Depression Mental and Behavioural Disorders
Conditions
Interventions
A two-arm randomised, single-site feasibility trial will be used to assess the feasibility and acceptability of an RCT of a brief immersive virtual reality (IVR) intervention for depression in a clini
IAPT).
IAPT services operate a stepped care model, with cases triaged for low versus high intensity treatment. Our participants will be recruited from the low-intensity stream, in which patients typi
Sponsors
University College London
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 15/05/2024: 1. Adults aged 18 years or older 2. Registered with Camden & Islington IAPT services (Islington site) for low-intensity psychological therapy for depression 3. Clinical caseness of depression (PHQ-9 = 10) 4. Willing and has capacity to provide written informed consent 5. Sufficiently fluent in English to complete assessments and intervention 6. Double vaccinated against Covid-19 7. Able to commit to attend the appointment schedule Previous participant inclusion criteria: 1. Adults aged 18 years or older 2. Registered with Camden & Islington IAPT services (Islington site) for low-intensity psychological therapy for depression 3. Diagnosis of depression (PHQ-9 score of 10+ and ICD-10 diagnosis of F32 depressive episode on the CIS-R) 4. Willing and has capacity to provide written informed consent 5. Sufficiently fluent in English to complete assessments and intervention 6. Double vaccinated against Covid-19 7. Able to commit to attend the appointment schedule
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 15/05/2024: 1. Current drug or alcohol dependence 2. Individuals at current risk of suicide or self-harm 3. Individuals with severe depression (PHQ-9 score of 20+) 4. IAPT clinician deemed participation not appropriate 5. Defined as clinically extremely vulnerable (at high risk of serious illness from coronavirus) 6. History of seizures, brain injury or epilepsy 7. Uncorrected hearing or vision impairment 8. Head or neck injury, or individuals suffering from musculoskeletal problems 9. Individuals with vestibular/balance issues 10. Individuals engaging in any concurrent psychological treatments or mental health research Previous participant exclusion criteria: 1. Current drug or alcohol dependence 2. Individuals at current risk of suicide or self-harm 3. Individuals with severe depression (ICD-10 F32 diagnosis of severe depressive episode and/or PHQ-9 score of 20+) 4. IAPT clinician deems participation not appropriate 5. Defined as clinically extremely vulnerable (at high risk of serious illness from coronavirus) 6. History of seizures, brain injury or Epilepsy 7. Uncorrected hearing or vision impairment 8. Head or neck injury, or individuals suffering from musculoskeletal problems 9. Individuals with vestibular/balance issues 10. Individuals engaging in any concurrent psychological treatments or mental health research during the course of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility and acceptability of a full RCT. This will be assessed by: 1. Recruitment rates 2. Eligibility rates 3. Willingness to be randomized rates 4. Retention rates 5. Ease of delivery. This will be assessed by engaging in qualitative research with those involved in recruitment and treatment to examine issues of implementation and practicality. 6. Acceptability of the intervention and adherence to the intervention protocol. This will be assessed by 1) using the Treatment Acceptability/Adherence Scale questionnaire (TAAS, Milosevic et al., 2015) mid-way through the intervention (end of session 2 out of 4) and 2) engaging in qualitative work with participants (both completing and dropping out). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Depression symptoms are measured using the Patient Health Questionnaire–9 (PHQ-9; Kroenke et al., 2001) at baseline, post-intervention (2-weeks after baseline), follow-up (6-weeks after baseline) and after treatment as usual (optional assessment). 2. Anxiety symptoms are measured using the General Anxiety Disorder–7 questionnaire (GAD-7; Spitzer et al., 2006) at baseline and follow-up (6-weeks after baseline). 3. Quality of life is measured using the Recovering Quality of Life (ReQoL-20, Keetharuth et al., 2018) and EuroQol Health and Well-being (EQ-HWB-S, EuroQol Research Foundation) questionnaires at baseline and follow-up (6-weeks after baseline). 4. Self-Compassion and Self-Criticism are measured at baseline, post-intervention (2-weeks after baseline), follow-up (6-weeks after baseline) using the Self-Compassion and Self-Criticism Scale (SCCS, Falconer et al., 2015). Other aspects of self-compassion and self-criticism are also measured at baseline and follow-up (6-weeks after baseline) using the Fears of Compassion Scale (FCS, Gilbert et al., 2011), the Types of Positive Affect Scale (TPAS; Gilbert et al., 2008) and the Forms of Self-Criticising/Attacking & Self-Reassuring Scale (FSCRS, Gilbert et al., 2004). | — |
Countries
England, United Kingdom
Outcome results
None listed