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 @ 2:35 PM
Ignite Modification Date:
2025-12-24 @ 2:35 PM
NCT ID:
NCT04744259
Eligibility Criteria:
Inclusion Criteria:
* Severe/profound intellectual disabilities
* 18 years old and over
* Clinically significant unipolar depression
* Has a family member or paid carer who has supported them for a minimum of 6 months to complete the screening and baseline visits OR is able to obtain information for the previous 4 months prior to randomisation. The carer, or another named individual, should be available for weekly-fortnightly treatment sessions with the practitioner, and should currently provide a minimum of 10 hours support per week to the participant.
Exclusion Criteria:
* Suicidal
* Mild/moderate intellectual disabilities
* Factors that prevent the person from interacting with the carer and therapist or retaining information from the therapy (e.g. late stage dementia, significant agitation, withdrawal arising from psychosis)
* Does not consent to her/his GP being contacted about their participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04744259
Study Brief:
Protocol Section:
NCT04744259