Protocol schedule of procedures for the ACT4FCD study
Screening | Baseline (T0) | 2 months (T1) | 4 months (T2) | 6 months (T3) | |
Enrolment | |||||
Consent to contact obtained by clinical staff in DMC, CNC or NPC | x | ||||
Informed consent | x | ||||
Contacted by RA to arrange screening interview | x | ||||
Screening | |||||
Diagnostic criteria for FCD | x | ||||
Risk Assessment | x | ||||
Demographics | x | ||||
Comorbidities | x | ||||
Medications | x | ||||
PHQ-9 | x | ||||
GAD-7 | x | ||||
Randomisation allocation | x | ||||
Interventions | ACT+TAU | Intervention completed | |||
Assessments | |||||
AAQ-II | x | x | x | X | |
MMQ | x | x | x | X | |
WHODAS 2.0 | x | x | x | X | |
EQ-5F-5L | x | x | x | X | |
PHQ-9 | x | x | x | X | |
GAD-7 | x | x | x | X | |
AD-SUS | x | X | |||
ICECAP-A | x | x | x | X | |
CGI-I | X | ||||
Likert 5-point satisfaction scale | x | ||||
AEs/SAEs | x | x | x | X | |
Qualitative interviews | |||||
Informed consent for qualitative interview (select participants) | x | x | |||
Qualitative interviews with select sample of participants | x | x |
AAQ-II, Acceptance and Action Questionnaire II; ACT4FCD, Acceptance and Commitment Therapy for Functional Cognitive Disorder; AD-SUS, Adult Service Use Schedule; AEs, adverse events; CNC, cognitive neurology clinic; DMC, diagnostic memory clinic; EQ-5F-5L, EuroQol 5-Dimension-5-Level; GAD-7, Generalised Anxiety Disorder 7; GCI-I, Clinical Global Impression-Improvement; ICECAP-A, ICEpop CAPability measure for Adults; MMQ, Multifactorial Memory Questionnaire; NPC, neuropsychiatry clinic; PHQ-9, 9-question Patient Health Questionnaire; RA, Research Assistant; SAE, serious adverse event; TAU, treatment as usual; WHODAS 2.0, WHO Disability Assessment Schedule.