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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04528485
Other study ID # DPT0468 Sea Swimming
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2020
Est. completion date March 16, 2021

Study information

Verified date August 2021
Source Devon Partnership NHS Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

There is a developing evidence to suggest that open cold water swimming could have an impact on depression and anxiety: - anecdotal reports of benefits to mental wellbeing as a result of regular open water bathing - research suggesting exercise is as effective as medication and talking therapies in the treatment of depression - ecotherapy (offering therapeutic intervention in nature) has a developing evidence base - cold water may have an impact on the inflammatory system which has been linked to depression The aim of this study is to recruit 10 people with mild to moderately severe depression to a sea swimming course, alongside their standard care. The course would involve two groups of 5, participating in eight sea sessions under the guidance and supervision of swim instructors and lifeguards. The primary aim of the course is to determine the recruitment rate and compliance with the course. The secondary aims of the course are to determine the impact on mental health through questionnaires for depression (PHQ9), anxiety (GAD7), functioning in daily life (WSAS). The inflammatory marker - C- reactive protein (CRP), will also be measured to monitor the inflammatory process in relation to psychological outcomes and the timeline of the course. Participants will need to commit to two sessions a week. It is anticipated that participants will need to commit around 2 hours of their time to the study each week. It would take around ten months from recruitment to follow-up. Participants would be able to leave the study at any time. Participants would engage in routine care alongside the course. Sea swimming can be a dangerous activity but participants would be well supported, in small groups and would only sea swim in safe conditions. Participants will be asked to report any medical conditions to ensure they could not be adversely effected.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date March 16, 2021
Est. primary completion date March 16, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adults living in North Devon and able to attend the course. - PHQ-9 score 5-19 - Able to swim two lengths of a 25m pool Exclusion Criteria: - Physical health problems that would make cold water immersion a risk including significant heart problems, inadequately treated high blood pressure e.g. new diagnosis not on stable medication, significantly reduced mobility. - Experience of other mental health problems at a significant level - Not able to swim or very anxious about getting into water - Suicide risk - Unable to speak English (as the sea swimming course will be conducted in English) - Unable to consent due to lack of capacity

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Sea swimming
8 sessions of swimming activities in the sea

Locations

Country Name City State
United Kingdom Croyde Beach Croyde Devon

Sponsors (1)

Lead Sponsor Collaborator
Devon Partnership NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (22)

Beilin B, Shavit Y, Razumovsky J, Wolloch Y, Zeidel A, Bessler H. Effects of mild perioperative hypothermia on cellular immune responses. Anesthesiology. 1998 Nov;89(5):1133-40. — View Citation

Bryleva EY, Keaton SA, Grit J, Madaj Z, Sauro-Nagendra A, Smart L, Halstead S, Achtyes E, Brundin L. The acute-phase mediator serum amyloid A is associated with symptoms of depression and fatigue. Acta Psychiatr Scand. 2017 May;135(5):409-418. doi: 10.1111/acps.12730. Epub 2017 Apr 4. — View Citation

Canli T. Reconceptualizing major depressive disorder as an infectious disease. Biol Mood Anxiety Disord. 2014 Oct 21;4:10. doi: 10.1186/2045-5380-4-10. eCollection 2014. — View Citation

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;(9):CD004366. doi: 10.1002/14651858.CD004366.pub6. Review. — View Citation

Denton, H. and Aranda K. The wellbeing benefits of sea swimming. Is it time to revisit the sea cure? Qualitative Research in Sport, Exercise and Health. 2019. pp. 1-17.

Dugdill L, Graham RC, McNair F. Exercise referral: the public health panacea for physical activity promotion? A critical perspective of exercise referral schemes; their development and evaluation. Ergonomics. 2005 Sep 15-Nov 15;48(11-14):1390-410. Review. — View Citation

Foley R. Swimming in Ireland: Immersions in therapeutic blue space. Health Place. 2015 Sep;35:218-25. doi: 10.1016/j.healthplace.2014.09.015. — View Citation

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Hage FG, Szalai AJ. C-reactive protein gene polymorphisms, C-reactive protein blood levels, and cardiovascular disease risk. J Am Coll Cardiol. 2007 Sep 18;50(12):1115-22. Epub 2007 Sep 4. Review. — View Citation

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Iacobucci G. NHS prescribed record number of antidepressants last year. BMJ. 2019 Mar 29;364:l1508. doi: 10.1136/bmj.l1508. — View Citation

Jones A, Hillsdon M, Coombes E. Greenspace access, use, and physical activity: understanding the effects of area deprivation. Prev Med. 2009 Dec;49(6):500-5. doi: 10.1016/j.ypmed.2009.10.012. Epub 2009 Oct 24. — View Citation

Maes M, Delange J, Ranjan R, Meltzer HY, Desnyder R, Cooremans W, Scharpé S. Acute phase proteins in schizophrenia, mania and major depression: modulation by psychotropic drugs. Psychiatry Res. 1997 Jan 15;66(1):1-11. — View Citation

Markanday A. Acute Phase Reactants in Infections: Evidence-Based Review and a Guide for Clinicians. Open Forum Infect Dis. 2015 Jul 3;2(3):ofv098. doi: 10.1093/ofid/ofv098. eCollection 2015 Sep. Review. — View Citation

Müller N, Schwarz MJ, Dehning S, Douhe A, Cerovecki A, Goldstein-Müller B, Spellmann I, Hetzel G, Maino K, Kleindienst N, Möller HJ, Arolt V, Riedel M. The cyclooxygenase-2 inhibitor celecoxib has therapeutic effects in major depression: results of a double-blind, randomized, placebo controlled, add-on pilot study to reboxetine. Mol Psychiatry. 2006 Jul;11(7):680-4. Epub 2006 Feb 21. — View Citation

Murray, C. J. L. et al. (1996) 'The Global burden of disease : a comprehensive assessment of mortality and disability from diseases, injuries, and risk factors in 1990 and projected to 2020 : summary / edited by Christopher J. L. Murray, Alan D. Lopez'. Geneva PP - Geneva: World Health Organization (Global burden of disease and injury series, volume 1). Available at: https://apps.who.int/iris/handle/10665/41864.

Pepys MB, Hirschfield GM. C-reactive protein: a critical update. J Clin Invest. 2003 Jun;111(12):1805-12. Review. Erratum in: J Clin Invest. 2003 Jul;112(2):299. — View Citation

Pizzo PA. A Prescription for Longevity in the 21st Century: Renewing Purpose, Building and Sustaining Social Engagement, and Embracing a Positive Lifestyle. JAMA. 2020 Feb 4;323(5):415-416. doi: 10.1001/jama.2019.21087. — View Citation

Ridker PM. Clinical application of C-reactive protein for cardiovascular disease detection and prevention. Circulation. 2003 Jan 28;107(3):363-9. Review. — View Citation

Tangvarasittichai S, Pongthaisong S, Tangvarasittichai O. Tumor Necrosis Factor-?, Interleukin-6, C-Reactive Protein Levels and Insulin Resistance Associated with Type 2 Diabetes in Abdominal Obesity Women. Indian J Clin Biochem. 2016 Mar;31(1):68-74. doi: 10.1007/s12291-015-0514-0. Epub 2015 Jul 26. — View Citation

Tipton MJ, Collier N, Massey H, Corbett J, Harper M. Cold water immersion: kill or cure? Exp Physiol. 2017 Nov 1;102(11):1335-1355. doi: 10.1113/EP086283. Epub 2017 Sep 21. Review. — View Citation

van Tulleken C, Tipton M, Massey H, Harper CM. Open water swimming as a treatment for major depressive disorder. BMJ Case Rep. 2018 Aug 21;2018. pii: bcr-2018-225007. doi: 10.1136/bcr-2018-225007. — View Citation

* Note: There are 22 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Recruitment and retention of participants The number of participants recruited and how many of them complete the course 5 weeks
Secondary Effect of course on measures of anxiety Comparison of GAD7 scores before the start and after completion of the intervention 5 weeks
Secondary Effect of course on measures of depression Comparison of PHQ9 scores before the start and after completion of the intervention 5 weeks
Secondary Effect of course on measures of functioning Comparison of WSAS scores before the start and after the completion of the intervention 5 weeks
Secondary Effect of course on inflammation Comparison of CRP pre- and post-course 5 weeks
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