xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06012149</url>
    </required_header>
    <id_info>
      <org_study_id>2020-07130</org_study_id>
      <nct_id>NCT06012149</nct_id>
    </id_info>
    <brief_title>Braining: Implementation of Physical Exercise for Patients in Specialist Psychiatry</brief_title>
    <official_title>Braining: Implementation of Physical Exercise for Patients in Specialist Psychiatry, Efficacy Evaluation in a Randomized Controlled Multicentre Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Region Stockholm</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Karolinska Institutet</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Region Stockholm</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to compare Braining, a physical exercise lifestyle&#xD;
        intervention in psychiatric care, with usual care. In this study, usual care is defined as&#xD;
        information about physical exercise.&#xD;
  &#xD;
        The main questions are:&#xD;
  &#xD;
          -  does Braining lead to increased physical exercise compared to usual care?&#xD;
  &#xD;
          -  what effect does Braining have on mental and physical health, quality of life and&#xD;
             functional level compared to usual care?&#xD;
  &#xD;
        The participants will join a twelve weeks long study period with clinician led exercise&#xD;
        classes up to three times per week. Before and after the study period they will leave blood&#xD;
        tests, take part in a mental and physical examination and fill in assessment scales. To&#xD;
        measure physical activity, the participants will carry an accelerometer, a device that&#xD;
        measures steps and acceleration. After six and twelve months, the participants take part in&#xD;
        the same measurements.&#xD;
  &#xD;
        The control group takes parts in the same measurements and follow up, but instead of having&#xD;
        clinician led exercise classes, they will exercise on their own during the twelve weeks study&#xD;
        period.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Braining is a clinical invention that helps patients in psychiatry to start and execute&#xD;
        physical exercise (PE) regularly in psychiatric care. The core components are basic moderate&#xD;
        to vigorous aerobic group training sessions and motivational work led by the psychiatric&#xD;
        staff. Braining is used as add-on treatment to regular psychiatric care and is included in&#xD;
        the patient care plan. Braining is unique in that it:&#xD;
  &#xD;
          1. Includes trained psychiatric clinical staff exercising together with patients from both&#xD;
             out- and inpatient ward units in daily, moderate to vigorous aerobic group training&#xD;
             sessions&#xD;
  &#xD;
          2. is included in regular healthcare fee, (free of charge)&#xD;
  &#xD;
          3. includes a motivational and educational visit (as a group seminar or as an individual&#xD;
             visit) at the start and end of a twelve-week exercise intervention&#xD;
  &#xD;
          4. includes regular measurements (self-assessment questionnaires, blood samples, physical&#xD;
             and mental health examination and education before and after the twelve-week exercise&#xD;
             intervention)&#xD;
  &#xD;
          5. offers short individual motivating visits before every training session, including&#xD;
             assessment of day shape and fitness to participate.&#xD;
  &#xD;
        This study will be a multi-center study performed at 5 psychiatric outpatient units in Region&#xD;
        Stockholm. Patients with symptoms of depression and/or anxiety who are not physically active&#xD;
        in accordance with WHO recommendations will be invited to participate in the study.&#xD;
  &#xD;
        The research questions are:&#xD;
  &#xD;
          -  Does Braining increase the amount of completed physical training (FT) compared to usual&#xD;
             care (advice on FT according to guidelines)?&#xD;
  &#xD;
          -  What effect does Braining have on the mental and physical health, quality of life and&#xD;
             functional level of participating patients compared to usual care? Examined from the&#xD;
             following points of view:&#xD;
  &#xD;
               -  psychiatric symptoms, such as depression, anxiety, insomnia, emotional regulation?&#xD;
  &#xD;
               -  somatic symptoms, such as blood pressure, resting heart rate, BMI, waist&#xD;
                  measurement, presence of somatic co-morbidity?&#xD;
  &#xD;
          -  How do participants rate Braining and treatment as usual regarding:&#xD;
  &#xD;
               1. Satisfaction with treatment&#xD;
  &#xD;
               2. Credibility of treatment&#xD;
  &#xD;
               3. Negative effects&#xD;
  &#xD;
          -  Is Braining a cost-effective intervention?&#xD;
  &#xD;
        Participants will be randomized to supplementary treatment with Braining or treatment as&#xD;
        usual (TAU) - advice regarding physical activity.&#xD;
  &#xD;
        Braining and TAU will be compared after a 12-week training period.&#xD;
  &#xD;
        Measurements of the participants´ psychiatric and somatic health are carried out before the&#xD;
        treatment, after 4, 8 and 12 weeks and 6 and 12 months after the end of treatment. Effects of&#xD;
        the treatment are examined via validated self-assessment forms, as well as somatic&#xD;
        examination with a focus on metabolic status. Venous blood samples are taken before and after&#xD;
        the 12-week training period, as well as 6 and 12 months after the end of the training period&#xD;
        to investigate changes in metabolic status. In a sub study on a smaller number of&#xD;
        participants the researchers will analyze associations with biological factors such as&#xD;
        genetic or epigenetic factors, metabolic factors, stress hormone levels, trace elements,&#xD;
        degree of inflammation and other biological markers of health and disease that can be&#xD;
        measured in ordinary blood tests, e.g. through &quot;OMIK&quot; design. Physical activity will be&#xD;
        measured by self assessment scales, accelerometer and by number of performed Braining&#xD;
        classes.&#xD;
  &#xD;
        Data analysis: Continuous data will be analyzed using mixed effects models or t-test, nominal&#xD;
        data analyzed mainly with chi2 test. In mixed effects models of differences between groups&#xD;
        the interaction effect of group and time will be the central estimate.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2026</completion_date>
    <primary_completion_date type="Anticipated">September 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>A randomized controlled superiority trial evaluating if the new method Braining is superior to treatment as usual with advice on physical exercise, concerning increasing physical activity.&#xD;
  The trial is a multicenter study conducted at 3-6 sites. Participants are individually randomized in blocks of 2-4 at each site.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Physical activity</measure>
      <time_frame>Change from Pre intervention start to 12 weeks post intervention start</time_frame>
      <description>Objectively measured physical activity. Total physical activity measured in accelerometer-counts and translated into minutes/day spent in inactivity, low, moderate and vigorous intensity.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Patient Health Questionnaire 9 (PHQ-9)</measure>
      <time_frame>Change from Pre intervention start to 12 weeks post intervention start</time_frame>
      <description>Self rated depressive symptoms. Minimum value 0, maximum value 27, where higher values indicate more depressive symptoms.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Physical activity</measure>
      <time_frame>Change from Pre intervention start to 6 months post intervention start</time_frame>
      <description>Objectively measured physical activity. Total physical activity measured in accelerometer-counts and translated into minutes/day spent in inactivity, low, moderate and vigorous intensity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical activity</measure>
      <time_frame>Change from Pre intervention start to 12 months post intervention start</time_frame>
      <description>Objectively measured physical activity. Total physical activity measured in accelerometer-counts and translated into minutes/day spent in inactivity, low, moderate and vigorous intensity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self reported physical activity</measure>
      <time_frame>Change from Pre intervention start to 12 weeks post intervention start</time_frame>
      <description>Self-reported physical activity: Total physical activity as Metabolic Energy Turnover (MET)hours/week and three level categories (low, moderate and high).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self reported physical activity</measure>
      <time_frame>Change from Pre intervention start to 6 months post intervention start</time_frame>
      <description>Self-reported physical activity: Total physical activity as Metabolic Energy Turnover (MET)hours/week and three level categories (low, moderate and high).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self reported physical activity</measure>
      <time_frame>Change from Pre intervention start to 12 months post intervention start</time_frame>
      <description>Self-reported physical activity: Total physical activity as Metabolic Energy Turnover (MET)hours/week and three level categories (low, moderate and high).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Health Questionnaire 9 (PHQ-9)</measure>
      <time_frame>Change from Pre intervention start to 6 months post intervention start</time_frame>
      <description>Self rated depressive symptoms. Minimum value 0, maximum value 27, where higher values indicate more depressive symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Health Questionnaire 9 (PHQ-9)</measure>
      <time_frame>Change from Pre intervention start to 12 months post intervention start</time_frame>
      <description>Self rated depressive symptoms. Minimum value 0, maximum value 27, where higher values indicate more depressive symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Generalised Anxiety Disorder 7-item scale (GAD-7)</measure>
      <time_frame>Change from Pre intervention start to 12 weeks post intervention start</time_frame>
      <description>Self rated anxiety symptoms. Minimum value 0, maximum value 21, where higher values indicate more anxiety symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Generalised Anxiety Disorder 7-item scale (GAD-7)</measure>
      <time_frame>Change from Pre intervention start to 6 months post intervention start</time_frame>
      <description>Self rated anxiety symptoms. Minimum value 0, maximum value 21, where higher values indicate more anxiety symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Generalised Anxiety Disorder 7-item scale (GAD-7)</measure>
      <time_frame>Change from Pre intervention start to 12 months post intervention start</time_frame>
      <description>Self rated anxiety symptoms. Minimum value 0, maximum value 21, where higher values indicate more anxiety symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Insomnia Severity Index (ISI)</measure>
      <time_frame>Change from Pre intervention start to 12 weeks post intervention start</time_frame>
      <description>Self rated insomnia symptoms. Minimum value 0, maximum value 28, where higher values indicate more insomnia symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Insomnia Severity Index (ISI)</measure>
      <time_frame>Change from Pre intervention start to 6 months post intervention start</time_frame>
      <description>Self rated insomnia symptoms. Minimum value 0, maximum value 28, where higher values indicate more insomnia symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Insomnia Severity Index (ISI)</measure>
      <time_frame>Change from Pre intervention start to 12 months post intervention start</time_frame>
      <description>Self rated insomnia symptoms. Minimum value 0, maximum value 28, where higher values indicate more insomnia symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Work and Social Adjustment Scale (WSAS)</measure>
      <time_frame>Change from Pre intervention start to 12 weeks post intervention start</time_frame>
      <description>The WSAS is a simple, reliable and valid measure of impaired functioning. It is a sensitive and useful outcome measure offering the potential for readily interpretable comparisons across studies and disorders. The maximum score of the WSAS is 40, lower scores are better. The 5 items are scored 0-8 ranging from Not at-all-Slightly-Definitely-Markedly-Very-severely</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Work and Social Adjustment Scale (WSAS)</measure>
      <time_frame>Change from Pre intervention start to 6 months post intervention start</time_frame>
      <description>The WSAS is a simple, reliable and valid measure of impaired functioning. It is a sensitive and useful outcome measure offering the potential for readily interpretable comparisons across studies and disorders. The maximum score of the WSAS is 40, lower scores are better. The 5 items are scored 0-8 ranging from Not at-all-Slightly-Definitely-Markedly-Very-severely</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Work and Social Adjustment Scale (WSAS)</measure>
      <time_frame>Change from Pre intervention start to 12 months post intervention start</time_frame>
      <description>The WSAS is a simple, reliable and valid measure of impaired functioning. It is a sensitive and useful outcome measure offering the potential for readily interpretable comparisons across studies and disorders. The maximum score of the WSAS is 40, lower scores are better. The 5 items are scored 0-8 ranging from Not at-all-Slightly-Definitely-Markedly-Very-severely</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EUROQOL 5 dimensions (EQ5D)</measure>
      <time_frame>Change from Pre intervention start to 12 weeks post intervention start</time_frame>
      <description>The EQ-5D [1] is an instrument that consists of two parts and measures health-related quality of life, regardless of disease profile. The instrument measures the general state of health within five dimensions. Values are anchored at 1 (full health) and 0 (a state as bad as being dead) as required by their use in economic evaluation. Values less than 0 represent health states regarded as worse than a state that is as bad as being dead. An EQ-5D value is also sometimes known as an 'index', 'score' or 'utility'.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EUROQOL 5 dimensions (EQ5D)</measure>
      <time_frame>Change from Pre intervention start to 6 months post intervention start</time_frame>
      <description>The EQ-5D [1] is an instrument that consists of two parts and measures health-related quality of life, regardless of disease profile. The instrument measures the general state of health within five dimensions. Values are anchored at 1 (full health) and 0 (a state as bad as being dead) as required by their use in economic evaluation. Values less than 0 represent health states regarded as worse than a state that is as bad as being dead. An EQ-5D value is also sometimes known as an 'index', 'score' or 'utility'.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EUROQOL 5 dimensions (EQ5D)</measure>
      <time_frame>Change from Pre intervention start to 12 months post intervention start</time_frame>
      <description>The EQ-5D [1] is an instrument that consists of two parts and measures health-related quality of life, regardless of disease profile. The instrument measures the general state of health within five dimensions. Values are anchored at 1 (full health) and 0 (a state as bad as being dead) as required by their use in economic evaluation. Values less than 0 represent health states regarded as worse than a state that is as bad as being dead. An EQ-5D value is also sometimes known as an 'index', 'score' or 'utility'.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality Adjusted Life Years (QALY)</measure>
      <time_frame>Change from 12-0 months pre intervention to 0-12 months post intervention</time_frame>
      <description>The quality-adjusted life year (QALY) is a generic measure of disease burden, including both the quality and the quantity of life lived. It is used in economic evaluation to assess the value of medical interventions. One QALY equates to one year in perfect health. QALY scores range from 1 (perfect health) to 0 (dead).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The incremental cost-effectiveness (ICER)</measure>
      <time_frame>Change from 12-0 months pre intervention to 0-12 months post intervention</time_frame>
      <description>The incremental cost-effectiveness ratio (ICER) is a statistic used in cost-effectiveness analysis to summarise the cost-effectiveness of a health care intervention. It is defined by the difference in cost between two possible interventions, divided by the difference in their effect. It represents the average incremental cost associated with 1 additional unit of the measure of effect. Costs will be described in monetary units, while effects will be measured in terms of health status.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood pressure</measure>
      <time_frame>Change from Pre intervention start to 12 weeks post intervention start</time_frame>
      <description>systolic and diastolic, mmHg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood pressure</measure>
      <time_frame>Change from Pre intervention start to 6 months post intervention start</time_frame>
      <description>systolic and diastolic, mmHg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood pressure</measure>
      <time_frame>Change from Pre intervention start to 12 months post intervention start</time_frame>
      <description>systolic and diastolic, mmHg</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body mass index (BMI)</measure>
      <time_frame>Change from Pre intervention start to 12 weeks post intervention start</time_frame>
      <description>Weight in kg divided by the square of height in m</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body mass index (BMI)</measure>
      <time_frame>Change from Pre intervention start to 6 months post intervention start</time_frame>
      <description>Weight in kg divided by the square of height in m</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body mass index (BMI)</measure>
      <time_frame>Change from Pre intervention start to 12 months post intervention start</time_frame>
      <description>Weight in kg divided by the square of height in m</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Waist circumference</measure>
      <time_frame>Change from Pre intervention start to 12 weeks post intervention start</time_frame>
      <description>Waist circumference, cm</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Waist circumference</measure>
      <time_frame>Change from Pre intervention start to 6 months post intervention start</time_frame>
      <description>Waist circumference, cm</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Waist circumference</measure>
      <time_frame>Change from Pre intervention start to 12 months post intervention start</time_frame>
      <description>Waist circumference, cm</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Heart rate (HR)</measure>
      <time_frame>Change from Pre intervention start to 12 weeks post intervention start</time_frame>
      <description>Heart rate, beats per minute, resting state</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Heart rate (HR)</measure>
      <time_frame>Change from Pre intervention start to 6 months post intervention start</time_frame>
      <description>Heart rate, beats per minute, resting state</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Heart rate (HR)</measure>
      <time_frame>Change from Pre intervention start to 12 months post intervention start</time_frame>
      <description>Heart rate, beats per minute, resting state</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>fasting blood sugar (FBS)</measure>
      <time_frame>Change from Pre intervention start to 12 weeks post intervention start</time_frame>
      <description>fasting blood sugar, mmol/l</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>fasting blood sugar (FBS)</measure>
      <time_frame>Change from Pre intervention start to 6 months post intervention start</time_frame>
      <description>fasting blood sugar, mmol/l</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>fasting blood sugar (FBS)</measure>
      <time_frame>Change from Pre intervention start to 12 months post intervention start</time_frame>
      <description>fasting blood sugar, mmol/l</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hemoglobin A1c (HbA1c)</measure>
      <time_frame>Change from Pre intervention start to 12 weeks post intervention start</time_frame>
      <description>Glycated hemoglobin, mmol/mol</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hemoglobin A1c (HbA1c)</measure>
      <time_frame>Change from Pre intervention start to 6 months post intervention start</time_frame>
      <description>Glycated hemoglobin, mmol/mol</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hemoglobin A1c (HbA1c)</measure>
      <time_frame>Change from Pre intervention start to 12 months post intervention start</time_frame>
      <description>Glycated hemoglobin, mmol/mol</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood lipids</measure>
      <time_frame>Change from Pre intervention start to 12 weeks post intervention start</time_frame>
      <description>Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood lipids</measure>
      <time_frame>Change from Pre intervention start to 6 months post intervention start</time_frame>
      <description>Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood lipids</measure>
      <time_frame>Change from Pre intervention start to 12 months post intervention start</time_frame>
      <description>Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sensitive C-reactive protein (CRP)</measure>
      <time_frame>Change from Pre intervention start to 12 weeks post intervention start</time_frame>
      <description>Measurement of inflammation and infection, mmol/L</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sensitive C-reactive protein (CRP)</measure>
      <time_frame>Change from Pre intervention start to 6 months post intervention start</time_frame>
      <description>Measurement of inflammation and infection, mmol/L</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sensitive C-reactive protein (CRP)</measure>
      <time_frame>Change from Pre intervention start to 12 months post intervention start</time_frame>
      <description>Measurement of inflammation and infection, mmol/L</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Complete blood count</measure>
      <time_frame>Change from Pre intervention start to 12 weeks post intervention start</time_frame>
      <description>The number of leukocytes, platelets and erythrocytes per unit volume in a sample of venous blood. Includes measurement of the hemoglobin, hematocrit and erythrocyte indices.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Complete blood count</measure>
      <time_frame>Change from Pre intervention start to 6 months post intervention start</time_frame>
      <description>The number of leukocytes, platelets and erythrocytes per unit volume in a sample of venous blood. Includes measurement of the hemoglobin, hematocrit and erythrocyte indices.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Complete blood count</measure>
      <time_frame>Change from Pre intervention start to 12 months post intervention start</time_frame>
      <description>The number of leukocytes, platelets and erythrocytes per unit volume in a sample of venous blood. Includes measurement of the hemoglobin, hematocrit and erythrocyte indices.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Negative effects</measure>
      <time_frame>12 weeks post inclusion</time_frame>
      <description>Self constructed question regarding if participants have had any negative effects of treatment: 1) Have you experienced any negative effects from the treatment 2) If yes, please specify:</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Client Satisfaction Questionnaire-8 (CSQ-8)</measure>
      <time_frame>12 weeks post inclusion</time_frame>
      <description>Self rated satisfaction of treatment. Minimum value 8, maximum value 32 where higher values indicate greater satisfaction with the treatment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Credibility/Expectancy Questionnaire (CEQ)</measure>
      <time_frame>2 weeks post inclusion</time_frame>
      <description>Self rated Credibility of treatment. Minimum value 3, maximum value 27 for each factor, where higher values indicate greater Credibility/Expectancy of the treatment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difficulties in Emotion Regulation Scale, Brief Version (DERS-16)</measure>
      <time_frame>Change from Pre intervention start to 12 weeks post intervention start</time_frame>
      <description>Self rated difficulties in emotion regulation. The sum ranges from 16 to 80, where higher levels indicate greater difficulty in emotion regulation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difficulties in Emotion Regulation Scale, Brief Version (DERS-16)</measure>
      <time_frame>Change from Pre intervention start to 6 months post intervention start</time_frame>
      <description>Self rated difficulties in emotion regulation. The sum ranges from 16 to 80, where higher levels indicate greater difficulty in emotion regulation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Difficulties in Emotion Regulation Scale, Brief Version (DERS-16)</measure>
      <time_frame>Change from Pre intervention start to 12 months post intervention start</time_frame>
      <description>Self rated difficulties in emotion regulation. The sum ranges from 16 to 80, where higher levels indicate greater difficulty in emotion regulation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time Line follow back (TLFB)</measure>
      <time_frame>Change from Pre intervention start to 12 weeks post intervention start.</time_frame>
      <description>Interview regarding alcohol and/or drug intake, measuring number of days with alcohol/drug consumption.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time Line follow back (TLFB)</measure>
      <time_frame>Change from Pre intervention start to 6 months post intervention start.</time_frame>
      <description>Interview regarding alcohol and/or drug intake, measuring number of days with alcohol/drug consumption.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time Line follow back (TLFB)</measure>
      <time_frame>Change from Pre intervention start to 12 months post intervention start.</time_frame>
      <description>Interview regarding alcohol and/or drug intake, measuring number of days with alcohol/drug consumption.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">208</enrollment>
    <condition>Mental Disorders</condition>
    <arm_group>
      <arm_group_label>Braining</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A 12 week program where participants are encouraged to participate in physical exercise at the psychiatric unit.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Treatment as usual</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Health interview and a 12 week program where participants are encouraged to engage in physical exercise outside the psychiatric setting.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Braining</intervention_name>
      <description>A 12 week program where participants are encouraged to participate in physical exercise at the psychiatric unit.</description>
      <arm_group_label>Braining</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Treatment as usual</intervention_name>
      <description>A 12 week program where participants are encouraged to engage in physical exercise</description>
      <arm_group_label>Treatment as usual</arm_group_label>
      <other_name>Advice on physical activity</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient at one of the psychiatric units&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Physically active with moderate to vigorous physical activity above recommendations&#xD;
               from World Health Organization (WHO) during the last 4 weeks&#xD;
  &#xD;
            -  Severe mental disorder such as ongoing mania, psychosis, and conditions when high risk&#xD;
               of suicide or high risk of violence available according to the assessment of&#xD;
               psychiatric staff at the unit.&#xD;
  &#xD;
            -  Medical conditions such as heart or lung disease, infection, withdrawal, where heart&#xD;
               rate-increasing physical activity is considered contraindicated due to Medical&#xD;
               reasons.&#xD;
  &#xD;
            -  Physical disability that makes it impossible to move independently to the gym and&#xD;
               performing the indicated exercise in the training sessions.&#xD;
  &#xD;
            -  Mental disability which means that you can not participate in group training.&#xD;
  &#xD;
            -  Difficulty speaking or understanding the Swedish language.&#xD;
  &#xD;
            -  Ongoing heavy substance use.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Region Stockholm, Psykiatri Sydväst (Psychiatric Clinic Psychiatry Southwest)</name>
        <address>
          <city>Stockholm</city>
          <zip>14186</zip>
          <country>Sweden</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Andreashuset</name>
        <address>
          <city>Stockholm</city>
          <country>Sweden</country>
        </address>
      </facility>
      <contact>
        <last_name>Rebecka Broman</last_name>
        <email>rebecka.broman@regionstockholm.se</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Läkemedel och hälsa</name>
        <address>
          <city>Stockholm</city>
          <country>Sweden</country>
        </address>
      </facility>
      <contact>
        <last_name>Rebecka Broman</last_name>
        <email>rebecka.broman@regionstockholm.se</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Region Stockholm, Liljeholmsberget</name>
        <address>
          <city>Stockholm</city>
          <country>Sweden</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Sweden</country>
    </location_countries>
    <verification_date>May 2023</verification_date>
    <study_first_submitted>July 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>physical exercise</keyword>
    <keyword>mental disorders</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Mental Disorders</mesh_term>
      <mesh_term>Psychotic Disorders</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06012149
  org study id: 2020-07130
  nct id: NCT06012149
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to compare Braining, a physical exercise lifestyle
        intervention in psychiatric care, with usual care. In this study, usual care is defined as
        information about physical exercise.
  
        The main questions are:
  
          -  does Braining lead to increased physical exercise compared to usual care?
  
          -  what effect does Braining have on mental and physical health, quality of life and
             functional level compared to usual care?
  
        The participants will join a twelve weeks long study period with clinician led exercise
        classes up to three times per week. Before and after the study period they will leave blood
        tests, take part in a mental and physical examination and fill in assessment scales. To
        measure physical activity, the participants will carry an accelerometer, a device that
        measures steps and acceleration. After six and twelve months, the participants take part in
        the same measurements.
  
        The control group takes parts in the same measurements and follow up, but instead of having
        clinician led exercise classes, they will exercise on their own during the twelve weeks study
        period.
  Braining is a clinical invention that helps patients in psychiatry to start and execute
        physical exercise (PE) regularly in psychiatric care. The core components are basic moderate
        to vigorous aerobic group training sessions and motivational work led by the psychiatric
        staff. Braining is used as add-on treatment to regular psychiatric care and is included in
        the patient care plan. Braining is unique in that it:
  
          1. Includes trained psychiatric clinical staff exercising together with patients from both
             out- and inpatient ward units in daily, moderate to vigorous aerobic group training
             sessions
  
          2. is included in regular healthcare fee, (free of charge)
  
          3. includes a motivational and educational visit (as a group seminar or as an individual
             visit) at the start and end of a twelve-week exercise intervention
  
          4. includes regular measurements (self-assessment questionnaires, blood samples, physical
             and mental health examination and education before and after the twelve-week exercise
             intervention)
  
          5. offers short individual motivating visits before every training session, including
             assessment of day shape and fitness to participate.
  
        This study will be a multi-center study performed at 5 psychiatric outpatient units in Region
        Stockholm. Patients with symptoms of depression and/or anxiety who are not physically active
        in accordance with WHO recommendations will be invited to participate in the study.
  
        The research questions are:
  
          -  Does Braining increase the amount of completed physical training (FT) compared to usual
             care (advice on FT according to guidelines)?
  
          -  What effect does Braining have on the mental and physical health, quality of life and
             functional level of participating patients compared to usual care? Examined from the
             following points of view:
  
               -  psychiatric symptoms, such as depression, anxiety, insomnia, emotional regulation?
  
               -  somatic symptoms, such as blood pressure, resting heart rate, BMI, waist
                  measurement, presence of somatic co-morbidity?
  
          -  How do participants rate Braining and treatment as usual regarding:
  
               1. Satisfaction with treatment
  
               2. Credibility of treatment
  
               3. Negative effects
  
          -  Is Braining a cost-effective intervention?
  
        Participants will be randomized to supplementary treatment with Braining or treatment as
        usual (TAU) - advice regarding physical activity.
  
        Braining and TAU will be compared after a 12-week training period.
  
        Measurements of the participants´ psychiatric and somatic health are carried out before the
        treatment, after 4, 8 and 12 weeks and 6 and 12 months after the end of treatment. Effects of
        the treatment are examined via validated self-assessment forms, as well as somatic
        examination with a focus on metabolic status. Venous blood samples are taken before and after
        the 12-week training period, as well as 6 and 12 months after the end of the training period
        to investigate changes in metabolic status. In a sub study on a smaller number of
        participants the researchers will analyze associations with biological factors such as
        genetic or epigenetic factors, metabolic factors, stress hormone levels, trace elements,
        degree of inflammation and other biological markers of health and disease that can be
        measured in ordinary blood tests, e.g. through "OMIK" design. Physical activity will be
        measured by self assessment scales, accelerometer and by number of performed Braining
        classes.
  
        Data analysis: Continuous data will be analyzed using mixed effects models or t-test, nominal
        data analyzed mainly with chi2 test. In mixed effects models of differences between groups
        the interaction effect of group and time will be the central estimate.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: A randomized controlled superiority trial evaluating if the new method Braining is superior to treatment as usual with advice on physical exercise, concerning increasing physical activity.
  The trial is a multicenter study conducted at 3-6 sites. Participants are individually randomized in blocks of 2-4 at each site.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Physical activity
  time frame: Change from Pre intervention start to 12 weeks post intervention start
  description: Objectively measured physical activity. Total physical activity measured in accelerometer-counts and translated into minutes/day spent in inactivity, low, moderate and vigorous intensity.
  measure: Patient Health Questionnaire 9 (PHQ-9)
  time frame: Change from Pre intervention start to 12 weeks post intervention start
  description: Self rated depressive symptoms. Minimum value 0, maximum value 27, where higher values indicate more depressive symptoms.
  measure: Physical activity
  time frame: Change from Pre intervention start to 6 months post intervention start
  description: Objectively measured physical activity. Total physical activity measured in accelerometer-counts and translated into minutes/day spent in inactivity, low, moderate and vigorous intensity.
  measure: Physical activity
  time frame: Change from Pre intervention start to 12 months post intervention start
  description: Objectively measured physical activity. Total physical activity measured in accelerometer-counts and translated into minutes/day spent in inactivity, low, moderate and vigorous intensity.
  measure: Self reported physical activity
  time frame: Change from Pre intervention start to 12 weeks post intervention start
  description: Self-reported physical activity: Total physical activity as Metabolic Energy Turnover (MET)hours/week and three level categories (low, moderate and high).
  measure: Self reported physical activity
  time frame: Change from Pre intervention start to 6 months post intervention start
  description: Self-reported physical activity: Total physical activity as Metabolic Energy Turnover (MET)hours/week and three level categories (low, moderate and high).
  measure: Self reported physical activity
  time frame: Change from Pre intervention start to 12 months post intervention start
  description: Self-reported physical activity: Total physical activity as Metabolic Energy Turnover (MET)hours/week and three level categories (low, moderate and high).
  measure: Patient Health Questionnaire 9 (PHQ-9)
  time frame: Change from Pre intervention start to 6 months post intervention start
  description: Self rated depressive symptoms. Minimum value 0, maximum value 27, where higher values indicate more depressive symptoms.
  measure: Patient Health Questionnaire 9 (PHQ-9)
  time frame: Change from Pre intervention start to 12 months post intervention start
  description: Self rated depressive symptoms. Minimum value 0, maximum value 27, where higher values indicate more depressive symptoms.
  measure: Generalised Anxiety Disorder 7-item scale (GAD-7)
  time frame: Change from Pre intervention start to 12 weeks post intervention start
  description: Self rated anxiety symptoms. Minimum value 0, maximum value 21, where higher values indicate more anxiety symptoms.
  measure: Generalised Anxiety Disorder 7-item scale (GAD-7)
  time frame: Change from Pre intervention start to 6 months post intervention start
  description: Self rated anxiety symptoms. Minimum value 0, maximum value 21, where higher values indicate more anxiety symptoms.
  measure: Generalised Anxiety Disorder 7-item scale (GAD-7)
  time frame: Change from Pre intervention start to 12 months post intervention start
  description: Self rated anxiety symptoms. Minimum value 0, maximum value 21, where higher values indicate more anxiety symptoms.
  measure: Insomnia Severity Index (ISI)
  time frame: Change from Pre intervention start to 12 weeks post intervention start
  description: Self rated insomnia symptoms. Minimum value 0, maximum value 28, where higher values indicate more insomnia symptoms.
  measure: Insomnia Severity Index (ISI)
  time frame: Change from Pre intervention start to 6 months post intervention start
  description: Self rated insomnia symptoms. Minimum value 0, maximum value 28, where higher values indicate more insomnia symptoms.
  measure: Insomnia Severity Index (ISI)
  time frame: Change from Pre intervention start to 12 months post intervention start
  description: Self rated insomnia symptoms. Minimum value 0, maximum value 28, where higher values indicate more insomnia symptoms.
  measure: The Work and Social Adjustment Scale (WSAS)
  time frame: Change from Pre intervention start to 12 weeks post intervention start
  description: The WSAS is a simple, reliable and valid measure of impaired functioning. It is a sensitive and useful outcome measure offering the potential for readily interpretable comparisons across studies and disorders. The maximum score of the WSAS is 40, lower scores are better. The 5 items are scored 0-8 ranging from Not at-all-Slightly-Definitely-Markedly-Very-severely
  measure: The Work and Social Adjustment Scale (WSAS)
  time frame: Change from Pre intervention start to 6 months post intervention start
  description: The WSAS is a simple, reliable and valid measure of impaired functioning. It is a sensitive and useful outcome measure offering the potential for readily interpretable comparisons across studies and disorders. The maximum score of the WSAS is 40, lower scores are better. The 5 items are scored 0-8 ranging from Not at-all-Slightly-Definitely-Markedly-Very-severely
  measure: The Work and Social Adjustment Scale (WSAS)
  time frame: Change from Pre intervention start to 12 months post intervention start
  description: The WSAS is a simple, reliable and valid measure of impaired functioning. It is a sensitive and useful outcome measure offering the potential for readily interpretable comparisons across studies and disorders. The maximum score of the WSAS is 40, lower scores are better. The 5 items are scored 0-8 ranging from Not at-all-Slightly-Definitely-Markedly-Very-severely
  measure: EUROQOL 5 dimensions (EQ5D)
  time frame: Change from Pre intervention start to 12 weeks post intervention start
  description: The EQ-5D [1] is an instrument that consists of two parts and measures health-related quality of life, regardless of disease profile. The instrument measures the general state of health within five dimensions. Values are anchored at 1 (full health) and 0 (a state as bad as being dead) as required by their use in economic evaluation. Values less than 0 represent health states regarded as worse than a state that is as bad as being dead. An EQ-5D value is also sometimes known as an 'index', 'score' or 'utility'.
  measure: EUROQOL 5 dimensions (EQ5D)
  time frame: Change from Pre intervention start to 6 months post intervention start
  description: The EQ-5D [1] is an instrument that consists of two parts and measures health-related quality of life, regardless of disease profile. The instrument measures the general state of health within five dimensions. Values are anchored at 1 (full health) and 0 (a state as bad as being dead) as required by their use in economic evaluation. Values less than 0 represent health states regarded as worse than a state that is as bad as being dead. An EQ-5D value is also sometimes known as an 'index', 'score' or 'utility'.
  measure: EUROQOL 5 dimensions (EQ5D)
  time frame: Change from Pre intervention start to 12 months post intervention start
  description: The EQ-5D [1] is an instrument that consists of two parts and measures health-related quality of life, regardless of disease profile. The instrument measures the general state of health within five dimensions. Values are anchored at 1 (full health) and 0 (a state as bad as being dead) as required by their use in economic evaluation. Values less than 0 represent health states regarded as worse than a state that is as bad as being dead. An EQ-5D value is also sometimes known as an 'index', 'score' or 'utility'.
  measure: Quality Adjusted Life Years (QALY)
  time frame: Change from 12-0 months pre intervention to 0-12 months post intervention
  description: The quality-adjusted life year (QALY) is a generic measure of disease burden, including both the quality and the quantity of life lived. It is used in economic evaluation to assess the value of medical interventions. One QALY equates to one year in perfect health. QALY scores range from 1 (perfect health) to 0 (dead).
  measure: The incremental cost-effectiveness (ICER)
  time frame: Change from 12-0 months pre intervention to 0-12 months post intervention
  description: The incremental cost-effectiveness ratio (ICER) is a statistic used in cost-effectiveness analysis to summarise the cost-effectiveness of a health care intervention. It is defined by the difference in cost between two possible interventions, divided by the difference in their effect. It represents the average incremental cost associated with 1 additional unit of the measure of effect. Costs will be described in monetary units, while effects will be measured in terms of health status.
  measure: Blood pressure
  time frame: Change from Pre intervention start to 12 weeks post intervention start
  description: systolic and diastolic, mmHg
  measure: Blood pressure
  time frame: Change from Pre intervention start to 6 months post intervention start
  description: systolic and diastolic, mmHg
  measure: Blood pressure
  time frame: Change from Pre intervention start to 12 months post intervention start
  description: systolic and diastolic, mmHg
  measure: Body mass index (BMI)
  time frame: Change from Pre intervention start to 12 weeks post intervention start
  description: Weight in kg divided by the square of height in m
  measure: Body mass index (BMI)
  time frame: Change from Pre intervention start to 6 months post intervention start
  description: Weight in kg divided by the square of height in m
  measure: Body mass index (BMI)
  time frame: Change from Pre intervention start to 12 months post intervention start
  description: Weight in kg divided by the square of height in m
  measure: Waist circumference
  time frame: Change from Pre intervention start to 12 weeks post intervention start
  description: Waist circumference, cm
  measure: Waist circumference
  time frame: Change from Pre intervention start to 6 months post intervention start
  description: Waist circumference, cm
  measure: Waist circumference
  time frame: Change from Pre intervention start to 12 months post intervention start
  description: Waist circumference, cm
  measure: Heart rate (HR)
  time frame: Change from Pre intervention start to 12 weeks post intervention start
  description: Heart rate, beats per minute, resting state
  measure: Heart rate (HR)
  time frame: Change from Pre intervention start to 6 months post intervention start
  description: Heart rate, beats per minute, resting state
  measure: Heart rate (HR)
  time frame: Change from Pre intervention start to 12 months post intervention start
  description: Heart rate, beats per minute, resting state
  measure: fasting blood sugar (FBS)
  time frame: Change from Pre intervention start to 12 weeks post intervention start
  description: fasting blood sugar, mmol/l
  measure: fasting blood sugar (FBS)
  time frame: Change from Pre intervention start to 6 months post intervention start
  description: fasting blood sugar, mmol/l
  measure: fasting blood sugar (FBS)
  time frame: Change from Pre intervention start to 12 months post intervention start
  description: fasting blood sugar, mmol/l
  measure: Hemoglobin A1c (HbA1c)
  time frame: Change from Pre intervention start to 12 weeks post intervention start
  description: Glycated hemoglobin, mmol/mol
  measure: Hemoglobin A1c (HbA1c)
  time frame: Change from Pre intervention start to 6 months post intervention start
  description: Glycated hemoglobin, mmol/mol
  measure: Hemoglobin A1c (HbA1c)
  time frame: Change from Pre intervention start to 12 months post intervention start
  description: Glycated hemoglobin, mmol/mol
  measure: Blood lipids
  time frame: Change from Pre intervention start to 12 weeks post intervention start
  description: Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L
  measure: Blood lipids
  time frame: Change from Pre intervention start to 6 months post intervention start
  description: Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L
  measure: Blood lipids
  time frame: Change from Pre intervention start to 12 months post intervention start
  description: Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L
  measure: Sensitive C-reactive protein (CRP)
  time frame: Change from Pre intervention start to 12 weeks post intervention start
  description: Measurement of inflammation and infection, mmol/L
  measure: Sensitive C-reactive protein (CRP)
  time frame: Change from Pre intervention start to 6 months post intervention start
  description: Measurement of inflammation and infection, mmol/L
  measure: Sensitive C-reactive protein (CRP)
  time frame: Change from Pre intervention start to 12 months post intervention start
  description: Measurement of inflammation and infection, mmol/L
  measure: Complete blood count
  time frame: Change from Pre intervention start to 12 weeks post intervention start
  description: The number of leukocytes, platelets and erythrocytes per unit volume in a sample of venous blood. Includes measurement of the hemoglobin, hematocrit and erythrocyte indices.
  measure: Complete blood count
  time frame: Change from Pre intervention start to 6 months post intervention start
  description: The number of leukocytes, platelets and erythrocytes per unit volume in a sample of venous blood. Includes measurement of the hemoglobin, hematocrit and erythrocyte indices.
  measure: Complete blood count
  time frame: Change from Pre intervention start to 12 months post intervention start
  description: The number of leukocytes, platelets and erythrocytes per unit volume in a sample of venous blood. Includes measurement of the hemoglobin, hematocrit and erythrocyte indices.
  measure: Negative effects
  time frame: 12 weeks post inclusion
  description: Self constructed question regarding if participants have had any negative effects of treatment: 1) Have you experienced any negative effects from the treatment 2) If yes, please specify:
  measure: The Client Satisfaction Questionnaire-8 (CSQ-8)
  time frame: 12 weeks post inclusion
  description: Self rated satisfaction of treatment. Minimum value 8, maximum value 32 where higher values indicate greater satisfaction with the treatment.
  measure: The Credibility/Expectancy Questionnaire (CEQ)
  time frame: 2 weeks post inclusion
  description: Self rated Credibility of treatment. Minimum value 3, maximum value 27 for each factor, where higher values indicate greater Credibility/Expectancy of the treatment.
  measure: Difficulties in Emotion Regulation Scale, Brief Version (DERS-16)
  time frame: Change from Pre intervention start to 12 weeks post intervention start
  description: Self rated difficulties in emotion regulation. The sum ranges from 16 to 80, where higher levels indicate greater difficulty in emotion regulation.
  measure: Difficulties in Emotion Regulation Scale, Brief Version (DERS-16)
  time frame: Change from Pre intervention start to 6 months post intervention start
  description: Self rated difficulties in emotion regulation. The sum ranges from 16 to 80, where higher levels indicate greater difficulty in emotion regulation.
  measure: Difficulties in Emotion Regulation Scale, Brief Version (DERS-16)
  time frame: Change from Pre intervention start to 12 months post intervention start
  description: Self rated difficulties in emotion regulation. The sum ranges from 16 to 80, where higher levels indicate greater difficulty in emotion regulation.
  measure: Time Line follow back (TLFB)
  time frame: Change from Pre intervention start to 12 weeks post intervention start.
  description: Interview regarding alcohol and/or drug intake, measuring number of days with alcohol/drug consumption.
  measure: Time Line follow back (TLFB)
  time frame: Change from Pre intervention start to 6 months post intervention start.
  description: Interview regarding alcohol and/or drug intake, measuring number of days with alcohol/drug consumption.
  measure: Time Line follow back (TLFB)
  time frame: Change from Pre intervention start to 12 months post intervention start.
  description: Interview regarding alcohol and/or drug intake, measuring number of days with alcohol/drug consumption.
  arm group label: Braining
  arm group type: Experimental
  description: A 12 week program where participants are encouraged to participate in physical exercise at the psychiatric unit.
  arm group label: Treatment as usual
  arm group type: Active Comparator
  description: Health interview and a 12 week program where participants are encouraged to engage in physical exercise outside the psychiatric setting.
  intervention type: Behavioral
  intervention name: Braining
  description: A 12 week program where participants are encouraged to participate in physical exercise at the psychiatric unit.
  arm group label: Braining
  intervention type: Behavioral
  intervention name: Treatment as usual
  description: A 12 week program where participants are encouraged to engage in physical exercise
  arm group label: Treatment as usual
  other name: Advice on physical activity
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  country: Sweden
  responsible party type: Sponsor
  mesh term: Mental Disorders
  mesh term: Psychotic Disorders
  sharing ipd: No