Schizophrenia Clinical Trial
Official title:
Using Motivational Techniques to Increase Levels of Physical Activity in Long Term Psychiatric Inpatient Wards
The current research project aims at investigating whether it is possible to obtain an increase in physical activity among inpatients with schizophrenia spectrum disorders by the use of motivational interviewing and environmental interventions, and whether interventions will be associated with an increase in physical fitness and/or improvement in mental health. The Norwegian health care system operates with a catchment-area based organization, which make high levels of representability of patients possible. Patients will be recruited from intermediate-long term inpatient departments where patients typically have schizophrenia spectrum disorders and are admitted for longer periods. There are thus unique possibilities for coordinated efforts to motivate for and change dysfunctional habits.
The aim of the study is to investigate if motivational interviewing and environmental
interventions may induce behavioral or clinical changes in intermediate-long term psychiatric
in-patients with severe mental disorders.
Specific research questions:
1. Will levels of physical activity increase?
2. Will self-esteem, life satisfaction or mental or physical health improve?
3. Will it be possible to identify subgroups of patients with differentiated responses to
the interventions? (i.e. for whom does it work?)
The study aims at including the majority of patients at all wards and the interventions will
be additions to the ordinary treatment routines. The design is thus observational. The
project will not influence the natural flow of patients through the wards during the study
period. The patient population will thus be in a state of continuous change throughout the
project period and the individual treatment periods will show substantial variation between
patients. The total study period at one site will be 15 months. Consecutive patients will be
included during a 12 month period form study start. All consenting patients admitted during
this period will be assessed according to protocol at admittance and discharge, at start of
interventions and every 3 months. The study will start in the first department in the first
quarter of 2013 and will end in the last department the second quarter of 2015.
The main interventions will consist of change in the ward routines on several fields. The
main organization of interventions will thus be according to wards and not according to
individual patients as it will be difficult to direct the interventions to specific patients
within the ward. As a consequence, once the interventions have started in a ward all
subsequent patients admitted will necessarily receive interventions from day one of their
admission into treatment.
Hypotheses will be tested by comparing assessments obtained before start of interventions
with assessments obtained after a period of active interventions. As start of interventions
in a ward will be an irreversible event, only patients in treatment in the ward at start of
interventions will be subjects to crossover studies. Some patients will complete their
treatment periods either before or after start of interventions and thus not be able to be
subject to individual crossover studies. Data from these patients will be pooled in a
pre-intervention and a post-intervention group respectively.
In the pre-intervention period all patients will receive individual treatment plans and make
weekly plans of activity together with the staff. All patients are generally encouraged to
physical training, and there are some common activities, but there is no specific focus on
this. All wards have a dietary standard which include presence of fruit and raw vegetables
between meals, pre-portioned dinner servings, restrictions on sugar-containing beverages and
sweets and a general focus on a low-fat and high-fiber menu.
Primary measures will be measures of physical activity and fitness, clinical-physical
measures or results from laboratory tests.
Procedure for informed consent and handling of data:
At start of project and at every new admittance after this point of time all patients are
informed about the project and asked to give informed consent to participation. A folder is
created for each individual participant (ring-binder) containing overview over assessments
with time-lines and place-holders for score sheets for baseline and follow-up assessments. An
information/registration sheet with the participants' signature is added to this folder.
Each unit will have a person responsible for data-collection. This person will supervise that
assessments are done according to protocol, distribute registration and score sheets and
collect sheets after assessments. The score sheets are added continuously to the individual
folders. One person is responsible for collecting and gathering data from all units.
At the clinical wards, the project information from individuals will be stored with the same
security as ordinary charts and other patient information. The research data will be put into
folders which will be kept locked in a room with restricted access within the hospital
premises in a 24-h locked building. Folders are only accessed when adding data (new score
sheets). One person supervises this and is in charge of this local folder-database.
The contents of the score sheets are eventually punched into a central computer database with
the necessary formal specifications and security measures.
Assessments at baseline only:
Diagnosis: The participants will be diagnosed with the Structural Clinical Interview for
DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, version IV) for axis I
disorders (SCID-I).
General and psychosocial data: Data are collected about age and gender, ethnicity, education,
occupation, housing and marital/civil status.
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