Clinical trial NCT05157386: Physical Exercise as Adjunctive Therapy for Affective Disorder and Anxiety
Official 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
Collaborators: name: Karolinska Institutet
First posted: 2021-12-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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:

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.
* 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.

Eligibility criteria: 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

Primary outcomes:
measure: Descriptives of the population
timeFrame: 2017-2020
measure: Feasibility - The population´s participation in Braining
timeFrame: 2017-2020
measure: PHQ-9 (Patient Health Questionnaire - 9 items)
timeFrame: At the individual's start of participation in Braining (T0)
measure: PHQ-9 (Patient Health Questionnaire - 9 items)
timeFrame: At inclusion (Ti)
measure: GAD-7 (Generalised Anxiety Disorder Assessment - 7 items)
timeFrame: At the individual's start of participation in Braining (T0)
measure: GAD-7 (Generalised Anxiety Disorder Assessment - 7 items)
timeFrame: At inclusion (Ti)
measure: CGI-S (Clinical Global Impressions - Severity Scale)
timeFrame: At the individual's start of participation in Braining (T0)
measure: CGI-S (Clinical Global Impressions - Severity Scale)
timeFrame: At inclusion (Ti)
measure: Blood pressure
timeFrame: At the individual's start of participation in Braining (T0)
measure: Blood pressure
timeFrame: At inclusion (Ti)
measure: BMI (Body Mass Index)
timeFrame: At the individual's start of participation in Braining (T0)
measure: BMI (Body Mass Index)
timeFrame: At inclusion (Ti)
measure: FBS (Fasting Blood Sugar)
timeFrame: At the individual's start of participation in Braining (T0)
measure: FBS (Fasting Blood Sugar)
timeFrame: At inclusion (Ti)
measure: EQ-5D ( EQ-5D™ is a trade mark of the EuroQol Group)
timeFrame: At the individual's start of participation in Braining (T0)
measure: EQ-5D ( EQ-5D™ is a trade mark of the EuroQol Group)
timeFrame: At inclusion (Ti)
Secondary outcomes:
measure: AS-18 (Affective Self Assessment Scale - 18 items)
timeFrame: At the individual's start of participation in Braining (T0)
measure: AS-18 (Affective Self Assessment Scale - 18 items)
timeFrame: At inclusion (Ti)
measure: YMRS (Young Ziegler Mania Rating Scale)
timeFrame: At the individual's start of participation in Braining (T0)
measure: YMRS (Young Ziegler Mania Rating Scale)
timeFrame: At inclusion (Ti)
measure: LSAS (Liebowitz Social Anxiety Scale)
timeFrame: At the individual's start of participation in Braining (T0)
measure: LSAS (Liebowitz Social Anxiety Scale)
timeFrame: At inclusion (Ti)
measure: PDSS (Panic Disorder Severity Scale)
timeFrame: At the individual's start of participation in Braining (T0)
measure: PDSS (Panic Disorder Severity Scale)
timeFrame: At inclusion (Ti)
measure: AUDIT (Alcohol Use Disorders Identification Test)
timeFrame: At the individual's start of participation in Braining (T0)
measure: AUDIT (Alcohol Use Disorders Identification Test)
timeFrame: At inclusion (Ti)
measure: DUDIT (Drug Use Disorders Identification Test)
timeFrame: At the individual's start of participation in Braining (T0)
measure: DUDIT (Drug Use Disorders Identification Test)
timeFrame: At inclusion (Ti)
measure: HR (Heart Rate)
timeFrame: At the individual's start of participation in Braining (T0)
measure: HR (Heart Rate)
timeFrame: At inclusion (Ti)
measure: Waist circumference
timeFrame: At the individual's start of participation in Braining (T0)
measure: Waist circumference
timeFrame: At inclusion (Ti)
measure: Blood lipids
timeFrame: At the individual's start of participation in Braining (T0)
measure: Blood lipids
timeFrame: At inclusion (Ti)
measure: HbA1c
timeFrame: At the individual's start of participation in Braining (T0)
measure: HbA1c
timeFrame: At inclusion (Ti)
measure: CRP
timeFrame: At the individual's start of participation in Braining (T0)
measure: CRP
timeFrame: At inclusion (Ti)
measure: WHODAS 2.0 (WHO Disability Assessment Schedule)
timeFrame: At the individual's start of participation in Braining (T0)
measure: WHODAS 2.0 (WHO Disability Assessment Schedule)
timeFrame: At inclusion (Ti)
measure: Occupational status
timeFrame: At the individual's start of participation in Braining (T0)
measure: Occupational status
timeFrame: At inclusion (Ti)
measure: Acceptability of treatment method among patients
timeFrame: Follow-up 2 years after inclusion
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Region Stockholm, Psykiatri Sydväst (Psychiatric Clinic Psychiatry Southwest)
Study officials:
affiliation: Karolinska Institute and Region Stockholm
name: Lina Martinsson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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