Standardised stress management mental health training: does it have a beneficial effect?
ISRCTN | ISRCTN21392756 |
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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
Scientific
29 Chavenage Lane
Tetbury
GL8 8JT
United Kingdom
Phone | +44 (0)1666 500181 |
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trevor@hicks64.freeserve.co.uk |
Study information
Study design | Single-centre open randomised controlled trial |
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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 |
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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
GL8 8JT
United Kingdom
Sponsor information
Ministry of Defence (UK)
Government
Government
Department of Community Mental Health
RAF Brize Norton
Carterton
OX18 3LX
United Kingdom
Phone | +44 (0)1993 897552 |
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trevor@hicks64.freeserve.co.uk | |
Website | http://www.mod.uk/DefenceInternet/Home/ |
https://ror.org/01bvxzn29 |
Funders
Funder type
Other
Investigator initiated and funded (UK)
No information available
Results and Publications
Intention to publish date | |
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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.