Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CSA/08/039
Study information
Scientific title
Post-deployment Battlemind training for UK Armed Forces personnel: a cluster-randomised controlled trial
Acronym
Study hypothesis
Primary hypothesis:
UK Armed Forces Personnel who receive Battlemind training, when compared with personnel who receive a standard post-deployment stress and homecoming brief, will report:
1. Better mental health outcomes
2. Fewer risk taking behaviours
3. Greater perceived team support
4. Fewer problems in combat-to-home transition
5. Less stigmatising beliefs about seeking help for mental health problems
Secondary hypotheses:
1. Those participants who have had greater exposure to stressors during deployment will have poorer mental health at baseline and will benefit more from the Battlemind intervention than those with fewer traumatic deployment experiences
2. Personnel receiving Battlemind will have a more positive perception of the training received than those receiving the standard post-deployment stress brief
Ethics approval
1. Ministry of Defence Research Ethics Committee approval received 16th December 2008 (ref: 0863/218)
2. King's College Hospital Research Ethics Committee approval received 18th December 2008 (ref: 08/H0808/179)
Study design
Single centre cluster randomised controlled trial
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 the contact details below to request a participant information sheet
Condition
Mental Health
Intervention
The intervention group will receive Battlemind training, a US developed post-deployment mental health training package aimed at assisting personnel to adjust to life post-deployment. Battlemind aims to build on people's combat strengths and skills by showing how these strengths can be adapted for the home environment.
The control group will receive the standard post-deployment briefs about stress and homecoming that are currently delivered to personnel returning home from operational tour.
Both intervention and control briefs will be delivered during the 'decompression' period that personnel undergo on their return from deployment. Both briefs will be delivered in a single session lasting approximately 45 minutes.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Severity of post-traumatic stress symptoms as indicated by the score on the Post-Traumatic Stress Disorder Checklist (PCL). PCL will be assessed prior to receiving the post-deployment brief and again 4 months later.
Secondary outcome measures
1. Psychological morbidity - 12-item General Health Questionnaire (GHQ-12), assessed prior to the brief and again 4 months later
2. Stigma - Help-Seeking Stigma Questionnaire assessed prior to the brief and again 4 months later
The following will be assessed at 4 months:
3. Depression - 9-items from the Patient Health Questionnaire. As of 17/02/2010 the following outcome was also added to this record: Anxiety - 7-items from the Patient Health Questionnaire.
4. Alcohol consumption - Alcohol Use Disorders Identification Test (AUDIT)
5. Driving behaviour
6. Sleep quality
7. Quality of combat-to-home transition
8. Relationship satisfaction
9. Anger
10. Team support
11. Occupational and social functioning (added to this record on 17/02/2010)
Overall trial start date
01/03/2009
Overall trial end date
31/01/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. UK Armed Forces personnel returning from operational tour
2. Aged 18 years and over; both men and women will be eligible to participate
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
2000
Participant exclusion criteria
1. Individual augmentees who do not return as part of a formed unit
2. Units that are primarily composed of reserve personnel or headquarters staff
Recruitment start date
01/03/2009
Recruitment end date
31/01/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Academic Centre for Defence Mental Health
London
SE5 9RJ
United Kingdom
Sponsor information
Organisation
King's College London (UK)
Sponsor details
Strand
London
WC2R 2LS
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Haldane-Spearman Consortium (UK) (ref: TIN no. HSC_07_01_02_002)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22409642
Publication citations
-
Results
Mulligan K, Fear NT, Jones N, Alvarez H, Hull L, Naumann U, Wessely S, Greenberg N, Postdeployment Battlemind training for the U.K. armed forces: a cluster randomized controlled trial., J Consult Clin Psychol, 2012, 80, 3, 331-341, doi: 10.1037/a0027664.