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

NCT05186688 | Completed

• 1 other identifier: Braining feasibility
• Study Type: interventional
• Target: 22
• 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 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.

Conditions

Mental Disorder

Keywords

physical exercise; mental disorders

Outcome Measures

Primary Outcomes (15)

• Actigraph GT3x

  Objectively measured physical activity and sedentary time: Total physical activity as counts/day and time spent in sedentary, low, moderate and vigorous intensity as min/day.

  Change from inclusion to follow up 3 months after inclusion

• Actigraph GT3x

  Objectively measured physical activity and sedentary time: Total physical activity as counts/day and time spent in sedentary, low, moderate and vigorous intensity as min/day.

  At follow up 12 months after intervention.

• International Physical Activity Questionnaires (IPAQ)

  Self-reported physical activity: Total physical activity as Metabolic Energy Turnover (MET)hours/week and three level categories (low, moderate and high).

  Change from inclusion to follow up 3 months after inclusion

• International Physical Activity Questionnaires (IPAQ)

  Self-reported physical activity: Total physical activity as Metabolic Energy Turnover (MET)hours/week and three level categories (low, moderate and high).

  At follow up 12 months after intervention.

• Patient Health Questionnaire 9 (PHQ-9)

  Self rated depressive symptoms. Minimum value 0, maximum value 27, where higher values indicate more depressive symptoms.

  Change from inclusion to follow up 3 months after inclusion

• Patient Health Questionnaire 9 (PHQ-9)

  Self rated depressive symptoms. Minimum value 0, maximum value 27, where higher values indicate more depressive symptoms.

  At follow up 12 months after intervention.

• Alcohol Use Disorders Identification Test AUDIT

  Self rated alcohol use. Minimum value 0, maximum value 32, where higher values indicate higher alcohol use.

  Change from inclusion to follow up 3 months after inclusion

• Alcohol Use Disorders Identification Test AUDIT

  Self rated alcohol use. Minimum value 0, maximum value 32, where higher values indicate higher alcohol use.

  At follow up 12 months after intervention.

• Drug Use Disorders Identification Test DUDIT

  Self rated drug use. Minimum value 0, maximum value 44, where higher values indicate higher drug use.

  Change from inclusion to follow up 3 months after inclusion

• Drug Use Disorders Identification Test DUDIT

  Self rated drug use. Minimum value 0, maximum value 44, where higher values indicate higher drug use.

  At follow up 12 months after intervention.

• Brunnsviken Brief Quality of Life Questionnaire (BBQ)

  Self rated quality of life. Minimum value 0, maximum value 96, where higher values indicate higher quality of life satisfaction.

  Change from inclusion to follow up 3 months after inclusion

• Brunnsviken Brief Quality of Life Questionnaire (BBQ)

  Self rated quality of life. Minimum value 0, maximum value 96, where higher values indicate higher quality of life satisfaction.

  At follow up 12 months after intervention.

• Acceptability of treatment among patients

  Semi-structured interviews

  At follow up 3-5 months after inclusion

• The Credibility/Expectancy Questionnaire (CEQ)

  Self rated Credibility of treatment. Minimum value 3, maximum value 27 for each factor, where higher values indicate greater Credibility/Expectancy of the treatment.

  Week 1 of treatment

• The Client Satisfaction Questionnaire-8 (CSQ-8)

  Self rated satisfaction of treatment. Minimum value 8, maximum value 32 where higher values indicate greater satisfaction with the treatment.

  post treatment, 12 weeks after enrollment

Secondary Outcomes (35)

• Generalised Anxiety Disorder 7-item scale (GAD-7)

  Change from inclusion to follow up 3 months after inclusion

• Generalised Anxiety Disorder 7-item scale (GAD-7)

  At follow up 12 months after intervention.

• Insomnia Severity Index (ISI)

  Change from inclusion to follow up 3 months after inclusion

• Insomnia Severity Index (ISI)

  At follow up 12 months after intervention.

• World health organization disability assessment schedule (WHODAS 2.0)

  Change from inclusion to follow up 3 months after inclusion

Study Arms (1)

Physical activity

EXPERIMENTAL

Patients are encouraged to participate in physical exercise at the psychiatric unit

Behavioral: Braining

Interventions

Braining BEHAVIORAL

"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 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.

Physical activity

Eligibility Criteria

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

You may qualify if:

• Patient at the psychiatric unit

You may not qualify if:

• 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.

Sponsors & Collaborators

• Region Stockholm: lead
• Karolinska Institutet: collaborator

Study Sites (1)

Region Stockholm, Liljeholmsberget

Stockholm, Sweden

Location

MeSH Terms

Conditions

Mental Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2021
• First Posted: January 11, 2022
• Study Start: March 2, 2022
• Primary Completion: July 31, 2022
• Study Completion: September 30, 2023
• Last Updated: December 9, 2024

Record last verified: 2024-11

Locations

SE (1)