Effectiveness of a Lifestyle Intervention for Increasing Physical Activity in Adults With Schizophrenia
NCT ID: NCT00338832
Last Updated: 2013-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
86 participants
INTERVENTIONAL
2006-06-30
2011-08-31
Brief Summary
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Detailed Description
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Participants in this 24-week, single-blind study will be randomly assigned to either the PRIME intervention group or the comparison group, which will involve the Program for Activity, Leisure Skills, and Socialization (PALSS). All participants will attend 90-minute sessions weekly for the first 16 weeks, then biweekly for the remaining 8 weeks. PRIME sessions will focus on learning about PA, setting PA-related goals, and assessing short- and long-term goals. Goals may include early-stage process-oriented goals, such as reading about PA benefits or finding a walking partner. Goals tailored to later stages of change include explicit PA goals, such as increasing frequency, duration, and intensity of PA. Training will also be accomplished online and via printed material. PALSS sessions will focus on motivating participants to engage in leisure and social activity. Sessions will include interactive, structured activity that will be led by a therapist, as well as unstructured leisure activities, such as board games, cards, general socialization, and viewing a travel video. Social and communication skills will not be explicitly taught or practiced. All participants will attend study visits at Months 2, 6, and 8 to assess outcomes. A follow-up visit will be held 2 months post-intervention.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
Participants will receive the Physically Ready for Invigorating Movement Every Day program
Physically Ready for Invigorating Movement Every Day (PRIME)
The PRIME program is a lifestyle intervention focused on increasing physical activity. The intervention is cognitive/behaviorally based, 24-weeks in length, and a lifestyle PA intervention known to be effective in the general population of adults. The program has been modified based on theory and empirical findings about this special subgroup. All participants will attend 90-minute sessions weekly for the first 16 weeks, then biweekly for the remaining 8 weeks. PRIME sessions will focus on learning about PA, setting PA-related goals, and assessing short- and long-term goals. Goals may include early-stage process-oriented goals, such as reading about PA benefits or finding a walking partner.
2
Participants will receive the Program for Activity, Leisure Skills, and Socialization
Program for Activity, Leisure Skills, and Socialization (PALSS)
PALSS sessions will focus on motivating participants to engage in leisure and social activity. Sessions will include interactive, structured activity that will be led by a therapist, as well as unstructured leisure activities, such as board games, cards, general socialization, and viewing a travel video. Social and communication skills will not be explicitly taught or practiced. All participants will attend 90-minute sessions weekly for the first 16 weeks, then biweekly for the remaining 8 weeks.
Interventions
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Physically Ready for Invigorating Movement Every Day (PRIME)
The PRIME program is a lifestyle intervention focused on increasing physical activity. The intervention is cognitive/behaviorally based, 24-weeks in length, and a lifestyle PA intervention known to be effective in the general population of adults. The program has been modified based on theory and empirical findings about this special subgroup. All participants will attend 90-minute sessions weekly for the first 16 weeks, then biweekly for the remaining 8 weeks. PRIME sessions will focus on learning about PA, setting PA-related goals, and assessing short- and long-term goals. Goals may include early-stage process-oriented goals, such as reading about PA benefits or finding a walking partner.
Program for Activity, Leisure Skills, and Socialization (PALSS)
PALSS sessions will focus on motivating participants to engage in leisure and social activity. Sessions will include interactive, structured activity that will be led by a therapist, as well as unstructured leisure activities, such as board games, cards, general socialization, and viewing a travel video. Social and communication skills will not be explicitly taught or practiced. All participants will attend 90-minute sessions weekly for the first 16 weeks, then biweekly for the remaining 8 weeks.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of schizophrenia or schizoaffective disorder
* Currently living in a residential facility
* Currently receiving outpatient care
* Medical clearance
* Willing to sign a release of medical information
Exclusion Criteria
* Medical conditions that may make increasing physical activity unsafe
* Pregnant
* Currently participating in regular moderate to vigorous physical activity (defined as more than 150 minutes per week)
21 Years
64 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Veterans Medical Research Foundation
OTHER
Responsible Party
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Laurie A. Lindamer
Research Scientist
Principal Investigators
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Laurie Lindamer, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Locations
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University of California, San Diego
La Jolla, California, United States
Countries
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Other Identifiers
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