Effectiveness of a Lifestyle Intervention for Increasing Physical Activity in Adults With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the effectiveness of a lifestyle intervention in increasing physical
      activity and reducing disease symptoms in sedentary adults with schizophrenia.
    

Detailed description: 
      Schizophrenia is a severely disabling brain disorder. People with schizophrenia often
      experience hallucinations, delusions, thought disorders, and movement disorders. Physical
      activity (PA) has been shown not only to increase quality of life, but also to reduce risk
      factors for several chronic diseases and conditions. The majority of adults, however, do not
      engage in the recommended amount of PA. Research has shown that people with schizophrenia are
      even less likely to be regularly physically active. Symptoms of schizophrenia,
      pharmacological treatments for the disease, and the lifestyle associated with the disease
      tend to contribute to physical inactivity and the resulting complications. Effective
      interventions to increase PA have been developed for the general adult population, but very
      little is known about how to adapt them for use in adults with schizophrenia. The PRIME
      (Physically Ready for Invigorating Movement Every Day) program is a lifestyle intervention
      focused on increasing physical activity. This study will evaluate the effectiveness of a
      modified PRIME program in reducing the risk for morbidity in sedentary adults with
      schizophrenia.

      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.
    

Intervention name(s): Physically Ready for Invigorating Movement Every Day (PRIME); Program for Activity, Leisure Skills, and Socialization (PALSS)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lifestyle Intervention; Schizoaffective Disorder