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Get Moving and Get Well - Pilot Study

Get Moving and Get Well: A Behavioral Activation Program for Veterans With SMI

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01884025
Acronym
GMGWP
Enrollment
27
Registered
2013-06-21
Start date
2013-06-30
Completion date
2015-08-31
Last updated
2018-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder, Major Depression, Post Traumatic Stress Disorder, Schizoaffective Disorder, Schizophrenia

Keywords

patient centered care, physical activity, behavioral activation, self efficacy, serious mental illness

Brief summary

Individuals with serious mental illness have greater morbidity from physical illness and mortality than the general population, but tend not to initiate or sustain engagement in health promotion interventions. Although promising weight management and wellness interventions have been developed for this population, they are very intensive and tend to have low enrollment, high attrition, and low reach. This pilot study will investigate a novel low-demand intervention that may be initially more acceptable, the Get Moving and Get Well! (GMGW) program. The primary objectives of the proposed study are to investigate the effects of participation in the GMGW program on measures of behavioral activation, self-efficacy, physical activity, general physical and mental health, mood, participants' intent to engage in more intensive physical health interventions, and actual engagement in those programs. Results of this pilot study will inform a future full-scale study of GMGW.

Detailed description

Anticipated Impacts on Veteran's Healthcare: Individuals with serious mental illness (SMI) have greater physical illness morbidity and mortality than the general population, but typically do not enroll in nor complete health promotion interventions. This pilot study will provide preliminary evaluation of a low-demand physical activity intervention that may be acceptable to Veterans with SMI and lead to improved health in this medically vulnerable population. Project Background: The relatively high rates of morbidity and mortality found among individuals with SMI have led to prioritization by Mental Health QUERI, and other groups, of prevention and health promotion in addition to improved coordination of physical health care for this population. Although promising health promotion interventions have been developed, they are intensive and none seem to successfully address the challenge of improving reach and enrollment while minimizing attrition. We propose to conduct a pilot evaluation of a novel low-demand intervention that may be an acceptable introduction to health promotion, the Get Moving and Get Well! (GMGW) program. Participants in the current version of GMGW have described benefits beyond those expected. We believe a 12-week GMGW program may be an effective and relatively low-demand intervention to promote self-efficacy and physical health in Veterans with SMI through increasing Veteran behavioral activation. Project Objectives: The objectives of the proposed study are to: (a) determine the effects of participation in the 12-week GMGW program on a measure of behavioral activation; (b) determine the effects of GMGW on measures of self-efficacy, physical activity, general physical and mental health, and mood; and (c) determine the effects of participation in the class on measures of intent to engage and actual engagement in more intensive physical health programs. Project Methods: In order to inform a future full scale study, we will complete the development of a 12-week manualized GMGW class, assess its acceptability, feasibility and time burden, and evaluate effects of the intervention on key outcome measures. To achieve the aims of the study, we will randomly assign 30 participants to either GMGW or an attention control condition. Participants will complete baseline measures investigating behavioral activation, self-efficacy, physical activity, physical and emotional health, mood, and intent to engage in health promotion activities before beginning the class. These measures will be repeated at the end of the 12-week class, along with questions investigating the acceptability of the interventions. A chart review will investigate actual engagement in health promotion interventions. We will be looking for the emergence of trends for differences in expected directions and response patterns within and between groups that will inform us about effect sizes for the measures and permit a power analysis for the full scale trial. We plan to use repeated measures analysis of variance, controlling for any variables that differ significantly between the intervention and control groups, to test the hypothesis that GMGW participants will have greater improvements on the measures at the end of the 12-week intervention than the control participants. Finally, we will also compare the number of participants who have evidence of participation in new health promotion activities in their medical record using a chi-square test of equal proportions.

Interventions

BEHAVIORALGet Moving and Get Well

Walking Class

BEHAVIORALHealth and Humor Class

Class about the role of humor in health

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* To be considered for participation, potential participants must be Veterans at the Central Arkansas Veterans Healthcare System. * They must express an interest in improving their physical health but not be referred to MOVE! at the time of enrollment in the study; * not have attended more than six class sessions of GMGW in the past; agree to be randomized to one of two treatment groups (GMGW or control health promotion class); * be between the ages of 18 and 65; speak and understand English; * and be able to increase walking and light to moderate physical activity as indicated by a progress note by their primary care provider. * Participants must meet PRRC admission criteria for serious mental illness (primary diagnosis of psychotic disorders, * bipolar disorder, major depression and/or severe PTSD) and * dysfunction (Global Assessment of Functioning (GAF) score of 50 or less); this will be assessed though a review of the Veteran's CPRS electronic record.

Exclusion criteria

* We will exclude Veterans who have been found to be legally incompetent or have a legal guardian of person.

Design outcomes

Primary

MeasureTime frameDescription
Change in Behavioral Activation for Depression ScaleBaseline (Time point 0 - Pre intervention/control class) and follow-up (Time point Week 12 - after completion of intervention/attention control class)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.

Secondary

MeasureTime frameDescription
Change in CHAMPS (Community Healthy Activities Model Program for Seniors) Questionnaire for Older Adults - Physical Activity Frequencybaseline and 12 week follow-upPhysical 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).
Change in Veterans RAND 12 (VR-12)Baseline and Follow -upThe 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.
Change in Personal Health Information Depression Scale (PHQ-8)Baseline and Follow-upDepression 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.
Change in Intent to EngageBaseline and Follow-upIntent 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.
Acceptabilityfollow-upMeasure 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.
Change in Exercise Self-Efficacy QuestionnaireBaseline (Time point 0 - Pre intervention/control class) and follow-up (Time point Week 12 - after completion of intervention/attention control class)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.
Change in CHAMPS (Community Healthy Activities Model Program for Seniors) Questionnaire for Older Adults - Physical Activity Durationbaseline and 12 week follow-upPhysical 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).
Change in CHAMPS (Community Healthy Activities Model Program for Seniors) Questionnaire for Older Adults - Cognitive Activity Frequencybaseline and 12 week follow-upPhysical 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).
Change in CHAMPS (Community Healthy Activities Model Program for Seniors) Questionnaire for Older Adults - Cognitive Durationbaseline and 12 week follow-upPhysical 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).
Number of Participants Beginning New Health Behaviors From the Beginning of Classes Through Three Months Post End of ClassStart of class through 3 months post-classA 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.
New Health Behaviors From the Beginning of Classes Through Three Months Post End of ClassStart of class through 3 months post-classA 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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
10
Health and Humor Class
Equally engaging attention control condition Health and Humor Class: Class about the role of humor in health
10
Total20

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up34

Baseline characteristics

CharacteristicGet Moving and Get WellHealth and Humor ClassTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
10 Participants10 Participants20 Participants
Age, Continuous55.1 years
STANDARD_DEVIATION 6.77
54.1 years
STANDARD_DEVIATION 8.8
54.6 years
STANDARD_DEVIATION 7.66
Race/Ethnicity, Customized
African American
4 participants4 participants8 participants
Race/Ethnicity, Customized
Caucasian (Non-Hispanic)
6 participants6 participants12 participants
Region of Enrollment
United States
10 participants10 participants20 participants
Sex: Female, Male
Female
5 Participants4 Participants9 Participants
Sex: Female, Male
Male
5 Participants6 Participants11 Participants
Years of Education
Bachelors Degree
2 participants2 participants4 participants
Years of Education
Graduate Degree
0 participants2 participants2 participants
Years of Education
HighSchool/GED
4 participants4 participants8 participants
Years of Education
Some COllege
4 participants2 participants6 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
2 / 131 / 14
serious
Total, serious adverse events
0 / 131 / 14

Outcome results

Primary

Change in Behavioral Activation for Depression Scale

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.

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Get Moving and Get WellChange in Behavioral Activation for Depression ScaleActivation1.3 units on a scaleStandard Deviation 6.11
Get Moving and Get WellChange in Behavioral Activation for Depression ScaleAvoidance/Rumination2.8 units on a scaleStandard Deviation 10.25
Get Moving and Get WellChange in Behavioral Activation for Depression ScaleWork/School Impairment4.8 units on a scaleStandard Deviation 6.27
Get Moving and Get WellChange in Behavioral Activation for Depression ScaleTotal Score12.5 units on a scaleStandard Deviation 21.99
Get Moving and Get WellChange in Behavioral Activation for Depression ScaleSocial Impairment3.6 units on a scaleStandard Deviation 5.8
Health and Humor ClassChange in Behavioral Activation for Depression ScaleSocial Impairment1.1 units on a scaleStandard Deviation 5.51
Health and Humor ClassChange in Behavioral Activation for Depression ScaleActivation1.2 units on a scaleStandard Deviation 8.9
Health and Humor ClassChange in Behavioral Activation for Depression ScaleAvoidance/Rumination3 units on a scaleStandard Deviation 9.76
Health and Humor ClassChange in Behavioral Activation for Depression ScaleTotal Score6.5 units on a scaleStandard Deviation 26.31
Health and Humor ClassChange in Behavioral Activation for Depression ScaleWork/School Impairment12 units on a scaleStandard Deviation 6.05
Comparison: Change in total BADS score.p-value: 0.59t-test, 2 sided
Comparison: Change in Activation Subscalep-value: 0.98t-test, 2 sided
Comparison: Change in Avoidance/Rumination Subscalep-value: 0.96t-test, 2 sided
Comparison: Change in Work/School Impairment Subscalep-value: 0.21t-test, 2 sided
Comparison: Change in Social Impairment Subscalep-value: 0.34t-test, 2 sided
Secondary

Acceptability

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.

Time frame: follow-up

Population: participants who completed follow-up measures.

ArmMeasureValue (MEAN)Dispersion
Get Moving and Get WellAcceptability23.9 units on a scaleStandard Deviation 3.72
Health and Humor ClassAcceptability20.2 units on a scaleStandard Deviation 5.2
p-value: 0.08t-test, 2 sided
Secondary

Change in CHAMPS (Community Healthy Activities Model Program for Seniors) Questionnaire for Older Adults - Cognitive Activity Frequency

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).

Time frame: baseline and 12 week follow-up

Population: Participants who completed baseline and follow-up measures

ArmMeasureValue (MEAN)Dispersion
Get Moving and Get WellChange in CHAMPS (Community Healthy Activities Model Program for Seniors) Questionnaire for Older Adults - Cognitive Activity Frequency-0.7 times/weekStandard Deviation 5.48
Health and Humor ClassChange in CHAMPS (Community Healthy Activities Model Program for Seniors) Questionnaire for Older Adults - Cognitive Activity Frequency-2.0 times/weekStandard Deviation 5.33
p-value: 0.6t-test, 2 sided
Secondary

Change in CHAMPS (Community Healthy Activities Model Program for Seniors) Questionnaire for Older Adults - Cognitive Duration

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).

Time frame: baseline and 12 week follow-up

Population: Participants who completed baseline and follow-up measures

ArmMeasureValue (MEAN)Dispersion
Get Moving and Get WellChange in CHAMPS (Community Healthy Activities Model Program for Seniors) Questionnaire for Older Adults - Cognitive Duration-0.15 units on a scaleStandard Deviation 3.72
Health and Humor ClassChange in CHAMPS (Community Healthy Activities Model Program for Seniors) Questionnaire for Older Adults - Cognitive Duration1.99 units on a scaleStandard Deviation 4.12
p-value: 0.26t-test, 2 sided
Secondary

Change in CHAMPS (Community Healthy Activities Model Program for Seniors) Questionnaire for Older Adults - Physical Activity Duration

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).

Time frame: baseline and 12 week follow-up

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

ArmMeasureValue (MEAN)Dispersion
Get Moving and Get WellChange in CHAMPS (Community Healthy Activities Model Program for Seniors) Questionnaire for Older Adults - Physical Activity Duration1.85 units on a scaleStandard Deviation 2.79
Health and Humor ClassChange in CHAMPS (Community Healthy Activities Model Program for Seniors) Questionnaire for Older Adults - Physical Activity Duration1.37 units on a scaleStandard Deviation 4.06
p-value: 0.85t-test, 2 sided
Secondary

Change in CHAMPS (Community Healthy Activities Model Program for Seniors) Questionnaire for Older Adults - Physical Activity Frequency

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).

Time frame: baseline and 12 week follow-up

Population: Participants who completed baseline and follow-up measures

ArmMeasureGroupValue (MEAN)Dispersion
Get Moving and Get WellChange in CHAMPS (Community Healthy Activities Model Program for Seniors) Questionnaire for Older Adults - Physical Activity FrequencyPhysical Activity Frequency2.7 times per weekStandard Deviation 11.84
Get Moving and Get WellChange in CHAMPS (Community Healthy Activities Model Program for Seniors) Questionnaire for Older Adults - Physical Activity FrequencyModerate Physical Activity Frequency1.3 times per weekStandard Deviation 5.42
Health and Humor ClassChange in CHAMPS (Community Healthy Activities Model Program for Seniors) Questionnaire for Older Adults - Physical Activity FrequencyPhysical Activity Frequency4.3 times per weekStandard Deviation 7.53
Health and Humor ClassChange in CHAMPS (Community Healthy Activities Model Program for Seniors) Questionnaire for Older Adults - Physical Activity FrequencyModerate Physical Activity Frequency2.1 times per weekStandard Deviation 3.51
Comparison: Change in overall physical activity frequency were compared between the two groups.p-value: 0.72t-test, 2 sided
Comparison: Change in moderate physical activity frequency between the two groups.p-value: 0.7t-test, 2 sided
Secondary

Change in Exercise Self-Efficacy Questionnaire

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.

Time frame: 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.

ArmMeasureValue (MEAN)Dispersion
Get Moving and Get WellChange in Exercise Self-Efficacy Questionnaire1.5 units on a scaleStandard Deviation 4.9
Health and Humor ClassChange in Exercise Self-Efficacy Questionnaire.6 units on a scaleStandard Deviation 6.7
p-value: 0.75t-test, 2 sided
Secondary

Change in Intent to Engage

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.

Time frame: Baseline and Follow-up

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

ArmMeasureValue (MEAN)Dispersion
Get Moving and Get WellChange in Intent to Engage-1.80 units on a scaleStandard Deviation 12.99
Health and Humor ClassChange in Intent to Engage3.10 units on a scaleStandard Deviation 16.17
p-value: 0.88t-test, 2 sided
Secondary

Change in Personal Health Information Depression Scale (PHQ-8)

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.

Time frame: Baseline and Follow-up

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

ArmMeasureValue (MEAN)Dispersion
Get Moving and Get WellChange in Personal Health Information Depression Scale (PHQ-8)-1.30 units on a scaleStandard Deviation 5.14
Health and Humor ClassChange in Personal Health Information Depression Scale (PHQ-8)-.50 units on a scaleStandard Deviation 4.72
p-value: 0.72t-test, 2 sided
Secondary

Change in Veterans RAND 12 (VR-12)

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.

Time frame: Baseline and Follow -up

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

ArmMeasureGroupValue (MEAN)Dispersion
Get Moving and Get WellChange in Veterans RAND 12 (VR-12)Physical Health0.54 units on a scaleStandard Deviation 9.033
Get Moving and Get WellChange in Veterans RAND 12 (VR-12)Mental Health7.52 units on a scaleStandard Deviation 12.75
Health and Humor ClassChange in Veterans RAND 12 (VR-12)Mental Health3.31 units on a scaleStandard Deviation 11.86
Health and Humor ClassChange in Veterans RAND 12 (VR-12)Physical Health-2.5097 units on a scaleStandard Deviation 8.74
Comparison: Change in the physical health scale of the RAND 12 were compared.p-value: 0.45t-test, 2 sided
Comparison: Change in the mental health scale of the RAND 12 were compared.p-value: 0.45t-test, 2 sided
Secondary

New Health Behaviors From the Beginning of Classes Through Three Months Post End of Class

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.

Time frame: Start of class through 3 months post-class

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

ArmMeasureValue (NUMBER)
Get Moving and Get WellNew Health Behaviors From the Beginning of Classes Through Three Months Post End of Class17 Events
Health and Humor ClassNew Health Behaviors From the Beginning of Classes Through Three Months Post End of Class7 Events
p-value: 0.16Chi-squared
Secondary

Number of Participants Beginning New Health Behaviors From the Beginning of Classes Through Three Months Post End of Class

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.

Time frame: Start of class through 3 months post-class

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

ArmMeasureValue (NUMBER)
Get Moving and Get WellNumber of Participants Beginning New Health Behaviors From the Beginning of Classes Through Three Months Post End of Class8 participants
Health and Humor ClassNumber of Participants Beginning New Health Behaviors From the Beginning of Classes Through Three Months Post End of Class5 participants
p-value: 0.08t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026