Clinical trial NCT01884025: Get Moving and Get Well - Pilot Study
Official title: Get Moving and Get Well: A Behavioral Activation Program for Veterans With SMI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Major Depression
Post Traumatic Stress Disorder
Keywords: patient centered care
physical activity
behavioral activation
self efficacy
serious mental illness
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2013-06-21
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Behavioral Activation for Depression Scale
timeFrame: Baseline (Time point 0 - Pre intervention/control class) and follow-up (Time point Week 12 - after completion of intervention/attention control class)
Secondary outcomes:
measure: Change in Exercise Self-Efficacy Questionnaire
timeFrame: Baseline (Time point 0 - Pre intervention/control class) and follow-up (Time point Week 12 - after completion of intervention/attention control class)
measure: Change in CHAMPS (Community Healthy Activities Model Program for Seniors) Questionnaire for Older Adults - Physical Activity Frequency
timeFrame: baseline and 12 week follow-up
measure: Change in Veterans RAND 12 (VR-12)
timeFrame: Baseline and Follow -up
measure: Change in Personal Health Information Depression Scale (PHQ-8)
timeFrame: Baseline and Follow-up
measure: Change in Intent to Engage
timeFrame: Baseline and Follow-up
measure: Acceptability
timeFrame: follow-up
measure: New Health Behaviors From the Beginning of Classes Through Three Months Post End of Class
timeFrame: Start of class through 3 months post-class
measure: Change in CHAMPS (Community Healthy Activities Model Program for Seniors) Questionnaire for Older Adults - Physical Activity Duration
timeFrame: baseline and 12 week follow-up
measure: Change in CHAMPS (Community Healthy Activities Model Program for Seniors) Questionnaire for Older Adults - Cognitive Activity Frequency
timeFrame: baseline and 12 week follow-up
measure: Change in CHAMPS (Community Healthy Activities Model Program for Seniors) Questionnaire for Older Adults - Cognitive Duration
timeFrame: baseline and 12 week follow-up
measure: Number of Participants Beginning New Health Behaviors From the Beginning of Classes Through Three Months Post End of Class
timeFrame: Start of class through 3 months post-class
Other outcomes:
Locations:
city: North Little Rock
country: United States
facility: Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
state: Arkansas
Study officials:
affiliation: Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR
name: Kristen M Viverito, PsyD
role: PRINCIPAL_INVESTIGATOR
References: