Physical Exercise as Adjunctive Therapy for Affective Disorder and Anxiety

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Descriptives of the population — 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 — 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) — 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) — 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) — 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) — 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) — 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) — 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 — At the individual's start of participation in Braining (T0)
  Blood pressure, systolic and diastolic, mmHg
• Blood pressure — At inclusion (Ti)
  Blood pressure, systolic and diastolic, mmHg
• BMI (Body Mass Index) — 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) — At inclusion (Ti)
  Weight in kg divided by the square of height in m
• FBS (Fasting Blood Sugar) — At the individual's start of participation in Braining (T0)
  Fasting blood sugar, mmol/L
• FBS (Fasting Blood Sugar) — At inclusion (Ti)
  Fasting blood sugar, mmol/L
• EQ-5D ( EQ-5D™ is a trade mark of the EuroQol Group) — 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) — 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.

Trial sites (1)

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