Schizophrenia Clinical Trial
— FYSAKTOfficial title:
Using Motivational Techniques to Increase Levels of Physical Activity in Long Term Psychiatric Inpatient Wards
NCT number | NCT03528278 |
Other study ID # | 2012/2266 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 23, 2013 |
Est. completion date | March 10, 2015 |
Verified date | May 2018 |
Source | Oslo University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 83 |
Est. completion date | March 10, 2015 |
Est. primary completion date | March 10, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Norway | Skjelfoss Psychiatric Centre | Hobøl | |
Norway | Oslo University Hospital | Oslo |
Lead Sponsor | Collaborator |
---|---|
Oslo University Hospital | Norwegian Centre for Mental Disorders Research (NORMENT) |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | At baseline and at 6 months follow-up | |
Secondary | 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. | At baseline and at 6 months follow-up | |
Secondary | 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. | At baseline and at 6 months follow-up | |
Secondary | Change from Baseline BMI at 6 months | Weight and height will be combined to report BMI in kg/m^2 | At baseline and at 6 months follow-up | |
Secondary | 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. | At baseline and at 6 months follow-up | |
Secondary | 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 | At baseline and at 6 months follow-up | |
Secondary | 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). | At baseline and at 6 months follow-up | |
Secondary | 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. | At baseline and at 6 months follow-up | |
Secondary | 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. | At baseline and at 6 months follow-up | |
Secondary | 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. | At baseline and at 6 months follow-up | |
Secondary | Change from Baseline Blood Pressure at 6 months | Systolic and diastolic blood pressure in mmHg. | At baseline and at 6 months follow-up | |
Secondary | Change from Baseline Blood Glucose in serum at 6 months | Glucose in serum, mmol/L | At baseline and at 6 months follow-up | |
Secondary | Change from Baseline HbA1C at 6 months | Glycosylated Hemoglobin (HbA1C) in full blood, % | At baseline and at 6 months follow-up | |
Secondary | Change from Baseline Insulin at 6 months | Insulin in serum, pmol/L | At baseline and at 6 months follow-up | |
Secondary | Change from Baseline Total Cholesterol at 6 months | Total Cholesterol in serum, mmol/L | At baseline and at 6 months follow-up | |
Secondary | Change from Baseline Triglycerides at 6 months | Triglycerides in serum, mmol/L | At baseline and at 6 months follow-up | |
Secondary | Change from Baseline HDL-cholesterol at 6 months | High Density Lipoprotein Cholesterol (HDL-cholesterol) in serum, mmol/L | At baseline and at 6 months follow-up | |
Secondary | Change from Baseline LDL-cholesterol at 6 months | Low Density Lipoprotein (LDL-cholesterol) in serum, mmol/L | At baseline and at 6 months follow-up | |
Secondary | Change from Baseline CRP at 6 months | C-Reactive Protein (CRP) in serum, mg/L | At baseline and at 6 months follow-up | |
Secondary | Change from Baseline Vitamin D at 6 months | Vitamin D total (Vit DTOT) in serum, nmol/L | At baseline and at 6 months follow-up | |
Secondary | 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). | At baseline and at 6 months follow-up |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05039489 -
A Study on the Brain Mechanism of cTBS in Improving Medication-resistant Auditory Hallucinations in Schizophrenia
|
N/A | |
Completed |
NCT05321602 -
Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder
|
Phase 1 | |
Completed |
NCT05111548 -
Brain Stimulation and Cognitive Training - Efficacy
|
N/A | |
Completed |
NCT04503954 -
Efficacy of Chronic Disease Self-management Program in People With Schizophrenia
|
N/A | |
Completed |
NCT02831231 -
Pilot Study Comparing Effects of Xanomeline Alone to Xanomeline Plus Trospium
|
Phase 1 | |
Completed |
NCT05517460 -
The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center
|
N/A | |
Completed |
NCT03652974 -
Disturbance of Plasma Cytokine Parameters in Clozapine-Resistant Treatment-Refractory Schizophrenia (CTRS) and Their Association With Combination Therapy
|
Phase 4 | |
Recruiting |
NCT04012684 -
rTMS on Mismatch Negativity of Schizophrenia
|
N/A | |
Recruiting |
NCT04481217 -
Cognitive Factors Mediating the Relationship Between Childhood Trauma and Auditory Hallucinations in Schizophrenia
|
N/A | |
Completed |
NCT00212784 -
Efficacy and Safety of Asenapine Using an Active Control in Subjects With Schizophrenia or Schizoaffective Disorder (25517)(P05935)
|
Phase 3 | |
Completed |
NCT04092686 -
A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
|
Phase 3 | |
Completed |
NCT01914393 -
Pediatric Open-Label Extension Study
|
Phase 3 | |
Recruiting |
NCT03790345 -
Vitamin B6 and B12 in the Treatment of Movement Disorders Induced by Antipsychotics
|
Phase 2/Phase 3 | |
Recruiting |
NCT05956327 -
Insight Into Hippocampal Neuroplasticity in Schizophrenia by Investigating Molecular Pathways During Physical Training
|
N/A | |
Terminated |
NCT03209778 -
Involuntary Memories Investigation in Schizophrenia
|
N/A | |
Terminated |
NCT03261817 -
A Controlled Study With Remote Web-based Adapted Physical Activity (e-APA) in Psychotic Disorders
|
N/A | |
Completed |
NCT02905604 -
Magnetic Stimulation of the Brain in Schizophrenia or Depression
|
N/A | |
Recruiting |
NCT05542212 -
Intra-cortical Inhibition and Cognitive Deficits in Schizophrenia
|
N/A | |
Completed |
NCT04411979 -
Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia
|
N/A | |
Terminated |
NCT03220438 -
TMS Enhancement of Visual Plasticity in Schizophrenia
|
N/A |