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 @ 5:14 PM
Ignite Modification Date:
2025-12-24 @ 5:14 PM
NCT ID:
NCT03874650
Eligibility Criteria:
Inclusion Criteria:
1. Have a diagnosis of an acquired brain injury (e.g., traumatic brain injury, stroke)
2. Speak and comprehend English
3. Are a minimum of 3 months post-acquired brain injury
4. Are identified as having low mood. Low mood will be identified by either:
1. A score of at least 7 on the depression subscale of the Hospital Anxiety and Depression Scale, indicating clinically significant levels of depression, or
2. Clinicians have identified that a client has low mood (i.e., through their own administration of the HADS within the past 3 months, through clinical interview determining that the client has low mood or would benefit emotionally from increased activity level)
Exclusion Criteria:
1. Are incapable of attending to and/or understanding the intervention materials (i.e., severe cognitive disability)
2. Have a diagnosis of dementia or other neurodegenerative disorder
3. Unstable psychotropic medication (i.e., have recently started/recently changed medications)
4. Are actively suicidal (i.e., have attempted suicide in the past 3 months, currently self-harm, and/or have a concrete plan to attempt suicide in the future, as identified by recurring clinician)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03874650
Study Brief:
Protocol Section:
NCT03874650