Accelerating the development of a psychological intervention to restore treatment decision-making capacity in patients with schizophrenia-spectrum disorder: a study protocol for a multi-site, assessor-blinded, pilot Umbrella trial (the DEC:IDES trial)

Table 2 Timing and purpose of assessments

Assessment	Time point					Purpose
Assessment	0 weeks	8 weeks	24 weeks	Every therapy session	If early withdrawal	Describe sample	Determine eligibility	Feasibility of assessing efficacy	Feasibility of assessing change in mechanisms	Assess adverse events	MacCAT-T validation
MacCAT-T	X	X	X			X	X	X			X
CIPD	X					X	X
ISMI	X					X	X
RSES	X	X	X			X	X		X
Beads Task	X	X	X			X	X		X
SIMS	X	X	X			X			X
Demographics interview^a	X					X
BNA	X					X
PANSS	X	X	X			X		X
QPR	X	X	X			X		X
SQoL	X	X	X			X		X
CSRI	X	X	X			X		X
BAI	X	X	X			X		X
BCSS	X	X	X			X		X
CDSS	X	X	X			X		X
CDSS item 8 (suicidality)	X	X	X	X		X				X
AEP—trial completers		X	X							X
AEP—withdrawal					X					X
CGI-P	X	X	X	X		X				X
CGI-R	X	X	X	X		X				X
SAI	X	X	X			X					X
CGI-C	X	X	X			X					X

Note: MacCAT-T MacArthur Competence Assessment Tool-Treatment; CIPD Clinical Interview for Psychotic Disorders; ISMI Internalised Stigma of Mental Illness Inventory; RSES Rosenberg Self Esteem Scale; SIMS Semi-structured Interview Measure of Stigma; BNA Brief Neurocognitive Assessment; PANSS Positive and Negative Syndrome Scale; QPR Questionnaire about the Process of Recovery; SQoL Schizophrenia Quality of Life Scale; CSRI Client Service Receipt Inventory; BAI Beck Anxiety Inventory; BCSS Brief Core Schema Scale; CDSS Calgary Depression Scale; AEP Adverse Events in Psychotherapy questionnaire; CGI-P Clinical Global Impression – Participant version; CGI-R Clinical Global Impression – Researcher version; SAI Schedule for Assessment of Insight; CGI-C Clinical Global Impression – Capacity version
^aIncorporates questions from the Alcohol Use Disorders Identification Test (AUDIT) and the Drug Abuse Screening Test (DAST)

ISSN: 2055-5784