AquaTherapy and Subsequent Training for 50 Veterans With PTSD - A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in PTSD symptoms measured by the PTSD Checklist - Military Version (PCL-M)
研究概览
简要总结
This project investigates the effect of Aquatic Therapy followed by group training for 50 veterans diagnosed with PTSD.
Around 40% of Danish veterans experience insufficient benefit from current standard treatments, especially regarding sleep and quality of life.
The study is a single-group, pre-post feasibility study, where participants receive 16 weeks of individual aquatic therapy (twice weekly) in a 34 °C pool, followed by 16 weeks of group-based aquatic exercise (once weekly). Participants are recruited through military psychiatric clinics and veteran organizations.
The primary outcome is change in PTSD symptoms measured by the PCL-M questionnaire. Secondary outcomes include sleep quality (PSQI), quality of life (WHO-5), anxiety and depression (HSCL-25), and social participation. Data are collected before, after, and at one-year follow-up. The study also evaluates feasibility in terms of recruitment, adherence, acceptability, and follow-up rates.
The aim is to achieve clinically relevant reductions in PTSD symptoms, improved sleep, and enhanced quality of life. The project is conducted in collaboration with military psychiatric services, and veteran organizations, and is managed by Gentofte Hospital. The intervention is considered safe and non-invasive, and all ethical and data protection regulations are followed. The project will provide rapid access to new treatment, generate knowledge for national implementation. Previous studies indicate marked and lasting improvements in sleep, symptoms, and quality of life, supporting reintegration into work and social life.
详细描述
Post-traumatic stress disorder (PTSD) is prevalent among military veterans and is commonly associated with persistent hyperarousal, sleep disturbances, and reduced quality of life. Although trauma-focused psychotherapy and pharmacological treatment are considered first-line interventions, a substantial proportion of veterans continue to experience residual symptoms, particularly related to sleep, physiological stress regulation, and daily functioning. This highlights the need for complementary, non-pharmacological interventions that address both psychological and somatic aspects of PTSD.
Aquatic therapy delivered in warm water represents a body-based intervention with potential relevance for trauma-exposed populations. The physical properties of warm water, including buoyancy, hydrostatic pressure, and thermal effects, may facilitate relaxation, reduce muscle tension, and support autonomic nervous system regulation. Trauma-informed aquatic therapy further emphasizes safety, predictability, and bodily awareness, which are considered central mechanisms in reducing hyperarousal and improving sleep and well-being in individuals with PTSD. Preliminary Danish and international studies suggest that aquatic therapy is safe and may lead to clinically meaningful improvements in PTSD-related symptoms, sleep quality, and quality of life among veterans with chronic PTSD.
The present study evaluates a structured, two-phase aquatic intervention consisting of an initial individual therapy phase followed by group-based aquatic exercise. The individual phase is designed to establish a sense of safety, promote relaxation, and enhance body awareness through one-to-one sessions with a physiotherapist in a warm water environment. This phase aims to reduce physiological stress responses and prepare participants for more active and socially oriented exercise. The subsequent group-based phase focuses on gradual reintroduction of physical activity and social participation through supervised aquatic exercise, with the intention of consolidating treatment gains and supporting longer-term maintenance.
The study is conducted as a single-group, pre-post feasibility study. The primary objective is to assess the feasibility of delivering the intervention to veterans with PTSD, including recruitment procedures, adherence to the intervention, acceptability of the treatment model, and the practicality of follow-up assessments. As a feasibility study, the trial is not powered to test efficacy, but to inform the design, procedures, and outcome selection for a future randomized controlled trial. Secondary objectives include exploring changes in PTSD-related symptoms, sleep quality, and quality of life to support planning of subsequent controlled studies.
Data are collected at baseline, immediately after completion of the intervention, and at one-year follow-up using validated self-report instruments. In addition, qualitative feedback is collected to capture participant experiences, perceived benefits, and potential barriers to participation. These data will be used to refine the intervention protocol and study procedures prior to potential scaling or evaluation in a controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Veteran diagnosed with PTSD.
- •Willingness to complete questionnaires and respond to texts.
- •Sufficient Danish language proficiency
- •Practical ability to participate (sessions are Wednesday and Friday afternoons)
- •Able to attend or arrange transport to Tuborgvej, 2400 Copenhagen NV
- •Any substance abuse must be under control
排除标准
- •Acute psychiatric crisis or severe comorbid psychiatric disorder that would prevent participation.
- •Physical conditions that contraindicate participation in aquatic therapy (e.g., open wounds, severe infections, or other medical contraindications for warm water therapy).
- •Lack of consent
研究组 & 干预措施
Aquatic Therapy and subsequent Group Training for Veterans With PTSD: 32-Week Feasibility Study
This arm consists of a 32-week intervention for veterans diagnosed with PTSD. The first phase is 16 weeks of individual Aquatic Therapy delivered twice weekly in a 34°C warm water pool by a physiotherapist, focusing on relaxation, movement, and body awareness.
The second phase is 16 weeks of group-based aquatic training, held once weekly in small groups, emphasizing cardiovascular fitness, strength, mobility, and relaxation. The intervention aims to reduce PTSD symptoms, improve sleep quality, and enhance quality of life. Outcomes are measured before, after, and at one-year follow-up using validated questionnaires (PCL-M, PSQI, WHO-5, HSCL-25) and participant feedback.
The program is delivered by experienced physiotherapists and is considered safe and non-invasive. The study is conducted in collaboration with military psychiatric services, veteran organizations, and academic partners
干预措施: AquaTherapy (Other)
结局指标
主要结局
Change in PTSD symptoms measured by the PTSD Checklist - Military Version (PCL-M)
时间窗: Baseline, end of 32-week intervention, and 1-year follow-up.
Outcome Measure Description: Change in PTSD symptom severity assessed using the Posttraumatic Stress Disorder Checklist - Military Version (PCL-M). The PCL-M is a 17-item self-report questionnaire with total scores ranging from 17 to 85, where higher scores indicate more severe PTSD symptoms. A clinically meaningful improvement is defined as a reduction of ≥10 points from baseline.
次要结局
- Change in sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI)(Baseline, end of 32-week intervention, and 1-year follow-up.)
- Change in quality of life measured by the WHO-5 Well-Being Index(Baseline, end of 32-week intervention, and 1-year follow-up.)
