Clinical trial NCT03777800: Body Therapy for War Veterans With Post Traumatic Stress Disorder (PTSD)
Official title: Body Therapy for War Veterans With Post Traumatic Stress Disorder (PTSD): A Combined Randomized Controlled Trial (RCT) and Qualitative Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Randomized Controlled Trial
Qualitative study
Mixed-methods
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: National Board of Health, Denmark
name: Soldaterlegatet
name: ManuVision
name: Copenhagen University Hospital, Denmark
name: Patientforeningen Danmark
First posted: 2018-12-17
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

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, 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Self-reported PTSD symptoms by the PTSD checklist - military version (PCL-M)
timeFrame: Change from baseline to midway (approximately 3 months), post-treatment (approximately 6 months) and, if possible, follow-up (12 months)
Secondary outcomes:
measure: Self-reported depression symptoms as measured by the Major Depression Inventory (MDI)
timeFrame: Change from baseline to midway (approximately 3 months), post-treatment (approximately 6 months) and, if possible, follow-up (12 months)
measure: Self-reported quality of life using the World Health Organization Five Well-Being Index (WHO-5)
timeFrame: Change from baseline to midway (approximately 3 months), post-treatment (approximately 6 months) and, if possible, follow-up (12 months)
measure: Function level using the Sheehan Disability Scale (SDS)
timeFrame: Change from baseline to midway (approximately 3 months), post-treatment (approximately 6 months) and, if possible, follow-up (12 months)
measure: Self-reported body awareness using the Multidimensional Assessment of Interceptive Awareness (MAIA) Questionnaire
timeFrame: Change from baseline to midway (approximately 3 months), post-treatment (approximately 6 months) and, if possible, follow-up (12 months)
Other outcomes:
measure: Participants' responsiveness
timeFrame: Post-treatment (approximately 6 months)
Locations:
city: Copenhagen
country: Denmark
facility: Military Psychiatric Center, Copenhagen University Hospital
Study officials:
affiliation: National Institute of Public Health, University of Southern Denmark
name: Nanna Ahlmark, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.