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NCT Number: NCT06012149

Braining: Implementation of Physical Exercise for Patients in Specialist Psychiatry

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Mental Disorders Behavior Motor Activity

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Region Stockholm, Psykiatri Sydväst (Psychiatric Clinic Psychiatry Southwest), Stockholm, Stockholm County, Sweden

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient at one of the psychiatric units

Exclusion criteria

  • 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.

Treatment and study plan

Braining

Behavioral

A 12 week program where participants are encouraged to participate in physical exercise at the psychiatric unit.

Structured advice on physical activity

Behavioral

A 12 week program where participants are encouraged to engage in physical exercise

Other names: Advice on physical activity

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Physical activity

    Time frame: Change from Pre intervention start to 6 months 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.

  2. Physical activity

    Time frame: Change from Pre intervention start to 12 months 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.

  3. Self reported physical activity

    Time frame: 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).

  4. Self reported physical activity

    Time frame: 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).

  5. Self reported physical activity

    Time frame: 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).

  6. Patient Health Questionnaire 9 (PHQ-9)

    Time frame: 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.

  7. Patient Health Questionnaire 9 (PHQ-9)

    Time frame: 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.

  8. Generalised Anxiety Disorder 7-item scale (GAD-7)

    Time frame: 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.

  9. Generalised Anxiety Disorder 7-item scale (GAD-7)

    Time frame: 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.

  10. Generalised Anxiety Disorder 7-item scale (GAD-7)

    Time frame: 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.

  11. Insomnia Severity Index (ISI)

    Time frame: 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.

  12. Insomnia Severity Index (ISI)

    Time frame: 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.

  13. Insomnia Severity Index (ISI)

    Time frame: 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.

  14. The Work and Social Adjustment Scale (WSAS)

    Time frame: 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. The 5 items are scored 0-8 ranging from Not at-all-Slightly-Definitely-Markedly-Very-severely

  15. The Work and Social Adjustment Scale (WSAS)

    Time frame: 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. The 5 items are scored 0-8 ranging from Not at-all-Slightly-Definitely-Markedly-Very-severely

  16. The Work and Social Adjustment Scale (WSAS)

    Time frame: 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. The 5 items are scored 0-8 ranging from Not at-all-Slightly-Definitely-Markedly-Very-severely

  17. EUROQOL 5 dimensions (EQ5D)

    Time frame: 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'.

  18. EUROQOL 5 dimensions (EQ5D)

    Time frame: 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'.

  19. EUROQOL 5 dimensions (EQ5D)

    Time frame: 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'.

  20. Quality Adjusted Life Years (QALY)

    Time frame: 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).

  21. The incremental cost-effectiveness (ICER)

    Time frame: 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.

  22. Blood pressure

    Time frame: Change from Pre intervention start to 12 weeks post intervention start

    systolic and diastolic, mmHg

  23. Blood pressure

    Time frame: Change from Pre intervention start to 6 months post intervention start

    systolic and diastolic, mmHg

  24. Blood pressure

    Time frame: Change from Pre intervention start to 12 months post intervention start

    systolic and diastolic, mmHg

  25. Body mass index (BMI)

    Time frame: Change from Pre intervention start to 12 weeks post intervention start

    Weight in kg divided by the square of height in m

  26. Body mass index (BMI)

    Time frame: Change from Pre intervention start to 6 months post intervention start

    Weight in kg divided by the square of height in m

  27. Body mass index (BMI)

    Time frame: Change from Pre intervention start to 12 months post intervention start

    Weight in kg divided by the square of height in m

  28. Waist circumference

    Time frame: Change from Pre intervention start to 12 weeks post intervention start

    Waist circumference, cm

  29. Waist circumference

    Time frame: Change from Pre intervention start to 6 months post intervention start

    Waist circumference, cm

  30. Waist circumference

    Time frame: Change from Pre intervention start to 12 months post intervention start

    Waist circumference, cm

  31. Heart rate (HR)

    Time frame: Change from Pre intervention start to 12 weeks post intervention start

    Heart rate, beats per minute, resting state

  32. Heart rate (HR)

    Time frame: Change from Pre intervention start to 6 months post intervention start

    Heart rate, beats per minute, resting state

  33. Heart rate (HR)

    Time frame: Change from Pre intervention start to 12 months post intervention start

    Heart rate, beats per minute, resting state

  34. fasting blood sugar (FBS)

    Time frame: Change from Pre intervention start to 12 weeks post intervention start

    fasting blood sugar, mmol/l

  35. fasting blood sugar (FBS)

    Time frame: Change from Pre intervention start to 6 months post intervention start

    fasting blood sugar, mmol/l

  36. fasting blood sugar (FBS)

    Time frame: Change from Pre intervention start to 12 months post intervention start

    fasting blood sugar, mmol/l

  37. Hemoglobin A1c (HbA1c)

    Time frame: Change from Pre intervention start to 12 weeks post intervention start

    Glycated hemoglobin, mmol/mol

  38. Hemoglobin A1c (HbA1c)

    Time frame: Change from Pre intervention start to 6 months post intervention start

    Glycated hemoglobin, mmol/mol

  39. Hemoglobin A1c (HbA1c)

    Time frame: Change from Pre intervention start to 12 months post intervention start

    Glycated hemoglobin, mmol/mol

  40. Blood lipids

    Time frame: Change from Pre intervention start to 12 weeks post intervention start

    Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L

  41. Blood lipids

    Time frame: Change from Pre intervention start to 6 months post intervention start

    Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L

  42. Blood lipids

    Time frame: Change from Pre intervention start to 12 months post intervention start

    Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L

  43. Sensitive C-reactive protein (CRP)

    Time frame: Change from Pre intervention start to 12 weeks post intervention start

    Measurement of inflammation and infection, mmol/L

  44. Sensitive C-reactive protein (CRP)

    Time frame: Change from Pre intervention start to 6 months post intervention start

    Measurement of inflammation and infection, mmol/L

  45. Sensitive C-reactive protein (CRP)

    Time frame: Change from Pre intervention start to 12 months post intervention start

    Measurement of inflammation and infection, mmol/L

  46. Complete blood count

    Time frame: 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.

  47. Complete blood count

    Time frame: 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.

  48. Complete blood count

    Time frame: 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.

  49. Negative effects

    Time frame: 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:

  50. The Client Satisfaction Questionnaire-8 (CSQ-8)

    Time frame: 12 weeks post inclusion

    Self rated satisfaction of treatment. Minimum value 8, maximum value 32 where higher values indicate greater satisfaction with the treatment.

  51. The Credibility/Expectancy Questionnaire (CEQ)

    Time frame: 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.

  52. Difficulties in Emotion Regulation Scale, Brief Version (DERS-16)

    Time frame: 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.

  53. Difficulties in Emotion Regulation Scale, Brief Version (DERS-16)

    Time frame: 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.

  54. Difficulties in Emotion Regulation Scale, Brief Version (DERS-16)

    Time frame: 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.

  55. Time Line follow back (TLFB)

    Time frame: 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.

  56. Time Line follow back (TLFB)

    Time frame: 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.

  57. Time Line follow back (TLFB)

    Time frame: 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.

  58. The Alcohol Use Disorders Identification Test (Audit - C)

    Time frame: Change from Pre intervention start to 12 weeks post intervention start.

    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.

  59. The Alcohol Use Disorders Identification Test (Audit - C)

    Time frame: Change from Pre intervention start to 6 months post intervention start.

    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.

  60. The Alcohol Use Disorders Identification Test (Audit - C)

    Time frame: Change from Pre intervention start to 12 months post intervention start.

    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.

  61. Physical Activity

    Time frame: Change from Pre intervention start to 12 weeks post intervention start

    Sit to stand transitions, steps per day, sedentary time, and time in light intensity physical activity measured with the ActivPAL accelerometer.

  62. Physical Activity

    Time frame: Change from Pre intervention start to 6 months post intervention start.

    Sit to stand transitions, steps per day, sedentary time, and time in light intensity physical activity measured with the ActivPAL accelerometer.

  63. Physical activity

    Time frame: Change from pre intervention start to 12 months past intervention start.

    Sit to stand transitions, steps per day, sedentary time, and time in light intensity physical activity measured with the ActivPAL accelerometer.

Sponsors and collaborators

Lead sponsor

Region Stockholm

Other Gov

Collaborators

  • Karolinska Institutet

Registry information

Official study title

Braining: Implementation of Physical Exercise for Patients in Specialist Psychiatry, Efficacy Evaluation in a Randomized Controlled Multicentre Trial

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 25, 2023
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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