Region Stockholm, Liljeholmsberget
Stockholm, Sweden
Location status: Recruiting
Location contact
Lina Martinsson, PhD
PRINCIPAL_INVESTIGATOR
Sigrid Salomonsson, PhD
SUB_INVESTIGATOR
Åsa Anger, MD
CONTACT
NCT Number: NCT05111756
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Stockholm, Sweden
Location status: Recruiting
Lina Martinsson, PhD
PRINCIPAL_INVESTIGATOR
Sigrid Salomonsson, PhD
SUB_INVESTIGATOR
Åsa Anger, MD
CONTACT
"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:
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Change from baseline to follow up observation 6 months after inclusion
Physical exercise conducted by staff, measured by actigraph
Time frame: Change from baseline to follow up observation 6 months after inclusion
Physical exercise conducted by staff, measured by self ratings of International Physical Activity Questionnaires (IPAQ)
Time frame: Change from baseline to follow up observation 6 months after inclusion
General health measured by self ratings of General health questionnaire (GHQ), scores 0-12, higher scores indicates more mental distress
Time frame: Change from baseline to follow up observation 6 months after inclusion
Perceived stress measured by self ratings of Perceived stress scale (PSS-10), , scores 0-40, higher scores indicates more mental distress
Time frame: 1 month after implementation start
Feasibility measured by self ratings of Feasibility of Intervention Measure (FIM)
Time frame: 6 months after implementation start
Feasibility measured by self ratings of Feasibility of Intervention Measure (FIM)
Time frame: 1 month after implementation start
Acceptability measured by self ratings of Acceptability of Intervention Measure (AIM)
Time frame: 6 months after implementation start
Acceptability measured by self ratings of Acceptability of Intervention Measure (AIM)
Time frame: 1 month after implementation start
Intervention Appropriateness measured by self ratings of Intervention Appropriateness Measure (IAM)
Time frame: 6 months after implementation start
Intervention Appropriateness measured by self ratings of Intervention Appropriateness Measure (IAM)
Time frame: Summary of compliance 6 months after implementation start
Compliance to intervention measured by weekly observations and reports of performed training activities
Time frame: 6 months after implementation start
Normalization of intervention measured by The Swedish version of the Normalization Process Theory Measure (S-NoMAD)
Time frame: 1 year after implementation start
Normalization of intervention measured by The Swedish version of the Normalization Process Theory Measure (S-NoMAD)
Time frame: 2 years after implementation start
Normalization of intervention measured by The Swedish version of the Normalization Process Theory Measure (S-NoMAD)
Time frame: After the implementation phase i.e., 6 months after implementation start
Qualitative interviews concerning acceptability, feasibility, appropriateness, compliance and normalization of the intervention
Time frame: Change from baseline to follow up observation 6 months after inclusion
Burnout measured by self ratings of Burnout Shirom-Melamed Burnout Questionnaire (SMBQ-6), scores 6-42, higher scores indicates more burnout symptoms
Time frame: Follow up 12 months after inclusion
Burnout measured by self ratings of Burnout Shirom-Melamed Burnout Questionnaire (SMBQ-6), scores 6-42, higher scores indicates more burnout symptoms
Time frame: Change from baseline to follow up observation 6 months after inclusion
Sleep difficulties measured by self ratings of Insomnia Severity Index (ISI), , scores 0-28, higher scores indicates more sleep difficulties
Time frame: Follow up 12 months after inclusion
Sleep difficulties measured by self ratings of Insomnia Severity Index (ISI), , scores 0-28, higher scores indicates more sleep difficulties
Time frame: Change from baseline to follow up observation 6 months after inclusion
Work and illness measured by section C of Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P)
Time frame: Follow up 12 months after inclusion
Work and illness measured by section C of Treatment Inventory of Costs in Patients with psychiatric disorders (TIC-P)
Time frame: Change from baseline to follow up observation 6 months after inclusion
Engagement at work measured by Utrecht work engagement scale (UWES-9S), scores 0-54, higher scores indicates more work engagement
Time frame: Follow up 12 months after inclusion
Engagement at work measured by Utrecht work engagement scale (UWES-9S), scores 0-54, higher scores indicates more work engagement
Time frame: Follow up observation 12 months after inclusion
Physical exercise conducted by staff, measured by actigraph
Time frame: Follow up 12 months after inclusion
Physical exercise conducted by staff, measured by self ratings of International Physical Activity Questionnaires (IPAQ)
Time frame: Follow up 12 months after inclusion
General health measured by self ratings of General health questionnaire (GHQ), scores 0-12, higher scores indicates more mental distress
Time frame: Follow up 12 months after inclusion
Perceived stress measured by self ratings of Perceived stress scale (PSS-10), , scores 0-40, higher scores indicates more mental distress
Time frame: During the period intervention start to 6 months follow up
Self constructed questions where staff rate how many Braining sessions they have attended per week.
Time frame: During the period 6 months follow up to 12 months follow up
Self constructed questions where staff rate how many Braining sessions they have attended per week.
Contact information is provided by the study sponsor or research team.
Lina Martinsson, PhD
CONTACT
Sigrid Salomonsson, PhD
CONTACT
Region Stockholm
Other Gov
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.
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