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Sea Swimming for Treatment of Depression and Anxiety

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ClinicalTrials.gov Identifier: NCT04528485
Recruitment Status : Active, not recruiting
First Posted : August 27, 2020
Last Update Posted : February 4, 2021
Sponsor:
Information provided by (Responsible Party):
Devon Partnership NHS Trust

Brief 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.


Condition or disease Intervention/treatment Phase
Depression, Anxiety Other: Sea swimming Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Effect of a Sea-safety Course on Mood, Mental Wellbeing and Inflammation
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Sea swimming
8 sessions over 4 weeks of swimming-based activities in the sea
Other: Sea swimming
8 sessions of swimming activities in the sea




Primary Outcome Measures :
  1. Recruitment and retention of participants [ Time Frame: 5 weeks ]
    The number of participants recruited and how many of them complete the course


Secondary Outcome Measures :
  1. Effect of course on measures of anxiety [ Time Frame: 5 weeks ]
    Comparison of GAD7 scores before the start and after completion of the intervention

  2. Effect of course on measures of depression [ Time Frame: 5 weeks ]
    Comparison of PHQ9 scores before the start and after completion of the intervention

  3. Effect of course on measures of functioning [ Time Frame: 5 weeks ]
    Comparison of WSAS scores before the start and after the completion of the intervention

  4. Effect of course on inflammation [ Time Frame: 5 weeks ]
    Comparison of CRP pre- and post-course



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04528485


Locations
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United Kingdom
Croyde Beach
Croyde, Devon, United Kingdom
Sponsors and Collaborators
Devon Partnership NHS Trust
Investigators
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Study Chair: C Mark Harper, MBBS Brighton and Sussex University Hospitals
Additional Information:
Publications:
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.
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.

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Responsible Party: Devon Partnership NHS Trust
ClinicalTrials.gov Identifier: NCT04528485    
Other Study ID Numbers: DPT0468 Sea Swimming
First Posted: August 27, 2020    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders