Peer Support for Increasing Physical Activity in People With Serious Mental Illnesses

Activating Consumers to Exercise in Community Psychiatry Through Peer Support

This study will determine the effectiveness of a peer support system in increasing physical activity and effecting health behavior change in people with serious mental illnesses.

Study Overview

• Status: Completed
• Conditions: Personality Disorders; Depression; Schizophrenia; Anxiety Disorders; Bipolar Disorder; Cognitive Disorders
• Intervention / Treatment: Behavioral: Physical activity intervention with peer support (PA+PS); Behavioral: Physical activity intervention without peer support (PA)

Detailed Description

People with serious mental illnesses (SMIs) are, by definition, significantly functionally impaired by the illness for an indefinite period of time. Schizophrenia, major depression, and bipolar disorder are considered SMIs. Severe anxiety disorders, cognitive disorders, and some personality disorders are sometimes categorized as SMIs, as well. The rate of obesity among people with SMIs is higher than that of people without mental illnesses. This disparity may be due to the negative symptoms that people with SMIs experience, such as vulnerability to stress, extreme dependency, and lack of motivation. This study will design and test a culturally appropriate physical activity intervention based on a peer support model for people with SMIs in an urban community psychiatry program. The intervention will be evaluated to determine its effectiveness in increasing physical activity and effecting health behavior change in people with SMIs.

Participants in this 4-month, open-label study will be randomly assigned to participate in either a physical activity intervention with peer support (PA+PS) or a physical activity intervention without peer support (PA). Participants in the PA+PS group will have three exercise sessions each week, which will include group exercise classes and open gym hours for supervised individual exercise. They will also meet with a peer educator once a week for 15 minutes. Peer educators will provide emotional, informational, instrumental, and appraisal support that is aimed to motivate participants to partake in the exercise sessions. Participants in the PA group will attend the three weekly exercise sessions but will not attend meetings with the peer educator. All outcomes will be assessed at a follow-up visit at the end of the intervention.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient at the Johns Hopkins Community Psychiatry program
• Plans to remain in Baltimore for 8 months after study entry
• If currently breastfeeding, has received approval from a physician to participate in the study

Exclusion Criteria:

• Any condition that would make weight loss medically inadvisable
• Diagnosis of or treatment for cancer (except non-melanoma skin cancer) within 2 years prior to study entry
• Liver failure
• History of anorexia nervosa
• Pregnant or planning to become pregnant during the study
• Inability to walk or participate in an exercise class
• Consumes more than 14 alcoholic drinks per week
• Symptoms of angina or a cardiovascular event within 6 months prior to study entry

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Participants will receive the peer-supported physical activity intervention	Behavioral: Physical activity intervention with peer support (PA+PS); Participants in the PA+PS group will have three exercise sessions each week for 4 months, which will include group exercise classes and open gym hours for supervised individual exercise. They will also meet with a peer educator once a week for 15 minutes. Peer educators will provide emotional, informational, instrumental, and appraisal support that is aimed to motivate participants to partake in the exercise sessions.
Active Comparator: 2; Participants will receive physical activity without peer support	Behavioral: Physical activity intervention without peer support (PA); Participants in the PA group will attend the three weekly exercise sessions for 4 months but will not attend meetings with the peer educator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cardiorespiratory fitness	Measured at Month 4

Secondary Outcome Measures

Outcome Measure	Time Frame
Weight	Measured at Month 4
Waist circumference	Measured at Month 4
Physical activity	Measured at Month 4
Health status	Measured at Month 4
Center for Epidemiology Depression Scale	Measured at Month 4
Exercise-related self-efficacy	Measured at Month 4
General perceived efficacy	Measured at Month 4
Participation	Measured at Month 4

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Gail L. Daumit, MD, MHS, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: April 5, 2007
• First Submitted That Met QC Criteria: April 5, 2007
• First Posted (Estimate): April 9, 2007

Study Record Updates

• Last Update Posted (Actual): December 6, 2017
• Last Update Submitted That Met QC Criteria: December 4, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Exercise; Mental Disorders; Mental Illness; Peer Support; Community Psychiatry
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Neurocognitive Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Personality Disorders; Schizophrenia; Disease; Anxiety Disorders; Bipolar Disorder; Cognition Disorders
• Other Study ID Numbers: R34MH078613 (U.S. NIH Grant/Contract); DAHBR 96-BHB