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

Physical Inactivity 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: Recruiting

Administrative data

• NCT number: NCT05111756
• Other study ID #: Braining - personell
• Status: Recruiting
• Start date: December 2, 2021
• Est. completion date: December 2025

Study information

• Verified date: July 2023
• Source: Region Stockholm
• Contact: Lina Martinsson, PhD
• Phone: +46707684604
• Email: lina.martinsson[@]ki.se
• Is FDA regulated: No
• Study type: Observational

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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Occupational Stress
• Physical Inactivity

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	Minutes spent on Physical movement (high, moderate, low)	Physical exercise conducted by staff, measured by actigraph	Change from baseline to follow up observation 6 months after inclusion
Primary	Minutes spent on Physical movement (high, moderate, low)	Physical exercise conducted by staff, measured by self ratings of International Physical Activity Questionnaires (IPAQ)	Change from baseline to follow up observation 6 months after inclusion
Primary	General health	General health measured by self ratings of General health questionnaire (GHQ), scores 0-12, higher scores indicates more mental distress	Change from baseline to follow up observation 6 months after inclusion
Primary	Perceived stress	Perceived stress measured by self ratings of Perceived stress scale (PSS-10), , scores 0-40, higher scores indicates more mental distress	Change from baseline to follow up observation 6 months after inclusion
Primary	Perceived feasibility of Intervention	Feasibility measured by self ratings of Feasibility of Intervention Measure (FIM)	1 month after implementation start
Primary	Perceived feasibility of Intervention	Feasibility measured by self ratings of Feasibility of Intervention Measure (FIM)	6 months after implementation start
Primary	Acceptability of Intervention	Acceptability measured by self ratings of Acceptability of Intervention Measure (AIM)	1 month after implementation start
Primary	Acceptability of Intervention	Acceptability measured by self ratings of Acceptability of Intervention Measure (AIM)	6 months after implementation start
Primary	Intervention Appropriateness	Intervention Appropriateness measured by self ratings of Intervention Appropriateness Measure (IAM)	1 month after implementation start
Primary	Intervention Appropriateness	Intervention Appropriateness measured by self ratings of Intervention Appropriateness Measure (IAM)	6 months after implementation start
Primary	Compliance to intervention	Compliance to intervention measured by weekly observations and reports of performed training activities	Summary of compliance 6 months after implementation start
Primary	Normalization of intervention	Normalization of intervention measured by The Swedish version of the Normalization Process Theory Measure (S-NoMAD)	6 months after implementation start
Primary	Normalization of intervention	Normalization of intervention measured by The Swedish version of the Normalization Process Theory Measure (S-NoMAD)	1 year after implementation start
Primary	Normalization of intervention	Normalization of intervention measured by The Swedish version of the Normalization Process Theory Measure (S-NoMAD)	2 years after implementation start
Primary	Qualitative interviews	Qualitative interviews concerning acceptability, feasibility, appropriateness, compliance and normalization of the intervention	After the implementation phase i.e., 6 months after implementation start
Secondary	Burnout	Burnout measured by self ratings of Burnout Shirom-Melamed Burnout Questionnaire (SMBQ-6), scores 6-42, higher scores indicates more burnout symptoms	Change from baseline to follow up observation 6 months after inclusion
Secondary	Burnout	Burnout measured by self ratings of Burnout Shirom-Melamed Burnout Questionnaire (SMBQ-6), scores 6-42, higher scores indicates more burnout symptoms	Follow up 12 months after inclusion
Secondary	Sleep difficulties	Sleep difficulties measured by self ratings of Insomnia Severity Index (ISI), , scores 0-28, higher scores indicates more sleep difficulties	Change from baseline to follow up observation 6 months after inclusion
Secondary	Sleep difficulties	Sleep difficulties measured by self ratings of Insomnia Severity Index (ISI), , scores 0-28, higher scores indicates more sleep difficulties	Follow up 12 months after inclusion
Secondary	Work and illness	Work and illness measured by section C of Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P)	Change from baseline to follow up observation 6 months after inclusion
Secondary	Work and illness	Work and illness measured by section C of Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P)	Follow up 12 months after inclusion
Secondary	Engagement at work	Engagement at work measured by Utrecht work engagement scale (UWES-9S), scores 0-54, higher scores indicates more work engagement	Change from baseline to follow up observation 6 months after inclusion
Secondary	Engagement at work	Engagement at work measured by Utrecht work engagement scale (UWES-9S), scores 0-54, higher scores indicates more work engagement	Follow up 12 months after inclusion
Secondary	Minutes spent on Physical movement (high, moderate, low)	Physical exercise conducted by staff, measured by actigraph	Follow up observation 12 months after inclusion
Secondary	Minutes spent on Physical movement (high, moderate, low)	Physical exercise conducted by staff, measured by self ratings of International Physical Activity Questionnaires (IPAQ)	Follow up 12 months after inclusion
Secondary	General health	General health measured by self ratings of General health questionnaire (GHQ), scores 0-12, higher scores indicates more mental distress	Follow up 12 months after inclusion
Secondary	Perceived stress	Perceived stress measured by self ratings of Perceived stress scale (PSS-10), , scores 0-40, higher scores indicates more mental distress	Follow up 12 months after inclusion
Secondary	Ratings of Braining sessions	Self constructed questions where staff rate how many Braining sessions they have attended per week.	During the period intervention start to 6 months follow up
Secondary	Ratings of Braining sessions	Self constructed questions where staff rate how many Braining sessions they have attended per week.	During the period 6 months follow up to 12 months follow up