Eligibility Module

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 @ 10:23 PM
Ignite Modification Date: 2025-12-24 @ 10:23 PM
NCT ID: NCT03959735
Eligibility Criteria: Inclusion Criteria: Stage 1 (Focus Groups): * Capacity to provide informed consent. * Aged ≥18 years. * Either be: 1) Inpatients at SLaM with a diagnosis of SMI (Major Depressive Disorder, Bipolar disorder, Schizophrenia Spectrum Disorders, 2) Carers providing unpaid support to someone with a SMI, 3) Clinical staff at SLaM. Stage 2 (HIIT Pilot RCT): * Inpatients at SLaM with a diagnosis of SMI. * Capacity to provide informed consent. * Aged 18 -60. * Ready to exercise according to the Physical Activity Readiness Questionnaire. Stage 3 (Follow-up): Qualitative interview: * inpatients who were eligible for stage 2. Stage 3 (Follow-up): Focus group: * staff who participated in stage 1. Exclusion Criteria: Stage 1 (Focus Groups): * Is aged \<18 years old. Stage 2 (HIIT Pilot RCT) \& Stage 3 qualitative interviews: * Is aged \<18 years old or \>60 years old. * Is pregnant. * Has an eating disorder. * Has a medical condition that impedes exercise, (as assessed via discussion with the patient's clinical team). Stage 3 focus group: * Did not complete stage one. ALL STAGES: * Is unable to provide informed consent. * Is unable to understand English.
Healthy Volunteers: False
Sex: ALL
Minimum Age: 18 Years
Study: NCT03959735
Study Brief:
Protocol Section: NCT03959735