Clinical trial NCT05186688: Braining - Physical Exercise in Psychiatry - Evaluation of Feasibility, and Health Among Patients
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorder
Keywords: physical exercise
mental disorders
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
Collaborators: name: Karolinska Institutet
First posted: 2022-01-11
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Actigraph GT3x
timeFrame: Change from inclusion to follow up 3 months after inclusion
measure: Actigraph GT3x
timeFrame: At follow up 12 months after intervention.
measure: International Physical Activity Questionnaires (IPAQ)
timeFrame: Change from inclusion to follow up 3 months after inclusion
measure: International Physical Activity Questionnaires (IPAQ)
timeFrame: At follow up 12 months after intervention.
measure: Patient Health Questionnaire 9 (PHQ-9)
timeFrame: Change from inclusion to follow up 3 months after inclusion
measure: Patient Health Questionnaire 9 (PHQ-9)
timeFrame: At follow up 12 months after intervention.
measure: Alcohol Use Disorders Identification Test AUDIT
timeFrame: Change from inclusion to follow up 3 months after inclusion
measure: Alcohol Use Disorders Identification Test AUDIT
timeFrame: At follow up 12 months after intervention.
measure: Drug Use Disorders Identification Test DUDIT
timeFrame: Change from inclusion to follow up 3 months after inclusion
measure: Drug Use Disorders Identification Test DUDIT
timeFrame: At follow up 12 months after intervention.
measure: Brunnsviken Brief Quality of Life Questionnaire (BBQ)
timeFrame: Change from inclusion to follow up 3 months after inclusion
measure: Brunnsviken Brief Quality of Life Questionnaire (BBQ)
timeFrame: At follow up 12 months after intervention.
measure: Acceptability of treatment among patients
timeFrame: At follow up 3-5 months after inclusion
measure: The Credibility/Expectancy Questionnaire (CEQ)
timeFrame: Week 1 of treatment
measure: The Client Satisfaction Questionnaire-8 (CSQ-8)
timeFrame: post treatment, 12 weeks after enrollment
Secondary outcomes:
measure: Generalised Anxiety Disorder 7-item scale (GAD-7)
timeFrame: Change from inclusion to follow up 3 months after inclusion
measure: Generalised Anxiety Disorder 7-item scale (GAD-7)
timeFrame: At follow up 12 months after intervention.
measure: Insomnia Severity Index (ISI)
timeFrame: Change from inclusion to follow up 3 months after inclusion
measure: Insomnia Severity Index (ISI)
timeFrame: At follow up 12 months after intervention.
measure: World health organization disability assessment schedule (WHODAS 2.0)
timeFrame: Change from inclusion to follow up 3 months after inclusion
measure: World health organization disability assessment schedule (WHODAS 2.0)
timeFrame: At follow up 12 months after intervention.
measure: Negative effects questionnaire (NEQ 20)
timeFrame: post treatment, 12 weeks after enrollment
measure: EuroQol (EQ-5D-5L) VAS
timeFrame: Change from inclusion to follow up 3 months after inclusion
measure: EuroQol (EQ-5D-5L) VAS
timeFrame: At follow up 12 months after intervention.
measure: Affective Self Rating Scale (AS-18)
timeFrame: Change from inclusion to follow up 3 months after inclusion
measure: Affective Self Rating Scale (AS-18)
timeFrame: At follow up 12 months after intervention.
measure: Blood pressure
timeFrame: Change from inclusion to follow up 3 months after inclusion
measure: Blood pressure
timeFrame: At follow up 12 months after intervention.
measure: Body mass index (BMI)
timeFrame: Change from inclusion to follow up 3 months after inclusion
measure: Body mass index (BMI)
timeFrame: At follow up 12 months after intervention.
measure: Waist circumference
timeFrame: Change from inclusion to follow up 3 months after inclusion
measure: Waist circumference
timeFrame: At follow up 12 months after intervention.
measure: Heart rate (HR)
timeFrame: Change from inclusion to follow up 3 months after inclusion
measure: Heart rate (HR)
timeFrame: At follow up 12 months after intervention.
measure: fasting blood sugar (FBS)
timeFrame: Change from inclusion to follow up 3 months after inclusion
measure: fasting blood sugar (FBS)
timeFrame: At follow up 12 months after intervention.
measure: Hemoglobin A1c (HbA1c)
timeFrame: Change from inclusion to follow up 3 months after inclusion
measure: hemoglobin A1c (HbA1c)
timeFrame: At follow up 12 months after intervention.
measure: Blood lipids
timeFrame: Change from inclusion to follow up 3 months after inclusion
measure: Blood lipids
timeFrame: At follow up 12 months after intervention.
measure: C-reactive protein (CRP)
timeFrame: Change from inclusion to follow up 3 months after inclusion
measure: C-reactive protein (CRP)
timeFrame: At follow up 12 months after intervention.
measure: Treatment Inventory of costs in patients with psychiatric disorders (TIC-P)
timeFrame: Change from inclusion to follow up 3 months after inclusion
measure: Treatment Inventory of costs in patients with psychiatric disorders (TIC-P)
timeFrame: At follow up 12 months after intervention.
measure: Thyroid releasing hormone (TSH)
timeFrame: Change from inclusion to follow up 3 months after inclusion
measure: Thyroid releasing hormone (TSH)
timeFrame: At follow up 12 months after intervention.
measure: Complete blood count
timeFrame: Change from inclusion to follow up 3 months after inclusion
measure: Complete blood count
timeFrame: At follow up 12 months after intervention.
measure: Blood liver function test
timeFrame: Change from inclusion to follow up 3 months after inclusion
measure: Blood liver function test
timeFrame: At follow up 12 months after intervention.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Region Stockholm, Liljeholmsberget
Study officials:
References: