Interactive Voice Response System for Patient-Reported Changes in Mood State Using Outbound Call Prompting

Christopher J. Weber, PhD; Henry Riordan, PhD; Evan Braxton; Bethanne Friedmann, PsyD; Mark Leibowitz, MD; and Neal R. Cutler, MD
Worldwide Clinical Trials, King of Prussia, Pennsylvania (Drs Weber and Friedmann and Mr Braxton); Cedra Clinical Research, San Antonio, Texas (Dr Liebowitz); and Worldwide Clinical Trials, Beverly Hills, California (Dr Cutler)

This poster presentation was supported by Worldwide Clinical Trials.

Background: The Profile of Mood States (POMS)¹ has been widely used in a variety of clinical trials to identify and quantify affective states.² Little research has examined the POMS as administered via Interactive Voice Response (IVR). We examined the psychometric properties of the IVR POMS and compliance associated with an outbound calling procedure.

Methods: Thirty-one healthy normal subjects from a phase II trial completed the IVR POMS daily. Outpatient POMS ratings were completed daily following a random call to the subject between 9am and 7pm. Inpatient POMS ratings were completed at three equally spaced time intervals throughout the day.

Results: Raw scores were analyzed from the two weeks prior to inpatient (pre-inpatient), the two weeks inpatient, and the two weeks immediately following inpatient (post-inpatient). Total Mood Disturbance (TMD) score, Tension-Anxiety (T-A), Depression-Dejection (D-D), and Anger-Hostility (A-H) subscale scores were averaged for each subject. One-way ANOVA’s showed no significant differences among the POMS scores when compared across the three time periods, suggesting relatively stable mood across in/outpatient status, as well as the relative utility of once daily versus multiple administrations. Although completion rates from pre-inpatient (80%) to post-inpatient (65%) showed a significant decrease (t=-3.23 p<0.003), this decrease did not appear to be related to POMS total or subscale scores, as a median split resulting in “high” versus “low” compliance groups showed no significant differences in TMD or subscale scores for either pre or post-inpatient conditions.

Conclusions: IVR administration of the POMS is an effective data collection method for inpatient and outpatient trials. Daily administration is as efficient as three times daily, suggesting that subjects accurately summate their mood state over 24 hours. Compliance with the IVR POMS appears to wane over time for reasons unrelated to mood states, suggesting the need for additional prompting as the trial progresses.

References

1. McNair DM, Lorr M, Droppelman LF. Manual: Profile of Mood States. San Diego, CA: Educational and Industrial Testing Service; 1971.
2. McNair DM, Heuchert JWP. Profile of Mood States: Technical Update. North Tonawanda, NY: Multi-Health Systems; 2005.

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