NOTE: Element change to Human Factors & Behavioral Performance; previously Behavioral Health & Performance (Ed., 1/18/17)

NOTE: End date is now 12/31/2017 per NSSC information (Ed., 11/29/16)

NOTE: Period of performance changed to 12/11/2013-12/10/2016 per NSSC information (previously noted as 9/18/2013-10/31/2015 per HRP information)--Ed., 9/9/14

We hypothesized that participants in the SMART-OP group would show significantly lower perceived stress, higher perceived control of stress, and increased resilience based on measures of self-report than the WLC from pre- to post-assessment. We also hypothesized that participants would rate the program as very useful and easy to use.

Our second aim was to provide feedback to SFRM and FOD (Flight Operations Directorate) based on data from the RCT and suggest modifications and implementation strategies of SMART-OP for use with astronauts.

The main deliverable of our task was to provide data on the effectiveness, usefulness, and usability of a self-guided, multimedia, stress management and resilience training program as tested in an RCT with flight controllers. The outcome data on perceived stress and perceived control over stress provides information on the efficacy of such training in helping to alleviate stress, a problem identified by SFRM working group in the training flow of flight controllers. Data on the usefulness and usability of SMART-OP will provide important information on the acceptability of self-guided multimedia behavioral health training with individuals who work in operational settings. For additional sources of data, we collected stress biomarker and heart rate data and had participants perform an acute stressor/frustrating task and measure neurocognitive performance. This data will inform future potential applications of such training with other individuals at JSC working in stressful environments including astronauts.

Since this is the last task report for this study, we are presenting task progress since the last report period from the end of 2017 as well as a summary of task progress over the course of the 4 years. Since the last report, recruitment was completed at the end of December 2017 and we wrapped up running the remaining subjects (approximately N=10) through the study protocol, which concluded in March 2018. The remainder of this last task period was spend organizing and cleaning data. The JSC Nutritional Biochemistry Lab conducted biomarker assays on saliva samples conducted over the course of the project and send those results to us. We closed out the assessments and organized a return of the equipment from JSC as well as all data retrieval via encrypted methods. Lastly, we spent this task period conducting analyses as well as writing up the final task report with study results and conclusions and began preparation for submitting a peer-reviewed manuscript.

Over the course of the 4-year study 189 individuals expressed interest in participating. This was typically done by signing an interest sheet after presentation pitches about the study to different groups of flight controllers. Eighty-eight or 46% of those interested were screened for eligibility which means that over half of those interested in the study were never screened for study eligibility. The team at UCLA worked with NASA BHP (Behavioral Health & Performance) personnel over the course of the study to try to address the issues in recruitment and screening and while strides were made; unfortunately most of the people who expressed interest in participating were never screened.

Of the 88 who were screened, 61 were eligible with the remaining 27 not eligible primarily due to having too low stress scores. Of the eligible 61, 45 individuals completed pre-assessment and were randomized to one of our two conditions. Twenty-four participants were randomized to the SMART-OP condition, and 21 participants were randomized to the wait-list condition (WLC). Forty-one participants completed the first post-assessment, 20 from SMART-OP and 21 from WLC which constituted the main outcome comparison groups. Sixteen participants from the WLC completed a second post-assessment after they completed SMART-OP sessions, for a total of 37 final post-assessments.

It should be noted that this was the first study to utilize the BHP Lab facilities and organizational structure; thus, there was steep learning curve to implementing this project. Many valuable lessons were learned over the course of this study in terms of subject recruitment that will ideally help future similarly conducted research.

NOTE: Element change to Human Factors & Behavioral Performance; previously Behavioral Health & Performance (Ed., 1/18/17)

NOTE: End date is now 12/31/2017 per NSSC information (Ed., 11/29/16)

NOTE: Period of performance changed to 12/11/2013-12/10/2016 per NSSC information (previously noted as 9/18/2013-10/31/2015 per HRP information)--Ed., 9/9/14

Study Implementation: The randomized controlled trial was launched at the end of 2014, and implementation has successfully continued for two years. Participants are randomized either to begin SMART-OP right away, or to a 6-week wait-list control. Before and after training, and before and after the wait period, participants complete a pre- or post-assessment that takes about two hours, and is administered by the Nutritional Biochemistry Lab at JSC. The self-guided SMART-OP sessions are conducted weekly and take about 35-45 minutes to complete. Participants in the wait-list control group complete a weekly stress measure that takes a minute or two to complete.

Recruitment: Participant recruitment is being addressed by the UCLA team in conjunction with Test Subject Screening (TSS) and Behavioral Health & Performance (BHP) element personnel. Several presentations were made by the Principal Investigator (PI) at JSC to generate study interest, and advertising is regularly done in the JSC Today. Since the time of this report last year, 68 new potential participants have expressed interest (through informational sessions/presentations, and advertisements) in the study. Fifteen of those have been cleared by TSS and were screened for eligibility, and 8 met inclusion criteria (no medical or psychiatric diagnoses, but stressed based on self-report).

Data collection: Collected data is extracted approximately weekly by our research team, and a data entry system has been developed in preparation for data analysis. We will be looking at self-report measures of stress, resilience, depression, anxiety, personality, emotion, sleep, and health behaviors, neurocognitive performance when stressed, psychophysiological data such as 24-hour heart rate, alpha amylase, and cortisol, and user feedback such as perceived system usability, working alliance, and treatment credibility.

NOTE: Period of performance changed to 12/11/2013-12/10/2016 per NSSC information (previously noted as 9/18/2013-10/31/2015 per HRP information)--Ed., 9/9/14

Study Implementation: The randomized controlled trial was launched at the end of our first year, and this year implementation has successfully continued with 20 new participants who have either completed or are currently in the process of completing SMART-OP. The self-guided SMART-OP sessions are conducted weekly and take about 35-45 minutes to complete. Participants are randomized either to begin SMART-OP right away, or to a 6-week wait-list control. Before and after training, and before and after the wait period, participants complete a pre- or post-assessment that takes about two hours and is administered by the Nutritional Biochemistry Lab at JSC. So far, 32 pre- and post-assessments have been successfully completed, as well as 76 SMART-OP training sessions.

Recruitment: Participant recruitment is being addressed by the UCLA team in conjunction with Test Subject Screening (TSS) and Behavioral Health & Performance (BHP) element personnel. Several presentations were made by the Principal Investigator at JSC to generate study interest, and advertising is regularly done in the JSC Today. Since the time of this report last year, 62 new potential participants have expressed interest (through informational sessions/presentations, and advertisements) in the study. Thirty-one of those have been cleared by TSS, we have screened 30 for eligibility, and 17 met inclusion criteria (no medical or psychiatric diagnoses, but stressed based on self-report).

Revisions: Four revisions to the originally proposed procedures were made during this past year. Most importantly we replaced the Attention Control condition with a wait-list control (WLC) condition. The Attention Control condition was eliminated due to concerns that this was not a sufficiently beneficial use of participants’ time, and because WLC is a more externally valid comparison group condition in the population of flight controllers. We also made a minor change to our eligibility screening procedure, and included an additional measure of stress to our pre- and post-assessment protocols. Lastly, we eliminated the proposed 3-month follow-up due to time constraints, and because the wait-list control group can serve as its own control condition by comparing within-subject changes across three assessments. An Institutional Review Board (IRB) approval for these revisions was obtained from JSC in April 2015.

Data collection: Collected data is extracted weekly by our research team, and a system for data entry is currently being developed in preparation for data analysis. We will be looking at over 500 variables of data, including self-report measures of stress, resilience, depression, anxiety, personality, emotion, sleep, and health behaviors, psychophysiological data such as 24-hour heart rate, alpha amylase, and cortisol, and user feedback such as perceived system usability, working alliance, and treatment credibility.

Study Implementation: The majority of work this past year was spent on various aspects of implementing the study at JSC. The study is designed to be conducted in a self-guided fashion where possible which means the study participant needs to conduct much of the assessment and all of the stress management training independently (i.e., without research coordinators). IRB (Institutional Review Board) protocols and approvals were obtained at JSC and UCLA to conduct the study. Biweekly teleconferences with NASA Behavioral Health and Performance (BHP) personnel addressed various areas of study implementation and maintained regular communication. Our progress this year covered several areas including reserving and setting up a study room on site to conduct the study including assessments. Study computers and iPads were programmed and authenticated for use in the study. Additional study materials were purchased including heart rate monitors. There were several logistical/technical issues/hurdles that were addressed to give the UCLA research team required access to conduct the study from afar. Accomplishing this involved regular communication with JSC BHP and IT staff and personnel. The UCLA research team made two trips to JSC to address various aspects of study implementation including giving several informational session presentations for study recruitment; adding software and other information to JSC computers for assessments and stress management training sessions; testing computers for functionality and reliability; and testing the downloading of training session and assessment data for functionality.

Assessment Procedures: The UCLA research team created several assessment tasks required for the study. The tasks involved computer programming so that study participants could conduct much of the assessments in a self-guided fashion. These involved creating online questionnaires, programming for computerized tasks designed to frustrate/stress users, modification of the neuropsychological battery for use in current study, creation of study protocols instructing the user how to conduct assessments and stress management training sessions on their own. The JSC Nutritional Biochemistry Lab (NBL) is leading a portion of the assessment procedures which involve collection of saliva and urine to measure stress biomarkers (cortisol and alpha amylase). This part of the assessment procedures was developed jointly between the UCLA and NBL teams, protocols formulated, and then the procedures were tested during the visits of the UCLA team to JSC.

SMART-OP Program Revisions: We made modifications to the SMART-OP program needed for implementation in the current study.

Recruitment: Participant recruitment is being coordinated by the UCLA team in conjunction with TSS and BHP personnel. Several presentations were made by the Principal Investigator (PI) at JSC to generate study interest; advertising was done in the JSC Today; pamphlets,and email announcements sent to various departments and personnel at JSC.

Randomized Controlled Trial: Study enrollment recently commenced. At the time of this report, 17 individuals have been cleared by TSS at NASA to participate in the study; 12 of them have been consented, 10 screened, and 5 of those met our eligibility criteria. Of the 5 eligible participants two have completed their pre-assessments and the remainder are scheduled to complete theirs.