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Sea Swimming for Treatment of Depression and Anxiety

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE August 24, 2020
First Posted Date  ICMJE August 27, 2020
Last Update Posted Date February 4, 2021
Actual Study Start Date  ICMJE July 1, 2020
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2020)
Recruitment and retention of participants [ Time Frame: 5 weeks ]
The number of participants recruited and how many of them complete the course
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2020)
  • Effect of course on measures of anxiety [ Time Frame: 5 weeks ]
    Comparison of GAD7 scores before the start and after completion of the intervention
  • Effect of course on measures of depression [ Time Frame: 5 weeks ]
    Comparison of PHQ9 scores before the start and after completion of the intervention
  • 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
  • Effect of course on inflammation [ Time Frame: 5 weeks ]
    Comparison of CRP pre- and post-course
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sea Swimming for Treatment of Depression and Anxiety
Official Title  ICMJE The Effect of a Sea-safety Course on Mood, Mental Wellbeing and Inflammation
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Depression, Anxiety
Intervention  ICMJE Other: Sea swimming
8 sessions of swimming activities in the sea
Study Arms  ICMJE Experimental: Sea swimming
8 sessions over 4 weeks of swimming-based activities in the sea
Intervention: Other: Sea swimming
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: August 24, 2020)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2021
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04528485
Other Study ID Numbers  ICMJE DPT0468 Sea Swimming
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Devon Partnership NHS Trust
Study Sponsor  ICMJE Devon Partnership NHS Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: C Mark Harper, MBBS Brighton and Sussex University Hospitals
PRS Account Devon Partnership NHS Trust
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP