Clinical trial NCT00458094: Peer Support for Increasing Physical Activity in People With Serious Mental Illnesses
Official title: Activating Consumers to Exercise in Community Psychiatry Through Peer Support
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Depression
Bipolar Disorder
Anxiety Disorders
Cognitive Disorders
Personality Disorders
Keywords: Exercise
Mental Illness
Community Psychiatry
Peer Support
Mental Disorders
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2007-04-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 criteria: 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

Primary outcomes:
measure: Cardiorespiratory fitness
timeFrame: Measured at Month 4
Secondary outcomes:
measure: Weight
timeFrame: Measured at Month 4
measure: Waist circumference
timeFrame: Measured at Month 4
measure: Physical activity
timeFrame: Measured at Month 4
measure: Health status
timeFrame: Measured at Month 4
measure: Center for Epidemiology Depression Scale
timeFrame: Measured at Month 4
measure: Exercise-related self-efficacy
timeFrame: Measured at Month 4
measure: General perceived efficacy
timeFrame: Measured at Month 4
measure: Participation
timeFrame: Measured at Month 4
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Gail L. Daumit, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References: