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SchizophreniaFYSAKTNCT03528278

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

An observational study of Schizophrenia and Bipolar Disorder, run by Oslo University Hospital at 2 sites in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Motivational interviewing and environmental interventions
How many people
83 participants
Where
2 sitesNorway
Study dates
23 Jan 2013to 10 Mar 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Norway2 sites
  • Skjelfoss Psychiatric Centre

    Hobøl, 1827

  • Oslo University Hospital

    Oslo, 0450

Other trials in Norway

About this study

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.

Read the detailed description

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.

Being tested
Motivational interviewing and environmental interventions
Medical subject headings
Schizophrenia, Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Motivational interviewing and environmental interventionsBehavioural

    • 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline Level of Physical Activity at 6 months

    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.

    Measured: At baseline and at 6 months follow-up

Secondary outcomes (20)
  1. Change from Baseline Level of Self-esteem at 6 months

    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.

    Measured: At baseline and at 6 months follow-up

  2. Change from Baseline Level of Motivation at 6 months

    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.

    Measured: At baseline and at 6 months follow-up

  3. Change from Baseline BMI at 6 months

    Weight and height will be combined to report BMI in kg/m^2

    Measured: At baseline and at 6 months follow-up

  4. Change from Baseline Life Satisfaction at 6 months

    Life satisfaction is assessed by the question for life satisfaction (HUNT3 questionnaire). The range is 1-7, lower scores represent higher satisfaction.

    Measured: At baseline and at 6 months follow-up

  5. Change from Baseline Level of Psychotic Symptoms at 6 months

    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

    Measured: At baseline and at 6 months follow-up

  6. Change from Baseline Level of Global Symptoms (GAF-S) at 6 months

    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).

    Measured: At baseline and at 6 months follow-up

  7. Change from Baseline Level of Depressive Symptoms at 6 months

    Depressive symptoms with the Montgomery Asberg Depression Rating Scale (MADRS). Range 0-60. Higher values represent a worse outcome.

    Measured: At baseline and at 6 months follow-up

  8. Change from Baseline Level of Apathy at 6 months

    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.

    Measured: At baseline and at 6 months follow-up

  9. Change from Baseline Waist Circumference at 6 months

    Waist circumference is measured with a horizontal tape measurement from the top of the right iliac crest. Measures in cm.

    Measured: At baseline and at 6 months follow-up

  10. Change from Baseline Blood Pressure at 6 months

    Systolic and diastolic blood pressure in mmHg.

    Measured: At baseline and at 6 months follow-up

  11. Change from Baseline Blood Glucose in serum at 6 months

    Glucose in serum, mmol/L

    Measured: At baseline and at 6 months follow-up

  12. Change from Baseline HbA1C at 6 months

    Glycosylated Hemoglobin (HbA1C) in full blood, %

    Measured: At baseline and at 6 months follow-up

  13. Change from Baseline Insulin at 6 months

    Insulin in serum, pmol/L

    Measured: At baseline and at 6 months follow-up

  14. Change from Baseline Total Cholesterol at 6 months

    Total Cholesterol in serum, mmol/L

    Measured: At baseline and at 6 months follow-up

  15. Change from Baseline Triglycerides at 6 months

    Triglycerides in serum, mmol/L

    Measured: At baseline and at 6 months follow-up

  16. Change from Baseline HDL-cholesterol at 6 months

    High Density Lipoprotein Cholesterol (HDL-cholesterol) in serum, mmol/L

    Measured: At baseline and at 6 months follow-up

  17. Change from Baseline LDL-cholesterol at 6 months

    Low Density Lipoprotein (LDL-cholesterol) in serum, mmol/L

    Measured: At baseline and at 6 months follow-up

  18. Change from Baseline CRP at 6 months

    C-Reactive Protein (CRP) in serum, mg/L

    Measured: At baseline and at 6 months follow-up

  19. Change from Baseline Vitamin D at 6 months

    Vitamin D total (Vit DTOT) in serum, nmol/L

    Measured: At baseline and at 6 months follow-up

  20. Change from Baseline Level of Psychosocial Functioning (GAF-F) at 6 months

    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).

    Measured: At baseline and at 6 months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2018
  2. Study start23 Jan 2013
  3. Primary completion10 Mar 2015
  4. Study completion10 Mar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Prospective
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03528278
Sponsor's protocol ID
2012/2266
Acronym
FYSAKT
Status last verified
May 2018
First submitted
24 Apr 2018
Last updated
17 May 2018
Results posted
No
Individual data sharing
No: Currently no IPD sharing plan

Publications

  • Ringen PA, Falk RS, Antonsen B, Faerden A, Mamen A, Rognli EB, Solberg DK, Martinsen EW, Andreassen OA. Using motivational techniques to reduce cardiometabolic risk factors in long term psychiatric inpatients: a naturalistic interventional study. BMC Psychiatry. 2018 Aug 15;18(1):255. doi: 10.1186/s12888-018-1832-6.

    PubMed 30111298

Questions about this trial

What is this clinical trial studying?

An observational study of Schizophrenia and Bipolar Disorder, run by Oslo University Hospital at 2 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline Level of Physical Activity at 6 months (time frame: At baseline and at 6 months follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03528278, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2018.

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