Purpose: In this study, we tested the potential benefits of using interactive multimedia technology to improve the process of informed consent for patients with mental health diagnoses considering participating in clinical research trials.

Methods: 31 adult women with a diagnosis of depression were recruited and consented to participate in a comparison study of standard paper consents and interactive computer-based consent materials. The subjects were asked to suppose or envisage that they were being asked to participate in two clinical research trials. Each subject received, in random order, either paper or computer materials for one of the two mental health intervention studies. The subjects were then tested for their understanding of the trials and asked about their preferences for how they would like to receive this type of information. This was followed by a similar presentation of the other study in the alternative format. After answering knowledge and usability/satisfaction questions about the second presentation, they were asked to directly compare the two methods.

Results: Across all simulated studies, the subjects had significantly higher knowledge scores for studies where they learned the material using the interactive computer system (p<.001). Subjects showed significant preference for the computer materials on most measures. On average, subjects evaluated the interactive computer materials as being more clear than the paper form (p<.01), as well as being easier to remember (p<.01). Subjects reported being either “quite satisfied” or “extremely satisfied” with the computer materials and overall rated them more highly than the paper materials (p<.01). They were also more likely to report being willing to volunteer for the study explained by the interactive computer materials (p<.05). Seven of the 31 subjects were naive or first-time computer users. These subjects' mean ratings of usability and satisfaction were not different from the sample as a whole.

Conclusions: These results suggest that for both novice and experienced computer users, the informed consent process can be improved by using interactive computer systems to facilitate the complex process of explaining clinical research protocols to patients in the mental health setting.