Physical Exercise as Adjunctive Therapy for Affective Disorder and Anxiety

NCT05157386 | Active Not Recruiting

• 1 other identifier: Braining Study 1 Retrospective
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Depression; Physical Inactivity; Bipolar Disorder; Anxiety Disorders; Anxiety; Posttraumatic Stress Disorder; ADHD; Autism; Social Phobia; Panic Disorder; Generalized Anxiety Disorder; Personality Disorders; Insomnia; Stress

Keywords

physical exercise; training; physical activity; treatment

Outcome Measures

Primary Outcomes (16)

• 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.

  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.

  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.

  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.

  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.

  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.

  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?".

  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?".

  At inclusion (Ti)

• Blood pressure

  Blood pressure, systolic and diastolic, mmHg

  At the individual's start of participation in Braining (T0)

• Blood pressure

  Blood pressure, systolic and diastolic, mmHg

  At inclusion (Ti)

• BMI (Body Mass Index)

  Weight in kg divided by the square of height in m

  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

  At inclusion (Ti)

• FBS (Fasting Blood Sugar)

  Fasting blood sugar, mmol/L

  At the individual's start of participation in Braining (T0)

• FBS (Fasting Blood Sugar)

  Fasting blood sugar, mmol/L

  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.

  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.

  At inclusion (Ti)

Secondary Outcomes (27)

• AS-18 (Affective Self Assessment Scale - 18 items)

  At the individual's start of participation in Braining (T0)

• AS-18 (Affective Self Assessment Scale - 18 items)

  At inclusion (Ti)

• YMRS (Young Ziegler Mania Rating Scale)

  At the individual's start of participation in Braining (T0)

• YMRS (Young Ziegler Mania Rating Scale)

  At inclusion (Ti)

• LSAS (Liebowitz Social Anxiety Scale)

  At the individual's start of participation in Braining (T0)

Study Arms (1)

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.

Other: Braining

Interventions

Braining OTHER

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.

Participants in Braining, years 2017-2020

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• ≥3 training sessions during the years 2017-2020

You may not qualify if:

• \<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

Sponsors & Collaborators

• Region Stockholm: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Region Stockholm, Psykiatri Sydväst (Psychiatric Clinic Psychiatry Southwest)

Stockholm, Stockholm County, 14186, Sweden

Location

Related Publications (15)

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• 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.

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• 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.

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Related Links

• 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

MeSH Terms

Conditions

Depression; Sedentary Behavior; Bipolar Disorder; Anxiety Disorders; Stress Disorders, Post-Traumatic; Attention Deficit Disorder with Hyperactivity; Autistic Disorder; Phobia, Social; Panic Disorder; Generalized Anxiety Disorder; Personality Disorders; Sleep Initiation and Maintenance Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Phobic Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Lina Martinsson, MD, PhD

  Karolinska Institute and Region Stockholm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: December 15, 2021
• Study Start: December 20, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)