Peer Support for Increasing Physical Activity in People With Serious Mental Illnesses
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia Depression Bipolar Disorder Anxiety Disorders Cognitive Disorders Personality Disorders |
Behavioral: Physical activity intervention with peer support (PA+PS) Behavioral: Physical activity intervention without peer support (PA) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Activating Consumers to Exercise in Community Psychiatry Through Peer Support |
- Cardiorespiratory fitness [ Time Frame: Measured at Month 4 ] [ Designated as safety issue: No ]
- Weight [ Time Frame: Measured at Month 4 ] [ Designated as safety issue: No ]
- Waist circumference [ Time Frame: Measured at Month 4 ] [ Designated as safety issue: No ]
- Physical activity [ Time Frame: Measured at Month 4 ] [ Designated as safety issue: No ]
- Health status [ Time Frame: Measured at Month 4 ] [ Designated as safety issue: No ]
- Center for Epidemiology Depression Scale [ Time Frame: Measured at Month 4 ] [ Designated as safety issue: No ]
- Exercise-related self-efficacy [ Time Frame: Measured at Month 4 ] [ Designated as safety issue: No ]
- General perceived efficacy [ Time Frame: Measured at Month 4 ] [ Designated as safety issue: No ]
- Participation [ Time Frame: Measured at Month 4 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Contact: Gail L. Daumit, MD, MHS | 410-614-6460 | gdaumit@jhmi.edu |
| Contact: Elisabeth Leatherman, MS, LGPC | 410 818 8049 | esultzb1@jhmi.edu |
| United States, Maryland | |
| Johns Hopkins University | Recruiting |
| Baltimore, Maryland, United States, 21205 | |
| Principal Investigator: | Gail L. Daumit, MD, MHS | Johns Hopkins University |
More Information
No publications provided
| Responsible Party: | Gail L. Daumit, MD, MHS, Johns Hopkins University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00458094 History of Changes |
| Other Study ID Numbers: | R34 MH078613, DAHBR 96-BHB |
| Study First Received: | April 5, 2007 |
| Last Updated: | April 10, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Mental Health (NIMH):
|
Exercise Mental Illness Community Psychiatry Peer Support Mental Disorders |
Additional relevant MeSH terms:
|
Anxiety Disorders Mental Disorders Bipolar Disorder Cognition Disorders Depression Depressive Disorder Personality Disorders |
Schizophrenia Affective Disorders, Psychotic Mood Disorders Delirium, Dementia, Amnestic, Cognitive Disorders Behavioral Symptoms Schizophrenia and Disorders with Psychotic Features |
ClinicalTrials.gov processed this record on May 23, 2013