Condition category
Mental and Behavioural Disorders
Date applied
06/09/2010
Date assigned
28/10/2010
Last edited
02/06/2015
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 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 measures

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

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

http://www.mod.uk/DefenceInternet/Home/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes