N/A N=27 Randomized Double-blind Treatment

Get Moving and Get Well - Pilot Study

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

Bottom Line

View on ClinicalTrials.gov: NCT01884025 ↗

Enrolled (actual)

Serious AEs

3.7%

Results posted

Nov 2018

Primary outcome: Primary: Change in Behavioral Activation for Depression Scale — 1.3; 1.2; 2.8; 3 units on a scale — p=0.59

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Get Moving and Get Well (Behavioral); Health and Humor Class (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Dec 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Behavioral Activation for Depression Scale	1.3; 1.2; 2.8; 3; 4.8; 12	0.59
SECONDARY Change in Exercise Self-Efficacy Questionnaire	1.5; .6	0.75
SECONDARY Change in CHAMPS (Community Healthy Activities Model Program for Seniors) Questionnaire for Older Adults - Physical Activity Frequency	2.7; 4.3; 1.3; 2.1	0.72
SECONDARY Change in Veterans RAND 12 (VR-12)	0.54; -2.5097; 7.52; 3.31	0.45
SECONDARY Change in Personal Health Information Depression Scale (PHQ-8)	-1.30; -.50	0.72
SECONDARY Change in Intent to Engage	-1.80; 3.10	0.88
SECONDARY Acceptability	23.9; 20.2	.08
SECONDARY New Health Behaviors From the Beginning of Classes Through Three Months Post End of Class	17; 7	.16
SECONDARY Change in CHAMPS (Community Healthy Activities Model Program for Seniors) Questionnaire for Older Adults - Physical Activity Duration	1.85; 1.37	.85
SECONDARY Change in CHAMPS (Community Healthy Activities Model Program for Seniors) Questionnaire for Older Adults - Cognitive Activity Frequency	-0.7; -2.0	.60
SECONDARY Change in CHAMPS (Community Healthy Activities Model Program for Seniors) Questionnaire for Older Adults - Cognitive Duration	-0.15; 1.99	.26
SECONDARY Number of Participants Beginning New Health Behaviors From the Beginning of Classes Through Three Months Post End of Class	8; 5	.08

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01884025). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.