Trial Outcomes & Findings for Improving Resiliency in Air Force Personnel (NCT NCT05460663)
NCT ID: NCT05460663
Last Updated: 2024-10-08
Results Overview
Resilience was measured using the CD-10, a 10-item scale derived from the original, 25-item Connor Davidson Resilience Scale. Respondents can answer each item using a five-point rating ranging from not true at all (0) to true nearly all the time (4). A total CD-RISC score is calculated by summing the score of all 10 items for a total possible score of 40, with a higher score reflecting a greater level of resilience. The CD-10 has a reported Cronbach's alpha of .85 and has demonstrated construct validity. The scale was administered to each participants at 4 times: baseline, and 12/18/24 weeks after SMART completion.
COMPLETED
NA
56 participants
Changes in self-reported CD-10 from Baseline at 12, 18, and 24 weeks post-SMART completion
2024-10-08
Participant Flow
Participant milestones
| Measure |
VTC/In-person SMART Training
The two-hour VTC or in-person will be provided SMART synchronously to a maximum of 10 individuals. A study team member will contact participants in the VTC group to provide available dates and times of scheduled classes, and these participants will be scheduled for a class they would like to attend. Participants in the VTC group will be provided a web-link prior to the session, and each session will have a unique password to access the training. Participants in the on-line training group will be provided a code to access the training website. If local conditions permit in-person group meetings (i.e. Health Protection Condition \[HPCON\] Alpha or Bravo), in-person group SMART training in a classroom will be offered as an alternative to VTC sessions.
Stress Management and Resilience Training (SMART): The Stress Management and Resilience Training (SMART) program was developed by Dr. Amit Sood. SMART focuses on improving the practices of gratitude, mindful presence, kindness, and developing a resilient mindset. The SMART program incorporates practices that focus on six individual factors that have been found to promote individual-level resilience: positive coping, positive affect, positive thinking, realism, behavioral control, and altruism. In this proposed study, SMART will be provided via either a two-hour, video teleconference (VTC) or in-person training or by completion of a self-paced, on-line version completed over a period of four to eight weeks.
|
CBT SMART Training
SMART will be provided via completion of a self-paced, on-line version completed over a period of four to eight weeks.
Stress Management and Resilience Training (SMART): The Stress Management and Resilience Training (SMART) program was developed by Dr. Amit Sood. SMART focuses on improving the practices of gratitude, mindful presence, kindness, and developing a resilient mindset. The SMART program incorporates practices that focus on six individual factors that have been found to promote individual-level resilience: positive coping, positive affect, positive thinking, realism, behavioral control, and altruism. In this proposed study, SMART will be provided via either a two-hour, video teleconference (VTC) or in-person training or by completion of a self-paced, on-line version completed over a period of four to eight weeks.
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|---|---|---|
|
Overall Study
STARTED
|
32
|
24
|
|
Overall Study
COMPLETED
|
30
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
Reasons for withdrawal
| Measure |
VTC/In-person SMART Training
The two-hour VTC or in-person will be provided SMART synchronously to a maximum of 10 individuals. A study team member will contact participants in the VTC group to provide available dates and times of scheduled classes, and these participants will be scheduled for a class they would like to attend. Participants in the VTC group will be provided a web-link prior to the session, and each session will have a unique password to access the training. Participants in the on-line training group will be provided a code to access the training website. If local conditions permit in-person group meetings (i.e. Health Protection Condition \[HPCON\] Alpha or Bravo), in-person group SMART training in a classroom will be offered as an alternative to VTC sessions.
Stress Management and Resilience Training (SMART): The Stress Management and Resilience Training (SMART) program was developed by Dr. Amit Sood. SMART focuses on improving the practices of gratitude, mindful presence, kindness, and developing a resilient mindset. The SMART program incorporates practices that focus on six individual factors that have been found to promote individual-level resilience: positive coping, positive affect, positive thinking, realism, behavioral control, and altruism. In this proposed study, SMART will be provided via either a two-hour, video teleconference (VTC) or in-person training or by completion of a self-paced, on-line version completed over a period of four to eight weeks.
|
CBT SMART Training
SMART will be provided via completion of a self-paced, on-line version completed over a period of four to eight weeks.
Stress Management and Resilience Training (SMART): The Stress Management and Resilience Training (SMART) program was developed by Dr. Amit Sood. SMART focuses on improving the practices of gratitude, mindful presence, kindness, and developing a resilient mindset. The SMART program incorporates practices that focus on six individual factors that have been found to promote individual-level resilience: positive coping, positive affect, positive thinking, realism, behavioral control, and altruism. In this proposed study, SMART will be provided via either a two-hour, video teleconference (VTC) or in-person training or by completion of a self-paced, on-line version completed over a period of four to eight weeks.
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|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
5
|
Baseline Characteristics
Improving Resiliency in Air Force Personnel
Baseline characteristics by cohort
| Measure |
In Person
n=32 Participants
VTC was initially provided due to COVID-19 isolation and travel restrictions. Once these restrictions were reduced, in-person training became feasible. The VTC and in-person training was accomplished with the same instructors and materials. Therefore, the VTC and in-person training were considered to be indistinguishable and equivalent in content and delivery and participants were categorized into one in-person/VTC arm for analysis.
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Computer Based Training
n=24 Participants
SMART CBT was provided via completion of a self-paced, on-line version completed over a period of four to eight weeks.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<30 years
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Customized
30+ years
|
25 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Military Grade
Officer
|
17 participants
n=5 Participants
|
11 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Military Grade
Enlisted
|
15 participants
n=5 Participants
|
13 participants
n=7 Participants
|
28 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Changes in self-reported CD-10 from Baseline at 12, 18, and 24 weeks post-SMART completionPopulation: Follow-up surveys were voluntary. Up to three reminder surveys were sent at each time point.
Resilience was measured using the CD-10, a 10-item scale derived from the original, 25-item Connor Davidson Resilience Scale. Respondents can answer each item using a five-point rating ranging from not true at all (0) to true nearly all the time (4). A total CD-RISC score is calculated by summing the score of all 10 items for a total possible score of 40, with a higher score reflecting a greater level of resilience. The CD-10 has a reported Cronbach's alpha of .85 and has demonstrated construct validity. The scale was administered to each participants at 4 times: baseline, and 12/18/24 weeks after SMART completion.
Outcome measures
| Measure |
CD-10 (In-Person/VTC)
n=32 Participants
Resilience was measured using the CD-10, a 10-item scale derived from the original, 25-item Connor Davidson Resilience Scale. Respondents answer each item using a five-point rating ranging from not true at all (0) to true nearly all the time (4). A total CD-10 score is calculated by summing the score of all 10 items for a total possible score of 40, with a higher score reflecting a greater level of resilience.
|
CD-10 (CBT)
n=24 Participants
CBT
|
|---|---|---|
|
Changes in Connor-Davidson 10-Item Scale (CD-10)
CD-10: Baseline
|
28 score on a scale
Interval 25.8 to 32.8
|
28.5 score on a scale
Interval 25.0 to 32.3
|
|
Changes in Connor-Davidson 10-Item Scale (CD-10)
CD-10: 12 Weeks
|
33.5 score on a scale
Interval 29.5 to 35.8
|
32 score on a scale
Interval 30.0 to 33.3
|
|
Changes in Connor-Davidson 10-Item Scale (CD-10)
CD-10: 18 Weeks
|
36 score on a scale
Interval 31.1 to 37.0
|
34 score on a scale
Interval 28.5 to 38.0
|
|
Changes in Connor-Davidson 10-Item Scale (CD-10)
CD-10: 24 Weeks
|
36.5 score on a scale
Interval 30.0 to 37.0
|
32.2 score on a scale
Interval 29.0 to 37.0
|
SECONDARY outcome
Timeframe: Changes in self-reported PSS from Baseline at 12, 18, and 24 weeks post-SMART completionPopulation: Follow-up surveys were voluntary. Up to three reminder surveys were sent at each time point.
The PSS was developed to provide both a global measure and a measure for current levels of perceived stress. The PSS is a 14-item instrument, and respondents answer each item on a four-point scale ranging from never (0) to very often (4). An individual's total score is calculated by reverse scoring seven items and then summing all item scores, resulting in a score range of 0-56, with a higher score reflecting a greater level of stress. The scale was administered to each participants at 4 times: baseline, and 12/18/24 weeks after SMART completion.
Outcome measures
| Measure |
CD-10 (In-Person/VTC)
n=32 Participants
Resilience was measured using the CD-10, a 10-item scale derived from the original, 25-item Connor Davidson Resilience Scale. Respondents answer each item using a five-point rating ranging from not true at all (0) to true nearly all the time (4). A total CD-10 score is calculated by summing the score of all 10 items for a total possible score of 40, with a higher score reflecting a greater level of resilience.
|
CD-10 (CBT)
n=24 Participants
CBT
|
|---|---|---|
|
Changes in Perceived Stress Scale (PSS)
Baseline
|
24.5 score on a scale
Interval 18.5 to 29.0
|
24.5 score on a scale
Interval 18.8 to 29.3
|
|
Changes in Perceived Stress Scale (PSS)
PSS: 12 Weeks
|
20 score on a scale
Interval 12.5 to 24.0
|
16 score on a scale
Interval 14.0 to 21.0
|
|
Changes in Perceived Stress Scale (PSS)
PSS: 18 Weeks
|
16.7 score on a scale
Interval 10.8 to 22.4
|
16.5 score on a scale
Interval 12.0 to 22.8
|
|
Changes in Perceived Stress Scale (PSS)
PSS: 24 Weeks
|
16.5 score on a scale
Interval 12.0 to 24.8
|
13 score on a scale
Interval 11.0 to 21.0
|
SECONDARY outcome
Timeframe: Changes in self-reported GAD-7 scores from Baseline at 12, 18, and 24 weeks post-SMART completionPopulation: Follow-up surveys were voluntary. Up to three reminder surveys were sent at each time point.
Anxiety was measured with the GAD-7. Respondents can answer each item using a four-point scale ranging from not at all (0) nearly every day (3). A total score is calculated by summing the scores of the seven items with possible scores ranging from 0-21, with a higher score reflecting a greater level of anxiety. Scores between 5-9 are indicative of mild anxiety, and score between 15-21 are indicative of severe anxiety. The scale was administered to each participants at 4 times: baseline, and 12/18/24 weeks after SMART completion.
Outcome measures
| Measure |
CD-10 (In-Person/VTC)
n=32 Participants
Resilience was measured using the CD-10, a 10-item scale derived from the original, 25-item Connor Davidson Resilience Scale. Respondents answer each item using a five-point rating ranging from not true at all (0) to true nearly all the time (4). A total CD-10 score is calculated by summing the score of all 10 items for a total possible score of 40, with a higher score reflecting a greater level of resilience.
|
CD-10 (CBT)
n=24 Participants
CBT
|
|---|---|---|
|
Changes in Generalized Anxiety Disorder Scale (GAD-7)
Baseline
|
5.5 score on a scale
Interval 1.8 to 10.3
|
4 score on a scale
Interval 2.0 to 8.3
|
|
Changes in Generalized Anxiety Disorder Scale (GAD-7)
GAD-7: 12 Weeks
|
3 score on a scale
Interval 0.25 to 7.8
|
2 score on a scale
Interval 2.0 to 6.0
|
|
Changes in Generalized Anxiety Disorder Scale (GAD-7)
GAD-7: 18 Weeks
|
2 score on a scale
Interval 0.0 to 3.5
|
3 score on a scale
Interval 0.0 to 5.8
|
|
Changes in Generalized Anxiety Disorder Scale (GAD-7)
GAD-7: 24 Weeks
|
2.7 score on a scale
Interval 1.3 to 5.8
|
2 score on a scale
Interval 1.0 to 7.0
|
SECONDARY outcome
Timeframe: Changes in self-reported QOL scores from Baseline at 12, 18, and 24 weeks post-SMART completionPopulation: Follow-up surveys were voluntary. Up to three reminder surveys were sent at each time point.
A single-item Linear Analogue Self-Assessment (LASA) QoL measure was used to measure overall quality of life for this study. Participants responded to each item using an 11-point Likert scale ranging from as bad as it can be (0) to as good as it can be (10), with a higher score reflecting a greater level of quality of life. The scale was administered to each participants at 4 times: baseline, and 12/18/24 weeks after SMART completion.
Outcome measures
| Measure |
CD-10 (In-Person/VTC)
n=32 Participants
Resilience was measured using the CD-10, a 10-item scale derived from the original, 25-item Connor Davidson Resilience Scale. Respondents answer each item using a five-point rating ranging from not true at all (0) to true nearly all the time (4). A total CD-10 score is calculated by summing the score of all 10 items for a total possible score of 40, with a higher score reflecting a greater level of resilience.
|
CD-10 (CBT)
n=24 Participants
CBT
|
|---|---|---|
|
Changes in Quality of Life (QOL)
Baseline
|
7 score on a scale
Interval 6.0 to 8.0
|
8 score on a scale
Interval 7.0 to 8.0
|
|
Changes in Quality of Life (QOL)
QoL: 12 Weeks
|
7 score on a scale
Interval 6.0 to 8.8
|
8 score on a scale
Interval 7.0 to 8.0
|
|
Changes in Quality of Life (QOL)
QoL: 18 Weeks
|
8 score on a scale
Interval 6.8 to 8.3
|
7 score on a scale
Interval 7.0 to 8.8
|
|
Changes in Quality of Life (QOL)
QoL: 24 Weeks
|
8 score on a scale
Interval 7.3 to 8.8
|
7 score on a scale
Interval 7.0 to 8.0
|
Adverse Events
VTC/In-person SMART Training
CBT SMART Training
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Stephen H. A. Hernandez, PhD, RN, FAAN
University of New Mexico, College of Nursing
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place