Physical Exercise as Adjunctive Therapy for Affective Disorder and Anxiety

Sponsor

Region Stockholm (Other)

Overall Status

Recruiting

CT.gov ID

NCT05157386

Collaborator

Karolinska Institutet (Other)

Enrollment

Location

29.4

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression Physical Inactivity Bipolar Disorder Anxiety Disorders Anxiety Posttraumatic Stress Disorder ADHD Autism Social Phobia Panic Disorder Generalized Anxiety Disorder Personality Disorders Insomnia Stress	Other: Braining

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.

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

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

Actual Study Start Date :

Dec 20, 2021

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Participants in Braining, years 2017-2020 Braining was primarily open for patients with a main or secondary diagnosis within affective disorder or anxiety syndromes, sleep disturbance or stress. Participants in Braining (n≈600), who have participated in three or more training sessions 2017-2020 (n≈250), and who agree to contribute to this study, will be included.	Other: 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.

Arm

Intervention/Treatment

Participants in Braining, years 2017-2020

Braining was primarily open for patients with a main or secondary diagnosis within affective disorder or anxiety syndromes, sleep disturbance or stress. Participants in Braining (n≈600), who have participated in three or more training sessions 2017-2020 (n≈250), and who agree to contribute to this study, will be included.

Other: 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.

Outcome Measures

Primary Outcome Measures

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.

Secondary Outcome Measures

AS-18 (Affective Self Assessment Scale - 18 items) [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.
AS-18 (Affective Self Assessment Scale - 18 items) [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.
YMRS (Young Ziegler Mania Rating Scale) [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.
YMRS (Young Ziegler Mania Rating Scale) [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.
LSAS (Liebowitz Social Anxiety Scale) [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.
LSAS (Liebowitz Social Anxiety Scale) [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.
PDSS (Panic Disorder Severity Scale) [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.
PDSS (Panic Disorder Severity Scale) [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.
AUDIT (Alcohol Use Disorders Identification Test) [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.
AUDIT (Alcohol Use Disorders Identification Test) [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.
DUDIT (Drug Use Disorders Identification Test) [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.
DUDIT (Drug Use Disorders Identification Test) [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.
HR (Heart Rate) [At the individual's start of participation in Braining (T0)]
Heart rate, bpm
HR (Heart Rate) [At inclusion (Ti)]
Heart rate, bpm
Waist circumference [At the individual's start of participation in Braining (T0)]
Waist circumference, cm
Waist circumference [At inclusion (Ti)]
Waist circumference, cm
Blood lipids [At the individual's start of participation in Braining (T0)]
Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L
Blood lipids [At inclusion (Ti)]
Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L
HbA1c [At the individual's start of participation in Braining (T0)]
Hemoglobin A1c, glycated hemoglobin, mmol/mol
HbA1c [At inclusion (Ti)]
Hemoglobin A1c, glycated hemoglobin, mmol/mol
CRP [At the individual's start of participation in Braining (T0)]
C-reactive protein, measurement of inflammation and infection, mmol/L
CRP [At inclusion (Ti)]
C-reactive protein, measurement of inflammation and infection, mmol/L
WHODAS 2.0 (WHO Disability Assessment Schedule) [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).
WHODAS 2.0 (WHO Disability Assessment Schedule) [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).
Occupational status [At the individual's start of participation in Braining (T0)]
Employment, unemployment, sick leave, early retirement, retirement pension
Occupational status [At inclusion (Ti)]
Employment, unemployment, sick leave, early retirement, retirement pension

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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