. 2005 Oct 19;32(1):47–68. doi: 10.1093/schbul/sbj012

Table 3.

Intervention Studies: Informed Consent in Schizophrenia

Intervention Type	Study Type and Sample N	Major Findings
Feedback with multiple learning trials; cued recall	• Carpenter et al. 2000¹⁵¹: Hypothetical study; N = 20 inpatients and 10 outpatients with SCZ or related, and 24 controls	• Pts scoring below the median of controls on MacCAT-CR Understanding subscale received multipronged educational remediation; at retesting, majority scored above cutoff; no remaining significant difference (Understanding scores) between pts and controls; Appreciation and Reasoning also improved.
	• Wirshing et al. 1998¹⁵⁵: Real studies; N = 49 inpatients and outpatients with SCZ	• Corrected feedback until 100% correct on post-test; also 7-day retesting. At initial testing, mean score was 80% correct, with 53% requiring second trial and 37% requiring third trial to obtain 100% correct. Scores significantly improved between initial testing and 7-day retest.
	• Stiles et al. 2001¹⁴¹: Hypothetical study; N = 79 (SCZ), 82 (depressed), and 80 (controls)	• Feedback during the consent process contributed to an increased comprehension in all groups.
	• Eyler, Mirzakhanian, and Jeste 2005²³⁰: Real study (fMRI); N = 44 outpatients with SCZ and related	• Interactive questioning during the consent process did not lead to a significant increase in comprehension.
	• Combs et al. 2005²²⁶: Hypothetical study; N = 25 inpatients with SCZ and 25 controls	• Compared to non-cued recall, cues (multiple-choice recognition task) significantly improved the performance of both groups.
Multimedia or video	• Dunn et al. 2002¹⁶⁴: Real study (low risk); N = 80 outpatients with SCZ or related disorder and 19 controls	• Pts and controls in computer- enhanced consent group had greater comprehension (20-item post-test) compared to their counterparts with the routine consent; those in enhanced consent group not significantly different from controls.
	• Wirshing et al. 2005²²⁷: Real studies; N = 83 pts with SCZ, with 2 control groups: medical patients and undergraduates (N not specified)	• Compared videotape regarding important aspects of informed consent with a control videotape; found significantly higher understanding of consent in informed consent video group vs. control video group, overall and within each study population.
	• Moser et al.⁸³ this issue: Hypothetical study; N = 30 pts with SCZ and 30 healthy controls	• Brief computer-based intervention (simplified) led to improved MacCAT-CR (Understanding and Appreciation) scores in SCZ group, who, postintervention, did not differ from controls on any of the 4 domains; those performing the worst at baseline showed most improvement.

Note: Abbreviations used: fMRI = functional magnetic resonance imaging; MacCAT-CR = MacArthur Competence Assessment Tool for Clinical Research;¹⁴⁶ pts = patients; SCZ = schizophrenia. Unless otherwise specified, “patients” refers to patients with schizophrenia.