Get Moving and Get Well - Pilot Study
Condition: Schizophrenia; Schizoaffective Disorder; Bipolar Disorder; Major Depression; Post Traumatic Stress Disorder
MeSH terms: Schizophrenia; Stress Disorders, Traumatic; Bipolar Disorder; Stress Disorders, Post-Traumatic; Psychotic Disorders
Study type: Interventional

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.
    

Intervention name(s): Get Moving and Get Well; Health and Humor Class
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Walking Class; Class about the role of humor in health
Other intervention name(s): GMGW; Health and Humor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: patient centered care; physical activity; behavioral activation; self efficacy; serious mental illness