Sea Swimming for Treatment of Depression and Anxiety

Sponsor
Devon Partnership NHS Trust (Other)
Overall Status
Completed
CT.gov ID
NCT04528485
Collaborator
(none)
61
1
1
8.5
7.2

Study Details

Study Description

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
  • Other: Sea swimming
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
61 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 :
Jul 1, 2020
Actual Primary Completion Date :
Mar 16, 2021
Actual Study Completion Date :
Mar 16, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Recruitment and retention of participants [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 [5 weeks]

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

  2. Effect of course on measures of depression [5 weeks]

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

  3. Effect of course on measures of functioning [5 weeks]

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

  4. Effect of course on inflammation [5 weeks]

    Comparison of CRP pre- and post-course

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Croyde Beach Croyde Devon United Kingdom

Sponsors and Collaborators

  • Devon Partnership NHS Trust

Investigators

  • Study Chair: C Mark Harper, MBBS, Brighton and Sussex University Hospitals

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Devon Partnership NHS Trust
ClinicalTrials.gov Identifier:
NCT04528485
Other Study ID Numbers:
  • DPT0468 Sea Swimming
First Posted:
Aug 27, 2020
Last Update Posted:
Aug 18, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 18, 2021