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

NCT05111756 | Recruiting

• 1 other identifier: Braining - personell
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Inactivity; Occupational Stress

Keywords

physical exercise; psychiatric staff; Occupational Stress; implementation; feasibility

Outcome Measures

Primary Outcomes (15)

• 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

• Minutes spent on Physical movement self rated (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

• 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

• 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

• Perceived feasibility of Intervention

  Feasibility measured by self ratings of Feasibility of Intervention Measure (FIM)

  1 month after implementation start

• Perceived feasibility of Intervention

  Feasibility measured by self ratings of Feasibility of Intervention Measure (FIM)

  6 months after implementation start

• Acceptability of Intervention

  Acceptability measured by self ratings of Acceptability of Intervention Measure (AIM)

  1 month after implementation start

• Acceptability of Intervention

  Acceptability measured by self ratings of Acceptability of Intervention Measure (AIM)

  6 months after implementation start

• Intervention Appropriateness

  Intervention Appropriateness measured by self ratings of Intervention Appropriateness Measure (IAM)

  1 month after implementation start

• Intervention Appropriateness

  Intervention Appropriateness measured by self ratings of Intervention Appropriateness Measure (IAM)

  6 months after implementation start

• Compliance to intervention

  Compliance to intervention measured by weekly observations and reports of performed training activities

  Summary of compliance 6 months after implementation start

• Normalization of intervention

  Normalization of intervention measured by The Swedish version of the Normalization Process Theory Measure (S-NoMAD)

  6 months after implementation start

• Normalization of intervention

  Normalization of intervention measured by The Swedish version of the Normalization Process Theory Measure (S-NoMAD)

  1 year after implementation start

• Normalization of intervention

  Normalization of intervention measured by The Swedish version of the Normalization Process Theory Measure (S-NoMAD)

  2 years after implementation start

• 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 Outcomes (14)

• Burnout

  Change from baseline to follow up observation 6 months after inclusion

• Burnout

  Follow up 12 months after inclusion

• Sleep difficulties

  Change from baseline to follow up observation 6 months after inclusion

• Sleep difficulties

  Follow up 12 months after inclusion

• Work and illness

  Change from baseline to follow up observation 6 months after inclusion

Study Arms (2)

Unit A

Staff at first phase units, receiving Braining, physical exercise

Unit B

Staff at second phase units, receiving Braining, physical exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Staff of a psychiatric care unit

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Stockholm: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Region Stockholm, Liljeholmsberget

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Sedentary Behavior; Occupational Stress; Motor Activity

Condition Hierarchy (Ancestors)

Behavior; Occupational Diseases; Stress, Psychological; Behavioral Symptoms

Study Officials

• Lina Martinsson, PhD

  Region Stockholm and Karolinska institiutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lina Martinsson, PhD

CONTACT

+46707684604; lina.martinsson@ki.se

Sigrid Salomonsson, PhD

CONTACT

0708442283; Sigrid.salomonsson@ki.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: November 8, 2021
• Study Start: December 2, 2021
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2026
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)