Physical Exercise as Adjunctive Therapy for Affective Disorder and Anxiety

An observational study of Depression and Physical Inactivity, run by Region Stockholm at 1 site in Sweden.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Trial summary

"Braining" is a clinical method for physical exercise as adjunctive therapy in psychiatric care. The core components are personnel-led group training sessions and motivating contact with psychiatric staff, as well as measurement and evaluation before and after the training period of 12 weeks. Objective. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Depression, Physical Inactivity, Bipolar Disorder
What is being tested?: Braining
How many people: 50 participants
Where: 1 siteSweden
Study dates: 20 Dec 2021to Dec 2025
Phase: Observational
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
Adult, Older adult

Study population: Braining 2017-2020 was primarily open for patients with a main or secondary diagnosis in affective illness or anxiety syndromes, or with depression, anxiety, sleep disturbance or stress as sub-symptoms of other psychiatric disorder.

Who may be able to join

≥3 training sessions during the years 2017-2020

Who cannot join

<3 training sessions during the years 2017-2020
Does not speak Swedish
Care in accordance with the Compulsory Mental Care Act (Lagen om psykiatrisk tvångsvård, LPT)
Total lack of data at the start of participation in Braining
Deceased

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Region Stockholm, Psykiatri Sydväst (Psychiatric Clinic Psychiatry Southwest)
Stockholm, Stockholm County, 14186

Other trials in Sweden

About this study

Official title: Physical Exercise as Adjunctive Therapy for Affective Disorder and Anxiety - a Retrospective Study of the Braining Project 2017-2020 Regarding Feasibility, Participants and Changes in Symptoms, Function and Physical Parameters

Objective. This study aims to describe the clinical and demographic variables in the population of patients who participated in Braining 2017-2020, investigate the feasibility of Braining, and analyse perceived short-term effects and side effects of Braining regarding psychiatric and somatic symptoms.

Method. The project is a retrospective, descriptive study. Patients at Psykiatri Sydväst (PSV, Psychiatric Clinic Psychiatry Southwest, Stockholm) who participated in Braining 2017-2020 during at least 3 training sessions, will be asked for inclusion. Medical and demographic data, as well as patient treatment evaluations, are already available in medical records.

Additionally, an extended 2-year long-term follow-up will be carried out. This includes blood and hair sample, physical examination as well as qualitative interviews with a representative subgroup.

Read the detailed description

The method "Braining" is a clinical invention that helps patients to initiate and execute physical exercise (PE) regularly in psychiatric care. The core components are basic high performance group training sessions and motivational work led by the psychiatric staff. Braining is used as add-on treatment to regular psychiatric care (treatment as usual; TAU) and is included in the patient care plan. Braining is unique in that it:

Includes trained psychiatric clinical staff leading group exercise sessions together with patients from both out- and inpatient ward units in daily, high endurance group training sessions.
Is included in regular healthcare fee (free of charge).
Includes a motivational and educational visit (as either a group seminar or as an individual visit) at the start and end of a training period; usually 12 weeks.
Includes regular measurements (self-assessment questionnaires, blood samples, physical and mental health examination and education before and after the twelve week training period).
Includes short individual motivating visits before every training session, including assessment of day shape and fitness to participate.

The scientific purpose of the project is to:

Describe clinical and demographic variables in patients participating in Braining 2017-2020.
Investigate the feasibility of the Braining method (PE together with staff as adjunctive therapy in Psychiatric care).
Analyse perceived short-term effects and side effects of Braining regarding psychiatric and somatic symptoms (degree of psychiatric symptoms, changes in molecular and cardiovascular parameters, lifestyle patterns, level of functioning and perceived quality of life). Also, if possible, provide an estimate of what long-term effects that might be expected in coming long-term clinical follow-ups.
Investigate patients' long term experience of Braining participation through qualitative interviews as well as analyse status and change of biomolecular markers two years after inclusion.

Specific goals:

All patients at PSV who participated in Braining 2017-2020 during at least 3 training sessions and do not meet the exclusion criteria will be asked for inclusion. For this population the investigators plan to describe:

Demographic and medical variables (such as diagnosis, age, gender, functional level, staff-assessed severity of psychiatric disease, self-assessment scales for symptoms of depression, mania / hypomania, and anxiety, self-assessed health-related quality of life, degree of sick leave, ongoing pharmacological treatment, ongoing CBT (cognitive behavioral therapy), need for emergency visits, inpatient care, suicidal attempts).
Feasibility of the Braining method. Evaluation of the degree of participation in Braining (such as number of training sessions performed, participation over time, differences between subgroups, possible incidents) as well as the participants' experience of Braining (based on surveys and follow-up interviews: positive or negative subjective assessments of the method, to what extent is the method recommended to other patients). Adverse events.
Differences before and after Braining in terms of statistically significant change in [I] degree of psychiatric symptoms and function, [II] cardio metabolic factors such as blood pressure, BMI, waist measurement, weight, [III] molecular parameters such as serum concentration of blood lipids, fasting blood sugar, HbA1c, CRP, [IV] health-related quality of life, [V] level of social function (such as work/study/sick leave) and care needs (such as need of inpatient care, medicine, emergency visits), [VI] assessed severity of psychiatric disorder, [VII] lifestyle patterns such as exercise, sleep, diet, substance use.

Conditions: Depression, Physical Inactivity, Bipolar Disorder, Anxiety Disorders, Anxiety, Posttraumatic Stress Disorder
Being tested: Braining
Keywords: physical exercise, training, physical activity, treatment
Medical subject headings: Depression, Sedentary Behavior, Bipolar Disorder, Anxiety Disorders, Stress Disorders, Post-Traumatic, Attention Deficit Disorder with Hyperactivity, Autistic Disorder, Phobia, Social

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BrainingOther
Core components of Braining: Personnel-led training sessions, motivating contact with psychiatric staff, measurement and evaluation before and after the training period; usually 12 weeks. PE is added on to treatment as usual (TAU). The training sessions are moderate to intense aerobic group training, 30-45 minutes. Each training session is preceded by a short (5-10 minutes) individual meeting with staff including assessment of daily form, motivational work, and the opportunity to ask questions. The target frequency for participation is preferably at least three training sessions/week during a 12 week period. The training period for each patient begins with an informative and motivating group or individual lecture or and an individual introductory meeting with staff including psychiatric and somatic examination, self-assessment scales for symptoms and quality of life, and blood samples. The training period ends with a meeting with staff with follow-up on the parameters.

Study groups in NCT05157386
Study group	Role	What they receive
Participants in Braining, years 2017-2020		Braining was primarily open for patients with a main or secondary diagnosis within affective disorder or anxiety syndromes, sleep disturbance or stress. Participants in Braining (n≈600), who have participated in three or more training sessions 2017-2020 (n≈250), and who agree to contribute to this study, will be included. Receives: Other: Braining

What is being measured

The primary outcome is the main question the study is designed to answer.

Descriptives of the population
The investigators plan to describe the population from a socioeconomic, demographic and medical perspective. The study design is observational, and therefore not hypothesis-driven. The study design is is not a clinical trial.
Measured: 2017-2020
Feasibility - The population´s participation in Braining
The population's participation in terms of number of training sessions, participation over time, differences between subgroups. General description of how the participants experienced the method (common positive or negative subjective assessments of the method, the extent to which the method is recommended to other patients), based on the participants' treatment evaluations. Adverse events. The study design is observational, and therefore not hypothesis-driven. The study design is not a clinical trial.
Measured: 2017-2020
PHQ-9 (Patient Health Questionnaire - 9 items)
Self-assessment of symptoms of depression. Symptom assessment tool that measures health using nine items on 4-point scales and a 4-point scale for impact on daily life. Score 0-27. A higher value indicates worse symptoms of depression.
Measured: At the individual's start of participation in Braining (T0)
PHQ-9 (Patient Health Questionnaire - 9 items)
Self-assessment of symptoms of depression. Symptom assessment tool that measures health using nine items on 4-point scales and a 4-point scale for impact on daily life. Score 0-27. A higher value indicates worse symptoms of depression.
Measured: At inclusion (Ti)
GAD-7 (Generalised Anxiety Disorder Assessment - 7 items)
Self-assessment of symptoms of generalised anxiety. Symptom assessment tool that measures seven anxiety symptoms on 4-point scales. Score 0-21. A higher value indicates worse symptoms of general anxiety.
Measured: At the individual's start of participation in Braining (T0)
GAD-7 (Generalised Anxiety Disorder Assessment - 7 items)
Self-assessment of symptoms of generalised anxiety. Symptom assessment tool that measures seven anxiety symptoms on 4-point scales. Score 0-21. A higher value indicates worse symptoms of general anxiety.
Measured: At inclusion (Ti)
CGI-S (Clinical Global Impressions - Severity Scale)
A one-item clinician assessed measure which evaluates the severity of psychopathology from 1 to 7, where 1 is 'normal' and 7 is 'among the most extremely ill patients' by the question "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?".
Measured: At the individual's start of participation in Braining (T0)
CGI-S (Clinical Global Impressions - Severity Scale)
A one-item clinician assessed measure which evaluates the severity of psychopathology from 1 to 7, where 1 is 'normal' and 7 is 'among the most extremely ill patients' by the question "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?".
Measured: At inclusion (Ti)
Blood pressure
Blood pressure, systolic and diastolic, mmHg
Measured: At the individual's start of participation in Braining (T0)
Blood pressure
Blood pressure, systolic and diastolic, mmHg
Measured: At inclusion (Ti)
BMI (Body Mass Index)
Weight in kg divided by the square of height in m
Measured: At the individual's start of participation in Braining (T0)
BMI (Body Mass Index)
Weight in kg divided by the square of height in m
Measured: At inclusion (Ti)
FBS (Fasting Blood Sugar)
Fasting blood sugar, mmol/L
Measured: At the individual's start of participation in Braining (T0)
FBS (Fasting Blood Sugar)
Fasting blood sugar, mmol/L
Measured: At inclusion (Ti)
EQ-5D ( EQ-5D™ is a trade mark of the EuroQol Group)
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 33333 (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 the individual's start of participation in Braining (T0)
EQ-5D ( EQ-5D™ is a trade mark of the EuroQol Group)
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 33333 (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 inclusion (Ti)

Secondary outcomes (27)

AS-18 (Affective Self Assessment Scale - 18 items)
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 the individual's start of participation in Braining (T0)
AS-18 (Affective Self Assessment Scale - 18 items)
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 inclusion (Ti)
YMRS (Young Ziegler Mania Rating Scale)
Interviewer-rated scale. Includes 11 items; seven are rated from 0 (absent) to 4; four from 0 to 8; total scores range from 0 to 60. A higher value indicates worse symptoms of hypomania/mania.
Measured: At the individual's start of participation in Braining (T0)
YMRS (Young Ziegler Mania Rating Scale)
Interviewer-rated scale. Includes 11 items; seven are rated from 0 (absent) to 4; four from 0 to 8; total scores range from 0 to 60. A higher value indicates worse symptoms of hypomania/mania.
Measured: At inclusion (Ti)
LSAS (Liebowitz Social Anxiety Scale)
Self-assessment of symptoms of social anxiety. Comprises 24 social situations that are each rated for level of fear and avoidance. Score (including both subscales) 0-144. A higher value indicates worse symptoms of social anxiety.
Measured: At the individual's start of participation in Braining (T0)
LSAS (Liebowitz Social Anxiety Scale)
Self-assessment of symptoms of social anxiety. Comprises 24 social situations that are each rated for level of fear and avoidance. Score (including both subscales) 0-144. A higher value indicates worse symptoms of social anxiety.
Measured: At inclusion (Ti)
PDSS (Panic Disorder Severity Scale)
Self-assessment of symptoms of panic disorder. The 7-item scale assesses the frequency of panic attacks, distress during panic attacks, anticipatory anxiety, agoraphobic fear and avoidance, body-sensation fear and avoidance, and impairment in work and social functioning on 5-point scales (0-4). Score 0-28. A higher value indicates worse symptoms of panic disorder.
Measured: At the individual's start of participation in Braining (T0)
PDSS (Panic Disorder Severity Scale)
Self-assessment of symptoms of panic disorder. The 7-item scale assesses the frequency of panic attacks, distress during panic attacks, anticipatory anxiety, agoraphobic fear and avoidance, body-sensation fear and avoidance, and impairment in work and social functioning on 5-point scales (0-4). Score 0-28. A higher value indicates worse symptoms of panic disorder.
Measured: At inclusion (Ti)
AUDIT (Alcohol Use Disorders Identification Test)
Self-report instrument used to identify problematic use of alcohol. Value 0-40. A score of 8 for men and 6 for women is usually set as the clinical cut-off for problematic use. A higher value indicates more problematic use.
Measured: At the individual's start of participation in Braining (T0)
AUDIT (Alcohol Use Disorders Identification Test)
Self-report instrument used to identify problematic use of alcohol. Value 0-40. A score of 8 for men and 6 for women is usually set as the clinical cut-off for problematic use. A higher value indicates more problematic use.
Measured: At inclusion (Ti)
DUDIT (Drug Use Disorders Identification Test)
Self-report instrument used to identify problems with illegal drugs and/or prescription drugs. Value 0-44. A score of 6 for men and 2 for women is usually set as the clinical cut-off for harmful use. A higher value indicates more problematic use.
Measured: At the individual's start of participation in Braining (T0)
DUDIT (Drug Use Disorders Identification Test)
Self-report instrument used to identify problems with illegal drugs and/or prescription drugs. Value 0-44. A score of 6 for men and 2 for women is usually set as the clinical cut-off for harmful use. A higher value indicates more problematic use.
Measured: At inclusion (Ti)
HR (Heart Rate)
Heart rate, bpm
Measured: At the individual's start of participation in Braining (T0)
HR (Heart Rate)
Heart rate, bpm
Measured: At inclusion (Ti)
Waist circumference
Waist circumference, cm
Measured: At the individual's start of participation in Braining (T0)
Waist circumference
Waist circumference, cm
Measured: At inclusion (Ti)
Blood lipids
Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L
Measured: At the individual's start of participation in Braining (T0)
Blood lipids
Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L
Measured: At inclusion (Ti)
HbA1c
Hemoglobin A1c, glycated hemoglobin, mmol/mol
Measured: At the individual's start of participation in Braining (T0)
HbA1c
Hemoglobin A1c, glycated hemoglobin, mmol/mol
Measured: At inclusion (Ti)
CRP
C-reactive protein, measurement of inflammation and infection, mmol/L
Measured: At the individual's start of participation in Braining (T0)
CRP
C-reactive protein, measurement of inflammation and infection, mmol/L
Measured: At inclusion (Ti)
WHODAS 2.0 (WHO Disability Assessment Schedule)
Self-assessment of disability. Covering six domains concerning functioning: cognitive, mobility, self-care, getting along with people, life activities, and social participation. The summary score is converted into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability).
Measured: At the individual's start of participation in Braining (T0)
WHODAS 2.0 (WHO Disability Assessment Schedule)
Self-assessment of disability. Covering six domains concerning functioning: cognitive, mobility, self-care, getting along with people, life activities, and social participation. The summary score is converted into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability).
Measured: At inclusion (Ti)
Occupational status
Employment, unemployment, sick leave, early retirement, retirement pension
Measured: At the individual's start of participation in Braining (T0)
Occupational status
Employment, unemployment, sick leave, early retirement, retirement pension
Measured: At inclusion (Ti)
Acceptability of treatment method among patients
Semi-structured interviews. Qualitative technique that explores patients' experiences. No scale.
Measured: Follow-up 2 years after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Dec 2021Dec 2025

First posted15 Dec 2021
Study start20 Dec 2021
Primary completionDec 2025 (estimated)
Study completionDec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for DepressionStudies 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: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 50 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05157386
Sponsor's protocol ID: Braining Study 1 Retrospective
Status last verified: Aug 2025
First submitted: 9 Nov 2021
Last updated: 13 Aug 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Whiteford HA, Degenhardt L, Rehm J, Baxter AJ, Ferrari AJ, Erskine HE, Charlson FJ, Norman RE, Flaxman AD, Johns N, Burstein R, Murray CJ, Vos T. Global burden of disease attributable to mental and substance use disorders: findings from the Global Burden of Disease Study 2010. Lancet. 2013 Nov 9;382(9904):1575-86. doi: 10.1016/S0140-6736(13)61611-6. Epub 2013 Aug 29.
PubMed 23993280
Goodwin GM, Haddad PM, Ferrier IN, Aronson JK, Barnes T, Cipriani A, Coghill DR, Fazel S, Geddes JR, Grunze H, Holmes EA, Howes O, Hudson S, Hunt N, Jones I, Macmillan IC, McAllister-Williams H, Miklowitz DR, Morriss R, Munafo M, Paton C, Saharkian BJ, Saunders K, Sinclair J, Taylor D, Vieta E, Young AH. Evidence-based guidelines for treating bipolar disorder: Revised third edition recommendations from the British Association for Psychopharmacology. J Psychopharmacol. 2016 Jun;30(6):495-553. doi: 10.1177/0269881116636545. Epub 2016 Mar 15.
PubMed 26979387
Aylett E, Small N, Bower P. Exercise in the treatment of clinical anxiety in general practice - a systematic review and meta-analysis. BMC Health Serv Res. 2018 Jul 16;18(1):559. doi: 10.1186/s12913-018-3313-5.
PubMed 30012142
Melo MC, Daher Ede F, Albuquerque SG, de Bruin VM. Exercise in bipolar patients: A systematic review. J Affect Disord. 2016 Jul 1;198:32-8. doi: 10.1016/j.jad.2016.03.004. Epub 2016 Mar 15.
PubMed 26998794
Strohle A, Graetz B, Scheel M, Wittmann A, Feller C, Heinz A, Dimeo F. The acute antipanic and anxiolytic activity of aerobic exercise in patients with panic disorder and healthy control subjects. J Psychiatr Res. 2009 Aug;43(12):1013-7. doi: 10.1016/j.jpsychires.2009.02.004. Epub 2009 Mar 16.
PubMed 19289240
Hofmann SG, Asnaani A, Vonk IJ, Sawyer AT, Fang A. The Efficacy of Cognitive Behavioral Therapy: A Review of Meta-analyses. Cognit Ther Res. 2012 Oct 1;36(5):427-440. doi: 10.1007/s10608-012-9476-1. Epub 2012 Jul 31.
PubMed 23459093
Shafran R, Clark DM, Fairburn CG, Arntz A, Barlow DH, Ehlers A, Freeston M, Garety PA, Hollon SD, Ost LG, Salkovskis PM, Williams JM, Wilson GT. Mind the gap: Improving the dissemination of CBT. Behav Res Ther. 2009 Nov;47(11):902-9. doi: 10.1016/j.brat.2009.07.003. Epub 2009 Aug 6.
PubMed 19664756
Layard R, Clark DM. Why More Psychological Therapy Would Cost Nothing. Front Psychol. 2015 Nov 25;6:1713. doi: 10.3389/fpsyg.2015.01713. eCollection 2015. No abstract available.
PubMed 26635648
Wolitzky-Taylor K, Zimmermann M, Arch JJ, De Guzman E, Lagomasino I. Has evidence-based psychosocial treatment for anxiety disorders permeated usual care in community mental health settings? Behav Res Ther. 2015 Sep;72:9-17. doi: 10.1016/j.brat.2015.06.010. Epub 2015 Jul 2.
PubMed 26159908
Abosi O, Lopes S, Schmitz S, Fiedorowicz JG. Cardiometabolic effects of psychotropic medications. Horm Mol Biol Clin Investig. 2018 Jan 10;36(1):/j/hmbci.2018.36.issue-1/hmbci-2017-0065/hmbci-2017-0065.xml. doi: 10.1515/hmbci-2017-0065.
PubMed 29320364
Ekelund U, Tarp J, Steene-Johannessen J, Hansen BH, Jefferis B, Fagerland MW, Whincup P, Diaz KM, Hooker SP, Chernofsky A, Larson MG, Spartano N, Vasan RS, Dohrn IM, Hagstromer M, Edwardson C, Yates T, Shiroma E, Anderssen SA, Lee IM. Dose-response associations between accelerometry measured physical activity and sedentary time and all cause mortality: systematic review and harmonised meta-analysis. BMJ. 2019 Aug 21;366:l4570. doi: 10.1136/bmj.l4570.
PubMed 31434697
Cooney GM, Dwan K, Greig CA, Lawlor DA, Rimer J, Waugh FR, McMurdo M, Mead GE. Exercise for depression. Cochrane Database Syst Rev. 2013 Sep 12;2013(9):CD004366. doi: 10.1002/14651858.CD004366.pub6.
PubMed 24026850
Helgadottir B, Forsell Y, Ekblom O. Physical activity patterns of people affected by depressive and anxiety disorders as measured by accelerometers: a cross-sectional study. PLoS One. 2015 Jan 13;10(1):e0115894. doi: 10.1371/journal.pone.0115894. eCollection 2015.
PubMed 25585123
Mead GE, Morley W, Campbell P, Greig CA, McMurdo M, Lawlor DA. Exercise for depression. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD004366. doi: 10.1002/14651858.CD004366.pub3.
PubMed 18843656
Rimer J, Dwan K, Lawlor DA, Greig CA, McMurdo M, Morley W, Mead GE. Exercise for depression. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD004366. doi: 10.1002/14651858.CD004366.pub5.
PubMed 22786489

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Physical Exercise as Adjunctive Therapy for Affective Disorder and Anxiety - a Retrospective Study of the Braining Project 2017-2020 Regarding Feasibility, Participants and Changes in Symptoms, Function and Physical Parameters
ClinicalTrials.gov ID: NCT05157386
Acronym / sponsor ID: Braining Study 1 Retrospective
Conditions: Depression, Physical Inactivity, Bipolar Disorder, Anxiety Disorders, Anxiety, Posttraumatic Stress Disorder
Keywords: physical exercise, training, physical activity, treatment
Study type: Observational
Recruitment status: Active, not recruiting
Enrolment: 50 participants (estimated)
Lead sponsor: Region StockholmOther government
Collaborators: Karolinska Institutet
Study start: 20 Dec 2021 (actual)
Primary completion: Dec 2025 (estimated)
Study completion: Dec 2025 (estimated)
First posted: 15 Dec 2021 (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.

Additionally, an extended 2-year long-term follow-up will be carried out. This includes blood and hair sample, physical examination as well as qualitative interviews with a representative subgroup.

Detailed description

Includes trained psychiatric clinical staff leading group exercise sessions together with patients from both out- and inpatient ward units in daily, high endurance group training sessions.
Is included in regular healthcare fee (free of charge).
Includes a motivational and educational visit (as either a group seminar or as an individual visit) at the start and end of a training period; usually 12 weeks.
Includes regular measurements (self-assessment questionnaires, blood samples, physical and mental health examination and education before and after the twelve week training period).
Includes short individual motivating visits before every training session, including assessment of day shape and fitness to participate.

The scientific purpose of the project is to:

Describe clinical and demographic variables in patients participating in Braining 2017-2020.
Investigate the feasibility of the Braining method (PE together with staff as adjunctive therapy in Psychiatric care).
Analyse perceived short-term effects and side effects of Braining regarding psychiatric and somatic symptoms (degree of psychiatric symptoms, changes in molecular and cardiovascular parameters, lifestyle patterns, level of functioning and perceived quality of life). Also, if possible, provide an estimate of what long-term effects that might be expected in coming long-term clinical follow-ups.
Investigate patients' long term experience of Braining participation through qualitative interviews as well as analyse status and change of biomolecular markers two years after inclusion.

Specific goals:

Demographic and medical variables (such as diagnosis, age, gender, functional level, staff-assessed severity of psychiatric disease, self-assessment scales for symptoms of depression, mania / hypomania, and anxiety, self-assessed health-related quality of life, degree of sick leave, ongoing pharmacological treatment, ongoing CBT (cognitive behavioral therapy), need for emergency visits, inpatient care, suicidal attempts).
Feasibility of the Braining method. Evaluation of the degree of participation in Braining (such as number of training sessions performed, participation over time, differences between subgroups, possible incidents) as well as the participants' experience of Braining (based on surveys and follow-up interviews: positive or negative subjective assessments of the method, to what extent is the method recommended to other patients). Adverse events.
Differences before and after Braining in terms of statistically significant change in [I] degree of psychiatric symptoms and function, [II] cardio metabolic factors such as blood pressure, BMI, waist measurement, weight, [III] molecular parameters such as serum concentration of blood lipids, fasting blood sugar, HbA1c, CRP, [IV] health-related quality of life, [V] level of social function (such as work/study/sick leave) and care needs (such as need of inpatient care, medicine, emergency visits), [VI] assessed severity of psychiatric disorder, [VII] lifestyle patterns such as exercise, sleep, diet, substance use.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
Participants in Braining, years 2017-2020	–	Other: BrainingBraining was primarily open for patients with a main or secondary diagnosis within affective disorder or anxiety syndromes, sleep disturbance or stress. Participants in Braining (n≈600), who have participated in three or more training sessions 2017-2020 (n≈250), and who agree to contribute to this study, will be included.

Who may qualify

Ages: 18 years and older
Sex: All
Age groups: Adult, Older adult
Study population: Braining 2017-2020 was primarily open for patients with a main or secondary diagnosis in affective illness or anxiety syndromes, or with depression, anxiety, sleep disturbance or stress as sub-symptoms of other psychiatric disorder.

Key inclusion criteria (1 listed)

≥3 training sessions during the years 2017-2020

Key exclusion criteria (5 listed)

<3 training sessions during the years 2017-2020
Does not speak Swedish
Care in accordance with the Compulsory Mental Care Act (Lagen om psykiatrisk tvångsvård, LPT)
Total lack of data at the start of participation in Braining
Deceased

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
BrainingCore components of Braining: Personnel-led training sessions, motivating contact with psychiatric staff, measurement and evaluation before and after the training period; usually 12 weeks. PE is added on to treatment as usual (TAU). The training sessions are moderate to intense aerobic group training, 30-45 minutes. Each training session is preceded by a short (5-10 minutes) individual meeting with staff including assessment of daily form, motivational work, and the opportunity to ask questions. The target frequency for participation is preferably at least three training sessions/week during a 12 week period. The training period for each patient begins with an informative and motivating group or individual lecture or and an individual introductory meeting with staff including psychiatric and somatic examination, self-assessment scales for symptoms and quality of life, and blood samples. The training period ends with a meeting with staff with follow-up on the parameters.	Other	Participants in Braining, years 2017-2020

Primary outcome

Descriptives of the population
Time frame: 2017-2020
The investigators plan to describe the population from a socioeconomic, demographic and medical perspective. The study design is observational, and therefore not hypothesis-driven. The study design is is not a clinical trial.
Feasibility - The population´s participation in Braining
Time frame: 2017-2020
The population's participation in terms of number of training sessions, participation over time, differences between subgroups. General description of how the participants experienced the method (common positive or negative subjective assessments of the method, the extent to which the method is recommended to other patients), based on the participants' treatment evaluations. Adverse events. The study design is observational, and therefore not hypothesis-driven. The study design is not a clinical trial.
PHQ-9 (Patient Health Questionnaire - 9 items)
Time frame: At the individual's start of participation in Braining (T0)
Self-assessment of symptoms of depression. Symptom assessment tool that measures health using nine items on 4-point scales and a 4-point scale for impact on daily life. Score 0-27. A higher value indicates worse symptoms of depression.
PHQ-9 (Patient Health Questionnaire - 9 items)
Time frame: At inclusion (Ti)
Self-assessment of symptoms of depression. Symptom assessment tool that measures health using nine items on 4-point scales and a 4-point scale for impact on daily life. Score 0-27. A higher value indicates worse symptoms of depression.
GAD-7 (Generalised Anxiety Disorder Assessment - 7 items)
Time frame: At the individual's start of participation in Braining (T0)
Self-assessment of symptoms of generalised anxiety. Symptom assessment tool that measures seven anxiety symptoms on 4-point scales. Score 0-21. A higher value indicates worse symptoms of general anxiety.
GAD-7 (Generalised Anxiety Disorder Assessment - 7 items)
Time frame: At inclusion (Ti)
Self-assessment of symptoms of generalised anxiety. Symptom assessment tool that measures seven anxiety symptoms on 4-point scales. Score 0-21. A higher value indicates worse symptoms of general anxiety.
CGI-S (Clinical Global Impressions - Severity Scale)
Time frame: At the individual's start of participation in Braining (T0)
A one-item clinician assessed measure which evaluates the severity of psychopathology from 1 to 7, where 1 is 'normal' and 7 is 'among the most extremely ill patients' by the question "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?".
CGI-S (Clinical Global Impressions - Severity Scale)
Time frame: At inclusion (Ti)
A one-item clinician assessed measure which evaluates the severity of psychopathology from 1 to 7, where 1 is 'normal' and 7 is 'among the most extremely ill patients' by the question "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?".
Blood pressure
Time frame: At the individual's start of participation in Braining (T0)
Blood pressure, systolic and diastolic, mmHg
Blood pressure
Time frame: At inclusion (Ti)
Blood pressure, systolic and diastolic, mmHg
BMI (Body Mass Index)
Time frame: At the individual's start of participation in Braining (T0)
Weight in kg divided by the square of height in m
BMI (Body Mass Index)
Time frame: At inclusion (Ti)
Weight in kg divided by the square of height in m
FBS (Fasting Blood Sugar)
Time frame: At the individual's start of participation in Braining (T0)
Fasting blood sugar, mmol/L
FBS (Fasting Blood Sugar)
Time frame: At inclusion (Ti)
Fasting blood sugar, mmol/L
EQ-5D ( EQ-5D™ is a trade mark of the EuroQol Group)
Time frame: At the individual's start of participation in Braining (T0)
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 33333 (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.
EQ-5D ( EQ-5D™ is a trade mark of the EuroQol Group)
Time frame: At inclusion (Ti)
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 33333 (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.

27 secondary outcomes

AS-18 (Affective Self Assessment Scale - 18 items)
Time frame: At the individual's start of participation in Braining (T0)
AS-18 (Affective Self Assessment Scale - 18 items)
Time frame: At inclusion (Ti)
YMRS (Young Ziegler Mania Rating Scale)
Time frame: At the individual's start of participation in Braining (T0)
YMRS (Young Ziegler Mania Rating Scale)
Time frame: At inclusion (Ti)
LSAS (Liebowitz Social Anxiety Scale)
Time frame: At the individual's start of participation in Braining (T0)
LSAS (Liebowitz Social Anxiety Scale)
Time frame: At inclusion (Ti)
PDSS (Panic Disorder Severity Scale)
Time frame: At the individual's start of participation in Braining (T0)
PDSS (Panic Disorder Severity Scale)
Time frame: At inclusion (Ti)
AUDIT (Alcohol Use Disorders Identification Test)
Time frame: At the individual's start of participation in Braining (T0)
AUDIT (Alcohol Use Disorders Identification Test)
Time frame: At inclusion (Ti)
DUDIT (Drug Use Disorders Identification Test)
Time frame: At the individual's start of participation in Braining (T0)
DUDIT (Drug Use Disorders Identification Test)
Time frame: At inclusion (Ti)
HR (Heart Rate)
Time frame: At the individual's start of participation in Braining (T0)
HR (Heart Rate)
Time frame: At inclusion (Ti)
Waist circumference
Time frame: At the individual's start of participation in Braining (T0)
Waist circumference
Time frame: At inclusion (Ti)
Blood lipids
Time frame: At the individual's start of participation in Braining (T0)
Blood lipids
Time frame: At inclusion (Ti)
HbA1c
Time frame: At the individual's start of participation in Braining (T0)
HbA1c
Time frame: At inclusion (Ti)
CRP
Time frame: At the individual's start of participation in Braining (T0)
CRP
Time frame: At inclusion (Ti)
WHODAS 2.0 (WHO Disability Assessment Schedule)
Time frame: At the individual's start of participation in Braining (T0)
WHODAS 2.0 (WHO Disability Assessment Schedule)
Time frame: At inclusion (Ti)
Occupational status
Time frame: At the individual's start of participation in Braining (T0)
Occupational status
Time frame: At inclusion (Ti)
Acceptability of treatment method among patients
Time frame: Follow-up 2 years after inclusion

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 13 Aug 2025.
Background: PubMed 23993280Whiteford HA, Degenhardt L, Rehm J, Baxter AJ, Ferrari AJ, Erskine HE, Charlson FJ, Norman RE, Flaxman AD, Johns N, Burstein R, Murray CJ, Vos T. Global burden of disease attributable to mental and substance use disorders: findings from the Global Burden of Disease Study 2010. Lancet. 2013 Nov 9;382(9904):1575-86. doi: 10.1016/S0140-6736(13)61611-6. Epub 2013 Aug 29.
Background: PubMed 26979387Goodwin GM, Haddad PM, Ferrier IN, Aronson JK, Barnes T, Cipriani A, Coghill DR, Fazel S, Geddes JR, Grunze H, Holmes EA, Howes O, Hudson S, Hunt N, Jones I, Macmillan IC, McAllister-Williams H, Miklowitz DR, Morriss R, Munafo M, Paton C, Saharkian BJ, Saunders K, Sinclair J, Taylor D, Vieta E, Young AH. Evidence-based guidelines for treating bipolar disorder: Revised third edition recommendations from the British Association for Psychopharmacology. J Psychopharmacol. 2016 Jun;30(6):495-553. doi: 10.1177/0269881116636545. Epub 2016 Mar 15.
Background: PubMed 30012142Aylett E, Small N, Bower P. Exercise in the treatment of clinical anxiety in general practice - a systematic review and meta-analysis. BMC Health Serv Res. 2018 Jul 16;18(1):559. doi: 10.1186/s12913-018-3313-5.
Background: PubMed 26998794Melo MC, Daher Ede F, Albuquerque SG, de Bruin VM. Exercise in bipolar patients: A systematic review. J Affect Disord. 2016 Jul 1;198:32-8. doi: 10.1016/j.jad.2016.03.004. Epub 2016 Mar 15.
Background: PubMed 19289240Strohle A, Graetz B, Scheel M, Wittmann A, Feller C, Heinz A, Dimeo F. The acute antipanic and anxiolytic activity of aerobic exercise in patients with panic disorder and healthy control subjects. J Psychiatr Res. 2009 Aug;43(12):1013-7. doi: 10.1016/j.jpsychires.2009.02.004. Epub 2009 Mar 16.
Background: PubMed 23459093Hofmann SG, Asnaani A, Vonk IJ, Sawyer AT, Fang A. The Efficacy of Cognitive Behavioral Therapy: A Review of Meta-analyses. Cognit Ther Res. 2012 Oct 1;36(5):427-440. doi: 10.1007/s10608-012-9476-1. Epub 2012 Jul 31.
Background: PubMed 19664756Shafran R, Clark DM, Fairburn CG, Arntz A, Barlow DH, Ehlers A, Freeston M, Garety PA, Hollon SD, Ost LG, Salkovskis PM, Williams JM, Wilson GT. Mind the gap: Improving the dissemination of CBT. Behav Res Ther. 2009 Nov;47(11):902-9. doi: 10.1016/j.brat.2009.07.003. Epub 2009 Aug 6.
Background: PubMed 26635648Layard R, Clark DM. Why More Psychological Therapy Would Cost Nothing. Front Psychol. 2015 Nov 25;6:1713. doi: 10.3389/fpsyg.2015.01713. eCollection 2015. No abstract available.
Background: PubMed 26159908Wolitzky-Taylor K, Zimmermann M, Arch JJ, De Guzman E, Lagomasino I. Has evidence-based psychosocial treatment for anxiety disorders permeated usual care in community mental health settings? Behav Res Ther. 2015 Sep;72:9-17. doi: 10.1016/j.brat.2015.06.010. Epub 2015 Jul 2.
Background: PubMed 29320364Abosi O, Lopes S, Schmitz S, Fiedorowicz JG. Cardiometabolic effects of psychotropic medications. Horm Mol Biol Clin Investig. 2018 Jan 10;36(1):/j/hmbci.2018.36.issue-1/hmbci-2017-0065/hmbci-2017-0065.xml. doi: 10.1515/hmbci-2017-0065.
Background: PubMed 31434697Ekelund U, Tarp J, Steene-Johannessen J, Hansen BH, Jefferis B, Fagerland MW, Whincup P, Diaz KM, Hooker SP, Chernofsky A, Larson MG, Spartano N, Vasan RS, Dohrn IM, Hagstromer M, Edwardson C, Yates T, Shiroma E, Anderssen SA, Lee IM. Dose-response associations between accelerometry measured physical activity and sedentary time and all cause mortality: systematic review and harmonised meta-analysis. BMJ. 2019 Aug 21;366:l4570. doi: 10.1136/bmj.l4570.
Background: PubMed 24026850Cooney GM, Dwan K, Greig CA, Lawlor DA, Rimer J, Waugh FR, McMurdo M, Mead GE. Exercise for depression. Cochrane Database Syst Rev. 2013 Sep 12;2013(9):CD004366. doi: 10.1002/14651858.CD004366.pub6.
Swedish Professional Associations for Physical Activity (Yrkesföreningar för Fysisk Aktivitet, YFA). 2021. Physical Activity in the Prevention and Treatment of Disease (FYSS). 2021.Link provided by the sponsor.
World Health Organization. (2020). WHO guidelines on physical activity and sedentary behaviour: at a glance. World Health Organization.Link provided by the sponsor.
2018 Physical Activity Guidelines Advisory Committee. 2018 Physical Activity Guidelines Advisory Committee Scientific Report. Washington, DC: U.S. Department of Health and Human Services, 2018Link provided by the sponsor.
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.

Lina Martinsson, MD, PhD principal investigator

Karolinska Institute and Region Stockholm

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Depression and Physical Inactivity, 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 5 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 13 Aug 2025. 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?

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?

Descriptives of the population (time frame: 2017-2020). The study lists 16 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 NCT05157386, which also lists 15 linked publications.

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 13 Aug 2025.