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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
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The goal of this clinical trial is to compare Braining, a physical exercise lifestyle intervention in psychiatric care, with structured advice on physical exercise.
The main questions are:
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:
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 (PT) compared to structured advice on physical exercise (advice on PT 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 structured advice on physical exercise? Examined from the following points of view:
How do participants rate Braining and structured advice on physical exercise regarding:
Is Braining a cost-effective intervention?
Participants will be randomized to supplementary treatment with Braining or structured advice on physical activity.
Braining and advice on physical activity 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 plan Continuous data will be analyzed using mixed effects models. The interaction effect of group and time will be the central estimate of the effect of the intervention Braining.
The primary analyses will follow the intention-to-treat principle and include all randomized participants. Adjusted as well as unadjusted results from analyses will be reported. Analyses will be adjusted for prespecified covariates to improve precision. Covariates adjusted for in the primary and secondary analysis will be age, sex, and unit where participants were registered as patients.
Missing data will be handled with multiple imputation with chained equations (MICE) to minimize bias compared to listwise deletion or single imputation and reflect the uncertainty caused by missingness. For each outcome, 20 datasets will be imputed and analyzed, pooling the results.
Per protocol analyses will be conducted as sensitivity analyses, including participants with at least 75% adherence to the intervention, defined as completion of ≥3 of 4 scheduled intervention visits. In the Braining arm, additional adherence will be defined as completion of at least eight Braining sessions. This approach is intended to estimate the effect of the intervention under conditions of adequate adherence.
Sensitivity analyses will examine the impact of alternative ActivPAL data validity criteria by restricting the sample to participants with 4-7 valid days of ActivPAL data. This analysis is intended to evaluate the robustness of the results to different assumptions regarding accelerometer data completeness.
Subgroup analysis:
These analyses are considered secondary/exploratory and will be interpreted cautiously.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Braining | Experimental | A 12 week program where participants are encouraged to participate in physical exercise at the psychiatric unit. |
|
| Structured advice on physical activity | Active Comparator | Health interview and a 12 week program where participants are encouraged to engage in physical exercise outside the psychiatric setting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Braining | Behavioral | A 12 week program where participants are encouraged to participate in physical exercise at the psychiatric unit. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physical activity | Moderate to vigorous intensity physical activity (MVPA) objectively measured with the ActivPAL accelerometer, operationalized as >100 steps per minute (SPM) and potentially vigorous intensity physical activity (VPA) > 125 SPM with ActivPAL. | Change from Pre intervention start to 12 weeks post intervention start |
| Patient Health Questionnaire 9 (PHQ-9) | Self rated depressive symptoms. Minimum value 0, maximum value 27, where higher values indicate more depressive symptoms. | Change from Pre intervention start to 12 weeks post intervention start |
| Measure | Description | Time Frame |
|---|---|---|
| Physical activity | Moderate to vigorous intensity physical activity (MVPA) objectively measured with the ActivPAL accelerometer, operationalized as >100 Steps per minute (SPM) and potentially vigorous intensity physical activity (VPA) > 125 SPM with ActivPAL. | Change from Pre intervention start to 6 months post intervention start |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Region Stockholm, Psykiatri Sydväst (Psychiatric Clinic Psychiatry Southwest) | Stockholm | Stockholm County | 14186 | Sweden | ||
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| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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A randomized controlled superiority trial evaluating if the new method Braining is superior to structured advice on physical activity, 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.
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Intervention will be blinded to investigators during analysis of primary outcomes.
| Structured advice on physical activity | Behavioral | A 12 week program where participants are encouraged to engage in physical exercise |
|
|
| Physical activity |
Moderate to vigorous intensity physical activity (MVPA) objectively measured with the ActivPAL accelerometer, operationalized as >100 Steps per minute (SPM) and potentially vigorous intensity physical activity (VPA) > 125 SPM with ActivPAL. |
| Change from Pre intervention start to 12 months post intervention start |
| Self reported physical activity | Self-reported physical activity: Total physical activity as Metabolic Energy Turnover (MET)hours/week and three level categories (low, moderate and high). | Change from Pre intervention start to 12 weeks post intervention start |
| Self reported physical activity | Self-reported physical activity: Total physical activity as Metabolic Energy Turnover (MET)hours/week and three level categories (low, moderate and high). | Change from Pre intervention start to 6 months post intervention start |
| Self reported physical activity | Self-reported physical activity: Total physical activity as Metabolic Energy Turnover (MET)hours/week and three level categories (low, moderate and high). | Change from Pre intervention start to 12 months post intervention start |
| Patient Health Questionnaire 9 (PHQ-9) | Self rated depressive symptoms. Minimum value 0, maximum value 27, where higher values indicate more depressive symptoms. | Change from Pre intervention start to 6 months post intervention start |
| Patient Health Questionnaire 9 (PHQ-9) | Self rated depressive symptoms. Minimum value 0, maximum value 27, where higher values indicate more depressive symptoms. | Change from Pre intervention start to 12 months post intervention start |
| Generalised Anxiety Disorder 7-item scale (GAD-7) | Self rated anxiety symptoms. Minimum value 0, maximum value 21, where higher values indicate more anxiety symptoms. | Change from Pre intervention start to 12 weeks post intervention start |
| Generalised Anxiety Disorder 7-item scale (GAD-7) | Self rated anxiety symptoms. Minimum value 0, maximum value 21, where higher values indicate more anxiety symptoms. | Change from Pre intervention start to 6 months post intervention start |
| Generalised Anxiety Disorder 7-item scale (GAD-7) | Self rated anxiety symptoms. Minimum value 0, maximum value 21, where higher values indicate more anxiety symptoms. | Change from Pre intervention start to 12 months post intervention start |
| Insomnia Severity Index (ISI) | Self rated insomnia symptoms. Minimum value 0, maximum value 28, where higher values indicate more insomnia symptoms. | Change from Pre intervention start to 12 weeks post intervention start |
| Insomnia Severity Index (ISI) | Self rated insomnia symptoms. Minimum value 0, maximum value 28, where higher values indicate more insomnia symptoms. | Change from Pre intervention start to 6 months post intervention start |
| Insomnia Severity Index (ISI) | Self rated insomnia symptoms. Minimum value 0, maximum value 28, where higher values indicate more insomnia symptoms. | Change from Pre intervention start to 12 months post intervention start |
| The Work and Social Adjustment Scale (WSAS) | 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 | Change from Pre intervention start to 12 weeks post intervention start |
| The Work and Social Adjustment Scale (WSAS) | 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 | Change from Pre intervention start to 6 months post intervention start |
| The Work and Social Adjustment Scale (WSAS) | 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 | Change from Pre intervention start to 12 months post intervention start |
| EUROQOL 5 dimensions (EQ5D) | 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'. | Change from Pre intervention start to 12 weeks post intervention start |
| EUROQOL 5 dimensions (EQ5D) | 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'. | Change from Pre intervention start to 6 months post intervention start |
| EUROQOL 5 dimensions (EQ5D) | 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'. | Change from Pre intervention start to 12 months post intervention start |
| Quality Adjusted Life Years (QALY) | 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). | Change from 12-0 months pre intervention to 0-12 months post intervention |
| The incremental cost-effectiveness (ICER) | 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. | Change from 12-0 months pre intervention to 0-12 months post intervention |
| Blood pressure | systolic and diastolic, mmHg | Change from Pre intervention start to 12 weeks post intervention start |
| Blood pressure | systolic and diastolic, mmHg | Change from Pre intervention start to 6 months post intervention start |
| Blood pressure | systolic and diastolic, mmHg | Change from Pre intervention start to 12 months post intervention start |
| Body mass index (BMI) | Weight in kg divided by the square of height in m | Change from Pre intervention start to 12 weeks post intervention start |
| Body mass index (BMI) | Weight in kg divided by the square of height in m | Change from Pre intervention start to 6 months post intervention start |
| Body mass index (BMI) | Weight in kg divided by the square of height in m | Change from Pre intervention start to 12 months post intervention start |
| Waist circumference | Waist circumference, cm | Change from Pre intervention start to 12 weeks post intervention start |
| Waist circumference | Waist circumference, cm | Change from Pre intervention start to 6 months post intervention start |
| Waist circumference | Waist circumference, cm | Change from Pre intervention start to 12 months post intervention start |
| Heart rate (HR) | Heart rate, beats per minute, resting state | Change from Pre intervention start to 12 weeks post intervention start |
| Heart rate (HR) | Heart rate, beats per minute, resting state | Change from Pre intervention start to 6 months post intervention start |
| Heart rate (HR) | Heart rate, beats per minute, resting state | Change from Pre intervention start to 12 months post intervention start |
| fasting blood sugar (FBS) | fasting blood sugar, mmol/l | Change from Pre intervention start to 12 weeks post intervention start |
| fasting blood sugar (FBS) | fasting blood sugar, mmol/l | Change from Pre intervention start to 6 months post intervention start |
| fasting blood sugar (FBS) | fasting blood sugar, mmol/l | Change from Pre intervention start to 12 months post intervention start |
| Hemoglobin A1c (HbA1c) | Glycated hemoglobin, mmol/mol | Change from Pre intervention start to 12 weeks post intervention start |
| Hemoglobin A1c (HbA1c) | Glycated hemoglobin, mmol/mol | Change from Pre intervention start to 6 months post intervention start |
| Hemoglobin A1c (HbA1c) | Glycated hemoglobin, mmol/mol | Change from Pre intervention start to 12 months post intervention start |
| Blood lipids | Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L | Change from Pre intervention start to 12 weeks post intervention start |
| Blood lipids | Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L | Change from Pre intervention start to 6 months post intervention start |
| Blood lipids | Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L | Change from Pre intervention start to 12 months post intervention start |
| Sensitive C-reactive protein (CRP) | Measurement of inflammation and infection, mmol/L | Change from Pre intervention start to 12 weeks post intervention start |
| Sensitive C-reactive protein (CRP) | Measurement of inflammation and infection, mmol/L | Change from Pre intervention start to 6 months post intervention start |
| Sensitive C-reactive protein (CRP) | Measurement of inflammation and infection, mmol/L | Change from Pre intervention start to 12 months post intervention start |
| Complete blood count | 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. | Change from Pre intervention start to 12 weeks post intervention start |
| Complete blood count | 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. | Change from Pre intervention start to 6 months post intervention start |
| Complete blood count | 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. | Change from Pre intervention start to 12 months post intervention start |
| Negative effects | 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: | 12 weeks post inclusion |
| The Client Satisfaction Questionnaire-8 (CSQ-8) | Self rated satisfaction of treatment. Minimum value 8, maximum value 32 where higher values indicate greater satisfaction with the treatment. | 12 weeks post inclusion |
| The Credibility/Expectancy Questionnaire (CEQ) | Self rated Credibility of treatment. Minimum value 3, maximum value 27 for each factor, where higher values indicate greater Credibility/Expectancy of the treatment. | 2 weeks post inclusion |
| Difficulties in Emotion Regulation Scale, Brief Version (DERS-16) | Self rated difficulties in emotion regulation. The sum ranges from 16 to 80, where higher levels indicate greater difficulty in emotion regulation. | Change from Pre intervention start to 12 weeks post intervention start |
| Difficulties in Emotion Regulation Scale, Brief Version (DERS-16) | Self rated difficulties in emotion regulation. The sum ranges from 16 to 80, where higher levels indicate greater difficulty in emotion regulation. | Change from Pre intervention start to 6 months post intervention start |
| Difficulties in Emotion Regulation Scale, Brief Version (DERS-16) | Self rated difficulties in emotion regulation. The sum ranges from 16 to 80, where higher levels indicate greater difficulty in emotion regulation. | Change from Pre intervention start to 12 months post intervention start |
| Time Line follow back (TLFB) | Interview regarding alcohol and/or drug intake, measuring number of days with alcohol/drug consumption. | Change from Pre intervention start to 12 weeks post intervention start. |
| Time Line follow back (TLFB) | Interview regarding alcohol and/or drug intake, measuring number of days with alcohol/drug consumption. | Change from Pre intervention start to 6 months post intervention start. |
| Time Line follow back (TLFB) | Interview regarding alcohol and/or drug intake, measuring number of days with alcohol/drug consumption. | Change from Pre intervention start to 12 months post intervention start. |
| The Alcohol Use Disorders Identification Test (Audit - C) | AUDIT-C is an alcohol screen that can help identify patients who are hazardous drinkers or have active alcohol use disorders (including alcohol abuse or dependence). The AUDIT-C is scored on a scale of 0-12 (scores of 0 reflect no alcohol use). In men, a score of 4 or more is considered positive; in women, a score of 3 or more is considered positive. Generally, the higher the AUDIT-C score, the more likely it is that the patient's drinking is affecting his/her health and safety. | Change from Pre intervention start to 12 weeks post intervention start. |
| The Alcohol Use Disorders Identification Test (Audit - C) | AUDIT-C is an alcohol screen that can help identify patients who are hazardous drinkers or have active alcohol use disorders (including alcohol abuse or dependence). The AUDIT-C is scored on a scale of 0-12 (scores of 0 reflect no alcohol use). In men, a score of 4 or more is considered positive; in women, a score of 3 or more is considered positive. Generally, the higher the AUDIT-C score, the more likely it is that the patient's drinking is affecting his/her health and safety. | Change from Pre intervention start to 6 months post intervention start. |
| The Alcohol Use Disorders Identification Test (Audit - C) | AUDIT-C is an alcohol screen that can help identify patients who are hazardous drinkers or have active alcohol use disorders (including alcohol abuse or dependence). The AUDIT-C is scored on a scale of 0-12 (scores of 0 reflect no alcohol use). In men, a score of 4 or more is considered positive; in women, a score of 3 or more is considered positive. Generally, the higher the AUDIT-C score, the more likely it is that the patient's drinking is affecting his/her health and safety. | Change from Pre intervention start to 12 months post intervention start. |
| Physical Activity | Sit to stand transitions, steps per day, sedentary time, and time in light intensity physical activity measured with the ActivPAL accelerometer. | Change from Pre intervention start to 12 weeks post intervention start |
| Physical Activity | Sit to stand transitions, steps per day, sedentary time, and time in light intensity physical activity measured with the ActivPAL accelerometer. | Change from Pre intervention start to 6 months post intervention start. |
| Physical activity | Sit to stand transitions, steps per day, sedentary time, and time in light intensity physical activity measured with the ActivPAL accelerometer. | Change from pre intervention start to 12 months past intervention start. |
| Region Stockholm, Psykiatri Nordväst och Beroendecentrum, mottagningar Väsby |
| Upplands Vasby |
| Stockholm County |
| Sweden |
| Region Stockholm, Beroendecentrum, Magnus Huss | Stockholm | Sweden |
| Region Stockholm, Liljeholmsberget | Stockholm | Sweden |
| Region Stockholm, Psykiatri Södra, Andreashuset | Stockholm | Sweden |