Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 24 of 133 for:    "Depressive Disorder" [DISEASE] | ( Map: Arkansas, United States )

Get Moving and Get Well - Pilot Study (GMGWP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01884025
Recruitment Status : Completed
First Posted : June 21, 2013
Results First Posted : November 5, 2018
Last Update Posted : November 5, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Major Depression
Post Traumatic Stress Disorder
Interventions Behavioral: Get Moving and Get Well
Behavioral: Health and Humor Class
Enrollment 27
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Get Moving and Get Well Health and Humor Class
Hide Arm/Group Description

Walking class developed for Veterans with serious mental illness and administered as part of the PRRC

Get Moving and Get Well: Walking Class

Equally engaging attention control condition

Health and Humor Class: Class about the role of humor in health

Period Title: Overall Study
Started 13 14
Completed 10 10
Not Completed 3 4
Reason Not Completed
Lost to Follow-up             3             4
Arm/Group Title Get Moving and Get Well Health and Humor Class Total
Hide Arm/Group Description

Walking class developed for Veterans with serious mental illness and administered as part of the PRRC

Get Moving and Get Well: Walking Class

Equally engaging attention control condition

Health and Humor Class: Class about the role of humor in health

Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
Participants who completed both baseline and follow-up measures.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
10
 100.0%
20
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
55.1  (6.77) 54.1  (8.8) 54.6  (7.66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
5
  50.0%
4
  40.0%
9
  45.0%
Male
5
  50.0%
6
  60.0%
11
  55.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Caucasian (Non-Hispanic) 6 6 12
African American 4 4 8
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 20 participants
10 10 20
Years of Education  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
HighSchool/GED 4 4 8
Some COllege 4 2 6
Bachelors Degree 2 2 4
Graduate Degree 0 2 2
1.Primary Outcome
Title Change in Behavioral Activation for Depression Scale
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population includes participants who completed both baseline and follow-up measures.
Arm/Group Title Get Moving and Get Well Health and Humor Class
Hide Arm/Group Description:

Walking class developed for Veterans with serious mental illness and administered as part of the PRRC

Get Moving and Get Well: Walking Class

Equally engaging attention control condition

Health and Humor Class: Class about the role of humor in health

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
Activation 1.3  (6.11) 1.2  (8.90)
Avoidance/Rumination 2.8  (10.25) 3  (9.76)
Work/School Impairment 4.8  (6.27) 12  (6.05)
Social Impairment 3.6  (5.8) 1.1  (5.51)
Total Score 12.5  (21.99) 6.5  (26.31)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Get Moving and Get Well, Health and Humor Class
Comments Change in total BADS score.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.59
Comments [Not Specified]
Method t-test, 2 sided
Comments t-Value: 0.55
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Get Moving and Get Well, Health and Humor Class
Comments Change in Activation Subscale
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.98
Comments [Not Specified]
Method t-test, 2 sided
Comments t Value: 0.03
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Get Moving and Get Well, Health and Humor Class
Comments Change in Avoidance/Rumination Subscale
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.96
Comments [Not Specified]
Method t-test, 2 sided
Comments

DF: 18

1 Value: -0.04

Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Get Moving and Get Well, Health and Humor Class
Comments Change in Work/School Impairment Subscale
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.21
Comments [Not Specified]
Method t-test, 2 sided
Comments t Value: 1.31
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Get Moving and Get Well, Health and Humor Class
Comments Change in Social Impairment Subscale
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.34
Comments [Not Specified]
Method t-test, 2 sided
Comments t Value: 0.99
2.Secondary Outcome
Title Change in Exercise Self-Efficacy Questionnaire
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population includes participants who completed both baseline and follow-up measures.
Arm/Group Title Get Moving and Get Well Health and Humor Class
Hide Arm/Group Description:

Walking class developed for Veterans with serious mental illness and administered as part of the PRRC

Get Moving and Get Well: Walking Class

Equally engaging attention control condition

Health and Humor Class: Class about the role of humor in health

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.5  (4.90) .6  (6.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Get Moving and Get Well, Health and Humor Class
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.75
Comments [Not Specified]
Method t-test, 2 sided
Comments t Value: 0.33
3.Secondary Outcome
Title Change in CHAMPS (Community Healthy Activities Model Program for Seniors) Questionnaire for Older Adults - Physical Activity Frequency
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed baseline and follow-up measures
Arm/Group Title Get Moving and Get Well Health and Humor Class
Hide Arm/Group Description:

Walking class developed for Veterans with serious mental illness and administered as part of the PRRC

Get Moving and Get Well: Walking Class

Equally engaging attention control condition

Health and Humor Class: Class about the role of humor in health

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: times per week
Physical Activity Frequency 2.7  (11.84) 4.3  (7.53)
Moderate Physical Activity Frequency 1.3  (5.42) 2.1  (3.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Get Moving and Get Well, Health and Humor Class
Comments Change in overall physical activity frequency were compared between the two groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.72
Comments [Not Specified]
Method t-test, 2 sided
Comments t Value: -0.36
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Get Moving and Get Well, Health and Humor Class
Comments Change in moderate physical activity frequency between the two groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.70
Comments [Not Specified]
Method t-test, 2 sided
Comments t Value: -0.39
4.Secondary Outcome
Title Change in Veterans RAND 12 (VR-12)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed both baseline and follow-up measures
Arm/Group Title Get Moving and Get Well Health and Humor Class
Hide Arm/Group Description:

Walking class developed for Veterans with serious mental illness and administered as part of the PRRC

Get Moving and Get Well: Walking Class

Equally engaging attention control condition

Health and Humor Class: Class about the role of humor in health

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
Physical Health 0.54  (9.033) -2.5097  (8.74)
Mental Health 7.52  (12.75) 3.31  (11.86)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Get Moving and Get Well, Health and Humor Class
Comments Change in the physical health scale of the RAND 12 were compared.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments [Not Specified]
Method t-test, 2 sided
Comments t Value: 0.77
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Get Moving and Get Well, Health and Humor Class
Comments Change in the mental health scale of the RAND 12 were compared.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments [Not Specified]
Method t-test, 2 sided
Comments t Value: 0.76
5.Secondary Outcome
Title Change in Personal Health Information Depression Scale (PHQ-8)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
participants who completed both baseline and follow-up measures
Arm/Group Title Get Moving and Get Well Health and Humor Class
Hide Arm/Group Description:

Walking class developed for Veterans with serious mental illness and administered as part of the PRRC

Get Moving and Get Well: Walking Class

Equally engaging attention control condition

Health and Humor Class: Class about the role of humor in health

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.30  (5.14) -.50  (4.72)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Get Moving and Get Well, Health and Humor Class
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.72
Comments [Not Specified]
Method t-test, 2 sided
Comments t Value: -0.36
6.Secondary Outcome
Title Change in Intent to Engage
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed both baseline and follow-up measures
Arm/Group Title Get Moving and Get Well Health and Humor Class
Hide Arm/Group Description:

Walking class developed for Veterans with serious mental illness and administered as part of the PRRC

Get Moving and Get Well: Walking Class

Equally engaging attention control condition

Health and Humor Class: Class about the role of humor in health

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.80  (12.99) 3.10  (16.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Get Moving and Get Well, Health and Humor Class
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.88
Comments [Not Specified]
Method t-test, 2 sided
Comments t Value: 0.15
7.Secondary Outcome
Title Acceptability
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
participants who completed follow-up measures.
Arm/Group Title Get Moving and Get Well Health and Humor Class
Hide Arm/Group Description:

Walking class developed for Veterans with serious mental illness and administered as part of the PRRC

Get Moving and Get Well: Walking Class

Equally engaging attention control condition

Health and Humor Class: Class about the role of humor in health

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
23.9  (3.72) 20.2  (5.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Get Moving and Get Well, Health and Humor Class
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .08
Comments [Not Specified]
Method t-test, 2 sided
Comments t Value: 1.83
8.Secondary Outcome
Title New Health Behaviors From the Beginning of Classes Through Three Months Post End of Class
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Veterans who completed both baseline and follow-up measures.
Arm/Group Title Get Moving and Get Well Health and Humor Class
Hide Arm/Group Description:

Walking class developed for Veterans with serious mental illness and administered as part of the PRRC

Get Moving and Get Well: Walking Class

Equally engaging attention control condition

Health and Humor Class: Class about the role of humor in health

Overall Number of Participants Analyzed 10 10
Measure Type: Number
Unit of Measure: Events
17 7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Get Moving and Get Well, Health and Humor Class
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .16
Comments Chi Squared 1.98
Method Chi-squared
Comments [Not Specified]
9.Secondary Outcome
Title Change in CHAMPS (Community Healthy Activities Model Program for Seniors) Questionnaire for Older Adults - Physical Activity Duration
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
participants who completed both baseline and follow-up measures
Arm/Group Title Get Moving and Get Well Health and Humor Class
Hide Arm/Group Description:

Walking class developed for Veterans with serious mental illness and administered as part of the PRRC

Get Moving and Get Well: Walking Class

Equally engaging attention control condition

Health and Humor Class: Class about the role of humor in health

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.85  (2.79) 1.37  (4.06)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Get Moving and Get Well, Health and Humor Class
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .85
Comments t value: .19
Method t-test, 2 sided
Comments [Not Specified]
10.Secondary Outcome
Title Change in CHAMPS (Community Healthy Activities Model Program for Seniors) Questionnaire for Older Adults - Cognitive Activity Frequency
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed baseline and follow-up measures
Arm/Group Title Get Moving and Get Well Health and Humor Class
Hide Arm/Group Description:

Walking class developed for Veterans with serious mental illness and administered as part of the PRRC

Get Moving and Get Well: Walking Class

Equally engaging attention control condition

Health and Humor Class: Class about the role of humor in health

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: times/week
-0.7  (5.48) -2.0  (5.33)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Get Moving and Get Well, Health and Humor Class
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .60
Comments t value: .54
Method t-test, 2 sided
Comments [Not Specified]
11.Secondary Outcome
Title Change in CHAMPS (Community Healthy Activities Model Program for Seniors) Questionnaire for Older Adults - Cognitive Duration
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed baseline and follow-up measures
Arm/Group Title Get Moving and Get Well Health and Humor Class
Hide Arm/Group Description:

Walking class developed for Veterans with serious mental illness and administered as part of the PRRC

Get Moving and Get Well: Walking Class

Equally engaging attention control condition

Health and Humor Class: Class about the role of humor in health

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.15  (3.72) 1.99  (4.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Get Moving and Get Well, Health and Humor Class
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .26
Comments t value: -1.17
Method t-test, 2 sided
Comments [Not Specified]
12.Secondary Outcome
Title Number of Participants Beginning New Health Behaviors From the Beginning of Classes Through Three Months Post End of Class
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Veterans who completed both baseline and follow-up measures.
Arm/Group Title Get Moving and Get Well Health and Humor Class
Hide Arm/Group Description:

Walking class developed for Veterans with serious mental illness and administered as part of the PRRC

Get Moving and Get Well: Walking Class

Equally engaging attention control condition

Health and Humor Class: Class about the role of humor in health

Overall Number of Participants Analyzed 10 10
Measure Type: Number
Unit of Measure: participants
8 5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Get Moving and Get Well, Health and Humor Class
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .08
Comments t value: 1.85
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Get Moving and Get Well Health and Humor Class
Hide Arm/Group Description

Walking class developed for Veterans with serious mental illness and administered as part of the PRRC

Get Moving and Get Well: Walking Class

Equally engaging attention control condition

Health and Humor Class: Class about the role of humor in health

All-Cause Mortality
Get Moving and Get Well Health and Humor Class
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Get Moving and Get Well Health and Humor Class
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      1/14 (7.14%)    
Psychiatric disorders     
Participant reproted Suicidal Ideation without Initent or Plan [1]  0/13 (0.00%)  0 1/14 (7.14%)  1
[1]
Veteran reported suicidal ideation. Licensed provider helped him return to emotional equilibrium. Veteran's primary mental health provider and bipolar support group leader were alerted. Veteran did attend the next classes with no problems reported.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Get Moving and Get Well Health and Humor Class
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/13 (15.38%)      1/14 (7.14%)    
Musculoskeletal and connective tissue disorders     
Pain [1]  2/13 (15.38%)  2 0/14 (0.00%)  0
Psychiatric disorders     
Displeasure with group [2]  0/13 (0.00%)  0 1/14 (7.14%)  1
[1]
Report of pain possibly related to class.
[2]
Veteran became unhappy with compensation for time.
Due to small sample size, comparisons were completed descriptively to attempt to identify the emergence of trends. T-tests were used to assess for significant differences between groups and no significant differences were found.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Kristen Viverito
Organization: Central Arkansas Veterans Healthcare System
Phone: 501-257-1699
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01884025     History of Changes
Other Study ID Numbers: PPO 13-187
First Submitted: June 5, 2013
First Posted: June 21, 2013
Results First Submitted: July 18, 2016
Results First Posted: November 5, 2018
Last Update Posted: November 5, 2018