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Not yet recruiting NCT07377214

Effect of Aquatic Therapy and Subsequent Training on Veterans With PTSD

No phase Interventional Post Traumatic Stress Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AquaTherapy.
Who it may be relevant to
Registry conditions: Post Traumatic Stress Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

AquaTherapy and Subsequent Training for 50 Veterans With PTSD - A Feasibility Study

Overview

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.

Detailed description

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.

The intervention is non-invasive and delivered by experienced physiotherapists trained in aquatic therapy for trauma-exposed populations. All study procedures are conducted in accordance with applicable ethical guidelines and data protection regulations

Interventions

  • Other AquaTherapy
    The intervention consists of a 32-week program for veterans diagnosed with PTSD, delivered in two consecutive phases. The first phase comprises 16 weeks of individual Aquatic Therapy where each participant receives one-on-one aquatic physiotherapy sessions with a trained physiotherapist in a warm water pool (34-36°C), twice weekly. These sessions focus on relaxation, gentle movement, and body awareness, aiming to reduce stress and establish a sense of safety and calm. Following the individual p

Primary outcome measures

  • Change in PTSD symptoms measured by the PTSD Checklist - Military Version (PCL-M) [Time frame: Baseline, end of 32-week intervention, and 1-year follow-up.]
Secondary outcome measures (2)
  • Change in sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI) [Time frame: Baseline, end of 32-week intervention, and 1-year follow-up.]
  • Change in quality of life measured by the WHO-5 Well-Being Index [Time frame: Baseline, end of 32-week intervention, and 1-year follow-up.]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Denmark · 1 center
  • AquaTerapi, Tuborgvej, 2400 Copenhagen NV — Copenhagen

Identifiers

NCT: NCT07377214 · 162026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗