Post Traumatic Stress DisorderNCT07377214
Effect of Aquatic Therapy and Subsequent Training on Veterans With PTSD
A study testing AquaTherapy in people with Post Traumatic Stress Disorder, run by AquaTerapi at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- AquaTherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
AquaTerapi, Tuborgvej, 2400 Copenhagen NV
Copenhagen, 2400
Lone Nedergaard, Pt, +4542409260, lone@aquaterapi.dk
About this study
Official title: AquaTherapy and Subsequent Training for 50 Veterans With PTSD - A Feasibility Study
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.
Read more
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.
Read the 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
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- AquaTherapy
- Keywords
- PTSD Aquatherapy feasibility study
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AquaTherapyOther
Also called Aquatic group training
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 phase, participants transition to a 16-week group-based aquatic training program. This second phase involves weekly sessions in small groups (up to six participants per group) and emphasizes cardiovascular fitness, strength, mobility, and relaxation, all conducted in the same warm water environment. The group format is designed to reinforce physical gains, promote social engagement, and support the maintenance of improved activity levels.
| Study group | Role | What they receive |
|---|---|---|
| Aquatic Therapy and subsequent Group Training for Veterans With PTSD: 32-Week Feasibility Study | Experimental | 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 Receives: Other: AquaTherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PTSD symptoms measured by the PTSD Checklist - Military Version (PCL-M)
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.
Measured: Baseline, end of 32-week intervention, and 1-year follow-up.
Secondary outcomes (2)
Change in sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI)
Outcome Measure Description: Change in sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI global score ranges from 0 to 21, where higher scores indicate poorer sleep quality. Clinically relevant improvement is defined as a reduction of ≥3 points in the global score or achieving a score of ≤5.
Measured: Baseline, end of 32-week intervention, and 1-year follow-up.
Change in quality of life measured by the WHO-5 Well-Being Index
Change in psychological well-being assessed using the World Health Organization-Five Well-Being Index (WHO-5). Scores range from 0 to 100, where higher scores indicate better well-being and quality of life. A change of ≥10 points is considered clinically meaningful.
Measured: Baseline, end of 32-week intervention, and 1-year follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The project is designed as a single-group pre-post feasibility study.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AquaTerapi
- Sponsor type
- University, hospital or other
- Collaborators
- Herlev and Gentofte Hospital
- Responsible party
- Sponsor
- Investigators
- Carsten Bogh Juhl, Prof., Principal investigator, Herlev & Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377214
- Sponsor's protocol ID
- 162026
- Status last verified
- Jan 2026
- First submitted
- 16 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AquaTherapy and Subsequent Training for 50 Veterans With PTSD - A Feasibility Study
- ClinicalTrials.gov ID
- NCT07377214
- Acronym / sponsor ID
- 162026
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- PTSD Aquatherapy feasibility study
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- AquaTerapiUniversity, hospital or other
- Collaborators
- Herlev and Gentofte Hospital
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The project is designed as a single-group pre-post feasibility study.
| Arm | Type | Receives |
|---|---|---|
| Aquatic Therapy and subsequent Group Training for Veterans With PTSD: 32-Week Feasibility Study | Experimental | Other: AquaTherapyThis 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AquaTherapyAlso: Aquatic group trainingThe 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 phase, participants transition to a 16-week group-based aquatic training program. This second phase involves weekly sessions in small groups (up to six participants per group) and emphasizes cardiovascular fitness, strength, mobility, and relaxation, all conducted in the same warm water environment. The group format is designed to reinforce physical gains, promote social engagement, and support the maintenance of improved activity levels. | Other | Aquatic Therapy and subsequent Group Training for Veterans With PTSD: 32-Week Feasibility Study |
Primary outcome
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.
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.
2 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Website presenting our research and clinical experience with Aquatic Therapy for stress and PTSDLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carsten Bogh Juhl, Prof. principal investigator
Herlev & Gentofte Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AquaTherapy in people with Post Traumatic Stress Disorder, run by AquaTerapi at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lone Nedergaard, Pt (+45 42409260, lone@aquaterapi.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.