Physical Exercise as Adjunctive Therapy for Affective Disorder and Anxiety
NCT ID: NCT05157386
Last Updated: 2025-08-13
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
50 participants
OBSERVATIONAL
2021-12-20
2025-12-31
Brief Summary
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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.
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Detailed Description
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1. 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.
2. Is included in regular healthcare fee (free of charge).
3. 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.
4. Includes regular measurements (self-assessment questionnaires, blood samples, physical and mental health examination and education before and after the twelve week training period).
5. 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
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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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.
Braining
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.
Interventions
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Braining
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Karolinska Institutet
OTHER
Region Stockholm
OTHER_GOV
Responsible Party
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Principal Investigators
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Lina Martinsson, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institute and Region Stockholm
Locations
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Region Stockholm, Psykiatri Sydväst (Psychiatric Clinic Psychiatry Southwest)
Stockholm, Stockholm County, Sweden
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
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Swedish Professional Associations for Physical Activity (Yrkesföreningar för Fysisk Aktivitet, YFA). 2021. Physical Activity in the Prevention and Treatment of Disease (FYSS). 2021.
World Health Organization. (2020). WHO guidelines on physical activity and sedentary behaviour: at a glance. World Health Organization.
2018 Physical Activity Guidelines Advisory Committee. 2018 Physical Activity Guidelines Advisory Committee Scientific Report. Washington, DC: U.S. Department of Health and Human Services, 2018
Other Identifiers
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Braining Study 1 Retrospective
Identifier Type: -
Identifier Source: org_study_id
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