Mental DisorderNCT05186688
Braining - Physical Exercise in Psychiatry - Evaluation of Feasibility, and Health Among Patients
A study testing Braining in people with Mental Disorder, run by Region Stockholm at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Disorder
- What is being tested?
- Braining
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteSweden
- Study dates
- 2 Mar 2022to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 the psychiatric unit
Who cannot join
- 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, abstinence 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
1 site in 1 country.
About this study
Official title: Braining Study - Implementation of Physical Activity for Patients and Staff in Specialist Psychiatry, Feasibility on Pilot Unit and Effect Evaluation in Randomized Controlled Multi-center Study.
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.
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.
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:
- How do patients experience Braining in regards such as feasibility, acceptability, credibility, and effects on health and quality of life?
- How do patients comply to Braining regarding completed training sessions and measurements?
- What preliminary effect does Braining have on mental and physical health, quality of life and level of function in participating patients before compared to after short- and long-term exposure?
Examined from the following points of view:
- psychiatric symptoms, such as depression, hypomania, anxiety, insomnia?
- Somatic symptoms, such as blood pressure, resting heart rate, BMI, waist circumference, occurrence of somatic co-morbidity? Braining is to be implemented at 2 psychiatric care units starting nov 2021. Approximately 50 patients will be included. Planned design is an open trial study with monthly measurements during ongoing intervention (weeks 1, 4, 8 and 12) and one follow-up (12 months post inclusion). Physical activity level is measured with Actigraph and IPAQ 1 week before, 6 weeks in, after the intervention and at follow up.
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.
- Conditions
- Mental Disorder
- Being tested
- Braining
- 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
"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.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity | Experimental | Patients are encouraged to participate in physical exercise at the psychiatric unit Receives: Behavioral: Braining |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At follow up 12 months after intervention.
Acceptability of treatment among patients
Semi-structured interviews
Measured: 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.
Measured: 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.
Measured: post treatment, 12 weeks after enrollment
Secondary outcomes (35)
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 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At follow up 12 months after intervention.
Blood pressure
systolic and diastolic, mmHg
Measured: Change from inclusion to follow up 3 months after inclusion
Blood pressure
systolic and diastolic, mmHg
Measured: At follow up 12 months after intervention.
Body mass index (BMI)
Weight in kg divided by the square of height in m
Measured: 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
Measured: At follow up 12 months after intervention.
Waist circumference
Waist circumference, cm
Measured: Change from inclusion to follow up 3 months after inclusion
Waist circumference
Waist circumference, cm
Measured: At follow up 12 months after intervention.
Heart rate (HR)
Heart rate, beats per minute
Measured: Change from inclusion to follow up 3 months after inclusion
Heart rate (HR)
Heart rate, beats per minute
Measured: At follow up 12 months after intervention.
fasting blood sugar (FBS)
fasting blood sugar, mmol/l
Measured: Change from inclusion to follow up 3 months after inclusion
fasting blood sugar (FBS)
fasting blood sugar, mmol/l
Measured: At follow up 12 months after intervention.
Hemoglobin A1c (HbA1c)
Glycated hemoglobin, mmol/mol
Measured: Change from inclusion to follow up 3 months after inclusion
hemoglobin A1c (HbA1c)
Glycated hemoglobin, mmol/mol
Measured: At follow up 12 months after intervention.
Blood lipids
Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L
Measured: Change from inclusion to follow up 3 months after inclusion
Blood lipids
Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L
Measured: At follow up 12 months after intervention.
C-reactive protein (CRP)
Measurement of inflammation and infection, mmol/L
Measured: Change from inclusion to follow up 3 months after inclusion
C-reactive protein (CRP)
Measurement of inflammation and infection, mmol/L
Measured: 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)
Measured: 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)
Measured: At follow up 12 months after intervention.
Thyroid releasing hormone (TSH)
Measurement of thyroid function, mUnits/L
Measured: Change from inclusion to follow up 3 months after inclusion
Thyroid releasing hormone (TSH)
Thyroid releasing hormone, measurement of thyroid function, mUnits/L
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: At follow up 12 months after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start2 Mar 2022
- Primary completion31 Jul 2022
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental DisorderStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186688
- Sponsor's protocol ID
- Braining feasibility
- Status last verified
- Nov 2024
- First submitted
- 25 Dec 2021
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Anger A, Kaaman L, Mac R, Holmberg J, Jayaram-Lindstrom N, Lundgren T, Hagstromer M, Sundberg CJ, Martinsson L, Salomonsson S. Braining, structured physical activity in specialized psychiatry for patients with substance use disorders-a feasibility study. Pilot Feasibility Stud. 2026 Aug 6;12(1):107. doi: 10.1186/s40814-026-01898-4.
PubMed 42563183
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Braining Study - Implementation of Physical Activity for Patients and Staff in Specialist Psychiatry, Feasibility on Pilot Unit and Effect Evaluation in Randomized Controlled Multi-center Study.
- ClinicalTrials.gov ID
- NCT05186688
- Acronym / sponsor ID
- Braining feasibility
- Conditions
- Mental Disorder
- Keywords
- physical exercise, mental disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Karolinska Institutet
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 11 Jan 2022 (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.
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.
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.
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:
- How do patients experience Braining in regards such as feasibility, acceptability, credibility, and effects on health and quality of life?
- How do patients comply to Braining regarding completed training sessions and measurements?
- What preliminary effect does Braining have on mental and physical health, quality of life and level of function in participating patients before compared to after short- and long-term exposure?
Examined from the following points of view:
- psychiatric symptoms, such as depression, hypomania, anxiety, insomnia?
- Somatic symptoms, such as blood pressure, resting heart rate, BMI, waist circumference, occurrence of somatic co-morbidity? Braining is to be implemented at 2 psychiatric care units starting nov 2021. Approximately 50 patients will be included. Planned design is an open trial study with monthly measurements during ongoing intervention (weeks 1, 4, 8 and 12) and one follow-up (12 months post inclusion). Physical activity level is measured with Actigraph and IPAQ 1 week before, 6 weeks in, after the intervention and at follow up.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physical activity | Experimental | Behavioral: BrainingPatients are encouraged to participate in physical exercise at the psychiatric unit |
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 the psychiatric unit
Key exclusion criteria (6 listed)
- 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, abstinence 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.
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 |
|---|---|---|
| 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. | Behavioural | Physical activity |
Primary outcome
Actigraph GT3x
Time frame: Change from inclusion to follow up 3 months after inclusion
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.
Actigraph GT3x
Time frame: At follow up 12 months after intervention.
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.
International Physical Activity Questionnaires (IPAQ)
Time frame: Change from inclusion to follow up 3 months after inclusion
Self-reported physical activity: Total physical activity as Metabolic Energy Turnover (MET)hours/week and three level categories (low, moderate and high).
International Physical Activity Questionnaires (IPAQ)
Time frame: At follow up 12 months after intervention.
Self-reported physical activity: Total physical activity as Metabolic Energy Turnover (MET)hours/week and three level categories (low, moderate and high).
Patient Health Questionnaire 9 (PHQ-9)
Time frame: Change from inclusion to follow up 3 months after inclusion
Self rated depressive symptoms. Minimum value 0, maximum value 27, where higher values indicate more depressive symptoms.
Patient Health Questionnaire 9 (PHQ-9)
Time frame: At follow up 12 months after intervention.
Self rated depressive symptoms. Minimum value 0, maximum value 27, where higher values indicate more depressive symptoms.
Alcohol Use Disorders Identification Test AUDIT
Time frame: Change from inclusion to follow up 3 months after inclusion
Self rated alcohol use. Minimum value 0, maximum value 32, where higher values indicate higher alcohol use.
Alcohol Use Disorders Identification Test AUDIT
Time frame: At follow up 12 months after intervention.
Self rated alcohol use. Minimum value 0, maximum value 32, where higher values indicate higher alcohol use.
Drug Use Disorders Identification Test DUDIT
Time frame: Change from inclusion to follow up 3 months after inclusion
Self rated drug use. Minimum value 0, maximum value 44, where higher values indicate higher drug use.
Drug Use Disorders Identification Test DUDIT
Time frame: At follow up 12 months after intervention.
Self rated drug use. Minimum value 0, maximum value 44, where higher values indicate higher drug use.
Brunnsviken Brief Quality of Life Questionnaire (BBQ)
Time frame: Change from inclusion to follow up 3 months after inclusion
Self rated quality of life. Minimum value 0, maximum value 96, where higher values indicate higher quality of life satisfaction.
Brunnsviken Brief Quality of Life Questionnaire (BBQ)
Time frame: At follow up 12 months after intervention.
Self rated quality of life. Minimum value 0, maximum value 96, where higher values indicate higher quality of life satisfaction.
Acceptability of treatment among patients
Time frame: At follow up 3-5 months after inclusion
Semi-structured interviews
The Credibility/Expectancy Questionnaire (CEQ)
Time frame: Week 1 of treatment
Self rated Credibility of treatment. Minimum value 3, maximum value 27 for each factor, where higher values indicate greater Credibility/Expectancy of the treatment.
The Client Satisfaction Questionnaire-8 (CSQ-8)
Time frame: post treatment, 12 weeks after enrollment
Self rated satisfaction of treatment. Minimum value 8, maximum value 32 where higher values indicate greater satisfaction with the treatment.
35 secondary outcomes
Generalised Anxiety Disorder 7-item scale (GAD-7)
Time frame: Change from inclusion to follow up 3 months after inclusion
Generalised Anxiety Disorder 7-item scale (GAD-7)
Time frame: At follow up 12 months after intervention.
Insomnia Severity Index (ISI)
Time frame: Change from inclusion to follow up 3 months after inclusion
Insomnia Severity Index (ISI)
Time frame: At follow up 12 months after intervention.
World health organization disability assessment schedule (WHODAS 2.0)
Time frame: Change from inclusion to follow up 3 months after inclusion
World health organization disability assessment schedule (WHODAS 2.0)
Time frame: At follow up 12 months after intervention.
Negative effects questionnaire (NEQ 20)
Time frame: post treatment, 12 weeks after enrollment
EuroQol (EQ-5D-5L) VAS
Time frame: Change from inclusion to follow up 3 months after inclusion
EuroQol (EQ-5D-5L) VAS
Time frame: At follow up 12 months after intervention.
Affective Self Rating Scale (AS-18)
Time frame: Change from inclusion to follow up 3 months after inclusion
Affective Self Rating Scale (AS-18)
Time frame: At follow up 12 months after intervention.
Blood pressure
Time frame: Change from inclusion to follow up 3 months after inclusion
Blood pressure
Time frame: At follow up 12 months after intervention.
Body mass index (BMI)
Time frame: Change from inclusion to follow up 3 months after inclusion
Body mass index (BMI)
Time frame: At follow up 12 months after intervention.
Waist circumference
Time frame: Change from inclusion to follow up 3 months after inclusion
Waist circumference
Time frame: At follow up 12 months after intervention.
Heart rate (HR)
Time frame: Change from inclusion to follow up 3 months after inclusion
Heart rate (HR)
Time frame: At follow up 12 months after intervention.
fasting blood sugar (FBS)
Time frame: Change from inclusion to follow up 3 months after inclusion
fasting blood sugar (FBS)
Time frame: At follow up 12 months after intervention.
Hemoglobin A1c (HbA1c)
Time frame: Change from inclusion to follow up 3 months after inclusion
hemoglobin A1c (HbA1c)
Time frame: At follow up 12 months after intervention.
Blood lipids
Time frame: Change from inclusion to follow up 3 months after inclusion
Blood lipids
Time frame: At follow up 12 months after intervention.
C-reactive protein (CRP)
Time frame: Change from inclusion to follow up 3 months after inclusion
C-reactive protein (CRP)
Time frame: At follow up 12 months after intervention.
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)
Time frame: At follow up 12 months after intervention.
Thyroid releasing hormone (TSH)
Time frame: Change from inclusion to follow up 3 months after inclusion
Thyroid releasing hormone (TSH)
Time frame: At follow up 12 months after intervention.
Complete blood count
Time frame: Change from inclusion to follow up 3 months after inclusion
Complete blood count
Time frame: At follow up 12 months after intervention.
Blood liver function test
Time frame: Change from inclusion to follow up 3 months after inclusion
Blood liver function test
Time frame: At follow up 12 months after intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Derived from this study: PubMed 42563183Anger A, Kaaman L, Mac R, Holmberg J, Jayaram-Lindstrom N, Lundgren T, Hagstromer M, Sundberg CJ, Martinsson L, Salomonsson S. Braining, structured physical activity in specialized psychiatry for patients with substance use disorders-a feasibility study. Pilot Feasibility Stud. 2026 Aug 6;12(1):107. doi: 10.1186/s40814-026-01898-4.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Braining in people with Mental Disorder, run by Region Stockholm at 1 site 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 6 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: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Actigraph GT3x (time frame: Change from inclusion to follow up 3 months after inclusion). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05186688, which also lists 1 linked publication.
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 9 Dec 2024.