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 @ 9:50 PM
Ignite Modification Date:
2025-12-24 @ 9:50 PM
NCT ID:
NCT02983032
Eligibility Criteria:
Inclusion Criteria:
* Carer of person with dementia
* Live with person being cared for
* Meet Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria for insomnia disorder with the exception that carers not meeting the frequency criterion of 3 times per week or duration criterion of 3 months will still be included if frequency is at least twice per week and duration 2 months.
* competent in English language and have good basic literacy skills.
Exclusion Criteria:
* unstable, moderate to severe mental health issues (particularly Major Depressive Disorder and Bipolar Disorder)
* already receiving a psychological intervention
* untreated sleep disorders eg obstructive sleep apnoea, restless legs syndrome and periodic limb movement disorders.
* current serious medical condition, such as cancer or recent remission from cancer
* learning disability or a neurological condition (e.g. Multiple Sclerosis, Parkinson's disease, epilepsy)
* being investigated for or existing diagnosis of degenerative condition
* sleep problem primarily due to having to be awake during the night/early morning to respond to the needs of the person they care for
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02983032
Study Brief:
Protocol Section:
NCT02983032