Plain English Summary
Background and study aims
We are carrying out a research project looking at low mood and stress in adults seeking employment and attending a disability employment service called Remploy. Low mood is a common mental health problem affecting up to 121 million people worldwide and is more common in unemployed people and those with physical health problems. Although approaches based on the talking therapy cognitive behavioural therapy (CBT) are known to be effective when given one to one by an expert practitioner, this can be expensive, and computerised CBT may be a useful alternative. This project aims to find out whether it is possible to devise an online CBT resource for people who are seeking work and attending Remploy.
Who can participate?
People attending Remploy, aged 16, with no active risk to self can enter the study. Participants must be able read, speak and understand English.
What does the study involve?
Eligible participants will be randomly allocated to begin using a self-help website straight away or after a 3-month delay. All participants will receive the same treatment. This study will help the researchers to compare the groups at 3 and 6 months and find out whether those who have received access to the online modules have greater improvements in mood and job seeking than those who have not yet used the website yet. During the study, participants will be able to access online modules with video and audio that address various aspects of low mood and anxiety. These modules use a cognitive behavioural therapy (CBT) guided self-help approach. They are informal and friendly sessions that aim to teach skills that may help to reduce feelings of stress and improve low mood. Participants will be assigned a support worker to help them progress through the sessions and apply what they have learned.
What are the possible benefits and risks of participating?
Participation within this study will allow people who are out of work and experiencing symptoms of low mood to use CBT-based educational online modules aimed at addressing these and other issues. Since the intervention is a life skills package that will be introduced as part of the Remploy service we do not expect any side effects or emergencies.
Where is the study run from?
Recruitment and delivery of the online package will take place at the Edinburgh and Hamilton Remploy offices in the UK.
When is study starting and how long is it expected to run for?
Recruitment is ongoing and will run until we have the needed number of participants. The study started in November 2012 and is expected to finish in December 2014.
Who is funding the study?
University of Glasgow, UK.
Who is the main contact?
Carrie-Anne McClay
c.mcclay.1@research.gla.ac.uk
info@help4depression.com
Trial website
Contact information
Type
Scientific
Primary contact
Prof Chris Williams
ORCID ID
Contact details
University of Glasgow
Mental Health and Wellbeing
College of Medical
Veterinary & Life Sciences
1st Floor Admin Building
Gartnavel Royal Hospital
1055 Great Western Road
Glasgow
G12 0XH
United Kingdom
+44 (0)141 211 3912
chris.williams@glasgow.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Evaluating an online support package delivered within a disability unemployment service: a randomised controlled feasibility study
Acronym
Study hypothesis
Primary question:
Is the study design feasible - is it possible to recruit from Remploy, randomise participants and collect data at baseline, 3 months and 6 months?
Secondary questions:
1. To what extent will participants adhere to the intervention?
2. Is the Living Life (LL) package satisfactory/acceptable to participants?
3. How many participants will be needed for a sufficiently powered future RCT?
Ethics approval
College of Medical, Veterinary & Life Sciences Ethics Committee for Non Clinical Research Involving Human Subjects, University of Glasgow; ref. 2012063
Study design
Feasibility study with a pre-post design randomised controlled design with a delayed access control group
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Low mood, depression and anxiety. Unemployment.
Intervention
Individuals who are suitable for the study will be randomly allocated to begin the online intervention immediately or after a 6-month delay.
Living Life guided CBT self-help online package consisting of modules including:
1. Why do I feel so bad?
2. I can't be bothered doing anything
3. Why does everything always go wrong?
4. I'm not good enough: (low confidence)
5. How to fix almost everything?
6. The things you do that mess you up
7. Are you strong enough to keep your temper?
8. 10 things you can do to help you feel happier straight away.
All participants can continue with treatment as usual during the study. All participants will be asked to complete outcome measures at baseline, 3 months and 6 months.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
The proportion of people taking up and adhering to the LL intervention.
Secondary outcome measures
1. Determine the feasibility of recruiting, delivering the intervention and gathering data from participants via the Remploy service.
2. Describe the difference in proportion of people in work at 12 weeks between the LL group and the TAU control group, or if not in work the number of interviews attended and job submissions made (measuring motivation).
3. Describe the subsequent number (frequency) and total (days) off work over 3 months and 6 months in both arms comparing within group comparisons from baseline, and between-groups at 3 and 6 months.
4. Describe and compare impact on mood, social function and satisfaction at 3 months and 6 months in both arms comparing within group comparisons from baseline, and between-groups at 3 and 6 months.
Overall trial start date
19/11/2012
Overall trial end date
15/12/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Willing to take up the offer of LL and appropriate for usual Remploy support
2. With no active risk to self at initial Remploy assessment (this is not routinely investigated but if suicidality is disclosed at the initial assessment the individual will not enter the study)
3. Able to register on the website, read and understand the LL resources via the internet or DVD
4. At home or in the Remploy office
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
The aim is to recruit 100 participants in total for this feasibility study, 50 intervention participants and 50 control participants to allow for comparison at the 3-month and 6-month follow-up points
Participant exclusion criteria
1. Unwilling or unable to use the LL approach
2. Active risk identified in which case usual care (referral to GP) will occur as is normal Remploy practice
Recruitment start date
19/11/2012
Recruitment end date
15/12/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Glasgow
Glasgow
G12 0XH
United Kingdom
Sponsor information
Organisation
University of Glasgow (UK)
Sponsor details
c/o Deirdre Kelliher
R114 Level 1
R&E
11 The Square
Glasgow
G12 8QQ
United Kingdom
+44 (0)141 330 2954
Deirdre.Kelliher@glasgow.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Glasgow (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 protocol in: http://www.pilotfeasibilitystudies.com/content/1/1/14