Clinical trial NCT06012149: Braining: Implementation of Physical Exercise for Patients in Specialist Psychiatry
Official title: Braining: Implementation of Physical Exercise for Patients in Specialist Psychiatry, Efficacy Evaluation in a Randomized Controlled Multicentre Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Disorders
Keywords: physical exercise
mental disorders
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
Collaborators: name: Karolinska Institutet
First posted: 2023-08-25
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled superiority trial evaluating if the new method Braining is superior to structured advice on physical activity, concerning increasing physical activity.

The trial is a multicenter study conducted at 3-6 sites. Participants are individually randomized in blocks of 2-4 at each site.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare Braining, a physical exercise lifestyle intervention in psychiatric care, with structured advice on physical exercise.

The main questions are:

* does Braining lead to increased physical exercise compared to structured advice on physical exercise?
* what effect does Braining have on mental and physical health, quality of life and functional level compared to structured advice on physical exercise?

The participants will join a twelve weeks long study period with clinician led exercise classes up to three times per week. Before and after the study period they will leave blood tests, take part in a mental and physical examination and fill in assessment scales. To measure physical activity, the participants will carry an accelerometer, a device that measures steps and acceleration. After six and twelve months, the participants take part in the same measurements.

The control group takes parts in the same measurements and follow up, but instead of having clinician led exercise classes, they will exercise on their own during the twelve weeks study period.

Detailed 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.

This study will be a multi-center study performed at 5 psychiatric outpatient units in Region Stockholm. Patients with symptoms of depression and/or anxiety who are not physically active in accordance with WHO recommendations will be invited to participate in the study.

The research questions are:

* Does Braining increase the amount of completed physical training (PT) compared to structured advice on physical exercise (advice on PT according to guidelines)?
* What effect does Braining have on the mental and physical health, quality of life and functional level of participating patients compared to structured advice on physical exercise? Examined from the following points of view:

  * psychiatric symptoms, such as depression, anxiety, insomnia, emotional regulation?
  * somatic symptoms, such as blood pressure, resting heart rate, BMI, waist measurement, presence of somatic co-morbidity?
* How do participants rate Braining and structured advice on physical exercise regarding:

  1. Satisfaction with treatment
  2. Credibility of treatment
  3. Negative effects
* Is Braining a cost-effective intervention?

Participants will be randomized to supplementary treatment with Braining or structured advice on physical activity.

Braining and advice on physical activity will be compared after a 12-week training period.

Measurements of the participants´ psychiatric and somatic health are carried out before the treatment, after 4, 8 and 12 weeks and 6 and 12 months after the end of treatment. Effects of the treatment are examined via validated self-assessment forms, as well as somatic examination with a focus on metabolic status. Venous blood samples are taken before and after the 12-week training period, as well as 6 and 12 months after the end of the training period to investigate changes in metabolic status. In a sub study on a smaller number of participants the researchers will analyze associations with biological factors such as genetic or epigenetic factors, metabolic factors, stress hormone levels, trace elements, degree of inflammation and other biological markers of health and disease that can be measured in ordinary blood tests, e.g. through "Omik" design. Physical activity will be measured by self assessment scales, accelerometer and by number of performed Braining classes.

Data analysis: 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.

Eligibility criteria: Inclusion Criteria:

* Patient at one of the psychiatric units

Exclusion Criteria:

* Physically active with moderate to vigorous physical activity above recommendations from World Health Organization (WHO) during the last 4 weeks
* 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, withdrawal, 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.

Primary outcomes:
measure: Physical activity
timeFrame: Change from Pre intervention start to 12 weeks post intervention start
measure: Patient Health Questionnaire 9 (PHQ-9)
timeFrame: Change from Pre intervention start to 12 weeks post intervention start
Secondary outcomes:
measure: Physical activity
timeFrame: Change from Pre intervention start to 6 months post intervention start
measure: Physical activity
timeFrame: Change from Pre intervention start to 12 months post intervention start
measure: Self reported physical activity
timeFrame: Change from Pre intervention start to 12 weeks post intervention start
measure: Self reported physical activity
timeFrame: Change from Pre intervention start to 6 months post intervention start
measure: Self reported physical activity
timeFrame: Change from Pre intervention start to 12 months post intervention start
measure: Patient Health Questionnaire 9 (PHQ-9)
timeFrame: Change from Pre intervention start to 6 months post intervention start
measure: Patient Health Questionnaire 9 (PHQ-9)
timeFrame: Change from Pre intervention start to 12 months post intervention start
measure: Generalised Anxiety Disorder 7-item scale (GAD-7)
timeFrame: Change from Pre intervention start to 12 weeks post intervention start
measure: Generalised Anxiety Disorder 7-item scale (GAD-7)
timeFrame: Change from Pre intervention start to 6 months post intervention start
measure: Generalised Anxiety Disorder 7-item scale (GAD-7)
timeFrame: Change from Pre intervention start to 12 months post intervention start
measure: Insomnia Severity Index (ISI)
timeFrame: Change from Pre intervention start to 12 weeks post intervention start
measure: Insomnia Severity Index (ISI)
timeFrame: Change from Pre intervention start to 6 months post intervention start
measure: Insomnia Severity Index (ISI)
timeFrame: Change from Pre intervention start to 12 months post intervention start
measure: The Work and Social Adjustment Scale (WSAS)
timeFrame: Change from Pre intervention start to 12 weeks post intervention start
measure: The Work and Social Adjustment Scale (WSAS)
timeFrame: Change from Pre intervention start to 6 months post intervention start
measure: The Work and Social Adjustment Scale (WSAS)
timeFrame: Change from Pre intervention start to 12 months post intervention start
measure: EUROQOL 5 dimensions (EQ5D)
timeFrame: Change from Pre intervention start to 12 weeks post intervention start
measure: EUROQOL 5 dimensions (EQ5D)
timeFrame: Change from Pre intervention start to 6 months post intervention start
measure: EUROQOL 5 dimensions (EQ5D)
timeFrame: Change from Pre intervention start to 12 months post intervention start
measure: Quality Adjusted Life Years (QALY)
timeFrame: Change from 12-0 months pre intervention to 0-12 months post intervention
measure: The incremental cost-effectiveness (ICER)
timeFrame: Change from 12-0 months pre intervention to 0-12 months post intervention
measure: Blood pressure
timeFrame: Change from Pre intervention start to 12 weeks post intervention start
measure: Blood pressure
timeFrame: Change from Pre intervention start to 6 months post intervention start
measure: Blood pressure
timeFrame: Change from Pre intervention start to 12 months post intervention start
measure: Body mass index (BMI)
timeFrame: Change from Pre intervention start to 12 weeks post intervention start
measure: Body mass index (BMI)
timeFrame: Change from Pre intervention start to 6 months post intervention start
measure: Body mass index (BMI)
timeFrame: Change from Pre intervention start to 12 months post intervention start
measure: Waist circumference
timeFrame: Change from Pre intervention start to 12 weeks post intervention start
measure: Waist circumference
timeFrame: Change from Pre intervention start to 6 months post intervention start
measure: Waist circumference
timeFrame: Change from Pre intervention start to 12 months post intervention start
measure: Heart rate (HR)
timeFrame: Change from Pre intervention start to 12 weeks post intervention start
measure: Heart rate (HR)
timeFrame: Change from Pre intervention start to 6 months post intervention start
measure: Heart rate (HR)
timeFrame: Change from Pre intervention start to 12 months post intervention start
measure: fasting blood sugar (FBS)
timeFrame: Change from Pre intervention start to 12 weeks post intervention start
measure: fasting blood sugar (FBS)
timeFrame: Change from Pre intervention start to 6 months post intervention start
measure: fasting blood sugar (FBS)
timeFrame: Change from Pre intervention start to 12 months post intervention start
measure: Hemoglobin A1c (HbA1c)
timeFrame: Change from Pre intervention start to 12 weeks post intervention start
measure: Hemoglobin A1c (HbA1c)
timeFrame: Change from Pre intervention start to 6 months post intervention start
measure: Hemoglobin A1c (HbA1c)
timeFrame: Change from Pre intervention start to 12 months post intervention start
measure: Blood lipids
timeFrame: Change from Pre intervention start to 12 weeks post intervention start
measure: Blood lipids
timeFrame: Change from Pre intervention start to 6 months post intervention start
measure: Blood lipids
timeFrame: Change from Pre intervention start to 12 months post intervention start
measure: Sensitive C-reactive protein (CRP)
timeFrame: Change from Pre intervention start to 12 weeks post intervention start
measure: Sensitive C-reactive protein (CRP)
timeFrame: Change from Pre intervention start to 6 months post intervention start
measure: Sensitive C-reactive protein (CRP)
timeFrame: Change from Pre intervention start to 12 months post intervention start
measure: Complete blood count
timeFrame: Change from Pre intervention start to 12 weeks post intervention start
measure: Complete blood count
timeFrame: Change from Pre intervention start to 6 months post intervention start
measure: Complete blood count
timeFrame: Change from Pre intervention start to 12 months post intervention start
measure: Negative effects
timeFrame: 12 weeks post inclusion
measure: The Client Satisfaction Questionnaire-8 (CSQ-8)
timeFrame: 12 weeks post inclusion
measure: The Credibility/Expectancy Questionnaire (CEQ)
timeFrame: 2 weeks post inclusion
measure: Difficulties in Emotion Regulation Scale, Brief Version (DERS-16)
timeFrame: Change from Pre intervention start to 12 weeks post intervention start
measure: Difficulties in Emotion Regulation Scale, Brief Version (DERS-16)
timeFrame: Change from Pre intervention start to 6 months post intervention start
measure: Difficulties in Emotion Regulation Scale, Brief Version (DERS-16)
timeFrame: Change from Pre intervention start to 12 months post intervention start
measure: Time Line follow back (TLFB)
timeFrame: Change from Pre intervention start to 12 weeks post intervention start.
measure: Time Line follow back (TLFB)
timeFrame: Change from Pre intervention start to 6 months post intervention start.
measure: Time Line follow back (TLFB)
timeFrame: Change from Pre intervention start to 12 months post intervention start.
measure: The Alcohol Use Disorders Identification Test (Audit - C)
timeFrame: Change from Pre intervention start to 12 weeks post intervention start.
measure: The Alcohol Use Disorders Identification Test (Audit - C)
timeFrame: Change from Pre intervention start to 6 months post intervention start.
measure: The Alcohol Use Disorders Identification Test (Audit - C)
timeFrame: Change from Pre intervention start to 12 months post intervention start.
Other outcomes:
Locations:
city: Upplands Väsby
country: Sweden
facility: Region Stockholm, Psykiatri Nordväst och Beroendecentrum, mottagningar Väsby
state: Stockholm
city: Stockholm
country: Sweden
facility: Region Stockholm, Psykiatri Sydväst (Psychiatric Clinic Psychiatry Southwest)
city: Stockholm
country: Sweden
facility: Region Stockholm, Beroendecentrum, Magnus Huss
city: Stockholm
country: Sweden
facility: Region Stockholm, Liljeholmsberget
city: Stockholm
country: Sweden
facility: Region Stockholm, Psykiatri Södra, Andreashuset
Study officials:
References: