Condition category
Mental and Behavioural Disorders
Date applied
28/01/2009
Date assigned
05/03/2009
Last edited
11/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Neil Greenberg

ORCID ID

Contact details

Academic Centre for Defence Mental Health
King's College London
Weston Education Centre
Cutcombe Road
London
SE5 9RJ
United Kingdom

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

http://www.kcl.ac.uk/

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

  1. 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.

Additional files

Editorial Notes