-month follow-up) Additional outcomes: 1. Symptoms of depression measured using the PHQ-9 from baseline and to programme completion 2. Impairment in functioning measured using the Work and Social Adjustment Scale (WSAS) at baseline and programme completion 3. Psychological flexibility measured using the Multidimensional Psychological Flexibility Inventory (MPFI) at baseline and programme completion | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactClare Palmer
Outcome results
None listed