Condition category
Mental and Behavioural Disorders
Date applied
28/01/2016
Date assigned
29/01/2016
Last edited
29/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Emergency workers dedicate their lives to improving public health yet suffer higher rates of mental ill health compared to the general population. The aim of this study is to evaluate a resilience intervention for emergency service workers that has been developed by the national mental health charity, Mind.

Who can participate?
People 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.

What does the study involve?
430 participants are randomly allocated to receive either Mind’s resilience group intervention (317) or reading material about mental health and wellbeing (113). Mental wellbeing, resilience and self-efficacy are compared between the two groups.

What are the possible benefits and risks of participating?
Participation in this study could lead to improved resilience and will aid us in evaluating Mind’s intervention, which will guide improvements to the intervention before it is made nationally available. There are no risks associated with taking part.

Where is the study run from?
Recruitment will be conducted in collaboration with local Mind services and local emergency services at the selected nine sites across England.

When is the study starting and how long is it expected to run for?
May 2015 to March 2016

Who is funding the study?
Mind, the mental health charity (UK)

Who is the main contact?
Dr Jennifer Wild
jennifer.wild@psy.ox.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Ms Shama El-Salahi

ORCID ID

Contact details

Department of Experimental Psychology
University of Oxford
South Parks Road
Oxford
OX1 3UD
United Kingdom

Type

Scientific

Additional contact

Dr Jennifer Wild

ORCID ID

http://orcid.org/0000-0001-5463-1711

Contact details

Department of Experimental Psychology
University of Oxford
South Parks Road
Oxford
OX1 3UD
United Kingdom
+44 (0)1865 618 612
jennifer.wild@psy.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Wild/Mind/Oxford/25/11/15

Study information

Scientific title

A randomised controlled trial to evaluate Mind’s resilience intervention for emergency service workers

Acronym

Study hypothesis

Hypothesis 1: Individuals who attend the resilience course will demonstrate greater improvements in resilience, well-being, self-efficacy, and social capital compared to individuals who receive the control intervention.

Hypothesis 2: Participants who attend the resilience course will have greater confidence in managing their own mental health and resilience compared to individuals who receive the control intervention.

Hypothesis 3: Participants who receive the resilience intervention will report that they found the intervention significantly more useful compared to those who receive the control intervention.

Hypothesis 4: Participants who receive the resilience intervention will sustain greater improvements in resilience, well-being, self-efficacy, social capital and use of psychological coping skills at follow-up compared to the control group.

Hypothesis 5: Participants who receive the resilience intervention will have fewer days off work due to illness compared to those who receive the control intervention.

Question 1: Does the resilience intervention lead to changes in attributions linked to depression?

Question 2: Does the resilience intervention lead to more active coping and acceptance?

Question 3: Does the resilience intervention lead to less rumination over time?

Question 4: Does the resilience intervention lead to greater use of adaptive responses to intrusive memories?

Question 5: Is the resilience intervention correlated with lower scores on measures of mental health (depression, PTSD) and health behaviours (alcohol use) at post-intervention and at follow-up compared to the control intervention?

Question 6: Does neuroticism predict the degree of change participants experience in wellbeing, resilience, self-effiacy, and social capital as a result of the resilience intervention?

Ethics approval

Medical Sciences Division Research Ethics Committee at the University of Oxford, May 2015, ref: MS-IDREC-C1-2015-059

Study design

Multi-centre randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

https://az1.qualtrics.com/ControlPanel/File.php?F=F_9XpnNTTGXlwzZm5

Condition

Resilience and linked mental health outcomes in emergency service workers

Intervention

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.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

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 measures

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.

Overall trial start date

12/05/2015

Overall trial end date

31/03/2016

Reason abandoned

Eligibility

Participant 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

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

N=430

Participant 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

Recruitment start date

15/05/2015

Recruitment end date

28/11/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Andover Mind Centre for Wellbeing
Andover
SO51 8DS

Trial participating centre

Mind Brighton and Hove
BN1 4GQ

Trial participating centre

Mind Coastal West Sussex
BN13 2QG

Trial participating centre

Solent Mind
SO17 1XF

Trial participating centre

Dudley Mind
DY8 2JP

Trial participating centre

Birmingham Mind
B1 3JR

Trial participating centre

Oxfordshire Mind
OX2 0DP

Trial participating centre

Mind in Cambridgeshire
PE19 1AJ

Trial participating centre

Mind Peterborough & Fenland
PE3 8DX

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

University Offices
Wellington Square
Oxford
OX1 2JD
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Mind, the mental health charity (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The trial will be submitted for publication in the October 2016. A systematic review of the literature on resilience interventions for emergency workers will be submitted in April 2016.

Intention to publish date

01/10/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes