An interventional study of Braining in Mental Disorder, sponsored by Region Stockholm. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-09.
Sponsored by Region Stockholm · Not applicable, Interventional, and Treatment
Physical exercise (PE) shows beneficial effects on somatic and psychiatric symptoms. "Braining" is a clinical invention where psychiatric staff exercise together with patients to help patients start and execute PE regularly. In the present study the feasibility of the intervention will be evaluated, how Braining is perceived, and preliminary effects on health and physical activity among patients. The investigators hypothesize that patients' health and physical activity will increase after participation in Braining at the unit. Braining will be implemented at two psychiatric pilot units in Region Stockholm, Sweden. During 6 months patients will be included and treated in 12 weeks PE intervention periods. To measure feasibility patients will answer self-rating questionnaires and be invited to semi structured interviews after receiving the intervention. Health will be measured by physical examination and blood test as well as self-ratings of depression, anxiety, sleep, hypomania, and quality of life before the intervention, every 4 weeks during the intervention, post the intervention, and at follow-up 12 months post the intervention. Physical activity will be rated before, during, after the intervention and at follow-up 12 months post the intervention using International Physical Activity Questionnaires (IPAQ) and Actigraph. All patients that fulfill inclusion criteria at the units will be invited to participate in the study, approximately 50 individuals in total.
"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:
In the present study focus is on the feasibility of the intervention, how Braining is perceived, and preliminary effects on health and physical activity among patients. The research questions are:
Examined from the following points of view:
Patients´ experience of Braining is examined with self-assessments and in interviews after the end of the intervention. Data analysis Qualitative analysis: Recorded material from interviews is transcribed and analyzed based on the thematic analysis method according to Braun \& Clarke et al 2006). The method aims to understand the individual's perspective in relation to a particular phenomenon and is often used as an inductive hypothesis-generating approach. Continuous data will be analyzed using mixed effects models or t-test, nominal data analyzed mainly with chi2 test. In mixed effects models of differences between groups the interaction effect of group and time will be the central estimate.
2,107 studies on the registry are indexed under Mental Disorders; 416 are open to participants now.
This study's enrollment of 22 is below the median of 94 across 1,574 interventional studies indexed under Mental Disorders.
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Exclusion Criteria:
Patients are encouraged to participate in physical exercise at the psychiatric unit
Behavioral: Braining
"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 session 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.
Actigraph GT3x
Objectively measured physical activity and sedentary time: Total physical activity as counts/day and time spent in sedentary, low, moderate and vigorous intensity as min/day.
Time frame: Change from inclusion to follow up 3 months after inclusion
Actigraph GT3x
Objectively measured physical activity and sedentary time: Total physical activity as counts/day and time spent in sedentary, low, moderate and vigorous intensity as min/day.
Time frame: At follow up 12 months after intervention.
International Physical Activity Questionnaires (IPAQ)
Self-reported physical activity: Total physical activity as Metabolic Energy Turnover (MET)hours/week and three level categories (low, moderate and high).
Time frame: Change from inclusion to follow up 3 months after inclusion
International Physical Activity Questionnaires (IPAQ)
Self-reported physical activity: Total physical activity as Metabolic Energy Turnover (MET)hours/week and three level categories (low, moderate and high).
Time frame: At follow up 12 months after intervention.
Patient Health Questionnaire 9 (PHQ-9)
Self rated depressive symptoms. Minimum value 0, maximum value 27, where higher values indicate more depressive symptoms.
Time frame: Change from inclusion to follow up 3 months after inclusion
Patient Health Questionnaire 9 (PHQ-9)
Self rated depressive symptoms. Minimum value 0, maximum value 27, where higher values indicate more depressive symptoms.
Time frame: At follow up 12 months after intervention.
Alcohol Use Disorders Identification Test AUDIT
Self rated alcohol use. Minimum value 0, maximum value 32, where higher values indicate higher alcohol use.
Time frame: Change from inclusion to follow up 3 months after inclusion
Alcohol Use Disorders Identification Test AUDIT
Self rated alcohol use. Minimum value 0, maximum value 32, where higher values indicate higher alcohol use.
Time frame: At follow up 12 months after intervention.
Drug Use Disorders Identification Test DUDIT
Self rated drug use. Minimum value 0, maximum value 44, where higher values indicate higher drug use.
Time frame: Change from inclusion to follow up 3 months after inclusion
Drug Use Disorders Identification Test DUDIT
Self rated drug use. Minimum value 0, maximum value 44, where higher values indicate higher drug use.
Time frame: At follow up 12 months after intervention.
Brunnsviken Brief Quality of Life Questionnaire (BBQ)
Self rated quality of life. Minimum value 0, maximum value 96, where higher values indicate higher quality of life satisfaction.
Time frame: Change from inclusion to follow up 3 months after inclusion
Brunnsviken Brief Quality of Life Questionnaire (BBQ)
Self rated quality of life. Minimum value 0, maximum value 96, where higher values indicate higher quality of life satisfaction.
Time frame: At follow up 12 months after intervention.
Acceptability of treatment among patients
Semi-structured interviews
Time frame: At follow up 3-5 months after 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.
Time frame: Week 1 of treatment
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.
Time frame: post treatment, 12 weeks after enrollment
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.
Time frame: Change from inclusion to follow up 3 months after inclusion
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.
Time frame: At follow up 12 months after intervention.
Insomnia Severity Index (ISI)
Self rated insomnia symptoms. Minimum value 0, maximum value 28, where higher values indicate more insomnia symptoms.
Time frame: Change from inclusion to follow up 3 months after inclusion
Insomnia Severity Index (ISI)
Self rated insomnia symptoms. Minimum value 0, maximum value 28, where higher values indicate more insomnia symptoms.
Time frame: At follow up 12 months after intervention.
World health organization disability assessment schedule (WHODAS 2.0)
Self rated disability. Minimum value 0, maximum value 100, where higher values indicate more disability.
Time frame: Change from inclusion to follow up 3 months after inclusion
World health organization disability assessment schedule (WHODAS 2.0)
Self rated disability. Minimum value 0, maximum value 100, where higher values indicate more disability.
Time frame: At follow up 12 months after intervention.
Negative effects questionnaire (NEQ 20)
Self rated negative effects of treatment. Minimum value 0, maximum value 80, where higher values indicate more negative effects.
Time frame: post treatment, 12 weeks after enrollment
EuroQol (EQ-5D-5L) VAS
Self-assessment instrument for describing and valuing health. Defines health in terms of five dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Also included is an overall health rating on a 0-100 hash-marked, vertical visual analogue scale (EQ-VAS). Assessment the scores from the descriptive component can be reported as a five digit number ranging from 11111 (full health) to 55555 (worst health). A number of methods exist for analysing these five digit profiles. However, frequently they are converted to a single utility index using country specific value sets. A higher index number indicates a poorer self-assessed health.
Time frame: Change from inclusion to follow up 3 months after inclusion
EuroQol (EQ-5D-5L) VAS
Self-assessment instrument for describing and valuing health. Defines health in terms of five dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Also included is an overall health rating on a 0-100 hash-marked, vertical visual analogue scale (EQ-VAS). Assessment the scores from the descriptive component can be reported as a five digit number ranging from 11111 (full health) to 55555 (worst health). A number of methods exist for analysing these five digit profiles. However, frequently they are converted to a single utility index using country specific value sets. A higher index number indicates a poorer self-assessed health.
Time frame: At follow up 12 months after intervention.
Affective Self Rating Scale (AS-18)
Self-assessment of symptoms of depression and hypomania/mania. 9 items for depression and 9 items for mania. Score 0-72. A score of over 10 on the depressive or manic/hypomanic subscale should give rise to suspicion of ongoing depression and hypomania/mania respectively. Scores of over 10 on both the depressive and manic/hypomanic scale at the same time give may indicate an affective mixed state.
Time frame: Change from inclusion to follow up 3 months after inclusion
Affective Self Rating Scale (AS-18)
Self-assessment of symptoms of depression and hypomania/mania. 9 items for depression and 9 items for mania. Score 0-72. A score of over 10 on the depressive or manic/hypomanic subscale should give rise to suspicion of ongoing depression and hypomania/mania respectively. Scores of over 10 on both the depressive and manic/hypomanic scale at the same time give may indicate an affective mixed state.
Time frame: At follow up 12 months after intervention.
Blood pressure
systolic and diastolic, mmHg
Time frame: Change from inclusion to follow up 3 months after inclusion
Blood pressure
systolic and diastolic, mmHg
Time frame: At follow up 12 months after intervention.
Body mass index (BMI)
Weight in kg divided by the square of height in m
Time frame: Change from inclusion to follow up 3 months after inclusion
Body mass index (BMI)
Weight in kg divided by the square of height in m
Time frame: At follow up 12 months after intervention.
Waist circumference
Waist circumference, cm
Time frame: Change from inclusion to follow up 3 months after inclusion
Waist circumference
Waist circumference, cm
Time frame: At follow up 12 months after intervention.
Heart rate (HR)
Heart rate, beats per minute
Time frame: Change from inclusion to follow up 3 months after inclusion
Heart rate (HR)
Heart rate, beats per minute
Time frame: At follow up 12 months after intervention.
fasting blood sugar (FBS)
fasting blood sugar, mmol/l
Time frame: Change from inclusion to follow up 3 months after inclusion
fasting blood sugar (FBS)
fasting blood sugar, mmol/l
Time frame: At follow up 12 months after intervention.
Hemoglobin A1c (HbA1c)
Glycated hemoglobin, mmol/mol
Time frame: Change from inclusion to follow up 3 months after inclusion
hemoglobin A1c (HbA1c)
Glycated hemoglobin, mmol/mol
Time frame: At follow up 12 months after intervention.
Blood lipids
Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L
Time frame: Change from inclusion to follow up 3 months after inclusion
Blood lipids
Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L
Time frame: At follow up 12 months after intervention.
C-reactive protein (CRP)
Measurement of inflammation and infection, mmol/L
Time frame: Change from inclusion to follow up 3 months after inclusion
C-reactive protein (CRP)
Measurement of inflammation and infection, mmol/L
Time frame: At follow up 12 months after intervention.
Treatment Inventory of costs in patients with psychiatric disorders (TIC-P)
Work and illness measured by section C of Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P)
Time frame: Change from inclusion to follow up 3 months after inclusion
Treatment Inventory of costs in patients with psychiatric disorders (TIC-P)
Work and illness measured by section C of Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P)
Time frame: At follow up 12 months after intervention.
Thyroid releasing hormone (TSH)
Measurement of thyroid function, mUnits/L
Time frame: Change from inclusion to follow up 3 months after inclusion
Thyroid releasing hormone (TSH)
Thyroid releasing hormone, measurement of thyroid function, mUnits/L
Time frame: At follow up 12 months after intervention.
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.
Time frame: Change from inclusion to follow up 3 months after inclusion
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.
Time frame: At follow up 12 months after intervention.
Blood liver function test
Alanine transaminase (ALT) µkat/L, aspartate transaminase (AST) µkat/L, alkaline phosphatase (ALP) µkat/L albumin g/L, bilirubin µmol/L, gamma-glutamyltransferase (GGT) µkat/L, L-lactate dehydrogenase (LD) µkat/L
Time frame: Change from inclusion to follow up 3 months after inclusion
Blood liver function test
Alanine transaminase (ALT) µkat/L, aspartate transaminase (AST) µkat/L, alkaline phosphatase (ALP) µkat/L albumin g/L, bilirubin µmol/L, gamma-glutamyltransferase (GGT) µkat/L, L-lactate dehydrogenase (LD) µkat/L
Time frame: At follow up 12 months after intervention.
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Region Stockholm