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

NCT03777800 | Completed DMC

• 1 other identifier: 10.128
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  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)

  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)

  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

  Change from baseline to midway (approximately 3 months), post-treatment (approximately 6 months) and, if possible, follow-up (12 months)

Other Outcomes (1)

• Participants' responsiveness

  Post-treatment (approximately 6 months)

Study Arms (2)

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.

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.

Behavioral: Treatment as usual

Interventions

Body therapy BEHAVIORAL

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.

Also known as: ManuVision

Body Therapy

Treatment as usual BEHAVIORAL

Standard treatment

Treatment As usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern Denmark: lead
• National Board of Health, Denmark: collaborator
• Soldaterlegatet: collaborator
• ManuVision: collaborator
• Copenhagen University Hospital, Denmark: collaborator
• Patientforeningen Danmark: collaborator

Study Sites (1)

Military Psychiatric Center, Copenhagen University Hospital

Copenhagen, 2100, Denmark

Location

Related Publications (1)

• 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.

  PMID: 32617435 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Trauma and Stressor Related Disorders; Behavioral Symptoms; Depression; Nervous System Diseases; Emotional Regulation

Interventions

Mind-Body Therapies; Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Mental Disorders; Behavior; Self-Control; Social Behavior

Intervention Hierarchy (Ancestors)

Complementary Therapies

Study Officials

• Nanna Ahlmark, PhD

  National Institute of Public Health, University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 11, 2018
• First Posted: December 17, 2018
• Study Start: January 14, 2019
• Primary Completion: October 1, 2020
• Study Completion: January 1, 2022
• Last Updated: December 13, 2023

Record last verified: 2023-12

Locations

DK (1)