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:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
NCT ID:
NCT04630912
Eligibility Criteria:
Inclusion Criteria:
Inclusion criteria for people with dementia
Participants were included in the study if they had:
* A clinical diagnosis of dementia (any type)
* A clinically significant level of psychological distress (a score of ≥8 on the GAD-7 and ≥10 on the PHQ-9).
* Ability to give informed consent
Inclusion criteria for caregiver of person with dementia
Participants were included in the study if they:
* Cared for someone with a clinical diagnosis of dementia (any type)
* Were paid or unpaid and regularly supported them with activities of daily living
* Aged 18+ (no maximum age limit)
* Able to give informed consent
Exclusion Criteria:
Exclusion criteria for people with dementia
Participants were excluded if they:
* Were already receiving psychotherapy
* Had insufficient English or language abilities to engage in therapy
* Were unable to consent to and/or engage in therapy
Exclusion criteria for caregiver of person with dementia
Participants were excluded if they:
* Had insufficient English or language abilities to support the person with dementia or engage in study/Change Interviews
* Were unable to consent to and/or engage in study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT04630912
Study Brief:
Protocol Section:
NCT04630912