Clinical trial NCT05111756: Braining - Physical Exercise in Psychiatry - Evaluation of Feasibility, Implementation and Health Among Staff
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: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Physical Inactivity
Occupational Stress
Keywords: physical exercise
psychiatric staff
Occupational Stress
implementation
feasibility
Lead sponsor: Region Stockholm
Sponsor class: OTHER_GOV
Collaborators: name: Karolinska Institutet
First posted: 2021-11-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Staff of a psychiatric care unit

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 feasibility of the intervention will be evaluated, how Braining is perceived and implemented, and effects on health and physical activity among staff. It is hypothesized that staff health and physical activity will increase after implementing Braining at the unit. Braining will be implemented at four psychiatric units in Region Stockholm, Sweden. During 6 months staff will be trained and receive implementation support. To measure feasibility the staff will answer self-rating questionnaires and be invited to a focus group interview post the implementation period. Implementation will be evaluated by ratings of compliance, the self-rating questionnaire Normalization Process Theory Measure (S-NoMAD), and focus group interviews. Health will be measured by self ratings of stress, sleep, general health, and engagement pre implementation and every month during the 6 month implementation phase. Ratings will be repeated at follow up 12 month after implementation started. Physical activity will be rated during the 6 months implementation phase using a tracker of activity and at follow up 12 month after implementation started. All staff at the units will be invited to participate in the evaluations, approximately 20 individuals per unit.

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 high performance 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. 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, high endurance 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 training period
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. 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 implemented, and effects on health and physical activity among staff. The research questions are:

* How do staff experience Braining regarding acceptability, applicability and suitability?
* Is there a correlation between the staff's work with Braining and occupational health, measured as performed PE, perceived stress, and general health?
* Is there a correlation between the staff's work with Braining and occupational health, measured as exhaustion, sleep, sick leave, and job engagement?
* Is there a significant interaction effect between change over time in occupational health, measured with PSS-10 and GHQ, and participation in Braining sessions according to "Ratings of Braining sessions"?
* Is there a significant interaction effect between change over time on physical activity measured with Actigraph and IPAQ and participation in Braining sessions according to "Ratings of Braining sessions"?
* Is there an interaction effect between physical activity measured with Actigraph and IPAQ and occupational health measured with PSS-10 and GHQ?
* Does Braining have a specific effect for staff who during baseline rate over cut-off on GHQ and PSS-10 respectively?
* How compliant are staff to the Braining method in the sense of number completed training sessions, quality of completed sessions, compliance with the core components of the method?
* To what extent is Braining integrated into ordinary work at the unit in short (6 months) and long term (1 and 2 years)?

Braining is to be implemented at 4 psychiatric care units the upcoming years starting nov 2021. Approximately 20 personnel on each unit will be included. Planned design is a longitudinal pre-post study with four measurements during ongoing intervention (weeks 1, 4, 8 and 12) and two follow-ups (6 months and 12 months post inclusion). Improved design with three baseline observation (data points) and possible interrupted time series design, (ITSD). Relationships between the staff's work with Braining and their own occupational health are examined self-estimates, see list. Physical activity level is measured with activity tracker before training and measured throughout the 6 months and at follow-up after 12 months.

Experience of the implementation process is evaluated with S-NoMAD, which is administered at two occasions during the intervention, after completion and at follow-up after 2 years. Staff experience of working with Braining is examined with self-assessments and in focus group interviews after the end of the intervention. Staff compliance with Braining is evaluated based on a checklist where data is collected through weekly follow-ups of the work on the unit as well as observation of completed training sessions.

Data analysis Qualitative analysis: Recorded material from focus group 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:

* Works at one of the relevant units regardless of occupational category, including administrative services.
* Permanent employment or fixed-term employment for at least one more year after the start of studies.

Exclusion Criteria:

* Medical conditions such as heart or lung disease, infection, abstinence where heart rate-increasing physical activity is considered contraindicated due to Medical reasons.
* Full-time sick leave\> 1 month during the training period

Primary outcomes:
measure: Minutes spent on Physical movement (high, moderate, low)
timeFrame: Change from baseline to follow up observation 6 months after inclusion
measure: Minutes spent on Physical movement self rated (high, moderate, low)
timeFrame: Change from baseline to follow up observation 6 months after inclusion
measure: General health
timeFrame: Change from baseline to follow up observation 6 months after inclusion
measure: Perceived stress
timeFrame: Change from baseline to follow up observation 6 months after inclusion
measure: Perceived feasibility of Intervention
timeFrame: 1 month after implementation start
measure: Perceived feasibility of Intervention
timeFrame: 6 months after implementation start
measure: Acceptability of Intervention
timeFrame: 1 month after implementation start
measure: Acceptability of Intervention
timeFrame: 6 months after implementation start
measure: Intervention Appropriateness
timeFrame: 1 month after implementation start
measure: Intervention Appropriateness
timeFrame: 6 months after implementation start
measure: Compliance to intervention
timeFrame: Summary of compliance 6 months after implementation start
measure: Normalization of intervention
timeFrame: 6 months after implementation start
measure: Normalization of intervention
timeFrame: 1 year after implementation start
measure: Normalization of intervention
timeFrame: 2 years after implementation start
measure: Qualitative interviews
timeFrame: After the implementation phase i.e., 6 months after implementation start
Secondary outcomes:
measure: Burnout
timeFrame: Change from baseline to follow up observation 6 months after inclusion
measure: Burnout
timeFrame: Follow up 12 months after inclusion
measure: Sleep difficulties
timeFrame: Change from baseline to follow up observation 6 months after inclusion
measure: Sleep difficulties
timeFrame: Follow up 12 months after inclusion
measure: Work and illness
timeFrame: Change from baseline to follow up observation 6 months after inclusion
measure: Work and illness
timeFrame: Follow up 12 months after inclusion
measure: Engagement at work
timeFrame: Change from baseline to follow up observation 6 months after inclusion
measure: Engagement at work
timeFrame: Follow up 12 months after inclusion
measure: Minutes spent on Physical movement (high, moderate, low)
timeFrame: Follow up observation 12 months after inclusion
measure: Minutes spent on Physical movement (high, moderate, low)
timeFrame: Follow up 12 months after inclusion
measure: General health
timeFrame: Follow up 12 months after inclusion
measure: Perceived stress
timeFrame: Follow up 12 months after inclusion
measure: Ratings of Braining sessions
timeFrame: During the period intervention start to 6 months follow up
measure: Ratings of Braining sessions
timeFrame: During the period 6 months follow up to 12 months follow up
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Region Stockholm, Liljeholmsberget
Study officials:
affiliation: Region Stockholm and Karolinska institiutet
name: Lina Martinsson, PhD
role: PRINCIPAL_INVESTIGATOR
References: