Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05157386

Physical Exercise as Adjunctive Therapy for Affective Disorder and Anxiety

"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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Depression ADHD Anxiety Anxiety Disorders Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Autism Autism Spectrum Disorder Autistic Disorder Behavior Behavioral Symptoms Bipolar Disorder Bipolar and Related Disorders Child Development Disorders, Pervasive Dyssomnias Generalized Anxiety Disorder Insomnia Mental Disorders Mood Disorders Motor Activity Nervous System Diseases Neurodevelopmental Disorders Panic Disorder Personality Disorders Phobia, Social Phobic Disorders Physical Inactivity Posttraumatic Stress Disorder Sedentary Behavior Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Social Phobia Stress Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Region Stockholm, Psykiatri Sydväst (Psychiatric Clinic Psychiatry Southwest)

Stockholm, Stockholm County, 14186, Sweden

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥3 training sessions during the years 2017-2020

Exclusion criteria

  • <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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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?".

  8. 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?".

  9. Blood pressure

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

    Blood pressure, systolic and diastolic, mmHg

  10. Blood pressure

    Time frame: At inclusion (Ti)

    Blood pressure, systolic and diastolic, mmHg

  11. 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

  12. BMI (Body Mass Index)

    Time frame: At inclusion (Ti)

    Weight in kg divided by the square of height in m

  13. FBS (Fasting Blood Sugar)

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

    Fasting blood sugar, mmol/L

  14. FBS (Fasting Blood Sugar)

    Time frame: At inclusion (Ti)

    Fasting blood sugar, mmol/L

  15. 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.

  16. 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.

Secondary outcomes

  1. AS-18 (Affective Self Assessment Scale - 18 items)

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

    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.

  2. AS-18 (Affective Self Assessment Scale - 18 items)

    Time frame: At inclusion (Ti)

    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.

  3. YMRS (Young Ziegler Mania Rating Scale)

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

    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.

  4. YMRS (Young Ziegler Mania Rating Scale)

    Time frame: At inclusion (Ti)

    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.

  5. LSAS (Liebowitz Social Anxiety Scale)

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

    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.

  6. LSAS (Liebowitz Social Anxiety Scale)

    Time frame: At inclusion (Ti)

    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.

  7. PDSS (Panic Disorder Severity Scale)

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

    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.

  8. PDSS (Panic Disorder Severity Scale)

    Time frame: At inclusion (Ti)

    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.

  9. AUDIT (Alcohol Use Disorders Identification Test)

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

    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.

  10. AUDIT (Alcohol Use Disorders Identification Test)

    Time frame: At inclusion (Ti)

    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.

  11. DUDIT (Drug Use Disorders Identification Test)

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

    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.

  12. DUDIT (Drug Use Disorders Identification Test)

    Time frame: At inclusion (Ti)

    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.

  13. HR (Heart Rate)

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

    Heart rate, bpm

  14. HR (Heart Rate)

    Time frame: At inclusion (Ti)

    Heart rate, bpm

  15. Waist circumference

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

    Waist circumference, cm

  16. Waist circumference

    Time frame: At inclusion (Ti)

    Waist circumference, cm

  17. Blood lipids

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

    Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L

  18. Blood lipids

    Time frame: At inclusion (Ti)

    Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L

  19. HbA1c

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

    Hemoglobin A1c, glycated hemoglobin, mmol/mol

  20. HbA1c

    Time frame: At inclusion (Ti)

    Hemoglobin A1c, glycated hemoglobin, mmol/mol

  21. CRP

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

    C-reactive protein, measurement of inflammation and infection, mmol/L

  22. CRP

    Time frame: At inclusion (Ti)

    C-reactive protein, measurement of inflammation and infection, mmol/L

  23. WHODAS 2.0 (WHO Disability Assessment Schedule)

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

    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).

  24. WHODAS 2.0 (WHO Disability Assessment Schedule)

    Time frame: At inclusion (Ti)

    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).

  25. Occupational status

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

    Employment, unemployment, sick leave, early retirement, retirement pension

  26. Occupational status

    Time frame: At inclusion (Ti)

    Employment, unemployment, sick leave, early retirement, retirement pension

  27. Acceptability of treatment method among patients

    Time frame: Follow-up 2 years after inclusion

    Semi-structured interviews. Qualitative technique that explores patients' experiences. No scale.

Sponsors and collaborators

Lead sponsor

Region Stockholm

Other Gov

Collaborators

  • Karolinska Institutet

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Dec 15, 2021
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.