Contact information
Type
Scientific
Primary contact
Dr Trevor Hicks
ORCID ID
Contact details
29 Chavenage Lane
Tetbury
GL8 8JT
United Kingdom
+44 (0)1666 500181
trevor@hicks64.freeserve.co.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Open randomised controlled trial examining whether a standardised stress management mental health training package is an effective tertiary stress intervention in full time military personnel
Acronym
Study hypothesis
The aim of this project is to examine whether a standardised stress management mental health training package (delivered over a 6-hour period to a group of up to 10 participants at a time) is an effective tertiary stress intervention in full time military personnel.
Ethics approval
Ministry of Defence Research Ethics Committee, 30/06/2010, ref: 101/Gen/09
Study design
Single-centre open 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 patient information sheet
Condition
Adjustment disorders, mild depression
Intervention
1. Intervention arm:
The standardised Stress Management Mental Health Training package will be delivered over a 6 hour period to up to 10 participants at a time by two Community Mental Health Nurses (CMHNs) based at the Department of Community Mental Health at RAF Brize Norton. The CMHNs will receive standardised training in presenting the Mental Health Training package from a Consultant Psychiatrist. The effectiveness of the standardised training will be verified by documented feedback about the training from the CMHN's and by validation of the standardised intervention by 3 monthly assessment of the standardised intervention by the Consultant Psychiatrist. The content of the standardised Mental Health Training package will consist of a PowerPoint presentation using a standard set of presentation slides, followed by 'break out' sessions allowing smaller group discussion of specific stress related issues. The Mental Health Training package is then concluded with brief relaxation training to help participants manage their stress related symptoms. Concordance to any intervening prescription drugs, psychotropic over the counter (OTC) and psychological treatments will be measured at each study visit by means of a clinical interview with the participant and the results recorded in the Case Report Form (CRF). Those subjects without any changes to their intervening prescriptions or receiving any alternative psychological treatments will be put into the intent-to-treat analysis.
2. Control arm:
Those that do not get the intervention will be allocated to a waiting list to be seen by the clinician who recruited the participant 6 weeks and 3 months post recruitment. No active treatment will be given to waiting list participants during the trial but will be offered after the trial period has ended (visit 5). The usual waiting time for non study patients to be seen for Standardised Stress Management Mental Health Training is currently in excess of 3 months and it is not envisaged that those participants who do participate in the study who do not get the intervention will have their treatment delayed.
Follow up will be at 6 weeks (visit 3) and 3 months (visit 4) with a further psychiatric clinical interview and further outcome measures using the GHQ-28, Beck Depression Inventory (BDI-II), Beck Anxiety Inventory (BAI) and the Clinical Global Impression (CGI). The rater of the CGI will be blinded to the other rating scores as this will be carried out prior to the participant's completion of the other rating scales. Follow up clinical interviews will record the occurrence of stressful events in the interim.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
General Health Questionnaire-28 score recorded as a continuous variable.
All outcomes will be assessed at the start of the trial (visit 2), 6 weeks (visit 3) and 12 weeks (visit 4).
Secondary outcome measures
1. Beck Depression Inventory (BDI-II),
2. Beck Anxiety Inventory (BAI)
3. Clinical Global Impression (CGI)
All outcomes will be assessed at the start of the trial (visit 2), 6 weeks (visit 3) and 12 weeks (visit 4).
Overall trial start date
01/09/2010
Overall trial end date
30/09/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged ≥18 years, either sex (though mainly male due to military demographics)
2. Suffering from adjustment disorder or mild depression
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
260
Participant exclusion criteria
1. Flying phobia
2. Post-traumatic stress disorder (PTSD)
3. More severe depressive disorders
4. Psychosis
5. Alcohol disorders
Recruitment start date
01/09/2010
Recruitment end date
30/09/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
29 Chavenage Lane
Tetbury
GL8 8JT
United Kingdom
Sponsor information
Organisation
Ministry of Defence (UK)
Sponsor details
Department of Community Mental Health
RAF Brize Norton
Carterton
OX18 3LX
United Kingdom
+44 (0)1993 897552
trevor@hicks64.freeserve.co.uk
Sponsor type
Government
Website
Funders
Funder type
Other
Funder name
Investigator initiated and funded (UK)
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
Basic results (scientific)
Publication list