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Using Motivational Techniques to Increase Levels of Physical Activity in Long Term Psychiatric Inpatient Wards (FYSAKT)

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ClinicalTrials.gov Identifier: NCT03528278
Recruitment Status : Completed
First Posted : May 17, 2018
Last Update Posted : May 17, 2018
Sponsor:
Collaborator:
Norwegian Centre for Mental Disorders Research (NORMENT)
Information provided by (Responsible Party):
Petter Andreas Ringen, Oslo University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Schizophrenia Bipolar Disorder Inpatient Facility Diagnoses Cardiovascular Risk Factor Behavioral: Motivational interviewing and environmental interventions

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Study Type : Observational
Actual Enrollment : 83 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Using Motivational Techniques to Increase Levels of Physical Activity in Long Term Psychiatric Inpatient Wards
Actual Study Start Date : January 23, 2013
Actual Primary Completion Date : March 10, 2015
Actual Study Completion Date : March 10, 2015

Resource links provided by the National Library of Medicine



Intervention Details:
  • Behavioral: Motivational interviewing and environmental interventions
    • Revision of ward routines towards facilitating physical activity in patients and motivational work by staff
    • Education of staff with certified MI-expert organized as an intensive course and follow-up guidance. The first course held shortly before start of interventions, the rest arranged within a month
    • Training equipment
    • Motivational Interviewing (MI) techniques applied by staff
    • Weekly treatment plans including physical activity which may consist of any continuous physical exercise.


Primary Outcome Measures :
  1. Change from Baseline Level of Physical Activity at 6 months [ Time Frame: At baseline and at 6 months follow-up ]
    Level of physical activity is assessed by the product of the answers to the questions of frequency (range1-5), intensity (range 1-3) and duration (range 1-4) of physical activity in the Health Survey of Northern Trondelag (HUNT) questionnaire, creating a physical activity index (PA-index). A higher score indicates higher levels of activity. Total range for the PA-index is 3-60.


Secondary Outcome Measures :
  1. Change from Baseline Level of Self-esteem at 6 months [ Time Frame: At baseline and at 6 months follow-up ]
    Self-esteem is assessed by the Rosenberg Self-Esteem Scale. It is a ten-item Likert-type scale with items answered on a four-point scale-from strongly agree to strongly disagree. Range is 10-40.Higher values represent a better outcome.

  2. Change from Baseline Level of Motivation at 6 months [ Time Frame: At baseline and at 6 months follow-up ]
    Measures for motivation: Four visual analog scales (VAS), with range 1-10 for assessing motivation for change; self-efficacy, perceived importance, perceived obstacles/difficulty for achieving change and readiness for change. Higher values represent higher motivation.

  3. Change from Baseline BMI at 6 months [ Time Frame: At baseline and at 6 months follow-up ]
    Weight and height will be combined to report BMI in kg/m^2

  4. Change from Baseline Life Satisfaction at 6 months [ Time Frame: At baseline and at 6 months follow-up ]
    Life satisfaction is assessed by the question for life satisfaction (HUNT3 questionnaire). The range is 1-7, lower scores represent higher satisfaction.

  5. Change from Baseline Level of Psychotic Symptoms at 6 months [ Time Frame: At baseline and at 6 months follow-up ]
    The level of psychotic symptoms will be measured with The Positive and Negative Symptom Scale (PANSS), using the subscores for positive (range 7-49), negative (range 7-49) and general symptoms (range 16-112). Higher values represent a worse outcome

  6. Change from Baseline Level of Global Symptoms (GAF-S) at 6 months [ Time Frame: At baseline and at 6 months follow-up ]
    Global symptoms and psychosocial functioning are measured by the Global Assessment of Functioning Scale (GAF), the scores are split into scales of symptoms (GAF-S) and functioning (GAF-F) to improve psychometric properties. The range is from 0 (worst) to 100 (best).

  7. Change from Baseline Level of Depressive Symptoms at 6 months [ Time Frame: At baseline and at 6 months follow-up ]
    Depressive symptoms with the Montgomery Asberg Depression Rating Scale (MADRS). Range 0-60. Higher values represent a worse outcome.

  8. Change from Baseline Level of Apathy at 6 months [ Time Frame: At baseline and at 6 months follow-up ]
    Apathy is measured with the abridged 12-item (items 1,2,4,5,6,7,9,10,14,16,17,18) of the clinical version of the Apathy Evaluation Scale (AES-C-Apathy). Range 12-48. Higher values represent a worse outcome.

  9. Change from Baseline Waist Circumference at 6 months [ Time Frame: At baseline and at 6 months follow-up ]
    Waist circumference is measured with a horizontal tape measurement from the top of the right iliac crest. Measures in cm.

  10. Change from Baseline Blood Pressure at 6 months [ Time Frame: At baseline and at 6 months follow-up ]
    Systolic and diastolic blood pressure in mmHg.

  11. Change from Baseline Blood Glucose in serum at 6 months [ Time Frame: At baseline and at 6 months follow-up ]
    Glucose in serum, mmol/L

  12. Change from Baseline HbA1C at 6 months [ Time Frame: At baseline and at 6 months follow-up ]
    Glycosylated Hemoglobin (HbA1C) in full blood, %

  13. Change from Baseline Insulin at 6 months [ Time Frame: At baseline and at 6 months follow-up ]
    Insulin in serum, pmol/L

  14. Change from Baseline Total Cholesterol at 6 months [ Time Frame: At baseline and at 6 months follow-up ]
    Total Cholesterol in serum, mmol/L

  15. Change from Baseline Triglycerides at 6 months [ Time Frame: At baseline and at 6 months follow-up ]
    Triglycerides in serum, mmol/L

  16. Change from Baseline HDL-cholesterol at 6 months [ Time Frame: At baseline and at 6 months follow-up ]
    High Density Lipoprotein Cholesterol (HDL-cholesterol) in serum, mmol/L

  17. Change from Baseline LDL-cholesterol at 6 months [ Time Frame: At baseline and at 6 months follow-up ]
    Low Density Lipoprotein (LDL-cholesterol) in serum, mmol/L

  18. Change from Baseline CRP at 6 months [ Time Frame: At baseline and at 6 months follow-up ]
    C-Reactive Protein (CRP) in serum, mg/L

  19. Change from Baseline Vitamin D at 6 months [ Time Frame: At baseline and at 6 months follow-up ]
    Vitamin D total (Vit DTOT) in serum, nmol/L

  20. Change from Baseline Level of Psychosocial Functioning (GAF-F) at 6 months [ Time Frame: At baseline and at 6 months follow-up ]
    Global symptoms and psychosocial functioning are measured by the Global Assessment of Functioning Scale (GAF), the scores are split into scales of symptoms (GAF-S) and functioning (GAF-F) to improve psychometric properties. Range from 0 (worst) to 100 (best).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Inpatients at closed-door wards at the psychiatric departments at Gaustad and Dikemark of the Oslo University Hospital and at the Skjelfoss Psychiatric center in Hobøl.
Criteria

Inclusion Criteria:

  • Inpatients at the psychiatric departments of Oslo University Hospital or at the Skjelfoss Psychiatric center
  • DSM-IV diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, psychotic disorder not otherwise specified (NOS), bipolar I disorder or bipolar disorder NOS and/or current use of antipsychotic medication
  • Informed consent to participation

Exclusion Criteria:

  • Pronounced cognitive deficit (IQ < 70)
  • Severe brain damage
  • BMI<17.5
  • Inability to speak Scandinavian or English
  • Inability to give informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03528278


Locations
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Norway
Skjelfoss Psychiatric Centre
Hobøl, Norway, 1827
Oslo University Hospital
Oslo, Norway, 0450
Sponsors and Collaborators
Oslo University Hospital
Norwegian Centre for Mental Disorders Research (NORMENT)
Investigators
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Principal Investigator: Petter Andreas Ringen, MD, PhD Oslo University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Petter Andreas Ringen, Chief Consultant, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT03528278    
Other Study ID Numbers: 2012/2266
First Posted: May 17, 2018    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Currently no IPD sharing plan
Additional relevant MeSH terms:
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Schizophrenia
Bipolar Disorder
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders