Depression Mental and Behavioural Disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Current key inclusion criteria as of 06/03/2026: 1. Participants give fully informed consent to participate 2. Symptoms of depression, as determined by the PHQ-9 (scores 8 and above) and meeting DSM 5 criteria for Major Depressive Disorder (this will also be assessed using the Mini International Neuropsychiatric Interview [MINI]) 3. 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 experience is required for outdoor unheated swimming pools (lidos) 4. Adult aged 18 years or older 5. Able to understand spoken instructions in English or in a language spoken by the swim coaches that are recruited Previous key inclusion criteria: 1. Participants give fully informed consent to participate 2. 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 assessed using the Mini International Neuropsychiatric Interview [MINI]) 3. 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 experience is required for outdoor unheated swimming pools (lidos) 4. Adult aged 18 years or older 5. Able to understand spoken instructions in English or in a language spoken by the swim coaches that are recruited
Exclusion criteria
Exclusion criteria: Current key exclusion criteria as of 06/03/2026: 1. High Risk of suicide, determined by asking the person reporting: 1.1. In the past month, having taken active steps with the intention of dying 1.2. Greater than 10% risk of acting on suicidal thoughts in the next few days 1.3. Or 50% or greater risk of acting on suicidal thoughts in the next 3 months, or 1.4. For those reporting a 1-49% risk of acting on suicidal thoughts in the next 3 months, the risk of acting on thoughts is deemed high following review by a study psychiatrist 2. Evidence of a current psychotic disorder (ascertained from the MINI psychotic disorders module conducted during a phone call with RA and further assessed by the medical team) 3. History of serious cardiac abnormalities determined after medical review and assessment 4. Respiratory conditions triggered by cold, such as poorly controlled exercise-induced asthma 5. Cold-water urticaria 6. Participants with a BMI of 17 or under 7. Moderate to severe learning disability 8. History of non-freezing cold injuries, if not mitigated (wearing boots/gloves) 9. Currently participating in another interventional research trial Previous key exclusion criteria: 1. Risk of suicide (participants deemed a high risk of suicide based on a score of 17 and over from the MINI suicidality module) 2. Evidence of a current psychotic disorder (ascertained from the MINI psychotic disorders module conducted during a phone call with RA and further assessed by the medical team) 3. History of serious cardiac abnormalities determined after medical review and assessment 4. Respiratory conditions triggered by cold such as poorly controlled exercise-induced asthma 5. Cold-water urticaria 6. Participants with a BMI of 17 or under 7. Moderate to severe learning disability 8. History of non-freezing cold injuries, if not mitigated (wearing boots/gloves)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depression severity is measured using Patient Health Questionnaire (PHQ-9) at baseline, at 12 and 38 weeks post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Anxiety symptom severity is measured using Generalised Anxiety Disorder Assessment (GAD-7) at baseline 12 and 38 weeks post-randomisation 2. Mindfulness total and subscale scores measured using the Five Facet Mindfulness Questionnaire (FFMQ-15) at baseline, 12 and 38 weeks post-randomisation 3. Health-related quality of life is measured using EQ-5D 5L and Recovering Quality of Life (ReQoL) at baseline, 12 and 38 weeks post-randomisation 4. Medication, health care resource use and travel to treatments/appointments measured using the Client Service Receipt Inventory-UK at baseline, 12 and 38 weeks post-randomisation 5. The impact of (mental) health on employment in a paid job and on unpaid work, like household chores, quantified using the Institute of Medical Technology Assessment (i-MTA) Productivity Cost Questionnaire (iPCQ) and “ad-hoc” form/logs at baseline, 12 and 38 weeks post-randomisation 6. Relevant set-up and ongoing resources necessary to offer the outdoor swimming courses measured using “ad-hoc” form/logs during the intervention swim courses 7. How participants experience the outdoor swimming course in relation to their experiences of depression, measured using interviews and diaries during the swim courses and interviews following the completion of the study | — |
Countries
England, United Kingdom