Mental DisordersNCT06012149
Braining: Implementation of Physical Exercise for Patients in Specialist Psychiatry
A study testing Braining and Structured advice on physical activity in people with Mental Disorders, run by Region Stockholm at 5 sites in Sweden.
Trial summary
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: does Braining lead to increased physical exercise compared to structured advice on physical exercise? what effect does Braining… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Disorders
- What is being tested?
- Braining and Structured advice on physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 5 sitesSweden
- Study dates
- 27 Sep 2023to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient at one of the psychiatric units
Who cannot join
- Physically active with moderate to vigorous physical activity above recommendations from World Health Organization (WHO) during the last 4 weeks
- 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.
- Medical conditions such as heart or lung disease, infection, withdrawal, where heart rate-increasing physical activity is considered contraindicated due to Medical reasons.
- Physical disability that makes it impossible to move independently to the gym and performing the indicated exercise in the training sessions.
- Mental disability which means that you can not participate in group training.
- Difficulty speaking or understanding the Swedish language.
- Ongoing heavy substance use.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Sweden5 sites
Region Stockholm, Psykiatri Sydväst (Psychiatric Clinic Psychiatry Southwest)
Stockholm, Stockholm County, 14186
Region Stockholm, Beroendecentrum, Magnus Huss
Stockholm
Region Stockholm, Liljeholmsberget
Stockholm
Region Stockholm, Psykiatri Södra, Andreashuset
Stockholm
Region Stockholm, Psykiatri Nordväst och Beroendecentrum, mottagningar Väsby
Upplands Vasby, Stockholm County
About this study
Official title: Braining: Implementation of Physical Exercise for Patients in Specialist Psychiatry, Efficacy Evaluation in a Randomized Controlled Multicentre Trial
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:
Read more
- does Braining lead to increased physical exercise compared to structured advice on physical exercise?
- what effect does Braining have on mental and physical health, quality of life and functional level compared to structured advice on physical exercise?
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.
Read the 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:
- 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
- is included in regular healthcare fee, (free of charge)
- 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
- includes regular measurements (self-assessment questionnaires, blood samples, physical and mental health examination and education before and after the twelve-week exercise intervention)
- 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 (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:
- 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 structured advice on physical exercise regarding:
- Satisfaction with treatment
- Credibility of treatment
- Negative effects
- 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:
- Will explore whether continuous variables of baseline depression severity, according to PHQ-9, moderate treatment effects in PHQ-9 and ActivPAL/MVPA.
- Will explore whether continuous variables of baseline physical activity levels, according to ActivPAL/MVPA, moderate treatment effects in primary analysis in ActivPAL/MVPA and PHQ-9.
- Will be conducted among participants with metabolic syndrome, defined as the presence of three or more cardiometabolic risk factors.
These analyses are considered secondary/exploratory and will be interpreted cautiously.
- Conditions
- Mental Disorders
- Being tested
- Braining, Structured advice on physical activity
- Keywords
- physical exercise, mental disorders
- Medical subject headings
- Mental Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrainingBehavioural
A 12 week program where participants are encouraged to participate in physical exercise at the psychiatric unit.
Structured advice on physical activityBehavioural
Also called Advice on physical activity
A 12 week program where participants are encouraged to engage in physical exercise
| Study group | Role | What they receive |
|---|---|---|
| Braining | Experimental | A 12 week program where participants are encouraged to participate in physical exercise at the psychiatric unit. Receives: Behavioral: Braining |
| 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. Receives: Behavioral: Structured advice on physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from Pre intervention start to 12 weeks post intervention start
Secondary outcomes (63)
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.
Measured: Change from Pre intervention start to 6 months post intervention start
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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'.
Measured: 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'.
Measured: 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'.
Measured: 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).
Measured: 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.
Measured: Change from 12-0 months pre intervention to 0-12 months post intervention
Blood pressure
systolic and diastolic, mmHg
Measured: Change from Pre intervention start to 12 weeks post intervention start
Blood pressure
systolic and diastolic, mmHg
Measured: Change from Pre intervention start to 6 months post intervention start
Blood pressure
systolic and diastolic, mmHg
Measured: 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
Measured: 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
Measured: 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
Measured: Change from Pre intervention start to 12 months post intervention start
Waist circumference
Waist circumference, cm
Measured: Change from Pre intervention start to 12 weeks post intervention start
Waist circumference
Waist circumference, cm
Measured: Change from Pre intervention start to 6 months post intervention start
Waist circumference
Waist circumference, cm
Measured: Change from Pre intervention start to 12 months post intervention start
Heart rate (HR)
Heart rate, beats per minute, resting state
Measured: Change from Pre intervention start to 12 weeks post intervention start
Heart rate (HR)
Heart rate, beats per minute, resting state
Measured: Change from Pre intervention start to 6 months post intervention start
Heart rate (HR)
Heart rate, beats per minute, resting state
Measured: Change from Pre intervention start to 12 months post intervention start
fasting blood sugar (FBS)
fasting blood sugar, mmol/l
Measured: Change from Pre intervention start to 12 weeks post intervention start
fasting blood sugar (FBS)
fasting blood sugar, mmol/l
Measured: Change from Pre intervention start to 6 months post intervention start
fasting blood sugar (FBS)
fasting blood sugar, mmol/l
Measured: Change from Pre intervention start to 12 months post intervention start
Hemoglobin A1c (HbA1c)
Glycated hemoglobin, mmol/mol
Measured: Change from Pre intervention start to 12 weeks post intervention start
Hemoglobin A1c (HbA1c)
Glycated hemoglobin, mmol/mol
Measured: Change from Pre intervention start to 6 months post intervention start
Hemoglobin A1c (HbA1c)
Glycated hemoglobin, mmol/mol
Measured: Change from Pre intervention start to 12 months post intervention start
Blood lipids
Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L
Measured: Change from Pre intervention start to 12 weeks post intervention start
Blood lipids
Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L
Measured: Change from Pre intervention start to 6 months post intervention start
Blood lipids
Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L
Measured: Change from Pre intervention start to 12 months post intervention start
Sensitive C-reactive protein (CRP)
Measurement of inflammation and infection, mmol/L
Measured: Change from Pre intervention start to 12 weeks post intervention start
Sensitive C-reactive protein (CRP)
Measurement of inflammation and infection, mmol/L
Measured: Change from Pre intervention start to 6 months post intervention start
Sensitive C-reactive protein (CRP)
Measurement of inflammation and infection, mmol/L
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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:
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from pre intervention start to 12 months past intervention start.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start27 Sep 2023
- Primary completionJun 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisordersStudies of the same condition, open and under way.
- More trials run by Region StockholmThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012149
- Sponsor's protocol ID
- 2020-07130
- Status last verified
- Dec 2025
- First submitted
- 7 Jul 2023
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Braining: Implementation of Physical Exercise for Patients in Specialist Psychiatry, Efficacy Evaluation in a Randomized Controlled Multicentre Trial
- ClinicalTrials.gov ID
- NCT06012149
- Acronym / sponsor ID
- 2020-07130
- Conditions
- Mental Disorders
- Keywords
- physical exercise, mental disorders
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Karolinska Institutet
- Study start
- 27 Sep 2023 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- does Braining lead to increased physical exercise compared to structured advice on physical exercise?
- what effect does Braining have on mental and physical health, quality of life and functional level compared to structured advice on physical exercise?
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.
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:
- 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
- is included in regular healthcare fee, (free of charge)
- 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
- includes regular measurements (self-assessment questionnaires, blood samples, physical and mental health examination and education before and after the twelve-week exercise intervention)
- 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 (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:
- 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 structured advice on physical exercise regarding:
- Satisfaction with treatment
- Credibility of treatment
- Negative effects
- 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:
- Will explore whether continuous variables of baseline depression severity, according to PHQ-9, moderate treatment effects in PHQ-9 and ActivPAL/MVPA.
- Will explore whether continuous variables of baseline physical activity levels, according to ActivPAL/MVPA, moderate treatment effects in primary analysis in ActivPAL/MVPA and PHQ-9.
- Will be conducted among participants with metabolic syndrome, defined as the presence of three or more cardiometabolic risk factors.
These analyses are considered secondary/exploratory and will be interpreted cautiously.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Braining | Experimental | Behavioral: BrainingA 12 week program where participants are encouraged to participate in physical exercise at the psychiatric unit. |
| Structured advice on physical activity | Active comparator | Behavioral: Structured advice on physical activityHealth interview and a 12 week program where participants are encouraged to engage in physical exercise outside the psychiatric setting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient at one of the psychiatric units
Key exclusion criteria (7 listed)
- Physically active with moderate to vigorous physical activity above recommendations from World Health Organization (WHO) during the last 4 weeks
- 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.
- Medical conditions such as heart or lung disease, infection, withdrawal, where heart rate-increasing physical activity is considered contraindicated due to Medical reasons.
- Physical disability that makes it impossible to move independently to the gym and performing the indicated exercise in the training sessions.
- Mental disability which means that you can not participate in group training.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BrainingA 12 week program where participants are encouraged to participate in physical exercise at the psychiatric unit. | Behavioural | Braining |
| Structured advice on physical activityAlso: Advice on physical activityA 12 week program where participants are encouraged to engage in physical exercise | Behavioural | Structured advice on physical activity |
Primary outcome
Physical activity
Time frame: Change from Pre intervention start to 12 weeks post intervention start
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.
Patient Health Questionnaire 9 (PHQ-9)
Time frame: 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.
63 secondary outcomes
Physical activity
Time frame: Change from Pre intervention start to 6 months post intervention start
Physical activity
Time frame: Change from Pre intervention start to 12 months post intervention start
Self reported physical activity
Time frame: Change from Pre intervention start to 12 weeks post intervention start
Self reported physical activity
Time frame: Change from Pre intervention start to 6 months post intervention start
Self reported physical activity
Time frame: Change from Pre intervention start to 12 months post intervention start
Patient Health Questionnaire 9 (PHQ-9)
Time frame: Change from Pre intervention start to 6 months post intervention start
Patient Health Questionnaire 9 (PHQ-9)
Time frame: Change from Pre intervention start to 12 months post intervention start
Generalised Anxiety Disorder 7-item scale (GAD-7)
Time frame: Change from Pre intervention start to 12 weeks post intervention start
Generalised Anxiety Disorder 7-item scale (GAD-7)
Time frame: Change from Pre intervention start to 6 months post intervention start
Generalised Anxiety Disorder 7-item scale (GAD-7)
Time frame: Change from Pre intervention start to 12 months post intervention start
Insomnia Severity Index (ISI)
Time frame: Change from Pre intervention start to 12 weeks post intervention start
Insomnia Severity Index (ISI)
Time frame: Change from Pre intervention start to 6 months post intervention start
Insomnia Severity Index (ISI)
Time frame: Change from Pre intervention start to 12 months post intervention start
The Work and Social Adjustment Scale (WSAS)
Time frame: Change from Pre intervention start to 12 weeks post intervention start
The Work and Social Adjustment Scale (WSAS)
Time frame: Change from Pre intervention start to 6 months post intervention start
The Work and Social Adjustment Scale (WSAS)
Time frame: Change from Pre intervention start to 12 months post intervention start
EUROQOL 5 dimensions (EQ5D)
Time frame: Change from Pre intervention start to 12 weeks post intervention start
EUROQOL 5 dimensions (EQ5D)
Time frame: Change from Pre intervention start to 6 months post intervention start
EUROQOL 5 dimensions (EQ5D)
Time frame: Change from Pre intervention start to 12 months post intervention start
Quality Adjusted Life Years (QALY)
Time frame: Change from 12-0 months pre intervention to 0-12 months post intervention
The incremental cost-effectiveness (ICER)
Time frame: Change from 12-0 months pre intervention to 0-12 months post intervention
Blood pressure
Time frame: Change from Pre intervention start to 12 weeks post intervention start
Blood pressure
Time frame: Change from Pre intervention start to 6 months post intervention start
Blood pressure
Time frame: Change from Pre intervention start to 12 months post intervention start
Body mass index (BMI)
Time frame: Change from Pre intervention start to 12 weeks post intervention start
Body mass index (BMI)
Time frame: Change from Pre intervention start to 6 months post intervention start
Body mass index (BMI)
Time frame: Change from Pre intervention start to 12 months post intervention start
Waist circumference
Time frame: Change from Pre intervention start to 12 weeks post intervention start
Waist circumference
Time frame: Change from Pre intervention start to 6 months post intervention start
Waist circumference
Time frame: Change from Pre intervention start to 12 months post intervention start
Heart rate (HR)
Time frame: Change from Pre intervention start to 12 weeks post intervention start
Heart rate (HR)
Time frame: Change from Pre intervention start to 6 months post intervention start
Heart rate (HR)
Time frame: Change from Pre intervention start to 12 months post intervention start
fasting blood sugar (FBS)
Time frame: Change from Pre intervention start to 12 weeks post intervention start
fasting blood sugar (FBS)
Time frame: Change from Pre intervention start to 6 months post intervention start
fasting blood sugar (FBS)
Time frame: Change from Pre intervention start to 12 months post intervention start
Hemoglobin A1c (HbA1c)
Time frame: Change from Pre intervention start to 12 weeks post intervention start
Hemoglobin A1c (HbA1c)
Time frame: Change from Pre intervention start to 6 months post intervention start
Hemoglobin A1c (HbA1c)
Time frame: Change from Pre intervention start to 12 months post intervention start
Blood lipids
Time frame: Change from Pre intervention start to 12 weeks post intervention start
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Braining and Structured advice on physical activity in people with Mental Disorders, run by Region Stockholm at 5 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity (time frame: Change from Pre intervention start to 12 weeks post intervention start). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.