Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2025-12-24 @ 2:58 PM
NCT ID:
NCT05236959
Eligibility Criteria:
Inclusion Criteria will be
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
3. age 18 or older
4. access to a working internet connection to participate in videoconferencing assessments and interventions
Potential participants will be excluded if
1. based on the judgment of their IAPT therapist they are eligible for, would be seen by, and their needs would be best met by secondary care specialist services
2. 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.
3. 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
4. if they 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT05236959
Study Brief:
Protocol Section:
NCT05236959