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Depression, AnxietyNCT04528485

Sea Swimming for Treatment of Depression and Anxiety

A study testing Sea swimming in people with Depression, Anxiety, run by Devon Partnership NHS Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Depression, Anxiety
What is being tested?
Sea swimming
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
1 siteUnited Kingdom
Study dates
1 Jul 2020to 16 Mar 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Croyde Beach

    Croyde, Devon

Other trials in United Kingdom

About this study

Official title: The Effect of a Sea-safety Course on Mood, Mental Wellbeing and Inflammation

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
Read more

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.

Being tested
Sea swimming
Medical subject headings
Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sea swimmingOther

    8 sessions of swimming activities in the sea

Study groups in NCT04528485
Study groupRoleWhat they receive
Sea swimmingExperimental8 sessions over 4 weeks of swimming-based activities in the sea
Receives: Other: Sea swimming

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment and retention of participants

    The number of participants recruited and how many of them complete the course

    Measured: 5 weeks

Secondary outcomes (4)

  1. Effect of course on measures of anxiety

    Comparison of GAD7 scores before the start and after completion of the intervention

    Measured: 5 weeks

  2. Effect of course on measures of depression

    Comparison of PHQ9 scores before the start and after completion of the intervention

    Measured: 5 weeks

  3. Effect of course on measures of functioning

    Comparison of WSAS scores before the start and after the completion of the intervention

    Measured: 5 weeks

  4. Effect of course on inflammation

    Comparison of CRP pre- and post-course

    Measured: 5 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2020
  2. Study start1 Jul 2020
  3. Primary completion16 Mar 2021
  4. Study completion16 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04528485
Sponsor's protocol ID
DPT0468 Sea Swimming
Status last verified
Aug 2021
First submitted
24 Aug 2020
Last updated
18 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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. doi: 10.1097/00000542-199811000-00013.

    PubMed 9822001

  • 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.

    PubMed 28374419

  • 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.

    PubMed 25364500

  • 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.

    PubMed 24026850

  • 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. doi: 10.1080/00140130500101544.

    PubMed 16338708

  • 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.

    PubMed 25456012

  • Gabay C, Kushner I. Acute-phase proteins and other systemic responses to inflammation. N Engl J Med. 1999 Feb 11;340(6):448-54. doi: 10.1056/NEJM199902113400607. No abstract available.

    PubMed 9971870

  • 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. doi: 10.1016/j.jacc.2007.06.012. Epub 2007 Sep 4.

    PubMed 17868801

  • Holt-Lunstad J, Smith TB, Layton JB. Social relationships and mortality risk: a meta-analytic review. PLoS Med. 2010 Jul 27;7(7):e1000316. doi: 10.1371/journal.pmed.1000316.

    PubMed 20668659

  • Iacobucci G. NHS prescribed record number of antidepressants last year. BMJ. 2019 Mar 29;364:l1508. doi: 10.1136/bmj.l1508. No abstract available.

    PubMed 30926584

  • 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.

    PubMed 19857513

  • Maes M, Delange J, Ranjan R, Meltzer HY, Desnyder R, Cooremans W, Scharpe S. Acute phase proteins in schizophrenia, mania and major depression: modulation by psychotropic drugs. Psychiatry Res. 1997 Jan 15;66(1):1-11. doi: 10.1016/s0165-1781(96)02915-0.

    PubMed 9061799

  • 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.

    PubMed 26258155

  • Muller N, Schwarz MJ, Dehning S, Douhe A, Cerovecki A, Goldstein-Muller B, Spellmann I, Hetzel G, Maino K, Kleindienst N, Moller 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. doi: 10.1038/sj.mp.4001805. Epub 2006 Feb 21.

    PubMed 16491133

Questions about this trial

What is this clinical trial studying?

A study testing Sea swimming in people with Depression, Anxiety, run by Devon Partnership NHS Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment and retention of participants (time frame: 5 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04528485, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2021.

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