Physical Exercise as Adjunctive Therapy for Affective Disorder and Anxiety
- Conditions
- Anxiety DisordersPosttraumatic Stress DisorderPanic DisorderInsomniaAnxietyAutismSocial PhobiaStressBipolar DisorderGeneralized Anxiety Disorder
- Interventions
- Other: Braining
- Registration Number
- NCT05157386
- Lead Sponsor
- Region Stockholm
- Brief Summary
"Braining" is a clinical method for physical exercise as adjunctive therapy in psychiatric care. The core components are personnel-led group training sessions and motivating contact with psychiatric staff, as well as measurement and evaluation before and after the training period of 12 weeks.
Objective. This study aims to describe the clinical and demographic variables in the population of patients who participated in Braining 2017-2020, investigate the feasibility of Braining, and analyse perceived short-term effects and side effects of Braining regarding psychiatric and somatic symptoms.
Method. The project is a retrospective, descriptive study. Patients at Psykiatri Sydväst (PSV, Psychiatric Clinic Psychiatry Southwest, Stockholm) who participated in Braining 2017-2020 during at least 3 training sessions, will be asked for inclusion. Medical and demographic data, as well as patient treatment evaluations, are already available in medical records.
Additionally, an extended 2-year long-term follow-up will be carried out. This includes blood and hair sample, physical examination as well as qualitative interviews with a representative subgroup.
- Detailed Description
The method "Braining" is a clinical invention that helps patients to initiate and execute physical exercise (PE) regularly in psychiatric care. The core components are basic high performance group training sessions and motivational work led by the psychiatric staff. Braining is used as add-on treatment to regular psychiatric care (treatment as usual; TAU) and is included in the patient care plan. Braining is unique in that it:
1. Includes trained psychiatric clinical staff leading group exercise sessions 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 either a group seminar or as an individual visit) at the start and end of a training period; usually 12 weeks.
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. Includes short individual motivating visits before every training session, including assessment of day shape and fitness to participate.
The scientific purpose of the project is to:
* Describe clinical and demographic variables in patients participating in Braining 2017-2020.
* Investigate the feasibility of the Braining method (PE together with staff as adjunctive therapy in Psychiatric care).
* Analyse perceived short-term effects and side effects of Braining regarding psychiatric and somatic symptoms (degree of psychiatric symptoms, changes in molecular and cardiovascular parameters, lifestyle patterns, level of functioning and perceived quality of life). Also, if possible, provide an estimate of what long-term effects that might be expected in coming long-term clinical follow-ups.
* Investigate patients' long term experience of Braining participation through qualitative interviews as well as analyse status and change of biomolecular markers two years after inclusion.
Specific goals:
All patients at PSV who participated in Braining 2017-2020 during at least 3 training sessions and do not meet the exclusion criteria will be asked for inclusion. For this population the investigators plan to describe:
* Demographic and medical variables (such as diagnosis, age, gender, functional level, staff-assessed severity of psychiatric disease, self-assessment scales for symptoms of depression, mania / hypomania, and anxiety, self-assessed health-related quality of life, degree of sick leave, ongoing pharmacological treatment, ongoing CBT (cognitive behavioral therapy), need for emergency visits, inpatient care, suicidal attempts).
* Feasibility of the Braining method. Evaluation of the degree of participation in Braining (such as number of training sessions performed, participation over time, differences between subgroups, possible incidents) as well as the participants' experience of Braining (based on surveys and follow-up interviews: positive or negative subjective assessments of the method, to what extent is the method recommended to other patients). Adverse events.
* Differences before and after Braining in terms of statistically significant change in \[I\] degree of psychiatric symptoms and function, \[II\] cardio metabolic factors such as blood pressure, BMI, waist measurement, weight, \[III\] molecular parameters such as serum concentration of blood lipids, fasting blood sugar, HbA1c, CRP, \[IV\] health-related quality of life, \[V\] level of social function (such as work/study/sick leave) and care needs (such as need of inpatient care, medicine, emergency visits), \[VI\] assessed severity of psychiatric disorder, \[VII\] lifestyle patterns such as exercise, sleep, diet, substance use.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 50
• ≥3 training sessions during the years 2017-2020
- <3 training sessions during the years 2017-2020
- Does not speak Swedish
- Care in accordance with the Compulsory Mental Care Act (Lagen om psykiatrisk tvångsvård, LPT)
- Total lack of data at the start of participation in Braining
- Deceased
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants in Braining, years 2017-2020 Braining Braining was primarily open for patients with a main or secondary diagnosis within affective disorder or anxiety syndromes, sleep disturbance or stress. Participants in Braining (n≈600), who have participated in three or more training sessions 2017-2020 (n≈250), and who agree to contribute to this study, will be included.
- Primary Outcome Measures
Name Time Method CGI-S (Clinical Global Impressions - Severity Scale) At inclusion (Ti) A one-item clinician assessed measure which evaluates the severity of psychopathology from 1 to 7, where 1 is 'normal' and 7 is 'among the most extremely ill patients' by the question "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?".
Blood pressure At inclusion (Ti) Blood pressure, systolic and diastolic, mmHg
BMI (Body Mass Index) At inclusion (Ti) Weight in kg divided by the square of height in m
FBS (Fasting Blood Sugar) At inclusion (Ti) Fasting blood sugar, mmol/L
EQ-5D ( EQ-5D™ is a trade mark of the EuroQol Group) At inclusion (Ti) Self-assessment instrument for describing and valuing health. Defines health in terms of five dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Also included is an overall health rating on a 0-100 hash-marked, vertical visual analogue scale (EQ-VAS). Assessment the scores from the descriptive component can be reported as a five digit number ranging from 11111 (full health) to 33333 (worst health). A number of methods exist for analysing these five digit profiles. However, frequently they are converted to a single utility index using country specific value sets. A higher index number indicates a poorer self-assessed health.
Descriptives of the population 2017-2020 The investigators plan to describe the population from a socioeconomic, demographic and medical perspective. The study design is observational, and therefore not hypothesis-driven. The study design is is not a clinical trial.
Feasibility - The population´s participation in Braining 2017-2020 The population's participation in terms of number of training sessions, participation over time, differences between subgroups. General description of how the participants experienced the method (common positive or negative subjective assessments of the method, the extent to which the method is recommended to other patients), based on the participants' treatment evaluations. Adverse events. The study design is observational, and therefore not hypothesis-driven. The study design is not a clinical trial.
PHQ-9 (Patient Health Questionnaire - 9 items) At inclusion (Ti) Self-assessment of symptoms of depression. Symptom assessment tool that measures health using nine items on 4-point scales and a 4-point scale for impact on daily life. Score 0-27. A higher value indicates worse symptoms of depression.
GAD-7 (Generalised Anxiety Disorder Assessment - 7 items) At inclusion (Ti) Self-assessment of symptoms of generalised anxiety. Symptom assessment tool that measures seven anxiety symptoms on 4-point scales. Score 0-21. A higher value indicates worse symptoms of general anxiety.
- Secondary Outcome Measures
Name Time Method HR (Heart Rate) At inclusion (Ti) Heart rate, bpm
LSAS (Liebowitz Social Anxiety Scale) At inclusion (Ti) Self-assessment of symptoms of social anxiety. Comprises 24 social situations that are each rated for level of fear and avoidance. Score (including both subscales) 0-144. A higher value indicates worse symptoms of social anxiety.
PDSS (Panic Disorder Severity Scale) At inclusion (Ti) Self-assessment of symptoms of panic disorder. The 7-item scale assesses the frequency of panic attacks, distress during panic attacks, anticipatory anxiety, agoraphobic fear and avoidance, body-sensation fear and avoidance, and impairment in work and social functioning on 5-point scales (0-4). Score 0-28. A higher value indicates worse symptoms of panic disorder.
AUDIT (Alcohol Use Disorders Identification Test) At inclusion (Ti) Self-report instrument used to identify problematic use of alcohol. Value 0-40. A score of 8 for men and 6 for women is usually set as the clinical cut-off for problematic use. A higher value indicates more problematic use.
CRP At inclusion (Ti) C-reactive protein, measurement of inflammation and infection, mmol/L
YMRS (Young Ziegler Mania Rating Scale) At inclusion (Ti) Interviewer-rated scale. Includes 11 items; seven are rated from 0 (absent) to 4; four from 0 to 8; total scores range from 0 to 60. A higher value indicates worse symptoms of hypomania/mania.
DUDIT (Drug Use Disorders Identification Test) At inclusion (Ti) Self-report instrument used to identify problems with illegal drugs and/or prescription drugs. Value 0-44. A score of 6 for men and 2 for women is usually set as the clinical cut-off for harmful use. A higher value indicates more problematic use.
WHODAS 2.0 (WHO Disability Assessment Schedule) At inclusion (Ti) Self-assessment of disability. Covering six domains concerning functioning: cognitive, mobility, self-care, getting along with people, life activities, and social participation. The summary score is converted into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability).
AS-18 (Affective Self Assessment Scale - 18 items) At inclusion (Ti) Self-assessment of symptoms of depression and hypomania/mania. 9 items for depression and 9 items for mania. Score 0-72. A score of over 10 on the depressive or manic/hypomanic subscale should give rise to suspicion of ongoing depression and hypomania/mania respectively. Scores of over 10 on both the depressive and manic/hypomanic scale at the same time give may indicate an affective mixed state.
Blood lipids At inclusion (Ti) Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L
Waist circumference At inclusion (Ti) Waist circumference, cm
HbA1c At inclusion (Ti) Hemoglobin A1c, glycated hemoglobin, mmol/mol
Occupational status At inclusion (Ti) Employment, unemployment, sick leave, early retirement, retirement pension
Acceptability of treatment method among patients Follow-up 2 years after inclusion Semi-structured interviews. Qualitative technique that explores patients' experiences. No scale.
Trial Locations
- Locations (1)
Region Stockholm, Psykiatri Sydväst (Psychiatric Clinic Psychiatry Southwest)
🇸🇪Stockholm, Sweden