Clinical Trials Logo

Clinical Trial Summary

The goal of this clinical trial is to compare Braining, a physical exercise lifestyle intervention in psychiatric care, with structured advice on physical exercise. The main questions are: - does Braining lead to increased physical exercise compared to structured advice on physical exercise? - what effect does Braining have on mental and physical health, quality of life and functional level compared to structured advice on physical exercise? The participants will join a twelve weeks long study period with clinician led exercise classes up to three times per week. Before and after the study period they will leave blood tests, take part in a mental and physical examination and fill in assessment scales. To measure physical activity, the participants will carry an accelerometer, a device that measures steps and acceleration. After six and twelve months, the participants take part in the same measurements. The control group takes parts in the same measurements and follow up, but instead of having clinician led exercise classes, they will exercise on their own during the twelve weeks study period.


Clinical Trial 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 moderate to vigorous aerobic group training sessions 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, moderate to vigorous aerobic 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 exercise intervention 4. includes regular measurements (self-assessment questionnaires, blood samples, physical and mental health examination and education before and after the twelve-week exercise intervention) 5. offers short individual motivating visits before every training session, including assessment of day shape and fitness to participate. This study will be a multi-center study performed at 5 psychiatric outpatient units in Region Stockholm. Patients with symptoms of depression and/or anxiety who are not physically active in accordance with WHO recommendations will be invited to participate in the study. The research questions are: - Does Braining increase the amount of completed physical training (PT) compared to structured advice on physical exercise (advice on PT according to guidelines)? - What effect does Braining have on the mental and physical health, quality of life and functional level of participating patients compared to structured advice on physical exercise? Examined from the following points of view: - psychiatric symptoms, such as depression, anxiety, insomnia, emotional regulation? - somatic symptoms, such as blood pressure, resting heart rate, BMI, waist measurement, presence of somatic co-morbidity? - How do participants rate Braining and structured advice on physical exercise regarding: 1. Satisfaction with treatment 2. Credibility of treatment 3. Negative effects - Is Braining a cost-effective intervention? Participants will be randomized to supplementary treatment with Braining or structured advice on physical activity. Braining and advice on physical activity will be compared after a 12-week training period. Measurements of the participants´ psychiatric and somatic health are carried out before the treatment, after 4, 8 and 12 weeks and 6 and 12 months after the end of treatment. Effects of the treatment are examined via validated self-assessment forms, as well as somatic examination with a focus on metabolic status. Venous blood samples are taken before and after the 12-week training period, as well as 6 and 12 months after the end of the training period to investigate changes in metabolic status. In a sub study on a smaller number of participants the researchers will analyze associations with biological factors such as genetic or epigenetic factors, metabolic factors, stress hormone levels, trace elements, degree of inflammation and other biological markers of health and disease that can be measured in ordinary blood tests, e.g. through "Omik" design. Physical activity will be measured by self assessment scales, accelerometer and by number of performed Braining classes. Data analysis: 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06012149
Study type Interventional
Source Region Stockholm
Contact
Status Recruiting
Phase N/A
Start date September 27, 2023
Completion date September 2026

See also
  Status Clinical Trial Phase
Completed NCT05321602 - Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder Phase 1
Completed NCT05080777 - Pilot Pragmatic Clinical Trial to Embed Tele-Savvy Into Health Care Systems N/A
Recruiting NCT03222375 - SQUEDâ„¢ Series 28.1 Home-use and Treatment of Autowave Reverberator of Autism N/A
Active, not recruiting NCT02836080 - Integrated Collaborative Care Teams for Youth With Mental Health and/or Addiction Challenges (YouthCan IMPACT) N/A
Active, not recruiting NCT02907658 - Efficacy of Internet Use Disorder Prevention N/A
Completed NCT02710344 - Using Telehealth to Improve Psychiatric Symptom Management N/A
Enrolling by invitation NCT02487888 - A Study of the Impact of Genetic Testing on Clinical Decision Making and Patient Care N/A
Recruiting NCT02292056 - Medication Safety and Contraceptive Counseling for Reproductive Aged Women With Psychiatric Conditions N/A
Active, not recruiting NCT02761733 - The Effectiveness of a Decision-Support Tool for Adult Consumers With Mental Health Needs and Their Care Managers N/A
Completed NCT01947283 - Effectiveness of DECIDE in Patient-Provider Communication, Therapeutic Alliance & Care Continuation N/A
Completed NCT01690013 - Life Quality and Health in Patients With Klinefelter Syndrome N/A
Completed NCT01633138 - Performance-based Reinforcement to Enhance Cognitive Remediation Therapy N/A
Completed NCT01656707 - Adaptive Treatment for Adolescent Cannabis Use Disorders N/A
Completed NCT01415323 - Agitation in the Acute Psychiatric Department
Completed NCT01701765 - Outcomes and Discharge of Long-stay Psychiatric Patients N/A
Completed NCT00375167 - Efficacy of the Recovery Workbook as a Psychoeducational Tool for Facilitating Recovery N/A
Terminated NCT00757497 - Transcranial Direct Current Brain Stimulation to Treat Patients With Childhood-Onset Schizophrenia Phase 1
Terminated NCT03527550 - Cognitive Control Training for Urgency in a Naturalistic Clinical Setting N/A
Withdrawn NCT03518996 - Non-Invasive Brain Stimulation and Delirium N/A
Completed NCT02707848 - Epidemiological Study for Psychiatric Disorder Among Children and Adolescents