OUTSIDE 2 (CPMS 56260, IRAS 328871)

UPDATED - 04/03/2025

The proposed OUTSIDE 2 study is a full-scale cluster superiority RCT with 1:1 allocation to determine if an 8-session outdoor swimming course (plus usual care) is a clinically and cost-effective intervention for depression compared to usual care alone. If this trial is successful the intervention will be recommended for wider rollout, with the research team working with policy makers and service providers. 

INCLUSION CRITERIA:

• Participants give fully informed consent to participate;  

• Symptoms of depression, as determined by the PHQ-9 (scores 5 and above) and meeting DSM 5 criteria for Major Depressive Disorder (this will also be screened for by the trial team through use of the Mini International Neuropsychiatric Interview [MINI]53);  

• Self-reported ability to swim a minimum distance in a heated pool for sea (50 m, 2 lengths of a normal swimming pool) and lake (25 m, 1 length of a normal swimming pool) locations, no swimming ability required for outdoor unheated swimming pool (lido);  

• Adult aged 18 years or older; 

• Able to understand spoken instructions in English or in a language spoken by the swim coaches that are recruited.

EXCLUSION CRITERIA:

• Risk of suicide (participants deemed a high risk of suicide based on a score of 17 and over from the MINI suicidality module); 

• Evidence of a psychotic disorder (ascertained from MINI psychotic disorders module conducted during phone call with RA and further assessed by the medical team53); 

• History of serious cardiac abnormalities determined after medical review and assessment; 

• Respiratory conditions triggered by cold such as poorly controlled exercise-induced asthma; 

• Cold-water urticaria; 

• Participants with a BMI of 17 or under;   

• Moderate to severe learning disability; 

• History of non-freezing cold injuries, if not mitigated (wearing boots/gloves). 

• Currently participating in another research trial  

Study Resources

Access for the SystmOne and EMIS study resources can be requested below.

For further guidance on using the resources, please refer to the guidance documents and further useful information on the PRIDES page.

The searches have been created with the study specific inclusion and exclusion criteria. 

If you require any further information or help, please contact the IT Specialists:

Jodie Button – jodie.button@nihr.ac.uk

James Baslington – james.baslington@nhs.net

Disclaimer:

Please note the resources provided are designed to assist with the identification of potentially suitable patients and to appropriately code these patients if required.

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