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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 27 February 2023
Main ID:  ISRCTN79407277
Date of registration: 29/01/2016
Prospective Registration: No
Primary sponsor: University of Oxford (UK)
Public title: A study of Mind's resilience intervention for emergency service workers
Scientific title: A randomised controlled trial to evaluate Mind’s resilience intervention for emergency service workers
Date of first enrolment: 15/05/2015
Target sample size: 430
Recruitment status: Completed
URL:  https://www.isrctn.com/ISRCTN79407277
Study type:  Interventional
Study design:  Multi-centre randomized controlled trial (Quality of life)  
Phase:  Not Applicable
Countries of recruitment
England United Kingdom
Contacts
Name: Jennifer    Wild
Address:  Department of Experimental Psychology University of Oxford South Parks Road OX1 3UD Oxford United Kingdom
Telephone: +44 (0)1865 618 612
Email: jennifer.wild@psy.ox.ac.uk
Affiliation: 
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: Employed or volunteering as front-line or office-based staff in one of the following emergency services: police, fire and rescue, ambulance and search and rescue
Exclusion criteria: Participants who score in the clinical range on measures of post-traumatic stress or depression at screening pre-baseline assessment will be excluded from the study since psychological treatment is likely to be more helpful

Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Resilience and linked mental health outcomes in emergency service workers
Mental and Behavioural Disorders
Intervention(s)

The study is a multi-centre randomized controlled trial in which emergency service workers are being randomly allocated to receive Mind’s 6-week resilience group or a control intervention. The interventions will be delivered to 430 participants; 317 will receive the group intervention and 113 will receive the control intervention.

Mind’s 6-week group intervention aims to improve resilience and linked mental health outcomes in emergency service workers, a population at risk of depression, post-traumatic stress, poor health, sickness absence and early retirement.

The control intervention consists of reading material about mental health and wellbeing that Mind already has available as topics on their website.

Participants will complete a number of measures assessing resilience, well being, self-efficacy, psychological coping strategies, post-traumatic stress, alcohol use and depression at baseline before the intervention begins, at post-intervention and and at 3 month follow-up.
Primary Outcome(s)

All measures are self-report questionnaires.

Baseline and Outcome Measures
We are administering the following outcome measures at pre-intervention, post-intervention and at 3 month follow-up:

1. Wellbeing: Warwick Edinburgh Mental Wellbeing scale (Tennant et al., 2007). The Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), developed by Warwick and Edinburgh Universities, is a scale of 14 positively worded items with five response categories for assessing mental wellbeing.
2. Resilience: Connor-Davidson Resilience Scale (CD-RISC; Connor & Davidson, 2003): This is a 25-item questionnaire. Each item carries a 5-point range of responses from ‘not true at all’ to ‘true nearly all of the time’. The total score ranges from 0-100 and provides a measure of resilience. The higher the score, the greater the resilience.
3. Self-efficacy: Schwarzer-Jerusalem General Self-Efficacy Scale (Schwarzer & Jerusalem,1995). The General Self-Efficacy Scale is a 10-item psychometric scale that is designed to assess optimistic self-beliefs to cope with a variety of difficult demands in life. In contrast to other scales that have been designed to assess optimism, this one explicitly refers to personal agency, i.e., the belief that one's actions are responsible for successful outcomes.
4. Ability to Problem-Solve and Achieve Goals. This is an unpublished questionnaire used in previous evaluations of Mind’s resilience intervention, which consists of 8 items to assess a person’s perception of how well they feel they can solve problems and achieve goals. It also taps self-efficacy.
5. Social Capital. Social Participation (Alden & Taylor, 2011). This is a 13-item questionnaire that assesses an individual’s social participation. Example items include: In the past month, did you: ‘Share your opinions and ideas with others?’, ‘Talk about meaningful personal experiences with others?’, ‘Attend work-or school-related social events?’. Participants rate how often they have actively participated in such activities in the last month on a 7-point scale ranging from 1=Not at all to 7=Often.
6. Social Support (Adapted version of Sarason et al., 1987): This questionnaire has 13 items, which assess perceived support from and closeness to friends, family and work colleagues. This questionnaire taps the sense of belonging and use of social support linked to social capital. Items include ‘Whenever you want to talk how often is there someone willing to listen?’ ‘Do you feel a sense of comradeship (or closeness) between yourself and people you work with?’ Responses are rated on a 7-point scale from 1=Never to 7=Always.
7. Psychological Coping Styles. Confidence in managing mental health and resilience (unpublished). This is a short questionnaire designed specifically for this study in which participants rate the degree to which they feel confidence in managing their mental health and improving their resilience.

We are administering the following outcome measure at pre-intervention and at follow-up only:
1. Days off work (unpublished). This is a brief questionnaire which asks how many days off work an individual has had in the past three months due to illness and how many days off due to stress.
Secondary Outcome(s)

The secondary outcome measures are self-report and are being administered at baseline, at post-intervention and at 3 month follow-up.

1. Attributions Questionnaire (Kleim et al., 2008): This questionnaire assesses attributions of negative events. The scale has 11 items that measure negative stable attributions (e.g., ‘When bad things happened to me, I was sure it would happen again’), negative internal attributions (e.g.,’ When bad things happened, I thought it was my fault’), and negative global attributions (e.g., ‘When bad things happened to me, I couldn’t see anything positive in my life’) and helplessness (e.g., ‘When things did not go well, I got easily discouraged’). We would expect the resilience intervention to lead to changes in attributions. High scores on this questionnaire at baseline may also influence the degree of change participants experience in well-being, resilience and social capital as a result of the resilience intervention.
2. Coping Behaviour Questionnaire (short version, Carver, Scheier, & Weintraub, 1989): This questionnaire is a shorter version of the well-known COPE questionnaire and assesses coping behaviour. It consists of 17 items. Participants rate what they do in very stressful situations, such as ‘I concentrate my efforts on doing something about the situation I am in’ on a scale of 1=Not at all to 4=A lot. The questionnaire taps 7 factors linked to coping: self-distraction, active coping, denial, substance use, self-blame, behavioural disengagement and acceptance.
3. The Responses to Intrusions Questionnaire (RIQ; Clohessy & Ehlers, 1999): Intrusive memories are commonly experienced by emergency service personnel both by frontline and office-based staff. The RIQ measures responses to intrusive memories, such as negative interpretations, rumination, dissociation, and suppression. Clohessy et al. (1999) found that particular strategies in response to intrusive memories were linked to mental ill-health in a study of ambulance workers. We will assess whether the resilience intervention leads to greater use of more adaptive responses to intrusive memories.
4. Ruminative Responses Scale (Treyner et al., 2003). This 22-item questionnaire measures rumination in daily life.

Clinical Measures
The following screening measures will be assessed at pre-intervention, post-intervention and at 3 month follow-up.
1. Trauma Screener (unpublished): This is a 19-item questionnaire looking at exposure to previous trauma relevant to the emergency services and includes items from the Clinician Administered PTSD Scale (CAPS, Blake et al., 1998).
2. Post-traumatic Stress Disorder Checklist (PCL; Weathers et al., 2013): The PCL-5 consists of 20 items that parallel the diagnostic criteria for PTSD set out in the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V; American Psychiatric Association, 2013).
3. Patient Health Questionnaire (PHQ-9; Kroenke et al., 2001): This is a well validated 9-item measure to assess symptoms of depression.
4. General Anxiety Disorder Scale (Spitzer et al., 2006). This is a 7-item well validated measure of anxiety. High scores are suggestive of an anxiety problem.
5. The Alcohol Use Disorders Identification Test (Babor et al., 2011): This short questionnaire was developed by the World Health Organisation to measure a person’s weekly intake of alcohol and substances. It also assesses whether a person’s use of alcohol or street drugs has caused problems for them.

The following questionnaire is only being administered at baseline:
1. Eysenck Personality Questionnaire, Neuroticisim Subscale (EPQ; Eysenck & Eysenck, 1975). The neuroticism subscale has 24 items, which assess emotionality, and may predict the degree of change participants experience in wellbeing, resilience, self-efficacy and social capital as a result of the resilience intervention.
Secondary ID(s)
Wild/Mind/Oxford/25/11/15
Source(s) of Monetary Support
Mind, the mental health charity (UK)
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Medical Sciences Division Research Ethics Committee at the University of Oxford, May 2015, ref: MS-IDREC-C1-2015-059
Results
Results available: Yes
Date Posted:
Date Completed: 31/03/2016
URL:
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