Stress Disorders, Post-TraumaticNCT03777800
Body Therapy for War Veterans With Post Traumatic Stress Disorder (PTSD)
A study testing Body therapy and Treatment as usual in people with Stress Disorders, Post-Traumatic and Trauma and Stressor Related Disorders, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The present study is a randomized, controlled trial that compares a certain type of body therapy, called ManuVision, to treatment as usual (TAU) in war veterans with posttraumatic stress disorder (PTSD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Trauma and Stressor Related Disorders, Behavioral Symptoms
- What is being tested?
- Body therapy and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteDenmark
- Study dates
- 14 Jan 2019to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Veterans
- Meet criteria for clinical PTSD or subclinical PTSD assessed by The Structured Clinical Interview for DSM-IV (SCID)
- Demonstrate understanding of informed consent and normal cognitive skills
Who cannot join
- Current substance dependence (alcohol or drugs)
- Severe mental disorders such as schizophrenia, Bipolar I or II disorder, or current psychiatric conditions such as psychosis or mania
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Military Psychiatric Center, Copenhagen University Hospital
Copenhagen, 2100
About this study
Official title: Body Therapy for War Veterans With Post Traumatic Stress Disorder (PTSD): A Combined Randomized Controlled Trial (RCT) and Qualitative Study.
The present study is a randomized, controlled trial that compares a certain type of body therapy, called ManuVision, to treatment as usual (TAU) in war veterans with posttraumatic stress disorder (PTSD). The purpose of the study is to determine whether participation in the body therapy treatment by war veterans who have PTSD, will reduce symptoms of PTSD and depression, and improve quality of life, function level and body awareness.
Study hypotheses state that the ManuVision approach, compared to the treatment as usual, will be more effective at reducing the PTSD symptoms experienced by veterans because it will help the veterans learning to become aware of, accept the PTSD symptoms, reading their own emotional state and gain body awareness and subsequently have emotional control and improved coping mechanism when PTSD symptoms arise. The awareness, accept and improved coping mechanisms means that the nervous system is not under the same pressure and that PTSD symptoms therefore may be reduced.
Read the detailed description
Background: A sizable proportion of soldiers involved in military missions are experiencing mental health and adjustment problems on their return, including PTSD. PTSD is both a psychological and a physical condition, which occurs as a post-reaction to one or more traumatic experiences. The symptoms include aggressive behaviour, difficulty sleeping, tiredness, anxiety, and social isolation, and many sufferers develop depression, and the war veterans are at a higher risk of suicide. Physiologically, people with PTSD experience an activation of their sympathetic nervous system, whereby the stress hormones adrenalin and cortisol are released, the heart rate increases, the blood pressure rises, and the body is geared toward a 'fight or flight' response. A major challenge for veterans with PTSD is emotional control and problems with reading their own and others' emotional state.
This study will provide a certain type of body therapy, called ManuVision, to war veterans with PTSD. ManuVision is a Danish developed body therapy working with direct physical treatment of the body and through this approach with the client's psychosocial resources. There are conversations during and before treatment, as appropriate, and trust is intentionally built from the first meeting through eye contact and open breathing on behalf of the ManuVision therapist. The treatment is based on the understanding that chock, trauma and stress are stored in the body blocking the muscles and breathing and affecting the nerve system.
The intervention in this project entails individual courses of body therapy including 24 treatment sessions over 6 months for veterans with PTSD, plus recommended daily meditation at home.
The study goals are to:
- Investigate how the body therapy treatment is implemented, and how the participants experience the treatment, respond to the treatment and which transformations participants experience in the everyday life (a process evaluation by qualitative methods).
- Compare the body therapy treatment with treatment as usual (TAU). Symptoms of PTSD, depression, function level, quality of life, and body awareness will be examined at pre-treatment, midway during the treatment period, post-treatment and, if possible, at follow-up to determine if symptoms change over time (an effect evaluation by quantitative methods).
The research questions are as follows:
- How is the treatment implemented, how do the participants experience and respond to the treatment, and what characterizes the interaction between veteran and practitioner? B. In which ways do the veterans experience transformations, e.g. in terms of their body, feelings, social relations, everyday lives, quality of life, and handling their PTSD symptoms? C. What is the effect of the intervention on PTSD symptoms, quality of life, function level, depression and body awareness? D. Are there better outcomes for participants who received more treatment (i.e., number of treatment sessions)?
In order to answer the research questions A and B we will use participant observation, qualitative interviews, and focus group interviews with veterans, family members and practitioners.
In order to answer the research question C concerning the intervention's effect, appropriate statistical methods (e.g., Repeated measures ANOVA) will be used to analyse the differences between the intervention and the control group based on validated questionnaires.
Finally, a dose-response analysis is carried out (D) based on the practitioners' registered number of treatment sessions. This will support and refine the effect estimations.
- Conditions
- Stress Disorders, Post-Traumatic, Trauma and Stressor Related Disorders, Behavioral Symptoms, Depression, Quality of Life
- Being tested
- Body therapy, Treatment as usual
- Keywords
- Veterans, Nervous System Diseases, Body Therapy, Mind-Body Therapies, Coping Skills, Breathing techniques, Body awareness, Emotional regulation, Randomized Controlled Trial, Qualitative study, Mixed-methods
- Medical subject headings
- Stress Disorders, Post-Traumatic, Trauma and Stressor Related Disorders, Behavioral Symptoms, Depression, Nervous System Diseases, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body therapyBehavioural
Also called ManuVision
Body therapy involving direct physical treatments, conversations, breathing exercises and relaxation in the sessions. Moreover, the participants are taught how to practice vipassana or awareness meditation every day at home.
The body therapist works directly with the muscle armour and the treatment sessions have focus on creating a safe environment and enabling cognitive realisation and awareness of symptoms.
Each participant is assigned a practitioner who acts as contact person and 'lifeline'. Furthermore, a coordinator is assigned in ManuVision who will also act as contact person when needed for the veterans. This provides peace of mind, trust, and ensures retention. The coordinator or the practitioner follows up on the veteran's progress prior to each session.
Treatment as usualBehavioural
Standard treatment
| Study group | Role | What they receive |
|---|---|---|
| Body Therapy | Experimental | Participants in the intervention condition will be assigned to a 6-month body therapy treatment focused on 24 individual body treatments including conversations and direct physical treatment of the body combined with home-based daily practice of meditation. Receives: Behavioral: Body therapy |
| Treatment As usual | Active comparator | Participants in the control condition will be offered treatment as usual, which is psychiatric medication and/or individual psychotherapy as deemed relevant by the psychiatrist. Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported PTSD symptoms by the PTSD checklist - military version (PCL-M)
The PTSD checklist contains 17 items corresponding to the DSM-IV criteria for PTSD. Past month symptom severity is indicated using a 5 point scale. Higher scores represent greater severity.
Measured: Change from baseline to midway (approximately 3 months), post-treatment (approximately 6 months) and, if possible, follow-up (12 months)
Secondary outcomes (4)
Self-reported depression symptoms as measured by the Major Depression Inventory (MDI)
The severity of depression is measured over the last 2 weeks in the form of a Likert scale at which the frequency of each symptom can be indicated from 0 (at no time) to 5 (all the time). Score range is from 0 (no depression) to 50 (extreme depression).
Measured: Change from baseline to midway (approximately 3 months), post-treatment (approximately 6 months) and, if possible, follow-up (12 months)
Self-reported quality of life using the World Health Organization Five Well-Being Index (WHO-5)
Each of the five items indicates current positive wellbeing during the previous two weeks from 0 (at no time) to 5 (all of the time).
Measured: Change from baseline to midway (approximately 3 months), post-treatment (approximately 6 months) and, if possible, follow-up (12 months)
Function level using the Sheehan Disability Scale (SDS)
A self-administered rating scale measuring functional impairment with regard to family, work and social network using three visual analogue scales.
Measured: Change from baseline to midway (approximately 3 months), post-treatment (approximately 6 months) and, if possible, follow-up (12 months)
Self-reported body awareness using the Multidimensional Assessment of Interceptive Awareness (MAIA) Questionnaire
MAIA contains 32 items. The items are organized into eight subscales: (1) Noticing: the awareness of body sensations; (2) Not-Distracting: the tendency to ignore or distract oneself from sensations of pain or discomfort; (3) Not-Worrying: emotional distress or worry with sensations of pain or discomfort; (4) Attention Regulation: the ability to sustain and control attention to body sensation; (5) Emotional Awareness: the awareness of the connection between body sensations and emotional states; (6) Self-Regulation: the ability to regulate psychological distress by attention to body sensations; (7) Body Listening: actively listening to the body for insight; (8) Trusting: experiencing one's body as safe and trustworthy.
Measured: Change from baseline to midway (approximately 3 months), post-treatment (approximately 6 months) and, if possible, follow-up (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start14 Jan 2019
- Primary completion1 Oct 2020
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- National Board of Health, Denmark, Soldaterlegatet, ManuVision, Copenhagen University Hospital, Denmark, Patientforeningen Danmark
- Responsible party
- Principal investigator, Susan Andersen, University of Southern Denmark
- Investigators
- Nanna Ahlmark, PhD, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03777800
- Sponsor's protocol ID
- 10.128
- Status last verified
- Dec 2023
- First submitted
- 11 Dec 2018
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ahlmark NG, Dahl A, Andersen HS, Tjornhoj-Thomsen T, Andersen S. Body therapy versus treatment as usual among Danish veterans with PTSD: Study protocol for a randomised controlled trial combined with a qualitative study. Contemp Clin Trials Commun. 2020 Jun 20;19:100596. doi: 10.1016/j.conctc.2020.100596. eCollection 2020 Sep.
PubMed 32617435
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Therapy for War Veterans With Post Traumatic Stress Disorder (PTSD): A Combined Randomized Controlled Trial (RCT) and Qualitative Study.
- ClinicalTrials.gov ID
- NCT03777800
- Acronym / sponsor ID
- 10.128
- Conditions
- Stress Disorders, Post-Traumatic, Trauma and Stressor Related Disorders, Behavioral Symptoms, Depression, Quality of Life
- Keywords
- Veterans, Nervous System Diseases, Body Therapy, Mind-Body Therapies, Coping Skills, Breathing techniques, Body awareness, Emotional regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- National Board of Health, Denmark, Soldaterlegatet, ManuVision, Copenhagen University Hospital, Denmark, Patientforeningen Danmark
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 17 Dec 2018 (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.
The present study is a randomized, controlled trial that compares a certain type of body therapy, called ManuVision, to treatment as usual (TAU) in war veterans with posttraumatic stress disorder (PTSD). The purpose of the study is to determine whether participation in the body therapy treatment by war veterans who have PTSD, will reduce symptoms of PTSD and depression, and improve quality of life, function level and body awareness.
Study hypotheses state that the ManuVision approach, compared to the treatment as usual, will be more effective at reducing the PTSD symptoms experienced by veterans because it will help the veterans learning to become aware of, accept the PTSD symptoms, reading their own emotional state and gain body awareness and subsequently have emotional control and improved coping mechanism when PTSD symptoms arise. The awareness, accept and improved coping mechanisms means that the nervous system is not under the same pressure and that PTSD symptoms therefore may be reduced.
Detailed description
Background: A sizable proportion of soldiers involved in military missions are experiencing mental health and adjustment problems on their return, including PTSD. PTSD is both a psychological and a physical condition, which occurs as a post-reaction to one or more traumatic experiences. The symptoms include aggressive behaviour, difficulty sleeping, tiredness, anxiety, and social isolation, and many sufferers develop depression, and the war veterans are at a higher risk of suicide. Physiologically, people with PTSD experience an activation of their sympathetic nervous system, whereby the stress hormones adrenalin and cortisol are released, the heart rate increases, the blood pressure rises, and the body is geared toward a 'fight or flight' response. A major challenge for veterans with PTSD is emotional control and problems with reading their own and others' emotional state.
This study will provide a certain type of body therapy, called ManuVision, to war veterans with PTSD. ManuVision is a Danish developed body therapy working with direct physical treatment of the body and through this approach with the client's psychosocial resources. There are conversations during and before treatment, as appropriate, and trust is intentionally built from the first meeting through eye contact and open breathing on behalf of the ManuVision therapist. The treatment is based on the understanding that chock, trauma and stress are stored in the body blocking the muscles and breathing and affecting the nerve system.
The intervention in this project entails individual courses of body therapy including 24 treatment sessions over 6 months for veterans with PTSD, plus recommended daily meditation at home.
The study goals are to:
- Investigate how the body therapy treatment is implemented, and how the participants experience the treatment, respond to the treatment and which transformations participants experience in the everyday life (a process evaluation by qualitative methods).
- Compare the body therapy treatment with treatment as usual (TAU). Symptoms of PTSD, depression, function level, quality of life, and body awareness will be examined at pre-treatment, midway during the treatment period, post-treatment and, if possible, at follow-up to determine if symptoms change over time (an effect evaluation by quantitative methods).
The research questions are as follows:
- How is the treatment implemented, how do the participants experience and respond to the treatment, and what characterizes the interaction between veteran and practitioner? B. In which ways do the veterans experience transformations, e.g. in terms of their body, feelings, social relations, everyday lives, quality of life, and handling their PTSD symptoms? C. What is the effect of the intervention on PTSD symptoms, quality of life, function level, depression and body awareness? D. Are there better outcomes for participants who received more treatment (i.e., number of treatment sessions)?
In order to answer the research questions A and B we will use participant observation, qualitative interviews, and focus group interviews with veterans, family members and practitioners.
In order to answer the research question C concerning the intervention's effect, appropriate statistical methods (e.g., Repeated measures ANOVA) will be used to analyse the differences between the intervention and the control group based on validated questionnaires.
Finally, a dose-response analysis is carried out (D) based on the practitioners' registered number of treatment sessions. This will support and refine the effect estimations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Body Therapy | Experimental | Behavioral: Body therapyParticipants in the intervention condition will be assigned to a 6-month body therapy treatment focused on 24 individual body treatments including conversations and direct physical treatment of the body combined with home-based daily practice of meditation. |
| Treatment As usual | Active comparator | Behavioral: Treatment as usualParticipants in the control condition will be offered treatment as usual, which is psychiatric medication and/or individual psychotherapy as deemed relevant by the psychiatrist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Veterans
- Meet criteria for clinical PTSD or subclinical PTSD assessed by The Structured Clinical Interview for DSM-IV (SCID)
- Demonstrate understanding of informed consent and normal cognitive skills
Key exclusion criteria (2 listed)
- Current substance dependence (alcohol or drugs)
- Severe mental disorders such as schizophrenia, Bipolar I or II disorder, or current psychiatric conditions such as psychosis or mania
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 |
|---|---|---|
| Body therapyAlso: ManuVisionBody therapy involving direct physical treatments, conversations, breathing exercises and relaxation in the sessions. Moreover, the participants are taught how to practice vipassana or awareness meditation every day at home. The body therapist works directly with the muscle armour and the treatment sessions have focus on creating a safe environment and enabling cognitive realisation and awareness of symptoms. Each participant is assigned a practitioner who acts as contact person and 'lifeline'. Furthermore, a coordinator is assigned in ManuVision who will also act as contact person when needed for the veterans. This provides peace of mind, trust, and ensures retention. The coordinator or the practitioner follows up on the veteran's progress prior to each session. | Behavioural | Body Therapy |
| Treatment as usualStandard treatment | Behavioural | Treatment As usual |
Primary outcome
Self-reported PTSD symptoms by the PTSD checklist - military version (PCL-M)
Time frame: Change from baseline to midway (approximately 3 months), post-treatment (approximately 6 months) and, if possible, follow-up (12 months)
The PTSD checklist contains 17 items corresponding to the DSM-IV criteria for PTSD. Past month symptom severity is indicated using a 5 point scale. Higher scores represent greater severity.
4 secondary outcomes
Self-reported depression symptoms as measured by the Major Depression Inventory (MDI)
Time frame: Change from baseline to midway (approximately 3 months), post-treatment (approximately 6 months) and, if possible, follow-up (12 months)
Self-reported quality of life using the World Health Organization Five Well-Being Index (WHO-5)
Time frame: Change from baseline to midway (approximately 3 months), post-treatment (approximately 6 months) and, if possible, follow-up (12 months)
Function level using the Sheehan Disability Scale (SDS)
Time frame: Change from baseline to midway (approximately 3 months), post-treatment (approximately 6 months) and, if possible, follow-up (12 months)
Self-reported body awareness using the Multidimensional Assessment of Interceptive Awareness (MAIA) Questionnaire
Time frame: Change from baseline to midway (approximately 3 months), post-treatment (approximately 6 months) and, if possible, follow-up (12 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Derived from this study: PubMed 32617435Ahlmark NG, Dahl A, Andersen HS, Tjornhoj-Thomsen T, Andersen S. Body therapy versus treatment as usual among Danish veterans with PTSD: Study protocol for a randomised controlled trial combined with a qualitative study. Contemp Clin Trials Commun. 2020 Jun 20;19:100596. doi: 10.1016/j.conctc.2020.100596. eCollection 2020 Sep.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Nanna Ahlmark, PhD principal investigator
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body therapy and Treatment as usual in people with Stress Disorders, Post-Traumatic and Trauma and Stressor Related Disorders, run by University of Southern Denmark 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 13 Dec 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported PTSD symptoms by the PTSD checklist - military version (PCL-M) (time frame: Change from baseline to midway (approximately 3 months), post-treatment (approximately 6 months) and, if possible, follow-up (12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03777800, which also lists 1 linked publication.
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 13 Dec 2023.