Standardised stress management mental health training: does it have a beneficial effect?

• Register: ISRCTN
• Last refreshed on: 30 October 2017
• Main ID: ISRCTN21392756
• Date of registration: 28/10/2010
• Prospective Registration: No
• Primary sponsor: Ministry of Defence (UK)
• Public title: Standardised stress management mental health training: does it have a beneficial effect?
• 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
• Date of first enrolment: 01/09/2010
• Target sample size: 260
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN21392756
• Study type: Interventional
• Study design: Single-centre open randomised controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: Trevor Hicks

Key inclusion & exclusion criteria

Inclusion criteria: 1. Aged =18 years, either sex (though mainly male due to military demographics)
2. Suffering from adjustment disorder or mild depression
Exclusion criteria: 1. Flying phobia
2. Post-traumatic stress disorder (PTSD)
3. More severe depressive disorders
4. Psychosis
5. Alcohol disorders

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Adjustment disorders, mild depression
Mental and Behavioural Disorders
Depressive episode

Intervention(s)

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

Primary Outcome(s)

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(s)

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).

Secondary ID(s)

N/A

Source(s) of Monetary Support

Investigator initiated and funded (UK)