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Sea Swimming for Treatment of Depression and Anxiety

Primary Purpose

Depression, Anxiety

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Sea swimming
Sponsored by
Devon Partnership NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Depression, Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Croyde Beach

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sea swimming

Arm Description

8 sessions over 4 weeks of swimming-based activities in the sea

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Effect of course on measures of anxiety
Comparison of GAD7 scores before the start and after completion of the intervention
Effect of course on measures of depression
Comparison of PHQ9 scores before the start and after completion of the intervention
Effect of course on measures of functioning
Comparison of WSAS scores before the start and after the completion of the intervention
Effect of course on inflammation
Comparison of CRP pre- and post-course

Full Information

First Posted
August 24, 2020
Last Updated
August 17, 2021
Sponsor
Devon Partnership NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04528485
Brief Title
Sea Swimming for Treatment of Depression and Anxiety
Official Title
The Effect of a Sea-safety Course on Mood, Mental Wellbeing and Inflammation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
March 16, 2021 (Actual)
Study Completion Date
March 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Devon Partnership NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sea swimming
Arm Type
Experimental
Arm Description
8 sessions over 4 weeks of swimming-based activities in the sea
Intervention Type
Other
Intervention Name(s)
Sea swimming
Intervention Description
8 sessions of swimming activities in the sea
Primary Outcome Measure Information:
Title
Recruitment and retention of participants
Description
The number of participants recruited and how many of them complete the course
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Effect of course on measures of anxiety
Description
Comparison of GAD7 scores before the start and after completion of the intervention
Time Frame
5 weeks
Title
Effect of course on measures of depression
Description
Comparison of PHQ9 scores before the start and after completion of the intervention
Time Frame
5 weeks
Title
Effect of course on measures of functioning
Description
Comparison of WSAS scores before the start and after the completion of the intervention
Time Frame
5 weeks
Title
Effect of course on inflammation
Description
Comparison of CRP pre- and post-course
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C Mark Harper, MBBS
Organizational Affiliation
Brighton and Sussex University Hospitals
Official's Role
Study Chair
Facility Information:
Facility Name
Croyde Beach
City
Croyde
State/Province
Devon
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
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Links:
URL
https://www.england.nhs.uk/wp-content/uploads/2016/02/Mental-Health-Taskforce-FYFV-final.pdf
Description
The Mental Health Taskforce (2016) The Five Year Forward View For Mental Health.
URL
https://www.nice.org.uk/guidance/cg90
Description
National Institute for Health and Care Excellence [NICE] (2018) 'Depression in adults: recognition and management [CG90]'.

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Sea Swimming for Treatment of Depression and Anxiety

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