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

ISRCTN	ISRCTN21392756
DOI	https://doi.org/10.1186/ISRCTN21392756
Secondary identifying numbers	N/A

Submission date: 06/09/2010
Registration date: 28/10/2010
Last edited: 04/10/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Trevor Hicks
Scientific

29 Chavenage Lane
Tetbury
GL8 8JT
United Kingdom

Phone	+44 (0)1666 500181
Email	trevor@hicks64.freeserve.co.uk

Study information

Study design	Single-centre open randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	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(s)	Ministry of Defence Research Ethics Committee, 30/06/2010, ref: 101/Gen/09
Health condition(s) or problem(s) studied	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
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 study start date	01/09/2010
Completion date	30/09/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	260
Key inclusion criteria	1. Aged ≥18 years, either sex (though mainly male due to military demographics) 2. Suffering from adjustment disorder or mild depression
Key exclusion criteria	1. Flying phobia 2. Post-traumatic stress disorder (PTSD) 3. More severe depressive disorders 4. Psychosis 5. Alcohol disorders
Date of first enrolment	01/09/2010
Date of final enrolment	30/09/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

29 Chavenage Lane

Tetbury
GL8 8JT
United Kingdom

Sponsor information

Ministry of Defence (UK)
Government

Department of Community Mental Health
RAF Brize Norton
Carterton
OX18 3LX
United Kingdom

Phone	+44 (0)1993 897552
Email	trevor@hicks64.freeserve.co.uk
Website	http://www.mod.uk/DefenceInternet/Home/
"ROR"	https://ror.org/01bvxzn29

Funders

Funder type

Other

Investigator initiated and funded (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

04/10/2017: No publications found in PubMed, verifying study status with principal investigator.