NCT07377214

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
20mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Jan 2026Dec 2027

Study Start

First participant enrolled

January 1, 2026

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

January 16, 2026

Last Update Submit

January 29, 2026

Conditions

Keywords

PTSD Aquatherapy feasibility study

Outcome Measures

Primary Outcomes (1)

  • 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.

    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)

    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.

Other Outcomes (8)

  • Change in anxiety and depression symptoms measured by the Hopkins Symptom Checklist-25 (HSCL-25)

    Baseline, end of 32-week intervention, and 1-year follow-up.

  • Feasibility measure: Adherence Rate

    End of intervention (week 32).

  • Feasibility measure: Acceptability

    End of intervention (week 32).

  • +5 more other outcomes

Study Arms (1)

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

Other: AquaTherapy

Interventions

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.

Also known as: Aquatic group training
Aquatic Therapy and subsequent Group Training for Veterans With PTSD: 32-Week Feasibility Study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AquaTerapi, Tuborgvej, 2400 Copenhagen NV

Copenhagen, 2400, Denmark

Location

Related Links

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Carsten Bogh Juhl, Prof.

    Herlev & Gentofte Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lone Nedergaard, Pt

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: The project is designed as a single-group pre-post feasibility study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2026

First Posted

January 29, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

February 2, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations