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

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00458094
• Collaborator: National Institute of Mental Health (NIMH) (NIH)
• Enrollment: 100
• Location: 1
• Arms: 2
• Duration (Months): 33.1
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	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)	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Activating Consumers to Exercise in Community Psychiatry Through Peer Support
• Study Start Date: Mar 1, 2007
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Cardiorespiratory fitness [Measured at Month 4]

Secondary Outcome Measures

1. Weight [Measured at Month 4]

2. Waist circumference [Measured at Month 4]

3. Physical activity [Measured at Month 4]

4. Health status [Measured at Month 4]

5. Center for Epidemiology Depression Scale [Measured at Month 4]

6. Exercise-related self-efficacy [Measured at Month 4]

7. General perceived efficacy [Measured at Month 4]

8. Participation [Measured at Month 4]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins University	Baltimore	Maryland	United States	21205

Sponsors and Collaborators

• Johns Hopkins University
• National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Gail L. Daumit, MD, MHS, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT00458094
• Other Study ID Numbers: R34MH078613; R34MH078613; DAHBR 96-BHB
• First Posted: Apr 9, 2007
• Last Update Posted: Dec 6, 2017
• Last Verified: Dec 1, 2017

• Keywords provided by Johns Hopkins University: Exercise; Mental Illness; Community Psychiatry; Peer Support; Mental Disorders
• Additional relevant MeSH terms: Disease; Schizophrenia; Bipolar Disorder; Anxiety Disorders; Personality Disorders; Cognition Disorders

Study Results

No Results Posted as of Dec 6, 2017