Trial Outcomes & Findings for Get Moving and Get Well - Pilot Study (NCT NCT01884025)

NCT ID: NCT01884025

Last Updated: 2018-11-05

Results Overview

The BADS asks respondents to rate how much the statements are true for four subscales: Activation, Avoidance/Rumination, Work/School Impairment, and Social Impairment. It has been found to have acceptable internal consistency (Cronbach's alpha of .87), test-retest reliability (Pearson's r = .74), good construct validity, and when administered to a clinically depressed sample, the factors held up. Items for each subscale are summed to generate subscale scores. The BADS is made up of 25 questions with response option range from 0 (not at all) to 6 (completely). (Subscore Ranges: Activation: 0-108, Avoidance/Rumination: 0-102, Work/School Impairment: 0-120, Social Impairment: 0-120 Total: 0-150). For all subscales, high scores are consistent with the scale name.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 27 participants
• Primary outcome timeframe: Baseline (Time point 0 - Pre intervention/control class) and follow-up (Time point Week 12 - after completion of intervention/attention control class)
• Results posted on: 2018-11-05

Participant Flow

Participant milestones

Measure	Get Moving and Get Well Walking class developed for Veterans with serious mental illness and administered as part of the PRRC Get Moving and Get Well: Walking Class	Health and Humor Class Equally engaging attention control condition Health and Humor Class: Class about the role of humor in health
Overall Study STARTED	13	14
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Measure	Get Moving and Get Well Walking class developed for Veterans with serious mental illness and administered as part of the PRRC Get Moving and Get Well: Walking Class	Health and Humor Class Equally engaging attention control condition Health and Humor Class: Class about the role of humor in health
Overall Study Lost to Follow-up	3	4

Baseline Characteristics

Get Moving and Get Well - Pilot Study

Baseline characteristics by cohort

Measure	Get Moving and Get Well n=10 Participants Walking class developed for Veterans with serious mental illness and administered as part of the PRRC Get Moving and Get Well: Walking Class	Health and Humor Class n=10 Participants Equally engaging attention control condition Health and Humor Class: Class about the role of humor in health	Total n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	55.1 years STANDARD_DEVIATION 6.77 • n=5 Participants	54.1 years STANDARD_DEVIATION 8.8 • n=7 Participants	54.6 years STANDARD_DEVIATION 7.66 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian (Non-Hispanic)	6 participants n=5 Participants	6 participants n=7 Participants	12 participants n=5 Participants
Race/Ethnicity, Customized African American	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants
Years of Education HighSchool/GED	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants
Years of Education Some COllege	4 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants
Years of Education Bachelors Degree	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Years of Education Graduate Degree	0 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Time point 0 - Pre intervention/control class) and follow-up (Time point Week 12 - after completion of intervention/attention control class)

Population: Analysis population includes participants who completed both baseline and follow-up measures.

The BADS asks respondents to rate how much the statements are true for four subscales: Activation, Avoidance/Rumination, Work/School Impairment, and Social Impairment. It has been found to have acceptable internal consistency (Cronbach's alpha of .87), test-retest reliability (Pearson's r = .74), good construct validity, and when administered to a clinically depressed sample, the factors held up. Items for each subscale are summed to generate subscale scores. The BADS is made up of 25 questions with response option range from 0 (not at all) to 6 (completely). (Subscore Ranges: Activation: 0-108, Avoidance/Rumination: 0-102, Work/School Impairment: 0-120, Social Impairment: 0-120 Total: 0-150). For all subscales, high scores are consistent with the scale name.

Outcome measures

Measure	Get Moving and Get Well n=10 Participants Walking class developed for Veterans with serious mental illness and administered as part of the PRRC Get Moving and Get Well: Walking Class	Health and Humor Class n=10 Participants Equally engaging attention control condition Health and Humor Class: Class about the role of humor in health
Change in Behavioral Activation for Depression Scale Activation	1.3 units on a scale Standard Deviation 6.11	1.2 units on a scale Standard Deviation 8.90
Change in Behavioral Activation for Depression Scale Avoidance/Rumination	2.8 units on a scale Standard Deviation 10.25	3 units on a scale Standard Deviation 9.76
Change in Behavioral Activation for Depression Scale Work/School Impairment	4.8 units on a scale Standard Deviation 6.27	12 units on a scale Standard Deviation 6.05
Change in Behavioral Activation for Depression Scale Social Impairment	3.6 units on a scale Standard Deviation 5.8	1.1 units on a scale Standard Deviation 5.51
Change in Behavioral Activation for Depression Scale Total Score	12.5 units on a scale Standard Deviation 21.99	6.5 units on a scale Standard Deviation 26.31

SECONDARY outcome

Timeframe: Baseline (Time point 0 - Pre intervention/control class) and follow-up (Time point Week 12 - after completion of intervention/attention control class)

Population: Analysis population includes participants who completed both baseline and follow-up measures.

Based on the exercise self-efficacy factors of resisting relapse and making time for exercise, the Exercise Self-Efficacy questionnaire asks respondents to circle how confident they are about their ability to exercise under difficult conditions, such as "when I am tired". An additional item will be added to include hot weather as a possible barrier to physical activity, because of the likelihood of high spring and summer temperatures in our location. This scale was found to be highly reliable (test-retest reliability was .90) (Markus et al., 1992). It is made up of six questions each on a likert-type scale ranging from 1 (not at all confident) to 7 (very confident). These are ratings are then summed for the total score; total score ranges from 6-42 with higher scores indicating higher exercise self efficacy.

Outcome measures

Measure	Get Moving and Get Well n=10 Participants Walking class developed for Veterans with serious mental illness and administered as part of the PRRC Get Moving and Get Well: Walking Class	Health and Humor Class n=10 Participants Equally engaging attention control condition Health and Humor Class: Class about the role of humor in health
Change in Exercise Self-Efficacy Questionnaire	1.5 units on a scale Standard Deviation 4.90	.6 units on a scale Standard Deviation 6.7

SECONDARY outcome

Timeframe: baseline and 12 week follow-up

Population: Participants who completed baseline and follow-up measures

Physical activity and cognitive/social activity will be measured by the CHAMPS (Stewart, et al., 2001) which asks respondents to identify if they participated in an activity (yes or no) how many times a week they participated (continuous variable) and if they did participate, for how many hours per week (rated on a six point scale ranging from less than one hour to more than 9 hours). The CHAMPS assesses for both physical and social/cognitive activities (e.g., "Visit with friends or family (other than those you live with);" "walk briskly").

Outcome measures

Measure	Get Moving and Get Well n=10 Participants Walking class developed for Veterans with serious mental illness and administered as part of the PRRC Get Moving and Get Well: Walking Class	Health and Humor Class n=10 Participants Equally engaging attention control condition Health and Humor Class: Class about the role of humor in health
Change in CHAMPS (Community Healthy Activities Model Program for Seniors) Questionnaire for Older Adults - Physical Activity Frequency Physical Activity Frequency	2.7 times per week Standard Deviation 11.84	4.3 times per week Standard Deviation 7.53
Change in CHAMPS (Community Healthy Activities Model Program for Seniors) Questionnaire for Older Adults - Physical Activity Frequency Moderate Physical Activity Frequency	1.3 times per week Standard Deviation 5.42	2.1 times per week Standard Deviation 3.51

SECONDARY outcome

Timeframe: Baseline and Follow -up

Population: Participants who completed both baseline and follow-up measures

The VR-12 is based on the Veterans RAND 36 (SF-36) and has been shown to be a good outcome measure of general physical and mental health with significant correlations with morbidity (Kazis, et al., 2006). It provides physical and mental health subscale scores. It consists of 12 questions (several with sub sections) which are rated on three point and five point likert-type scales. These ratings are then assigned values with some scored opposite so that higher values always indicate more positive health. The Physical Health component can range from 10-59 and the Mental Health component from 6-33.

Outcome measures

Measure	Get Moving and Get Well n=10 Participants Walking class developed for Veterans with serious mental illness and administered as part of the PRRC Get Moving and Get Well: Walking Class	Health and Humor Class n=10 Participants Equally engaging attention control condition Health and Humor Class: Class about the role of humor in health
Change in Veterans RAND 12 (VR-12) Physical Health	0.54 units on a scale Standard Deviation 9.033	-2.5097 units on a scale Standard Deviation 8.74
Change in Veterans RAND 12 (VR-12) Mental Health	7.52 units on a scale Standard Deviation 12.75	3.31 units on a scale Standard Deviation 11.86

SECONDARY outcome

Timeframe: Baseline and Follow-up

Population: participants who completed both baseline and follow-up measures

Depression will be measured by the Patient Health Questionnaire-8 (PHQ-8) which has been validated across several populations (Kroenke & Spitzer, 2002). Respondents rate how often they were bothered by eight problems on a likert-type scale ranging from 0 (not at all) to 3 (nearly every day). Scores can range from 0-24; higher scores indicate higher levels of depression with score >10 indicating clinically relevant depression.

Outcome measures

Measure	Get Moving and Get Well n=10 Participants Walking class developed for Veterans with serious mental illness and administered as part of the PRRC Get Moving and Get Well: Walking Class	Health and Humor Class n=10 Participants Equally engaging attention control condition Health and Humor Class: Class about the role of humor in health
Change in Personal Health Information Depression Scale (PHQ-8)	-1.30 units on a scale Standard Deviation 5.14	-.50 units on a scale Standard Deviation 4.72

SECONDARY outcome

Timeframe: Baseline and Follow-up

Population: Participants who completed both baseline and follow-up measures

Intent to engage in health promotion was measured with an established scale (Ajzen, 1991) adapted for this project. The Intent To Engage questionnaire consists of eight questions each assessing assess intent, confidence and social support to complete health promotion activities. Each of these is rated on a likert-type scale ranging from 1-7 with some responses reverse scored so that higher responses indicate better intent, confidence, and social support. These are summed for a total score. Total scores range from 24 to 56.

Outcome measures

Measure	Get Moving and Get Well n=10 Participants Walking class developed for Veterans with serious mental illness and administered as part of the PRRC Get Moving and Get Well: Walking Class	Health and Humor Class n=10 Participants Equally engaging attention control condition Health and Humor Class: Class about the role of humor in health
Change in Intent to Engage	-1.80 units on a scale Standard Deviation 12.99	3.10 units on a scale Standard Deviation 16.17

SECONDARY outcome

Timeframe: follow-up

Population: participants who completed follow-up measures.

Measure of Patient self-report of acceptability of intervention. Participants responded to four questions using a 7 (0-7) point likert-type scale with higher ratings indicating higher acceptability. These were summed for a total score ranging from 0-28.

Outcome measures

Measure	Get Moving and Get Well n=10 Participants Walking class developed for Veterans with serious mental illness and administered as part of the PRRC Get Moving and Get Well: Walking Class	Health and Humor Class n=10 Participants Equally engaging attention control condition Health and Humor Class: Class about the role of humor in health
Acceptability	23.9 units on a scale Standard Deviation 3.72	20.2 units on a scale Standard Deviation 5.20

SECONDARY outcome

Timeframe: Start of class through 3 months post-class

Population: Veterans who completed both baseline and follow-up measures.

A chart review was completed in order to identify documentation of new health behaviors. Mental health notes were first reviewed and then key terms were searched in all notes during the time period. S We considered a new health behaviors as: Starting or increasing physical activity in a formal program; Starting or increasing physical activity on own; Starting nicotine replacement/report cutting down or quitting smoking/join a smoking cessation group; Treatment for alcohol or SA/Report cutting down on Alcohol use; Report changing diet/formal nutrition consult/etc. Chart abstractors were instructed to make free text notes explaining each event the counted. These were reviewed by the PI for accuracy.

Outcome measures

Measure	Get Moving and Get Well n=10 Participants Walking class developed for Veterans with serious mental illness and administered as part of the PRRC Get Moving and Get Well: Walking Class	Health and Humor Class n=10 Participants Equally engaging attention control condition Health and Humor Class: Class about the role of humor in health
New Health Behaviors From the Beginning of Classes Through Three Months Post End of Class	17 Events	7 Events

SECONDARY outcome

Timeframe: baseline and 12 week follow-up

Population: participants who completed both baseline and follow-up measures

Physical activity and cognitive/social activity will be measured by the CHAMPS (Stewart, et al., 2001) which asks respondents to identify if they participated in an activity (yes or no) how many times a week they participated (continuous variable) and if they did participate, for how many hours per week (rated on a 1 - 6 point scale ranging from less than one hour to more than 9 hours). The CHAMPS assesses for both physical and social/cognitive activities (e.g., "Visit with friends or family (other than those you live with);" "walk briskly").

Outcome measures

Measure	Get Moving and Get Well n=10 Participants Walking class developed for Veterans with serious mental illness and administered as part of the PRRC Get Moving and Get Well: Walking Class	Health and Humor Class n=10 Participants Equally engaging attention control condition Health and Humor Class: Class about the role of humor in health
Change in CHAMPS (Community Healthy Activities Model Program for Seniors) Questionnaire for Older Adults - Physical Activity Duration	1.85 units on a scale Standard Deviation 2.79	1.37 units on a scale Standard Deviation 4.06

SECONDARY outcome

Timeframe: baseline and 12 week follow-up

Population: Participants who completed baseline and follow-up measures

Physical activity and cognitive/social activity will be measured by the CHAMPS (Stewart, et al., 2001) which asks respondents to identify if they participated in an activity (yes or no) how many times a week they participated (continuous variable) and if they did participate, for how many hours per week (rated on a 1-6 point scale ranging from less than one hour to more than 9 hours). The CHAMPS assesses for both physical and social/cognitive activities (e.g., "Visit with friends or family (other than those you live with);" "walk briskly").

Outcome measures

Measure	Get Moving and Get Well n=10 Participants Walking class developed for Veterans with serious mental illness and administered as part of the PRRC Get Moving and Get Well: Walking Class	Health and Humor Class n=10 Participants Equally engaging attention control condition Health and Humor Class: Class about the role of humor in health
Change in CHAMPS (Community Healthy Activities Model Program for Seniors) Questionnaire for Older Adults - Cognitive Activity Frequency	-0.7 times/week Standard Deviation 5.48	-2.0 times/week Standard Deviation 5.33

SECONDARY outcome

Timeframe: baseline and 12 week follow-up

Population: Participants who completed baseline and follow-up measures

Physical activity and cognitive/social activity will be measured by the CHAMPS (Stewart, et al., 2001) which asks respondents to identify if they participated in an activity (yes or no) how many times a week they participated (continuous variable) and if they did participate, for how many hours per week (rated on a 1-6 point scale ranging from less than one hour to more than 9 hours). The CHAMPS assesses for both physical and social/cognitive activities (e.g., "Visit with friends or family (other than those you live with);" "walk briskly").

Outcome measures

Measure	Get Moving and Get Well n=10 Participants Walking class developed for Veterans with serious mental illness and administered as part of the PRRC Get Moving and Get Well: Walking Class	Health and Humor Class n=10 Participants Equally engaging attention control condition Health and Humor Class: Class about the role of humor in health
Change in CHAMPS (Community Healthy Activities Model Program for Seniors) Questionnaire for Older Adults - Cognitive Duration	-0.15 units on a scale Standard Deviation 3.72	1.99 units on a scale Standard Deviation 4.12

SECONDARY outcome

Timeframe: Start of class through 3 months post-class

Population: Veterans who completed both baseline and follow-up measures.

A chart review was completed in order to identify documentation of new health behaviors. Mental health notes were first reviewed and then key terms were searched in all notes during the time period. S We considered a new health behaviors as: Starting or increasing physical activity in a formal program; Starting or increasing physical activity on own; Starting nicotine replacement/report cutting down or quitting smoking/join a smoking cessation group; Treatment for alcohol or SA/Report cutting down on Alcohol use; Report changing diet/formal nutrition consult/etc. Chart abstractors were instructed to make free text notes explaining each event the counted. These were reviewed by the PI for accuracy.

Outcome measures

Measure	Get Moving and Get Well n=10 Participants Walking class developed for Veterans with serious mental illness and administered as part of the PRRC Get Moving and Get Well: Walking Class	Health and Humor Class n=10 Participants Equally engaging attention control condition Health and Humor Class: Class about the role of humor in health
Number of Participants Beginning New Health Behaviors From the Beginning of Classes Through Three Months Post End of Class	8 participants	5 participants

Adverse Events

Get Moving and Get Well

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Health and Humor Class

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Get Moving and Get Well n=13 participants at risk Walking class developed for Veterans with serious mental illness and administered as part of the PRRC Get Moving and Get Well: Walking Class	Health and Humor Class n=14 participants at risk Equally engaging attention control condition Health and Humor Class: Class about the role of humor in health
Psychiatric disorders Participant reproted Suicidal Ideation without Initent or Plan	0.00% 0/13	7.1% 1/14 • Number of events 1

Other adverse events

Measure	Get Moving and Get Well n=13 participants at risk Walking class developed for Veterans with serious mental illness and administered as part of the PRRC Get Moving and Get Well: Walking Class	Health and Humor Class n=14 participants at risk Equally engaging attention control condition Health and Humor Class: Class about the role of humor in health
Musculoskeletal and connective tissue disorders Pain	15.4% 2/13 • Number of events 2	0.00% 0/14
Psychiatric disorders Displeasure with group	0.00% 0/13	7.1% 1/14 • Number of events 1

Additional Information

Dr. Kristen Viverito

Central Arkansas Veterans Healthcare System

Phone: 501-257-1699

Email: KRISTEN.VIVERITO@VA.GOV

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place