Get Moving and Get Well - Pilot Study

NCT01884025 | Completed Results

• 1 other identifier: PPO 13-187
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (Time point 0 - Pre intervention/control class) and follow-up (Time point Week 12 - after completion of intervention/attention control class)

Secondary Outcomes (11)

• Change in Exercise Self-Efficacy Questionnaire

  Baseline (Time point 0 - Pre intervention/control class) and follow-up (Time point Week 12 - after completion of intervention/attention control class)

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

  baseline and 12 week follow-up

• Change in Veterans RAND 12 (VR-12)

  Baseline and Follow -up

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

  Baseline and Follow-up

• Change in Intent to Engage

  Baseline and Follow-up

Study Arms (2)

Get Moving and Get Well

EXPERIMENTAL

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

Behavioral: Get Moving and Get Well

Health and Humor Class

SHAM COMPARATOR

Equally engaging attention control condition

Behavioral: Health and Humor Class

Interventions

Get Moving and Get Well BEHAVIORAL

Walking Class

Also known as: GMGW

Get Moving and Get Well

Health and Humor Class BEHAVIORAL

Class about the role of humor in health

Also known as: Health and Humor

Health and Humor Class

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

North Little Rock, Arkansas, 72114-1706, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Bipolar Disorder; Depressive Disorder, Major; Stress Disorders, Post-Traumatic; Motor Activity

Interventions

Health

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Depressive Disorder; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Behavior

Intervention Hierarchy (Ancestors)

Population Characteristics

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Kristen Viverito
• Organization: Central Arkansas Veterans Healthcare System

KRISTEN.VIVERITO@VA.GOV

501-257-1699

Study Officials

• Kristen M Viverito, PsyD

  Central Arkansas Veterans Healthcare System Eugene J. Towbin Healthcare Center, Little Rock, AR

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2013
• First Posted: June 21, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: August 1, 2015
• Last Updated: November 5, 2018
• Results First Posted: November 5, 2018

Record last verified: 2018-03

Locations

US (1)