Condition category
Mental and Behavioural Disorders
Date applied
16/02/2017
Date assigned
23/02/2017
Last edited
21/02/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Around 4% of British military veterans suffer from post-traumatic stress disorder (PTSD). PTSD is an anxiety disorder caused by very stressful, frightening or distressing events. Psychological therapy with a focus on the traumatic event is the treatment of choice for PTSD and can be very helpful but, unfortunately, treatment resistance (inadequate response to treatment) is high. There is an urgent need to find effective treatments for military veterans who do not respond to, or are unable to engage with, current first-line treatments. Modular motion-assisted memory desensitisation and reconsolidation (3MDR) is a new treatment that is based on the principles of existing trauma-focused treatments in a new context in which the patient walks on a treadmill whilst interacting with a series of self-selected images that are displayed on a large screen. It aims to help patients learn how to move through their avoidance by, literally, approaching their traumatic memories. The aim of this study is to find out whether 3MDR can help British military veterans with PTSD who have not responded to the current first-choice treatment for PTSD.

Who can participate?
Veterans with PTSD, aged 18 or over, who have not benefitted from trauma-focused psychological treatment

What does the study involve?
Participants’ symptoms of PTSD, depression, anxiety and functioning are assessed and they are randomly allocated to receive either 3MDR immediately or after a delay of 12 weeks. The assessments are repeated at the end of treatment and four weeks later. The 3MDR is delivered weekly over six weeks by experienced psychological therapists. An evaluation of the process of 3MDR treatment is also undertaken by collecting information during the 3MDR sessions and by interviewing therapists and participants regarding their experiences.

What are the possible benefits and risks of participating?
Participants may benefit from a treatment that helps reduce their symptoms of PTSD. As with any trauma-focused therapy, there is a risk of increased distress when considering the traumatic experiences.

Where is the study run from?
Cardiff University (UK)

When is the study starting and how long is it expected to run for?
January 2017 to January 2019

Who is funding the study?
Forces In Mind Trust (FIMT) (UK)

Who is the main contact?
1. Prof. Jonathan Bisson (scientific) (bissonji@cf.ac.uk)
2. Miss Kali Barawi (public) (barawik1@cf.ac.uk)

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jonathan Bisson

ORCID ID

http://orcid.org/0000-0001-5170-1243

Contact details

Cardiff University
Hadyn Ellis Building
Maindy Road
Cathays
Cardiff
CF24 4HQ
United Kingdom
+44 (0)292 068 8321
bissonji@cf.ac.uk

Type

Public

Additional contact

Miss Kali Barawi

ORCID ID

Contact details

Cardiff University
Hadyn Ellis Building
Maindy Road
Cathays
Cardiff
CF24 4HQ
United Kingdom
+44 (0)292 068 8321
barawik1@cf.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SPON 1546-16

Study information

Scientific title

Phase II randomised controlled trial of military motion-assisted memory desensitization and reconsolidation for treatment resistant post traumatic stress disorder in military veterans

Acronym

3MDR for TRPTSD

Study hypothesis

3MDR (Military Motion-Assisted Memory Desensitization and Reconsolidation) will reduce symptoms of PTSD (Post Traumatic Stress Disorder) in British military veterans with treatment-resistant, combat-related PTSD to a significantly greater degree than a waiting list.

Ethics approval

Wales REC 3, 14/02/2017, ref: 17/WA/0005

Study design

Exploratory single-blind randomised parallel group controlled trial with nested mechanistic and process evaluation to assess fidelity, adherence and factors that influence outcome

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Treatment-resistant post traumatic stress disorder

Intervention

An experienced researcher blind to randomisation will conduct all assessments. The initial assessment will ensure that the inclusion criteria are satisfied. Demographic and other background data will be collected along with completion of all the outcome measures. Participants will then be asked to monitor their symptoms for two weeks. The baseline assessment of all the outcome measures will occur after this; those who continue to fulfil the inclusion criteria will be randomised (computer generated via a trials unit) to one of the two groups:
1. The 3MDR therapy delivered weekly over nine weeks (two weeks preparation, six weeks 3MDR and one concluding session) by experienced psychological therapists, trained in 3MDR and supervised by its originators, who work with Veterans’ NHS Wales and Cardiff University.
2. The waiting list group receive no intervention for 12 weeks post-randomisation and then receive 3MDR over nine weeks.

Follow up will occur 12 and 26 weeks after randomisation. This will involve re-administration of all the outcome measures. At 26 weeks participants will be asked to participate in semi-structured interviews to elicit their experience and views of the programme. Progress will be monitored with the IES-R, PHQ-9 and GAD-7 at each treatment session.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Symptoms of PTSD, measured using the Clinician Administered PTSD Scale for DSM5 (CAPS5) at baseline, 12 and 26 weeks

Secondary outcome measures

1. Traumatic stress, measured using the Impact of Event Scale – revised
2. Quality of life/functional impairment, measured using the Work and Social Adjustment Scale
3. Depression, measured using the Patient Health Questionnaire-9 (PHQ-9)
4. Anxiety, measured using General Anxiety Disorder-7 (GAD-7)
5. Alcohol use, measured using AUDIT-O36
6. Changes in sleep, measured using the insomnia severity index (ISI)
7. Perceived social support, measured using the Multidimensional Scale for Perceived Social Support
8. Health-related quality of life, measured using the EQ5D-5L
All measured at baseline, 12 and 26 weeks

Overall trial start date

02/01/2017

Overall trial end date

31/01/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 or over
2. Informed consent
3. Meet DSM529 criteria for combat-related PTSD
4. Treatment resistance, defined as prior receipt of a trauma focused psychological treatment without loss of PTSD diagnosis

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

42

Participant exclusion criteria

1. Psychosis
2. DSM5 severe major depressive episode
3. Substance dependence
4. Change in psychotropic medication within 1 month
5. Suicidal intent
6. Inability to walk at a normal pace for 30-45 minutes on a treadmill

Recruitment start date

01/04/2017

Recruitment end date

28/02/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cardiff and Vale Health Board
Monmouth House University Hospital of Wales Heath Park Campus
Cardiff
CF14 4XW
United Kingdom

Trial participating centre

Abertawe Bro Morgannwg University Health Board
71 Quarella Road
Bridgend
CF31 1YE
United Kingdom

Trial participating centre

Aneurin Bevan University Health Board
Talygarn County Hospital Coed-Y-Gric Road
Pontypool, Gwent
NP4 5YA
United Kingdom

Trial participating centre

Cwm Taf University Health Board
Maritime Resource Centre Woodland Terrace Maesycoed
Pontypridd
CF37 1DZ
United Kingdom

Sponsor information

Organisation

Cardiff University

Sponsor details

Research and Innovation Services
7th Floor
McKenzie House
30-36 Newport Road
Cardiff
CF24 0DE
United Kingdom
+44 (0)29 2087 9277
falconerhe@cardiff.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Forces In Mind Trust (FIMT)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The trial results will be publicised through social media. The trialists have experience of successfully engaging local and national media and will work with the National Centre for Mental Health (NCMH) communications team to formulate strategies for press releases and the dissemination of findings through newspaper articles, television and radio features. Study outcomes will be presented to the academic community at national and international conferences by means of oral presentation, poster presentation, and interactive workshops. The trialists will target conferences likely to be attended by large numbers of therapists and managers working in IAPT and other primary and secondary care NHS psychological treatment services across the UK. They will also disseminate to the third sector and other services likely to deal with individuals with PTSD who could potentially benefit from treatment (e.g. the UK veteran mental health charity Combat Stress). The aim is to publish the results in high impact open-access, peer reviewed journals such as the British Journal of Psychiatry. The trialists expect at least two high impact peer reviewed publications and three conference presentations.

IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Jon Bisson (bissonji@cf.ac.uk)

Intention to publish date

01/04/2019

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes