Depression Mental and Behavioural Disorders Mood [affective] disorders
Conditions
Interventions
Current intervention as of 03/10/2022:
Design
We will randomise 234 patients who have not responded to high-intensity IAPT interventions for depression, but do not meet eligibility criteria for second
Barnhofer et al., 2009). MBCT consists of
Sponsors
Sussex Partnership NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 04/01/2022: 1. Non-response to a minimal effective dose of high-intensity treatment in IAPT (at least 12 sessions, in line with NICE draft guideline suggestions) defined in line with the caseness threshold adopted by IAPT as a Patient Health Questionnaire-9 (PHQ-9) score of 10 or higher 2. Meeting criteria for a current episode of Major Depression according to DSM-5 as assessed through the Mini International Neuropsychiatric Interview for DSM-5 (MINI) 3. Aged 18 years or older 4. Access to a working internet connection to participate in video conferencing assessments and interventions. According to the IAPT database, the majority of patients who receive high-intensity psychological treatment will also have received treatment with antidepressant medication, and most of these patients will therefore meet consensus criteria for treatment resistance _____ Previous inclusion criteria: 1. Non-response to a minimal effective dose of high-intensity treatment in IAPT (at least 12 sessions, in line with NICE draft guideline suggestions) defined in line with the caseness threshold adopted by IAPT as a Patient Health Questionnaire-9 (PHQ-9) score of 10 or higher 2. Meeting criteria for a current episode of Major Depression according to DSM-5 as assessed through the Mini International Neuropsychiatric Interview for DSM-5 (MINI) 3. Age between 18 and 65 years 4. Access to a working internet connection to participate in video conferencing assessments and interventions. According to the IAPT database, the majority of patients who receive high-intensity psychological treatment will also have received treatment with antidepressant medication, and most of these patients will therefore meet consensus criteria for treatment resistance
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 04/01/2022: 1. Based on the judgment of their IAPT therapist they are eligible for secondary care specialist services 2. Receiving individual psychotherapy or counselling from other sources than the NHS at a frequency of more than once a month 3. They present with a level of risk to self or others that cannot be safely managed in a primary care service context (i.e. active suicidal plans), a history of psychosis or psychotic symptoms, a current episode of mania, alcohol or substance abuse or dependence within the past 3 months, current post-traumatic stress disorder, obsessive-compulsive disorder or eating disorder 4. They suffer from any other significant disease or disorder that may either put the participant at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial 5. Have an insufficient ability to understand or read English 6. Patients who are currently taking antidepressant medication will be allowed into the trial and medication use will be documented for statistical analysis _____ Previous exclusion criteria: 1. Based on the judgment of their IAPT therapist they are eligible for secondary care specialist services 2. Receiving individual psychotherapy or counselling from other sources than the NHS at a frequency ofmore than once a month 3. Report the presence of active suicidal plans, a history of psychosis or psychotic symptoms, a current episode of mania, alcohol or substance abuse or dependence within the past 3 months 4. Suffer from severe medical illness 5. Have an insufficient ability to understand or read English. Patients who are currently taking antidepressant medication will be allowed into the trial and medication use will be documented for statistical analysis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depressive symptomatology as assessed using the PHQ-9 at baseline and 34 weeks post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Depressive symptomatology as assessed using the PHQ-9 at baseline and 10 weeks post-randomisation 2. Service-use information will be collected using the Adults Service Use Schedule throughout the study | — |
Countries
England, United Kingdom
Outcome results
None listed