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Body Therapy for War Veterans With Post Traumatic Stress Disorder (PTSD)

Primary Purpose

Stress Disorders, Post-Traumatic, Trauma and Stressor Related Disorders, Behavioral Symptoms

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Body therapy
Treatment as usual
Sponsored by
University of Southern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring Veterans, Nervous System Diseases, Body Therapy, Mind-Body Therapies, Coping Skills, Breathing techniques, Body awareness, Emotional regulation, Randomized Controlled Trial, Qualitative study, Mixed-methods

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Military Psychiatric Center, Copenhagen University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Body Therapy

Treatment As usual

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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).
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.
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.

Full Information

First Posted
December 11, 2018
Last Updated
March 8, 2019
Sponsor
University of Southern Denmark
Collaborators
National Board of Health, Denmark, Soldaterlegatet, ManuVision, Copenhagen University Hospital, Denmark, Patientforeningen Danmark
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1. Study Identification

Unique Protocol Identification Number
NCT03777800
Brief Title
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

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 14, 2019 (Actual)
Primary Completion Date
April 1, 2020 (Anticipated)
Study Completion Date
October 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern Denmark
Collaborators
National Board of Health, Denmark, Soldaterlegatet, ManuVision, Copenhagen University Hospital, Denmark, Patientforeningen Danmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Body Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment As usual
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Body therapy
Other Intervention Name(s)
ManuVision
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual
Intervention Description
Standard treatment
Primary Outcome Measure Information:
Title
Self-reported PTSD symptoms by the PTSD checklist - military version (PCL-M)
Description
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.
Time Frame
Change from baseline to midway (approximately 3 months), post-treatment (approximately 6 months) and, if possible, follow-up (12 months)
Secondary Outcome Measure Information:
Title
Self-reported depression symptoms as measured by the Major Depression Inventory (MDI)
Description
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).
Time Frame
Change from baseline to midway (approximately 3 months), post-treatment (approximately 6 months) and, if possible, follow-up (12 months)
Title
Self-reported quality of life using the World Health Organization Five Well-Being Index (WHO-5)
Description
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).
Time Frame
Change from baseline to midway (approximately 3 months), post-treatment (approximately 6 months) and, if possible, follow-up (12 months)
Title
Function level using the Sheehan Disability Scale (SDS)
Description
A self-administered rating scale measuring functional impairment with regard to family, work and social network using three visual analogue scales.
Time Frame
Change from baseline to midway (approximately 3 months), post-treatment (approximately 6 months) and, if possible, follow-up (12 months)
Title
Self-reported body awareness using the Multidimensional Assessment of Interceptive Awareness (MAIA) Questionnaire
Description
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.
Time Frame
Change from baseline to midway (approximately 3 months), post-treatment (approximately 6 months) and, if possible, follow-up (12 months)
Other Pre-specified Outcome Measures:
Title
Participants' responsiveness
Description
A 3-item questionnaire with a 0-10 response scale to measure the participants' judgement of the treatment (only the intervention group)
Time Frame
Post-treatment (approximately 6 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nanna Ahlmark, PhD
Phone
+4565 50 78 15
Email
naah@niph.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Susan Andersen, PhD
Phone
+4565507816
Email
sua@niph.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nanna Ahlmark, PhD
Organizational Affiliation
National Institute of Public Health, University of Southern Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Military Psychiatric Center, Copenhagen University Hospital
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henrik S Andersen, Dr.Med.
Phone
+45 38647173
Email
Henrik.Steen.Andersen@regionh.dk

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32617435
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.
Results Reference
derived

Learn more about this trial

Body Therapy for War Veterans With Post Traumatic Stress Disorder (PTSD)

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