Physical Exercise as Adjunctive Therapy for Affective Disorder and Anxiety

  • End date
    Jun 24, 2024
  • participants needed
  • sponsor
    Region Stockholm
Updated on 24 March 2022
a 12
somatic symptoms


"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.


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:

  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.

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.

Condition Depression, Physical Inactivity, Bipolar Disorder, Anxiety Disorders, Anxiety, Posttraumatic Stress Disorder, ADHD, Autism, Social Phobia, Panic Disorder, Generalized Anxiety Disorder, Personality Disorders, Insomnia, Stress
Treatment Braining
Clinical Study IdentifierNCT05157386
SponsorRegion Stockholm
Last Modified on24 March 2022


Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact


Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider


Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 



Reply by • Private

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note