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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Region Stockholm
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- CGI-S (Clinical Global Impressions - Severity Scale)
Study Overview
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.
Detailed Description
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:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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?".
Blood pressure
Time Frame: At inclusion (Ti)
Blood pressure, systolic and diastolic, mmHg
BMI (Body Mass Index)
Time Frame: At inclusion (Ti)
Weight in kg divided by the square of height in m
FBS (Fasting Blood Sugar)
Time Frame: At inclusion (Ti)
Fasting blood sugar, mmol/L
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.
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.
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.
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.
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.
Secondary Outcomes
- LSAS (Liebowitz Social Anxiety Scale)(At inclusion (Ti))
- PDSS (Panic Disorder Severity Scale)(At inclusion (Ti))
- AUDIT (Alcohol Use Disorders Identification Test)(At inclusion (Ti))
- CRP(At inclusion (Ti))
- HR (Heart Rate)(At inclusion (Ti))
- YMRS (Young Ziegler Mania Rating Scale)(At inclusion (Ti))
- DUDIT (Drug Use Disorders Identification Test)(At inclusion (Ti))
- WHODAS 2.0 (WHO Disability Assessment Schedule)(At inclusion (Ti))
- AS-18 (Affective Self Assessment Scale - 18 items)(At inclusion (Ti))
- Blood lipids(At inclusion (Ti))
- Waist circumference(At inclusion (Ti))
- HbA1c(At inclusion (Ti))
- Occupational status(At inclusion (Ti))
- Acceptability of treatment method among patients(Follow-up 2 years after inclusion)