Braining Versus Treatment as Usual
Study Details
Study Description
Brief Summary
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.
Exclusion criteria are severe somatic disease, such as untreated heart or lung disease or severe physical impairment or severe psychiatric comorbidities such as psychotic mania.
Included patients 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. 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:
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psychiatric symptoms, such as depression, anxiety, insomnia?
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somatic symptoms, such as blood pressure, resting heart rate, BMI, waist measurement, presence of somatic co-morbidity?
How do patients rate Braining and treatment as usual regarding:
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Satisfaction with treatment
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Credibility of treatment
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Negative effects
Patients will be measured pretreatment, during treatment, post treatment and at follow-ups 6 and 12 months after inclusion.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
"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:
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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
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is included in regular healthcare fee, (free of charge)
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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
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includes regular measurements (self-assessment questionnaires, blood samples, physical and mental health examination and education before and after the twelve-week exercise intervention)
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offers short individual motivating visits before every training session, including assessment of day shape and fitness to participate.
The present study is a randomized multicentre study evaluating the effect of Braining on physical activity, mental and somatic health compared to treatment as usual.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Braining A 12 week program where participants are encouraged to participate in physical exercise at the psychiatric unit. |
Behavioral: Braining
A 12 week program where participants are encouraged to participate in physical exercise at the psychiatric unit.
|
| Active Comparator: Treatment as usual Health interview and a 12 week program where participants are encouraged to engage in physical exercise outside the psychiatric setting. |
Behavioral: Treatment as usual
A 12 week program where participants are encouraged to engage in physical exercise
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Physical activity [Change from Pre intervention start to 12 weeks post intervention start]
Objectively measured physical activity. Total physical activity measured in accelerometer-counts and translated into minutes/day spent in inactivity, low, moderate and vigorous intensity.
- Patient Health Questionnaire 9 (PHQ-9) [Change from Pre intervention start to 12 weeks post intervention start]
Self rated depressive symptoms. Minimum value 0, maximum value 27, where higher values indicate more depressive symptoms.
Secondary Outcome Measures
- Physical activity [Change from Pre intervention start to 6 months post intervention start]
Objectively measured physical activity. Total physical activity measured in accelerometer-counts and translated into minutes/day spent in inactivity, low, moderate and vigorous intensity.
- Physical activity [Change from Pre intervention start to 12 months post intervention start]
Objectively measured physical activity. Total physical activity measured in accelerometer-counts and translated into minutes/day spent in inactivity, low, moderate and vigorous intensity.
- Self reported physical activity [Change from Pre intervention start to 12 weeks post intervention start]
Self-reported physical activity: Total physical activity as Metabolic Energy Turnover (MET)hours/week and three level categories (low, moderate and high).
- Self reported physical activity [Change from Pre intervention start to 6 months post intervention start]
Self-reported physical activity: Total physical activity as Metabolic Energy Turnover (MET)hours/week and three level categories (low, moderate and high).
- Self reported physical activity [Change from Pre intervention start to 12 months post intervention start]
Self-reported physical activity: Total physical activity as Metabolic Energy Turnover (MET)hours/week and three level categories (low, moderate and high).
- Patient Health Questionnaire 9 (PHQ-9) [Change from Pre intervention start to 6 months post intervention start]
Self rated depressive symptoms. Minimum value 0, maximum value 27, where higher values indicate more depressive symptoms.
- Patient Health Questionnaire 9 (PHQ-9) [Change from Pre intervention start to 12 months post intervention start]
Self rated depressive symptoms. Minimum value 0, maximum value 27, where higher values indicate more depressive symptoms.
- Generalised Anxiety Disorder 7-item scale (GAD-7) [Change from Pre intervention start to 12 weeks post intervention start]
Self rated anxiety symptoms. Minimum value 0, maximum value 21, where higher values indicate more anxiety symptoms.
- Generalised Anxiety Disorder 7-item scale (GAD-7) [Change from Pre intervention start to 6 months post intervention start]
Self rated anxiety symptoms. Minimum value 0, maximum value 21, where higher values indicate more anxiety symptoms.
- Generalised Anxiety Disorder 7-item scale (GAD-7) [Change from Pre intervention start to 12 months post intervention start]
Self rated anxiety symptoms. Minimum value 0, maximum value 21, where higher values indicate more anxiety symptoms.
- Insomnia Severity Index (ISI) [Change from Pre intervention start to 12 weeks post intervention start]
Self rated insomnia symptoms. Minimum value 0, maximum value 28, where higher values indicate more insomnia symptoms.
- Insomnia Severity Index (ISI) [Change from Pre intervention start to 6 months post intervention start]
Self rated insomnia symptoms. Minimum value 0, maximum value 28, where higher values indicate more insomnia symptoms.
- Insomnia Severity Index (ISI) [Change from Pre intervention start to 12 months post intervention start]
Self rated insomnia symptoms. Minimum value 0, maximum value 28, where higher values indicate more insomnia symptoms.
- The Work and Social Adjustment Scale (WSAS) [Change from Pre intervention start to 12 weeks post intervention start]
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. - Page 6 of 10 [DRAFT] - The 5 items are scored 0-8 ranging from Not at-all-Slightly-Definitely-Markedly-Very-severely
- The Work and Social Adjustment Scale (WSAS) [Change from Pre intervention start to 6 months post intervention start]
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. - Page 6 of 10 [DRAFT] - The 5 items are scored 0-8 ranging from Not at-all-Slightly-Definitely-Markedly-Very-severely
- The Work and Social Adjustment Scale (WSAS) [Change from Pre intervention start to 12 months post intervention start]
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. - Page 6 of 10 [DRAFT] - The 5 items are scored 0-8 ranging from Not at-all-Slightly-Definitely-Markedly-Very-severely
- EUROQOL 5 dimensions (EQ5D) [Change from Pre intervention start to 12 weeks post intervention start]
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'.
- EUROQOL 5 dimensions (EQ5D) [Change from Pre intervention start to 6 months post intervention start]
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'.
- EUROQOL 5 dimensions (EQ5D) [Change from Pre intervention start to 12 months post intervention start]
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'.
- Quality Adjusted Life Years (QALY) [Change from 12-0 months pre intervention to 0-12 months post intervention]
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).
- The incremental cost-effectiveness (ICER) [Change from 12-0 months pre intervention to 0-12 months post intervention]
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.
- Blood pressure [Change from Pre intervention start to 12 weeks post intervention start]
systolic and diastolic, mmHg
- Blood pressure [Change from Pre intervention start to 6 months post intervention start]
systolic and diastolic, mmHg
- Blood pressure [Change from Pre intervention start to 12 months post intervention start]
systolic and diastolic, mmHg
- Body mass index (BMI) [Change from Pre intervention start to 12 weeks post intervention start]
Weight in kg divided by the square of height in m
- Body mass index (BMI) [Change from Pre intervention start to 6 months post intervention start]
Weight in kg divided by the square of height in m
- Body mass index (BMI) [Change from Pre intervention start to 12 months post intervention start]
Weight in kg divided by the square of height in m
- Waist circumference [Change from Pre intervention start to 12 weeks post intervention start]
Waist circumference, cm
- Waist circumference [Change from Pre intervention start to 6 months post intervention start]
Waist circumference, cm
- Waist circumference [Change from Pre intervention start to 12 months post intervention start]
Waist circumference, cm
- Heart rate (HR) [Change from Pre intervention start to 12 weeks post intervention start]
Heart rate, beats per minute, resting state
- Heart rate (HR) [Change from Pre intervention start to 6 months post intervention start]
Heart rate, beats per minute, resting state
- Heart rate (HR) [Change from Pre intervention start to 12 months post intervention start]
Heart rate, beats per minute, resting state
- fasting blood sugar (FBS) [Change from Pre intervention start to 12 weeks post intervention start]
fasting blood sugar, mmol/l
- fasting blood sugar (FBS) [Change from Pre intervention start to 6 months post intervention start]
fasting blood sugar, mmol/l
- fasting blood sugar (FBS) [Change from Pre intervention start to 12 months post intervention start]
fasting blood sugar, mmol/l
- Hemoglobin A1c (HbA1c) [Change from Pre intervention start to 12 weeks post intervention start]
Glycated hemoglobin, mmol/mol
- Hemoglobin A1c (HbA1c) [Change from Pre intervention start to 6 months post intervention start]
Glycated hemoglobin, mmol/mol
- Hemoglobin A1c (HbA1c) [Change from Pre intervention start to 12 months post intervention start]
Glycated hemoglobin, mmol/mol
- Blood lipids [Change from Pre intervention start to 12 weeks post intervention start]
Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L
- Blood lipids [Change from Pre intervention start to 6 months post intervention start]
Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L
- Blood lipids [Change from Pre intervention start to 12 months post intervention start]
Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L
- Sensitive C-reactive protein (CRP) [Change from Pre intervention start to 12 weeks post intervention start]
Measurement of inflammation and infection, mmol/L
- Sensitive C-reactive protein (CRP) [Change from Pre intervention start to 6 months post intervention start]
Measurement of inflammation and infection, mmol/L
- Sensitive C-reactive protein (CRP) [Change from Pre intervention start to 12 months post intervention start]
Measurement of inflammation and infection, mmol/L
- Complete blood count [Change from Pre intervention start to 12 weeks post intervention start]
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.
- Complete blood count [Change from Pre intervention start to 6 months post intervention start]
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.
- Complete blood count [Change from Pre intervention start to 12 months post intervention start]
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.
- Negative effects [12 weeks post inclusion]
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:
- The Client Satisfaction Questionnaire-8 (CSQ-8) [12 weeks post inclusion]
Self rated satisfaction of treatment. Minimum value 8, maximum value 32 where higher values indicate greater satisfaction with the treatment.
- The Credibility/Expectancy Questionnaire (CEQ) [2 weeks post inclusion]
Self rated Credibility of treatment. Minimum value 3, maximum value 27 for each factor, where higher values indicate greater Credibility/Expectancy of the treatment.
- Difficulties in Emotion Regulation Scale, Brief Version (DERS-16) [Change from Pre intervention start to 12 weeks post intervention start]
Self rated difficulties in emotion regulation. The sum ranges from 16 to 80, where higher levels indicate greater difficulty in emotion regulation.
- Difficulties in Emotion Regulation Scale, Brief Version (DERS-16) [Change from Pre intervention start to 6 months post intervention start]
Self rated difficulties in emotion regulation. The sum ranges from 16 to 80, where higher levels indicate greater difficulty in emotion regulation.
- Difficulties in Emotion Regulation Scale, Brief Version (DERS-16) [Change from Pre intervention start to 12 months post intervention start]
Self rated difficulties in emotion regulation. The sum ranges from 16 to 80, where higher levels indicate greater difficulty in emotion regulation.
- Time Line follow back (TLFB) [Change from Pre intervention start to 12 weeks post intervention start.]
Interview regarding alcohol and/or drug intake, measuring number of days with alcohol/drug consumption.
- Time Line follow back (TLFB) [Change from Pre intervention start to 6 months post intervention start.]
Interview regarding alcohol and/or drug intake, measuring number of days with alcohol/drug consumption.
- Time Line follow back (TLFB) [Change from Pre intervention start to 12 months post intervention start.]
Interview regarding alcohol and/or drug intake, measuring number of days with alcohol/drug consumption.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patient at one of the psychiatric units
Exclusion Criteria:
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Physically active with moderate to vigorous physical activity above recommendations from World Health Organization (WHO) during the last 4 weeks
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Severe mental disorder such as ongoing mania, psychosis, and conditions when high risk of suicide or high risk of violence available according to the assessment of psychiatric staff at the unit.
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Medical conditions such as heart or lung disease, infection, withdrawal, where heart rate-increasing physical activity is considered contraindicated due to Medical reasons.
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Physical disability that makes it impossible to move independently to the gym and performing the indicated exercise in the training sessions.
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Mental disability which means that you can not participate in group training.
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Difficulty speaking or understanding the Swedish language.
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Ongoing heavy substance use.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Region Stockholm, Psykiatri Sydväst (Psychiatric Clinic Psychiatry Southwest) | Stockholm | Sweden | 14186 | |
| 2 | Andreashuset | Stockholm | Sweden | ||
| 3 | Läkemedel och hälsa | Stockholm | Sweden | ||
| 4 | Region Stockholm, Liljeholmsberget | Stockholm | Sweden |
Sponsors and Collaborators
- Region Stockholm
- Karolinska Institutet
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020-07130