Braining - Physical Exercise in Psychiatry - Evaluation of Feasibility, and Health Among Patients

Mental Disorder Clinical Trial

Official title:

Braining Study - Implementation of Physical Activity for Patients and Staff in Specialist Psychiatry, Feasibility on Pilot Unit and Effect Evaluation in Randomized Controlled Multi-center Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05186688
• Other study ID #: Braining feasibility
• Status: Completed
• Phase: N/A
• Start date: March 2, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2023
• Source: Region Stockholm
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Physical exercise (PE) shows beneficial effects on somatic and psychiatric symptoms. "Braining" is a clinical invention where psychiatric staff exercise together with patients to help patients start and execute PE regularly. In the present study the feasibility of the intervention will be evaluated, how Braining is perceived, and preliminary effects on health and physical activity among patients. The investigators hypothesize that patients' health and physical activity will increase after participation in Braining at the unit. Braining will be implemented at two psychiatric pilot units in Region Stockholm, Sweden. During 6 months patients will be included and treated in 12 weeks PE intervention periods. To measure feasibility patients will answer self-rating questionnaires and be invited to semi structured interviews after receiving the intervention. Health will be measured by physical examination and blood test as well as self-ratings of depression, anxiety, sleep, hypomania, and quality of life before the intervention, every 4 weeks during the intervention, post the intervention, and at follow-up 12 months post the intervention. Physical activity will be rated before, during, after the intervention and at follow-up 12 months post the intervention using International Physical Activity Questionnaires (IPAQ) and Actigraph. All patients that fulfill inclusion criteria at the units will be invited to participate in the study, approximately 50 individuals in total.

Description:

"Braining" is a clinical invention that helps patients in psychiatry to start and execute physical exercise (PE) regularly in psychiatric care. The core components are basic moderate to vigorous aerobic group training sessions and motivational work led by the psychiatric staff. Braining is used as add-on treatment to regular psychiatric care and is included in the patient care plan. Braining is unique in that it:

1. Includes trained psychiatric clinical staff exercising together with patients from both out- and inpatient ward units in daily, moderate to vigorous aerobic group training sessions

2. is included in regular healthcare fee, (free of charge)

3. includes a motivational and educational visit (as a group seminar or as an individual visit) at the start and end of a twelve-week exercise intervention

4. includes regular measurements (self-assessment questionnaires, blood samples, physical and mental health examination and education before and after the twelve-week exercise intervention)

5. offers short individual motivating visits before every training session, including assessment of day shape and fitness to participate.

In the present study focus is on the feasibility of the intervention, how Braining is perceived, and preliminary effects on health and physical activity among patients. The research questions are:

1. How do patients experience Braining in regards such as feasibility, acceptability, credibility, and effects on health and quality of life?

2. How do patients comply to Braining regarding completed training sessions and measurements?

3. What preliminary effect does Braining have on mental and physical health, quality of life and level of function in participating patients before compared to after short- and long-term exposure?

Examined from the following points of view:

• psychiatric symptoms, such as depression, hypomania, anxiety, insomnia?

• Somatic symptoms, such as blood pressure, resting heart rate, BMI, waist circumference, occurrence of somatic co-morbidity? Braining is to be implemented at 2 psychiatric care units starting nov 2021. Approximately 50 patients will be included. Planned design is an open trial study with monthly measurements during ongoing intervention (weeks 1, 4, 8 and 12) and one follow-up (12 months post inclusion). Physical activity level is measured with Actigraph and IPAQ 1 week before, 6 weeks in, after the intervention and at follow up.

Patients´ experience of Braining is examined with self-assessments and in interviews after the end of the intervention. Data analysis Qualitative analysis: Recorded material from interviews is transcribed and analyzed based on the thematic analysis method according to Braun & Clarke et al 2006). The method aims to understand the individual's perspective in relation to a particular phenomenon and is often used as an inductive hypothesis-generating approach. Continuous data will be analyzed using mixed effects models or t-test, nominal data analyzed mainly with chi2 test. In mixed effects models of differences between groups the interaction effect of group and time will be the central estimate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 30, 2023
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient at the psychiatric unit

Exclusion Criteria:

• Severe mental disorder such as ongoing mania, psychosis, and conditions when high risk of suicide or high risk of violence available according to the assessment of psychiatric staff at the unit.

• Medical conditions such as heart or lung disease, infection, abstinence where heart rate-increasing physical activity is considered contraindicated due to Medical reasons.

• Physical disability that makes it impossible to move independently to the gym and performing the indicated exercise in the training sessions.

• Mental disability which means that you can not participate in group training.

• Difficulty speaking or understanding the Swedish language.

• Ongoing heavy substance use.

Related Conditions & MeSH terms

• Mental Disorder
• Mental Disorders
• Psychotic Disorders

Intervention

Behavioral:
• Braining
"Braining" is a clinical invention that helps patients in psychiatry to start and execute physical exercise (PE) regularly in psychiatric care. The core components are basic moderate to vigorous aerobic group training session and motivational work led by the psychiatric staff. Braining is used as add-on treatment to regular psychiatric care and is included in the patient care plan.

Locations

Country	Name	City	State
Sweden	Region Stockholm, Liljeholmsberget	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Region Stockholm	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Actigraph GT3x	Objectively measured physical activity and sedentary time: Total physical activity as counts/day and time spent in sedentary, low, moderate and vigorous intensity as min/day.	Change from inclusion to follow up 3 months after inclusion
Primary	Actigraph GT3x	Objectively measured physical activity and sedentary time: Total physical activity as counts/day and time spent in sedentary, low, moderate and vigorous intensity as min/day.	At follow up 12 months after intervention.
Primary	International Physical Activity Questionnaires (IPAQ)	Self-reported physical activity: Total physical activity as Metabolic Energy Turnover (MET)hours/week and three level categories (low, moderate and high).	Change from inclusion to follow up 3 months after inclusion
Primary	International Physical Activity Questionnaires (IPAQ)	Self-reported physical activity: Total physical activity as Metabolic Energy Turnover (MET)hours/week and three level categories (low, moderate and high).	At follow up 12 months after intervention.
Primary	Patient Health Questionnaire 9 (PHQ-9)	Self rated depressive symptoms. Minimum value 0, maximum value 27, where higher values indicate more depressive symptoms.	Change from inclusion to follow up 3 months after inclusion
Primary	Patient Health Questionnaire 9 (PHQ-9)	Self rated depressive symptoms. Minimum value 0, maximum value 27, where higher values indicate more depressive symptoms.	At follow up 12 months after intervention.
Primary	Alcohol Use Disorders Identification Test AUDIT	Self rated alcohol use. Minimum value 0, maximum value 32, where higher values indicate higher alcohol use.	Change from inclusion to follow up 3 months after inclusion
Primary	Alcohol Use Disorders Identification Test AUDIT	Self rated alcohol use. Minimum value 0, maximum value 32, where higher values indicate higher alcohol use.	At follow up 12 months after intervention.
Primary	Drug Use Disorders Identification Test DUDIT	Self rated drug use. Minimum value 0, maximum value 44, where higher values indicate higher drug use.	Change from inclusion to follow up 3 months after inclusion
Primary	Drug Use Disorders Identification Test DUDIT	Self rated drug use. Minimum value 0, maximum value 44, where higher values indicate higher drug use.	At follow up 12 months after intervention.
Primary	Brunnsviken Brief Quality of Life Questionnaire (BBQ)	Self rated quality of life. Minimum value 0, maximum value 96, where higher values indicate higher quality of life satisfaction.	Change from inclusion to follow up 3 months after inclusion
Primary	Brunnsviken Brief Quality of Life Questionnaire (BBQ)	Self rated quality of life. Minimum value 0, maximum value 96, where higher values indicate higher quality of life satisfaction.	At follow up 12 months after intervention.
Primary	Acceptability of treatment among patients	Semi-structured interviews	At follow up 3-5 months after inclusion
Primary	The Credibility/Expectancy Questionnaire (CEQ)	Self rated Credibility of treatment. Minimum value 3, maximum value 27 for each factor, where higher values indicate greater Credibility/Expectancy of the treatment.	Week 1 of treatment
Primary	The Client Satisfaction Questionnaire-8 (CSQ-8)	Self rated satisfaction of treatment. Minimum value 8, maximum value 32 where higher values indicate greater satisfaction with the treatment.	post treatment, 12 weeks after enrollment
Secondary	Generalised Anxiety Disorder 7-item scale (GAD-7)	Self rated anxiety symptoms. Minimum value 0, maximum value 21, where higher values indicate more anxiety symptoms.	Change from inclusion to follow up 3 months after inclusion
Secondary	Generalised Anxiety Disorder 7-item scale (GAD-7)	Self rated anxiety symptoms. Minimum value 0, maximum value 21, where higher values indicate more anxiety symptoms.	At follow up 12 months after intervention.
Secondary	Insomnia Severity Index (ISI)	Self rated insomnia symptoms. Minimum value 0, maximum value 28, where higher values indicate more insomnia symptoms.	Change from inclusion to follow up 3 months after inclusion
Secondary	Insomnia Severity Index (ISI)	Self rated insomnia symptoms. Minimum value 0, maximum value 28, where higher values indicate more insomnia symptoms.	At follow up 12 months after intervention.
Secondary	World health organization disability assessment schedule (WHODAS 2.0)	Self rated disability. Minimum value 0, maximum value 100, where higher values indicate more disability.	Change from inclusion to follow up 3 months after inclusion
Secondary	World health organization disability assessment schedule (WHODAS 2.0)	Self rated disability. Minimum value 0, maximum value 100, where higher values indicate more disability.	At follow up 12 months after intervention.
Secondary	Negative effects questionnaire (NEQ 20)	Self rated negative effects of treatment. Minimum value 0, maximum value 80, where higher values indicate more negative effects.	post treatment, 12 weeks after enrollment
Secondary	EuroQol (EQ-5D-5L) VAS	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 55555 (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.	Change from inclusion to follow up 3 months after inclusion
Secondary	EuroQol (EQ-5D-5L) VAS	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 55555 (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.	At follow up 12 months after intervention.
Secondary	Affective Self Rating Scale (AS-18)	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.	Change from inclusion to follow up 3 months after inclusion
Secondary	Affective Self Rating Scale (AS-18)	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.	At follow up 12 months after intervention.
Secondary	Blood pressure	systolic and diastolic, mmHg	Change from inclusion to follow up 3 months after inclusion
Secondary	Blood pressure	systolic and diastolic, mmHg	At follow up 12 months after intervention.
Secondary	Body mass index (BMI)	Weight in kg divided by the square of height in m	Change from inclusion to follow up 3 months after inclusion
Secondary	Body mass index (BMI)	Weight in kg divided by the square of height in m	At follow up 12 months after intervention.
Secondary	Waist circumference	Waist circumference, cm	Change from inclusion to follow up 3 months after inclusion
Secondary	Waist circumference	Waist circumference, cm	At follow up 12 months after intervention.
Secondary	Heart rate (HR)	Heart rate, beats per minute	Change from inclusion to follow up 3 months after inclusion
Secondary	Heart rate (HR)	Heart rate, beats per minute	At follow up 12 months after intervention.
Secondary	fasting blood sugar (FBS)	fasting blood sugar, mmol/l	Change from inclusion to follow up 3 months after inclusion
Secondary	fasting blood sugar (FBS)	fasting blood sugar, mmol/l	At follow up 12 months after intervention.
Secondary	Hemoglobin A1c (HbA1c)	Glycated hemoglobin, mmol/mol	Change from inclusion to follow up 3 months after inclusion
Secondary	hemoglobin A1c (HbA1c)	Glycated hemoglobin, mmol/mol	At follow up 12 months after intervention.
Secondary	Blood lipids	Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L	Change from inclusion to follow up 3 months after inclusion
Secondary	Blood lipids	Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L	At follow up 12 months after intervention.
Secondary	C-reactive protein (CRP)	Measurement of inflammation and infection, mmol/L	Change from inclusion to follow up 3 months after inclusion
Secondary	C-reactive protein (CRP)	Measurement of inflammation and infection, mmol/L	At follow up 12 months after intervention.
Secondary	Treatment Inventory of costs in patients with psychiatric disorders (TIC-P)	Work and illness measured by section C of Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P)	Change from inclusion to follow up 3 months after inclusion
Secondary	Treatment Inventory of costs in patients with psychiatric disorders (TIC-P)	Work and illness measured by section C of Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P)	At follow up 12 months after intervention.
Secondary	Thyroid releasing hormone (TSH)	Measurement of thyroid function, mUnits/L	Change from inclusion to follow up 3 months after inclusion
Secondary	Thyroid releasing hormone (TSH)	Thyroid releasing hormone, measurement of thyroid function, mUnits/L	At follow up 12 months after intervention.
Secondary	Complete blood count	The number of leukocytes, platelets and erythrocytes per unit volume in a sample of venous blood. Includes measurement of the hemoglobin, hematocrit and erythrocyte indices.	Change from inclusion to follow up 3 months after inclusion
Secondary	Complete blood count	The number of leukocytes, platelets and erythrocytes per unit volume in a sample of venous blood. Includes measurement of the hemoglobin, hematocrit and erythrocyte indices.	At follow up 12 months after intervention.
Secondary	Blood liver function test	Alanine transaminase (ALT) µkat/L, aspartate transaminase (AST) µkat/L, alkaline phosphatase (ALP) µkat/L albumin g/L, bilirubin µmol/L, gamma-glutamyltransferase (GGT) µkat/L, L-lactate dehydrogenase (LD) µkat/L	Change from inclusion to follow up 3 months after inclusion
Secondary	Blood liver function test	Alanine transaminase (ALT) µkat/L, aspartate transaminase (AST) µkat/L, alkaline phosphatase (ALP) µkat/L albumin g/L, bilirubin µmol/L, gamma-glutamyltransferase (GGT) µkat/L, L-lactate dehydrogenase (LD) µkat/L	At follow up 12 months after intervention.