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

Depression Clinical Trial

Official title:

Activating Consumers to Exercise in Community Psychiatry Through Peer Support

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00458094
• Other study ID #: R34MH078613
• Secondary ID: R34MH078613DAHBR
• Status: Completed
• Phase: N/A
• First received: April 5, 2007
• Last updated: December 4, 2017
• Start date: March 2007
• Est. completion date: December 2009

Study information

• Verified date: December 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Bipolar Disorder
• Cognition Disorders
• Cognitive Disorders
• Depression
• Disease
• Personality Disorders
• Schizophrenia

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.
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiorespiratory fitness		Measured at Month 4
Secondary	Weight		Measured at Month 4
Secondary	Waist circumference		Measured at Month 4
Secondary	Physical activity		Measured at Month 4
Secondary	Health status		Measured at Month 4
Secondary	Center for Epidemiology Depression Scale		Measured at Month 4
Secondary	Exercise-related self-efficacy		Measured at Month 4
Secondary	General perceived efficacy		Measured at Month 4
Secondary	Participation		Measured at Month 4