Research & Development-

Current Research
For a comprehensive resource providing important information for prospective subjects interested in joining one of our studies, and health professionals who are interested in learning about our research activities, please visit http://healthtrials.org.

Prior Research Findings
The following is a list which summarizes a few of our prior research studies.

Index
LifeSign Publications
LifeSign Reviews and Citations
SleepKey Insommia Research
DietMate Publications
Recent Presentations at Scientific Meetings
Summary of Prior Research Findings

PICS, Inc. research and development is funded, in part, by Small Business Innovation Research (SBIR) grants awarded by the National Institute on Drug Abuse (NIDA) and the National Cancer Institute (NCI). Here are some of the reports and published articles associated with these studies.

LifeSign Publications

Prue, D. M., Riley, A., W., Orlandi, M. A., & Jerome, A. (1990). Development of a computer-assisted smoking cessation program: A preliminary report. Journal of Advancement in Medicine, 3, 131-139.

The effectiveness of a self-help smoking cessation program implemented by a hand-held micro computer was evaluated with 77 smokers. The computer implements a gradual rate reduction protocol that targets both physiological dependence on nicotine and conditioned stimuli that may elicit smoking. One-year post treatment abstinence rates for two samples of smokers were 18.5% and 22%. The results of this study suggest that a computer-based self-help program may meet the needs of health care providers for an easily administered, effective tool for assisting patients with smoking cessation.

Jerome, A., Perrone, R., & Kalfus, G. (1992). Computer-assisted smoking treatment: A controlled evaluation and long-term follow-up. Journal of Advancement in Medicine, 5, 29-41.

The present study provided a controlled outcome evaluation and long-term follow-up assessment of a computer-assisted smoking treatment (CAST), implemented by a credit card-sized, fully dedicated microcomputer. Seventy-one smokers were randomly assigned to one of three groups: 1) CAST, 2) CAST plus therapist assistance, or 3) waitlist control. Results indicated that subjects complied with the computer treatment protocol and that daily cigarette consumption and carbon monoxide levels decreased across treatment weeks in both CAST groups. At 18-month follow-up, 24% of subjects in the CAST group and 36% of subjects in the CAST plus therapist assistance group were abstinent. These findings are comparable to outcomes reported for many clinic-based interventions and thereby suggest that this CAST program can be utilized effectively in either a self-help or therapist-assisted format.

Jerome, A., Fiero, P. L., & Behar, A. (2000). Computerized scheduled gradual reduction for smokeless tobacco cessation: Development and preliminary evaluation of a self-help program. Computers in Human Behavior, 16, 493-505.

The paper chronicles the development and feasibility testing of a computerized scheduled gradual reduction program for smokeless tobacco cessation. During Study 1, the LifeSign smoking cessation computer was adapted for use with smokeless tobacco by pairing it with an electronic timer. The computer recorded frequency of dips during a baseline phase and prompted for tobacco use during a gradual reduction phase. The timer was used to track the length of dips during baseline and to hold them to a fixed length during the reduction phase. Abstinence rates among 60 male daily smokeless tobacco users who received the program were 29% at 3-month follow-up (biochemically validated) and 19% at 12-month follow-up. Self-reported changes in topography of tobacco use were consistent with the scheduled reduction protocol. Study 2 evaluated a prototype computer that tracked both frequency and duration of dips during baseline and gradually reduced both parameters during the reduction phase. Among 19 subjects who received the program, self-reported abstinence was 56% at end of treatment and 11% at 12-month follow-up. Results of these two studies demonstrate the feasibility of computerized scheduled gradual reduction for smokeless tobacco cessation and provide a basis for further product development.

Severson, H. H., Akers, L., Andrews, J. A., Lichtenstein, E., & Jerome, A. (2000). Evaluating two self-help interventions for smokeless tobacco cessation. Addictive Behaviors, 25, 465-470.

The need for effective, low-cost self-help treatment methods for smokeless tobacco (ST) addiction becomes more evident as rates of product use and associated morbidities increase. This study evaluated two self-help methods for ST cessation. One hundred ninety-eight ST users were randomly assigned into two conditions: half received LifeSign, a credit-card sized computer designed for gradual ST cessation, and half received the Enough Snuff self-help manual and a video. Subjects in both conditions received telephone support for their quit effort. The study was conducted entirely through phone and mail, allowing the delivery of the intervention to both rural and urban users. Self-reported rates of sustained abstinence (no tobacco use at two months and six months) were 24.5% for the manual/video condition, and 18.4% for the LifeSign condition.

Riley, W., Jerome, A., Behar, A., & Zack, S. (2002). Feasibility of computerized scheduled gradual reduction for adolescent smoking cessation. Substance Use & Misuse, 37, 277-285.

The purpose of this project was to modify a smoking cessation program that uses computerized scheduled gradual reduction for use with adolescent smokers and to test the feasibility of this cessation approach in group support and minimal contact modalities. Utilizing a lesson plan approach with high school marketing students in five high schools and student survey feedback, the LifeSign program was modified to be an acceptable smoking cessation program for adolescent smokers. In the first study, 17 adolescent smokers used the modified program with seven associated weekly group support sessions. At the end of treatment, 29% had quit smoking, and over half of those who continued to smoke reduced their smoking rate by 50%. In the second study, the LifeSign for Teens program was evaluated with 18 adolescent smokers in a minimal contact format. At the end of treatment, 17% had quit smoking, and mean smoking rate reductions of 43% were found among those who continued smoking. At 1-year follow-up, all subjects who had quit at posttreatment reported continuous abstinence. The results of these two small trials suggest that a computerized scheduled gradual reduction approach may be an accepted and potentially efficacious approach for smoking cessation among adolescent smokers.

Riley, W., Jerome, A., Behar, A., & Weil, J. (in press). Computer and manual self-help behavioral strategies for smoking reduction: Initial feasibility and one year follow-up. Nicotine and Tobacco Research.

This study sought to test the feasibility of two self-help behavioral interventions to reduce and maintain a 50% reduction in those unable or unwilling to quit, and to evaluate the impact of smoking reduction on subsequent quit attempts. Ninety-three smokers who desired to reduce rather than quit smoking were entered in the study and randomly assigned to either computerized scheduled gradual reduction (CSGR) or to a manual-based selective elimination reduction (SER). Both groups produced significant reductions in smoking, approximately 10 cigarettes per day, during the seven week treatment phase which were maintained over one year. Except for significantly greater mean percent reductions in smoking from pre- to post-treatment (37% for CSGR, 20% for SER) and a greater percentage of subjects meeting the 50% reduction goal (30% for CSGR, 16% for SER) which approached significance, the CSGR intervention produced reductions in smoking comparable to the SER intervention, particularly at the 6 and 12 month follow-up. Although subjects with a current desire for smoking cessation were excluded from this study, one third of subjects reported a 24 hr. quit attempt for the year following study initiation, and 8.6% of subjects met seven-day point-prevalence criteria for abstinence (CO validated) at the 12 month follow-up. The results of this study lend support to the feasibility of self-help behavioral interventions to produce sustained reductions in smoking rates without apparent negative impact on subsequent quit attempts.

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LifeSign Reviews and Citations

The Behavior Therapist (Vol. 13, No. 3, March, 1990)

"I was very impressed with the program. It clearly incorporates sound behavioral principles both the computerized cessation program itself, and in the supporting materials provided in the manual."

"Existing data, most from small N studies, suggest that the program may be at least as effective as other self-help smoking reduction programs, and perhaps more so."

"The bland paragraphs above don’t communicate my intense excitement about the program. Whatever the data ultimately suggest regarding the effectiveness of the program in its current state, this is an important development in behavioral self-help programming because of the potential that this technology portends."

"I think LifeSign opens tremendously important doors to research and applications in self-help behavioral programs."

Robert K. Klepac, Ph.D.

Wilford Hall Medical Center

SRNT Newsletter (Vol 6, No. 1, April, 2000)

"Robin Corelli and Karen Hudmon, in collaboration with the Pharmacy Partnership of the California Medical Association Foundation, have orchestrated a project whereby pharmacy faculty members and tobacco researchers have designed a six-hour, comprehensive, tobacco curriculum program for pharmacy students."

"The three hour workshop component includes role playing with case studies and hands-on experience with pharmaceutical aids for smoking cessation and the LifeSign hand-held computer for scheduled, gradual reduction of smoking."

Compliance in Health Care and Research (2001). Edited by Lora Burke and Ira Ockene, American Heart Association Monograph Series, Futura Publishing, Armonk, NY

"The LifeSign (PICS, Inc., Reston, VA) is a compact electronic recording device approximately the size of a credit card and one-half inch thick. The individual records each time a tobacco product is used by pushing one button."

"The primary advantage of using electronic recording devices is that data are collected in real time, at the time of the symptoms or behavioral performance."

Lora Burke, PhD, MPH, RN

Chapter 8, Electronic Measurement

Institute of Medicine (2001). Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction. Washington, DC. National Academy Press.

"More recent exploration of reduced smoking has used computerized devices to gradually wean smokers from cigarettes as a means to achieve cessation. One computerized program, LifeSign Computer Assisted Smoking Program, involves a scheduled reduction by increasing the interval between cigarettes and informing individuals when to smoke. The scheduled time-interval approach seems the most promising of the behavioral treatment methods based on studies by Ciniciripini and colleagues (Ciniciripini et al., 1995 and 1997) compared to abrupt discontinuation or nonscheduled reduction of cigarettes. This behavioral method systematically reduces the level of nicotine exposure, disrupts habitual smoking patterns, and gives smokers the opportunity to develop new behaviors or skills in response to cues associated with smoking."

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SleepKey Research

Association for Advancement in Behavior Therapy (AABT) 2002 Abstract

William Riley, Patti Mihm, and Albert Behar, PICS, Inc., Charles Morin, Universite Laval (2002). Initial Evaluation of a Computerized Behavioral Intervention for Primary Insomnia.   Poster presented at the 2002 Annual Meeting of the Association for Advancement in Behavior Therapy, November, 2002, Reno, NV.

Despite substantial evidence of the efficacy of behavioral interventions for primary, chronic insomnia, these interventions remain largely unavailable to those suffering from insomnia. Therefore, a number of self-help interventions have been developed and evaluated in recent years to make these treatments widely disseminable and more accessible.   For this project, a computerized behavioral intervention was developed, the Insomnia Assessment and Treatment Program (IATP), which was prototyped on a small, specific purpose, handheld computer. The program uses an active sampling procedure to assess sleep or wake states (low volume auditory beep every 10 minutes). During a week of baseline recording, the IATP calculates total sleep time, sleep onset latency, sleep efficiency and other relevant variables.   From these data, the IATP devises a sleep restriction and stimulus control program, prompting the user when to go to bed and get out of bed each night and continues to record sleep behavior each night and adjusting the intervention accordingly.     Eighty six participants (60% female; 80% White, 10% Black, 10% Asian) meeting criteria for chronic primary insomnia were randomly assigned to receive either the IATP or a similar device which monitored sleep only and a manualized behavioral treatment (MBT). In addition to the data from the monitoring units, the participants also keep sleep diaries each night. At the initial and six week follow-up visit, participants also completed the Pittsburgh Sleep Quality Index (PSQI). To assess concurrent validity, the device monitoring data were compared to the sleep diary data for weekly means of relevant variables.   Sleep onset latency correlations for each week ranged from .68 to .95.    Lower but significant correlations also were obtained for total sleep time (.30 to .75) and for sleep efficiency (.34 to .79).   On treatment outcome, repeated measures ANOVAs revealed a significantly greater improvements for the IATP than the MBT on the PSQI (F= 3.65, p < .05), sleep efficiency (F = 2.85, p < .05). Sleep latency reduced in both groups but the time by group interaction was not significant. An intent to treat analysis of those reaching 90% or greater sleep efficiency at week 6 revealed that 35% of the IATP group but only 9% of the MBT group met this criteria ( = 7.03, p < .01).   On a subjective rating of sleep improvement, 46% of the IATP group rated their sleep as much or very much improved whereas none of the MBT did so.   The results of this project indicate that behavioral interventions for insomnia can be delivered by a self-help computer device (the IATP) and that the IATP produces greater improvement in sleep behavior than a manualized treatment approach.  

Insomnia Phase I

“Computerized Self-help Behavioral Treatment for Insomnia: Phase I Study Results” by William T. Riley, Ph.D., PICS, Inc. You will need to allow popup windows in order to view the document (PDF)

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DietMate Publications

DietMate: Computerized Self-Management for Weight Control This paper provides a conceptual overview and description of the DietMate Program (Albert Jerome, Ph.D. & Lee W. Frederiksen, Ph.D. (1992). Behavior Therapist, 15 (10), 256-258.

DietMate Clinical Studies An overview of five important clinical studies performed to evaluate the DietMate program and product for various applications in health improvement. Detailed reports of these five studies follow.

Study 5.

Computerized Diet and Exercise Intervention for High Blood Pressure This paper describes results of a Phase I SBIR study funded by NHLBI examining DietMate as an intervention for High Blood Pressure (Albert Jerome, Ph.D., 1996).

Study 4.

Phase II Study: Computer-Assisted Cholesterol Reduction The purpose of this Phase II research study was to develop and evaluate a dietary and exercise intervention for high blood cholesterol implemented via a hand-held microcomputer. (Albert Jerome, Ph.D., 1996).

Study 3.

DietMate: A Computerized Intervention for Computer-Assisted Cholesterol Reduction This paper describes results of a Phase I SBIR study funded by NHLBI examining DietMate as an intervention for cholesterol reduction and weight loss (Albert Jerome, Ph.D., 1992).

Study 2.

Computerized Self-Management for the Treatment of Obesity Presented at the 25th Annual Convention of the Association for the Advancement of Behavior Therapy, New York, N.Y., November, 1991. (Albert Jerome, Ph.D., Lee W. Frederiksen, Ph.D., Candace B. Frederiksen, B.A. (1991).

Study 1.

DietMate: A Computerized Intervention for Weight Loss This paper describes the initial DietMate validation study conducted with an early prototype of the product (Albert Jerome, Ph.D., 1991.)

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Recent Presentations at Scientific Meetings

William T. Riley, PH.D., Bradford W. Applegate, PH.D., Allison Sowell , M.S.; PICS, Inc. (2004) A Comparison Of Computer-Assisted Scheduled Gradual Reduction VS. Self Help in Unmotivated Smokers.

Abstract:

Despite recent advances in treatment, many tobacco users are unwilling or unable to quit. Harm reduction strategies have recently been proposed as an alternative to current treatment approaches. The present data examines the efficacy of a computerized scheduled reduction program (SGR) as compared to a self-help manual (SH).
Participants who smoked > 15 cpd and had no intentions of quitting in the next 30 days (N = 268) were randomly assigned to SGR or SH conditions. The SGR condition monitored use for 7 days, followed by SGR to achieve a 50% reduction. SH participants received information on reducing use. Smoking rates and associated variables were measured at baseline, 9 weeks, and 6 months.
Participants smoked 27 cpd and were 46 years old, on average. The sample was 50% male and 59% Caucasian. There were no significant differences between conditions at baseline. Treatment completion was 74% at 9 weeks and 61% at 6 months.
Repeated measures MANOVA indicated both main and interaction effects between SGR and SH conditions, (both p’s < .05). SGR participants reduced intake from 27 to 18.5 cpd at 9 weeks, compared to a reduction of 27 to 22 CPD in the SH condition. Effects diminished at 6 months as SGR participants maintained their rates and SH participants reduced smoking to comparable rates. Secondary analyses revealed that a greater proportion of SGR participants achieved > 50% reduction in smoking than SH participants. Changes in health status and motivation to quit were associated with reducing intake, but not sufficiently to justify reduction as a harm reduction approach.

Beasley, J.M, Riley, W. T., & Jean-Mary, J. (2004) Sources of Error From Palm-Based Food Records. Poster presented at the 3rd Annual Conference of the International Society of Behavioral Nutrition and Physical Activity. Washington, D.C.

Objective: The purpose of this study was to analyze the potential sources of error from food records using a Palm-based program, DietMatePro. After three days of using DietMatePro, subjects recorded an observed, weighed lunch. Actual food portions were compared with estimates recorded by the subjects using the DietMatePro. Thirty-nine healthy adults participated in the trial. Observed lunch data were analyzed using the ESHA Food Processor and compared to energy and nutrient values obtained from the DietMatePro. Due to a malfunction on five Palms, data were available for comparison with the observed lunch for 34 subjects. Over- and under-estimation errors between actual and recorded food calories and macronutrients were partialed into errors attributable to unrecorded foods, selecting similar but not exact food matches, portion estimation errors, and nutrition analysis database differences. Sixty-seven percent of the absolute error in caloric estimation was due to portion size estimation error, 21 percent was due to failing to report a food consumed, 10 percent to mismatches of similar foods, and 2 percent to differences between the nutrient database values for the same food. Differences between Palm-based food recording and observed, weighed foods indicate that portion estimation error is the primary source of error in food records. Concurrent validity of the DietMatePro is supported by the small error due to differences between the DietMatePro and ESHA databases. To improve dietary assessment, methods for increasing the accuracy of portion size estimation are needed.
Supported by NINR #R44NR008443.

Riley, W. T., Sowell, A., & Behar, A. (2004) Feasibility of a palm-based program to increase physical activity in sedentary individuals. Poster presented at the 3rd Annual Conference of the International Society of Behavioral Nutrition and Physical Activity. Washington, D.C.

Objective: The purpose of this study was to develop and assess a palm-based exercise program.

Methods and Materials: Fifty-two healthy, sedentary adults were provided with the palm-based program which designed a personalized exercise program consistent with American College of Sports Medicine guidelines, monitored progress, prompted exercise activity, and recommended gradually increasing exercise durations. All subjects underwent simple physical fitness tests and completed a standardized 7-day physical activity recall at baseline and 12 week visits. Physical activity recall also was assessed via phone at weeks 4 and 8.

Results: Repeated measures ANOVAs for exercise frequency per week revealed a significant increase from 1.3 at week 0 to 3.4 at week 4 which was maintained at week 8 (4.3) and at week 12 (4.1) (F = 6.72, p < .0001). Weekly estimated MET expenditure at these time points also showed a similar but less robust pattern (F = 3.49, p < .02). There was a significant improvement in sit-and-reach flexibility from baseline to 12 weeks (15.7 to 17.3 in.; t = -5.47, p < .0001) and a trend toward improved cardiovascular fitness on the three-minute step test (heart rate change of 30.3 vs. 24.2 bpm; t = 1.82, p = .08). Compliance to the program was not as high as anticipated (only 24% reported using most or all days during the treatment period), but was strongly associated with outcome on the fitness measures.

Significance: These results support the feasibility of a palm-based exercise program to encourage exercise in sedentary individuals.
Supported by National Institute of Nursing Research (NR04370)

Jeannette M. Beasley*, M.P.H., William T. Riley, Ph.D., and Jersino Jean-Mary, B.S., PICS, INC. This was presented at the Society For Behavioral Medicine Conference: FEASIBILITY OF A PALM-BASED DIETARY ASSESSMENT PROGRAM

Objective: The purpose of this project was to test the usability of a Palm-based food record, the Dietary Research Monitoring System (DRMS).

Methods and Materials: The usability and validity of the DRMS prototype was assessed during a three-day trial, validating the DRMS nutrition data to a 24-hour dietary recall. At the follow-up visit, subjects were timed recording a weighed lunch. Actual food portions compared with estimates recorded in the DRMS. Thirty-nine healthy subjects (54% female, 46% male; 93% White, 7% African American; 3% Hispanic or Latino) participated in the 3-day usability trial. Observed lunch and 24-hour dietary recall data were analyzed using the ESHA Food Processor SQL and compared to energy and nutrient values obtained from the Dietary Research Monitoring System. Due to a DRMS program malfunction, subsets of the data were available for comparison with the 24-hour recall (N=28) and the observed lunch (N=33).

Results: Pearson correlations of associations between DRMS data and the comparison measure ranged from .549-.796 for the 24-hr recall and .549-.850 for the observed lunch, depending on the nutrient measured. It took an average of 10 (SD=6.38) minutes for subjects to record the observed lunch. Using 5 point Likert scales, subjects rated that the food record accurately reflected food intake (4.05, SD 1.18), and that they would use the program to track food intake (3.79, SD=1.34).

Significance: The results of this initial usability trial indicate that the DRMS produces comparable measures of association with other dietary assessment techniques. With revisions based on feedback, the DRMS could be
a useful tool to automate measurement of food intake.

This study was conducted while the first author was at PICS. Supported by NHLBI grant # R43HL67613.


William Riley, Allison Sowell, Albert Behar, and Jeannette Beasley.  PICS, Inc. Reston, VA.  This was presented at the 5th International Food Data Conference and 27th US National Nutrient Databank Conference in June 2003: DEVELOPMENT AND INITIAL VALIDATION OF A PALM-BASED DIETARY ASSESSMENT PROGRAM

Objective: The purpose of this project was to develop and test the feasibility of a Palm-based dietary research monitoring system (DRMS).

Methods and Materials: The validity of the DRMS prototype was assessed in a within subjects, counterbalanced design comparing use of the DRMS with use of a seven-day food diary, and comparing the nutritional data from these prospective methods to 24 hr. dietary recall and food frequency questionnaires.   Fifty-nine healthy subjects (69% female, 31% male; 85% White, 10% African American, and 5% Other) participated in and completed the 3-week assessment trial.  Subjects were randomly assigned to order of use (DRMS in week 1 and food diary in week 3 or vice versa with no recording during week 2).  Total calories and major macronutrient values obtained from the DRMS and the food diary were compared to food frequency questionnaires and 24 hr. dietary recalls obtained at the end of each week of prospective monitoring.

Results: In comparing DRMS data with other dietary assessment measures, pearson correlations of associations ranged from .322-.388 with the GSEL Food Frequency Questionnaire and .529-.635 with the 24-hour recall data, depending on the nutrient measured. Correlations of calories (t=-3.44,p<.05)
and fat (t=-3.32, p<.05) between the food diary and the FFQ were significantly greater than the correlations between DRMS and the FFQ. Using 5 point Likert scales, subjects rated the food diary as significantly more accurate (4.11 vs 2.63) and easy to use (4.09 vs 2.55) than the DRMS. The mean number of meals that subjects failed to record each week was less than one for each meal type and not significantly different between recording methods.

Significance: The results of this initial validity trial indicates that the DRMS produces comparable results to the standard food diary monitoring approach and, with improvements, may be a useful tool to automate the assessment of dietary intake.


William Riley, PhD, Allison Sowell, MA, Jeannette Beasley, MPH, PICS, Reston, VA 20191. This was presented at the 2003 Society for Nutrition Education 36th Annual Conference in July 2003:  HOW MANY BYTES: A WEB-BASED FOOD PORTION TUTORIAL EDUCATES CONSUMERS

A recent study by Smiciklas-Wright et al. (2002) comparing CSFII data trends in portion sizes concluded that educating clients regarding appropriate portion sizes would be a challenge to health care providers1. First quarter 2002 NHIS data revealing 24.5% (95% CI = 23.1%-25.8%) of US adults are obese underscores the importance of the issue.  The objective of this study was to develop and evaluate a web-based food portion tutorial to improve food portion estimation.  For initial development, 23 foods across the major food groups were photographed, with portion sizes scaled based on USDA serving sizes.   A test module provided feedback to the user regarding accuracy of portion size estimation.  A feasibility trial with 76 subjects randomly assigned participants to tutorial exposure before (pre-exposure) or after (post-exposure) choosing and estimating portions among 15 food and beverage selections. Estimated portions were compared to actual portion sizes as measured by a portion control scale, and impact on caloric value was measured.  A significant difference was found between conditions on the discrepancy between estimated and actual calories for the meal (t68.2)=3.07, p=.003); however, the difference was primarily due to the overestimation of calories for the pre-exposure group (271 kcal) versus the post-exposure group (27 kcal). Users reported a mean overall usefulness of the tutorial as 4.1 (SD 0.8) based on a 5-point Likert scale.  The tutorial had a
significant impact on food portion estimation among study participants, and future design efforts will focus on eliminating the tendency towards overestimation. This study was funded by NIH.

Smiciklas-Wright H, Mitchell DC, Mickle SJ, Goldman JD, Cook A. Foods commonly eaten in the United States, 1989-1991 and 1994-1996: Are portion sizes changing? J Am Diet Assoc. 2003 Jan;103(1):41-47

William T. Riley, PH.D., Melissa Pici, B.A., Valerie L. Forman, Ph.D., Albert Behar, M.S.; PICS, Inc.  (2003) Computerized Dosing of Nicotine Inhalers:  Effects on Use and Quit Rates.  Paper presented at the 9th Annual Meeting of the Society For Research on Nicotine and Tobacco.  New Orleans, LA.

Abstract:

The purpose of this study was to develop and evaluate a computerized program to encourage adequate dosing of nicotine inhalers.  Two handheld computerized dosing/prompting programs were developed.  Both utilized a one week smoking baseline to determmine the intitial inhaler prompting schedule but differed in the length of the stable dosing period prior to tapering use (3 weeks vs. 12 weeks).   These computer prompting programs were compared to an inhaler only condition in a radomized trial of 462 smokers evaluated at 9 and 18 weeks (1 yr. follow-ups pending).   At 9 weeks, 32% of the computerized dosing groups has been quit for 7 days or longer (biochemically validated) compared to 20% for the inhaler only condition (chi-square = 4.69, p < .05).  Continuous quit rates at 9 weeks were 21% for the computerized dosing groups and 11% for the inhaler only group (chi-square = 5.76, p < .02).  At 18 weeks, 26% of the computerized dosing groups and 18% of the inhaler only group met point prevalence criteria.  Continuous quit rates at 18 weeks were not significantly different (14% vs. 9%).  Those in the computerized dosing conditions also reported higher doses per day in the first week of use than those in the inhaler only condition (9 vs. 7; t= 3.34, p < .001).  No signficant differences were found between the two computerized programs.  The results of this study indicate that computerized prompting increases initial nicotine inhaler dosing and produces higher initial quit rates than typical inhaler administration. 

Valerie L. Forman, Ph.D., Melissa Pici, B.A., William T. Riley, Ph.D., PICS, Inc.  (2003)  Impact of September 11th Tradegy on Smoking and Relapse Rates.  Paper presented at the 9th Annual Meeting of the Society For Research on Nicotine and Tobacco.  New Orleans, LA.

Abstract:

The September 11, 2001 terrorist attacks on the United States had widespread behavioral and emotional impacts.  Although one study found an increase in smoking rates amoung Manhattan, New York residents following the tradegy (Vlahov et al., 2002), no studies have examined the effect on individuals trying to quit smoking at the time of the attacks.  Local media in the Washington, D.C. area was used to recruit 462 smokers into a study comparing the effect of computerized-scheduled reduction to ad-lib dosing of nicotine inhalers on quit rates.  The terrorist attack was temporarily associated with various stages of the study protocol.  Mean smoking rates the week before September 11th were slightly lower than mean smoking rates the week after September 11th (11.8 cigarettes per day versus 12.6 cigarettes per day respectively).  Higher ratings on the Impact of Events (IES) scale, completed retrospectively after all subjects had completed the 18-week evaluation, were associated with increased cigarette use following the terrorist attacks (Pearson's r=0.25 p<0.01).   Among the 303 participants who completed smoking diaries, 43.9% did not change smoking rates, 23.1% decreased smoking, and 34.3% increased smoking the week following the tradegy.  Thirteen of the 82 subjects who had quit prior to September 11th relapsed in the week following the attacks (15.9%); IES scores among those who relapsed were moderately higher than subjects who remained quit (36.9 versus 29.8, respectively).   Although the terrorist attacks were associated with increases in smoking and relapse rates, the effect was relatively small and not significant.  Greater perceived impact of the events of September 11th, however, predicted moderate increases in smoking and relapse rates. 

Riley, W., Mihm, P., Behar, A., and Morin, C. (2002). Initial evaluation of a computerized behavioral intervention for primary insomnia. Paper presented at the 36th Annual Convention of the Association for the Advancement of Behavior Therapy. Reno, NV.

Abstract:

Despite substantial evidence of the efficacy of behavioral interventions for primary, chronic insomnia, these interventions remain largely unavailable to those suffering from insomnia. Therefore, a number of self-help interventions have been developed and evaluated in recent years to make these treatments widely disseminable and more accessible. For this project, a computerized behavioral intervention was developed, the Insomnia Assessment and Treatment Program (IATP), which was prototyped on a small, specific purpose, handheld computer. The program uses an active sampling procedure to assess sleep or wake states (low volume auditory beep every 10 minutes). During a week of baseline recording, the IATP calculates total sleep time, sleep onset latency, sleep efficiency and other relevant variables. From these data, the IATP devises a sleep restriction and stimulus control program, prompting the user when to go to bed and get out of bed each night and continues to record sleep behavior each night and adjusting the intervention accordingly. Eighty six participants (60% female; 80% White, 10% Black, 10% Asian) meeting criteria for chronic primary insomnia were randomly assigned to receive either the IATP or a similar device which monitored sleep only and a manualized behavioral treatment (MBT). In addition to the data from the monitoring units, the participants also keep sleep diaries each night. At the initial and six week follow-up visit, participants also completed the Pittsburgh Sleep Quality Index (PSQI). To assess concurrent validity, the device monitoring data were compared to the sleep diary data for weekly means of relevant variables. Sleep onset latency correlations for each week ranged from .68 to .95. Lower but significant correlations also were obtained for total sleep time (.30 to .75) and for sleep efficiency (.34 to .79). On treatment outcome, repeated measures ANOVAs revealed a significantly greater improvements for the IATP than the MBT on the PSQI (F= 3.65, p < .05), sleep efficiency (F = 2.85, p < .05). Sleep latency reduced in both groups but the time by group interaction was not significant. An intent to treat analysis of those reaching 90% or greater sleep efficiency at week 6 revealed that 35% of the IATP group but only 9% of the MBT group met this criteria (c 2 = 7.03, p < .01). On a subjective rating of sleep improvement, 46% of the IATP group rated their sleep as much or very much improved whereas none of the MBT did so. The results of this project indicate that behavioral interventions for insomnia can be delivered by a self-help computer device (the IATP) and that the IATP produces greater improvement in sleep behavior than a manualized treatment approach.

Obermayer, J., Riley, B., Asif, O., Jean-Mary, J. (2003).  College smoking cessation using wireless devices. Poster presented at the 2004 Society of Behavioral Medicine 25th Anniversary Annual Meeting & Scientific Sessions on March 24-27, Baltimore Marriott Waterfront Hotel, Baltimore, Maryland.

Objective: The purpose of this project was to develop and test the feasibility of a smoking cessation program delivered in the form of text messages via mobile phones.

Methodology: The usability of this prototype was assessed in a sample of college students from local colleges and universities. Forty-six subjects (54% male, 46% male; 72% White, 15% Asian, 7% African American, and 6% Other) participated in and completed the 6-week assessment trial. Subjects registered on the study website to personalize and initialize their smoking cessation program. This allowed subjects to create a quitting plan, indicate situations and times when they were at high risk for smoking, and input and track their progress towards quitting. Pre-test and post-test measures included cigarette logs, nicotine dependence scale, smoking and quitting documentation questionnaire, and a program use questionnaire.

Results: During this study period, 20 subjects (43%) successfully completed a 24-hour quit attempt. At the end of the six-week study period, there were 10 subjects (22%) who met the 7-day point prevalence criterion for quitting. Among subjects who had not quit, cigarette logs and nicotine dependence scale scores indicated that these subjects substantially reduced their mean cigarette counts of 77 cigarettes/week to 32 cigarettes/week (t = 5.34, p < .001). These subjects also experienced lowered (-0.37 to –1, t = 5.4, p < .001) nicotine dependence as measured by the Nicotine Dependence Syndrome Scale (NDSS). All of the subjects rated the program positively on usability, comparison to other methods tried, and overall satisfaction.

Significance: The results of this initial study trial indicates that the WICS program produces high quit rates in comparison to the overall 10% quit rate for self-help smoking cessation programs, as well as resulting in positive outcomes for non-abstinent subjects. Smoking on college campuses has increased substantially in the last decade, yet programs have not targeted these smokers who have unique patterns and causes of smoking. College students are early adopters of communications technologies and may, therefore, readily adopt a smoking cessation program delivered via these technologies.

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PICS, Inc. 2005