Ignite Creation Date:
2024-05-06 @ 12:29 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03777800
Status:
COMPLETED
Last Update Posted:
2023-12-13
First Post:
2018-12-11
Brief Title:
Body Therapy for War Veterans With Post Traumatic Stress Disorder PTSD
Sponsor:
University of Southern Denmark
Organization:
University of Southern Denmark
Study Overview
Official Title:
Body Therapy for War Veterans With Post Traumatic Stress Disorder PTSD A Combined Randomized Controlled Trial RCT and Qualitative Study
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 clients 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
1 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
2 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
A 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 eg 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 ie 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 interventions effect appropriate statistical methods eg 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
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 clients 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
1 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
2 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
A 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 eg 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 ie 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 interventions effect appropriate statistical methods eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None