Physical Exercise as Adjunctive Therapy for Affective Disorder and Anxiety

Depression Clinical Trial

Official title:

Physical Exercise as Adjunctive Therapy for Affective Disorder and Anxiety - a Retrospective Study of the Braining Project 2017-2020 Regarding Feasibility, Participants and Changes in Symptoms, Function and Physical Parameters

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05157386
• Other study ID #: Braining Study 1 Retrospective
• Status: Active, not recruiting
• Start date: December 20, 2021
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: Region Stockholm
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• =3 training sessions during the years 2017-2020

Exclusion Criteria:

• <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

Related Conditions & MeSH terms

• ADHD
• Anxiety
• Anxiety Disorders
• Autism
• Bipolar Disorder
• Depression
• Generalized Anxiety Disorder
• Insomnia
• Mood Disorders
• Panic Disorder
• Personality Disorders
• Phobia, Social
• Physical Inactivity
• Posttraumatic Stress Disorder
• Social Phobia
• Stress
• Stress Disorders, Post-Traumatic

Intervention

Other:
• Braining
Core components of Braining: Personnel-led training sessions, motivating contact with psychiatric staff, measurement and evaluation before and after the training period; usually 12 weeks. PE is added on to treatment as usual (TAU). The training sessions are moderate to intense aerobic group training, 30-45 minutes. Each training session is preceded by a short (5-10 minutes) individual meeting with staff including assessment of daily form, motivational work, and the opportunity to ask questions. The target frequency for participation is preferably at least three training sessions/week during a 12 week period. The training period for each patient begins with an informative and motivating group or individual lecture or and an individual introductory meeting with staff including psychiatric and somatic examination, self-assessment scales for symptoms and quality of life, and blood samples. The training period ends with a meeting with staff with follow-up on the parameters.

Locations

Country	Name	City	State
Sweden	Region Stockholm, Psykiatri Sydväst (Psychiatric Clinic Psychiatry Southwest)	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Region Stockholm	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

References & Publications (15)

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Cooney GM, Dwan K, Greig CA, Lawlor DA, Rimer J, Waugh FR, McMurdo M, Mead GE. Exercise for depression. Cochrane Database Syst Rev. 2013 Sep 12;2013(9):CD004366. doi: 10.1002/14651858.CD004366.pub6. — View Citation

Ekelund U, Tarp J, Steene-Johannessen J, Hansen BH, Jefferis B, Fagerland MW, Whincup P, Diaz KM, Hooker SP, Chernofsky A, Larson MG, Spartano N, Vasan RS, Dohrn IM, Hagstromer M, Edwardson C, Yates T, Shiroma E, Anderssen SA, Lee IM. Dose-response associations between accelerometry measured physical activity and sedentary time and all cause mortality: systematic review and harmonised meta-analysis. BMJ. 2019 Aug 21;366:l4570. doi: 10.1136/bmj.l4570. — View Citation

Goodwin GM, Haddad PM, Ferrier IN, Aronson JK, Barnes T, Cipriani A, Coghill DR, Fazel S, Geddes JR, Grunze H, Holmes EA, Howes O, Hudson S, Hunt N, Jones I, Macmillan IC, McAllister-Williams H, Miklowitz DR, Morriss R, Munafo M, Paton C, Saharkian BJ, Saunders K, Sinclair J, Taylor D, Vieta E, Young AH. Evidence-based guidelines for treating bipolar disorder: Revised third edition recommendations from the British Association for Psychopharmacology. J Psychopharmacol. 2016 Jun;30(6):495-553. doi: 10.1177/0269881116636545. Epub 2016 Mar 15. — View Citation

Helgadottir B, Forsell Y, Ekblom O. Physical activity patterns of people affected by depressive and anxiety disorders as measured by accelerometers: a cross-sectional study. PLoS One. 2015 Jan 13;10(1):e0115894. doi: 10.1371/journal.pone.0115894. eCollection 2015. — View Citation

Hofmann SG, Asnaani A, Vonk IJ, Sawyer AT, Fang A. The Efficacy of Cognitive Behavioral Therapy: A Review of Meta-analyses. Cognit Ther Res. 2012 Oct 1;36(5):427-440. doi: 10.1007/s10608-012-9476-1. Epub 2012 Jul 31. — View Citation

Layard R, Clark DM. Why More Psychological Therapy Would Cost Nothing. Front Psychol. 2015 Nov 25;6:1713. doi: 10.3389/fpsyg.2015.01713. eCollection 2015. No abstract available. — View Citation

Mead GE, Morley W, Campbell P, Greig CA, McMurdo M, Lawlor DA. Exercise for depression. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD004366. doi: 10.1002/14651858.CD004366.pub3. — View Citation

Melo MC, Daher Ede F, Albuquerque SG, de Bruin VM. Exercise in bipolar patients: A systematic review. J Affect Disord. 2016 Jul 1;198:32-8. doi: 10.1016/j.jad.2016.03.004. Epub 2016 Mar 15. — View Citation

Rimer J, Dwan K, Lawlor DA, Greig CA, McMurdo M, Morley W, Mead GE. Exercise for depression. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD004366. doi: 10.1002/14651858.CD004366.pub5. — View Citation

Shafran R, Clark DM, Fairburn CG, Arntz A, Barlow DH, Ehlers A, Freeston M, Garety PA, Hollon SD, Ost LG, Salkovskis PM, Williams JM, Wilson GT. Mind the gap: Improving the dissemination of CBT. Behav Res Ther. 2009 Nov;47(11):902-9. doi: 10.1016/j.brat.2009.07.003. Epub 2009 Aug 6. — View Citation

Strohle A, Graetz B, Scheel M, Wittmann A, Feller C, Heinz A, Dimeo F. The acute antipanic and anxiolytic activity of aerobic exercise in patients with panic disorder and healthy control subjects. J Psychiatr Res. 2009 Aug;43(12):1013-7. doi: 10.1016/j.jpsychires.2009.02.004. Epub 2009 Mar 16. — View Citation

Whiteford HA, Degenhardt L, Rehm J, Baxter AJ, Ferrari AJ, Erskine HE, Charlson FJ, Norman RE, Flaxman AD, Johns N, Burstein R, Murray CJ, Vos T. Global burden of disease attributable to mental and substance use disorders: findings from the Global Burden of Disease Study 2010. Lancet. 2013 Nov 9;382(9904):1575-86. doi: 10.1016/S0140-6736(13)61611-6. Epub 2013 Aug 29. — View Citation

Wolitzky-Taylor K, Zimmermann M, Arch JJ, De Guzman E, Lagomasino I. Has evidence-based psychosocial treatment for anxiety disorders permeated usual care in community mental health settings? Behav Res Ther. 2015 Sep;72:9-17. doi: 10.1016/j.brat.2015.06.010. Epub 2015 Jul 2. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Descriptives of the population	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.	2017-2020
Primary	Feasibility - The population´s participation in Braining	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.	2017-2020
Primary	PHQ-9 (Patient Health Questionnaire - 9 items)	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.	At the individual's start of participation in Braining (T0)
Primary	PHQ-9 (Patient Health Questionnaire - 9 items)	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.	At inclusion (Ti)
Primary	GAD-7 (Generalised Anxiety Disorder Assessment - 7 items)	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.	At the individual's start of participation in Braining (T0)
Primary	GAD-7 (Generalised Anxiety Disorder Assessment - 7 items)	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.	At inclusion (Ti)
Primary	CGI-S (Clinical Global Impressions - Severity Scale)	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?".	At the individual's start of participation in Braining (T0)
Primary	CGI-S (Clinical Global Impressions - Severity Scale)	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?".	At inclusion (Ti)
Primary	Blood pressure	Blood pressure, systolic and diastolic, mmHg	At the individual's start of participation in Braining (T0)
Primary	Blood pressure	Blood pressure, systolic and diastolic, mmHg	At inclusion (Ti)
Primary	BMI (Body Mass Index)	Weight in kg divided by the square of height in m	At the individual's start of participation in Braining (T0)
Primary	BMI (Body Mass Index)	Weight in kg divided by the square of height in m	At inclusion (Ti)
Primary	FBS (Fasting Blood Sugar)	Fasting blood sugar, mmol/L	At the individual's start of participation in Braining (T0)
Primary	FBS (Fasting Blood Sugar)	Fasting blood sugar, mmol/L	At inclusion (Ti)
Primary	EQ-5D ( EQ-5D™ is a trade mark of the EuroQol Group)	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.	At the individual's start of participation in Braining (T0)
Primary	EQ-5D ( EQ-5D™ is a trade mark of the EuroQol Group)	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.	At inclusion (Ti)
Secondary	AS-18 (Affective Self Assessment Scale - 18 items)	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.	At the individual's start of participation in Braining (T0)
Secondary	AS-18 (Affective Self Assessment Scale - 18 items)	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.	At inclusion (Ti)
Secondary	YMRS (Young Ziegler Mania Rating Scale)	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.	At the individual's start of participation in Braining (T0)
Secondary	YMRS (Young Ziegler Mania Rating Scale)	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.	At inclusion (Ti)
Secondary	LSAS (Liebowitz Social Anxiety Scale)	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.	At the individual's start of participation in Braining (T0)
Secondary	LSAS (Liebowitz Social Anxiety Scale)	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.	At inclusion (Ti)
Secondary	PDSS (Panic Disorder Severity Scale)	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.	At the individual's start of participation in Braining (T0)
Secondary	PDSS (Panic Disorder Severity Scale)	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.	At inclusion (Ti)
Secondary	AUDIT (Alcohol Use Disorders Identification Test)	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.	At the individual's start of participation in Braining (T0)
Secondary	AUDIT (Alcohol Use Disorders Identification Test)	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.	At inclusion (Ti)
Secondary	DUDIT (Drug Use Disorders Identification Test)	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.	At the individual's start of participation in Braining (T0)
Secondary	DUDIT (Drug Use Disorders Identification Test)	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.	At inclusion (Ti)
Secondary	HR (Heart Rate)	Heart rate, bpm	At the individual's start of participation in Braining (T0)
Secondary	HR (Heart Rate)	Heart rate, bpm	At inclusion (Ti)
Secondary	Waist circumference	Waist circumference, cm	At the individual's start of participation in Braining (T0)
Secondary	Waist circumference	Waist circumference, cm	At inclusion (Ti)
Secondary	Blood lipids	Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L	At the individual's start of participation in Braining (T0)
Secondary	Blood lipids	Total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, mmol/L	At inclusion (Ti)
Secondary	HbA1c	Hemoglobin A1c, glycated hemoglobin, mmol/mol	At the individual's start of participation in Braining (T0)
Secondary	HbA1c	Hemoglobin A1c, glycated hemoglobin, mmol/mol	At inclusion (Ti)
Secondary	CRP	C-reactive protein, measurement of inflammation and infection, mmol/L	At the individual's start of participation in Braining (T0)
Secondary	CRP	C-reactive protein, measurement of inflammation and infection, mmol/L	At inclusion (Ti)
Secondary	WHODAS 2.0 (WHO Disability Assessment Schedule)	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).	At the individual's start of participation in Braining (T0)
Secondary	WHODAS 2.0 (WHO Disability Assessment Schedule)	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).	At inclusion (Ti)
Secondary	Occupational status	Employment, unemployment, sick leave, early retirement, retirement pension	At the individual's start of participation in Braining (T0)
Secondary	Occupational status	Employment, unemployment, sick leave, early retirement, retirement pension	At inclusion (Ti)
Secondary	Acceptability of treatment method among patients	Semi-structured interviews. Qualitative technique that explores patients' experiences. No scale.	Follow-up 2 years after inclusion

External Links

•   2018 Physical Activity Guidelines Advisory Committee. 2018 Physical Activity Guidelines Advisory Committee Scientific Report. Washington, DC: U.S. Department of Health and Human Services, 2018
•   Swedish Professional Associations for Physical Activity (Yrkesföreningar för Fysisk Aktivitet, YFA). 2021. Physical Activity in the Prevention and Treatment of Disease (FYSS). 2021.
•   World Health Organization. (2020). WHO guidelines on physical activity and sedentary behaviour: at a glance. World Health Organization.