Condition category
Mental and Behavioural Disorders
Date applied
22/06/2015
Date assigned
28/07/2015
Last edited
04/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The research team at the University of Glasgow are carrying out a research project looking at low mood and stress in the community. Low mood is a common mental health problem affecting up to 121 million people worldwide (World Health Organisation) and people often do not receive the help they need. Although approaches based on cognitive behavioural therapy (CBT) are known to be successful in a one-to-one setting, this can be expensive and there are often long waiting lists. We want to know if computerised CBT could be used as an alternative. We aim to find out whether it is possible to investigate an online CBT resource, recruiting from the general population.

Who can participate?
Patients aged 18 or over, living in the UK and with the ability to understand the written and spoken English language. They must also have regular access to a computer with audio and broadband connection and score of 10 or more on PHQ-9 (a depression diagnostic measure).

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 start to use a self-help CBT website straight away. Those in group 2 start to use the website after a 3 month delay. This study design help researchers to compare the groups 3 months after they start the trial and see how many join the programme and then stick to it, whether the approach is acceptable to them and whether those who have used the resource have greater improvements in mood than those who have not yet used the website. During the study, participants are able to access online modules with video and audio that addresses various aspects of low mood and anxiety. They are informal and friendly sessions that aim to teach skills that may help to reduce feelings of stress and improve low mood. Participants are 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?
By using the package it is hoped that participants may learn new skills to help with symptoms of low mood, anxiety or depression. Sometimes when people find out more about low mood and stress they can feel worse to start with. However this is usually just for a short time and most people feel better again quite quickly as they work through online courses like this one. The support workers will be trained to signpost participants to additional help if needed.

Where is the study run from?
University of Glasgow. Participants will use the self-help website at home.

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

Who is funding the study?
NHS Greater Glasgow and Clyde (UK)

Who is the main contact?
Carrie-Anne McClay
c.mcclay.1@research.gla.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Ms Carrie-Anne McClay

ORCID ID

Contact details

Administration Building
Gartnavel Royal Hospital
1055 Great Western Road
Glasgow
G12 0XH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A pilot randomised controlled trial of an online CBT life skills programme for low mood and anxiety.

Acronym

Study hypothesis

This is a pilot study that aims to address the following questions:
1. Is the study design feasible- is it possible to recruit from the community, remotely randomise participants, deliver the online intervention with telephone/email support and collect data at baseline and 3 months post randomisation?
Secondary questions:
2. To what extent will participants adhere to the online intervention?
3. Is the Living Life package acceptable to participants?
4. How many participants will be needed for a sufficiently powered future RCT?

Ethics approval

College of Medical, Veterinary and Life Sciences Ethics Committee for Non Clinical Research Involving Human Subjects, University of Glasgow, ref. 200140159.

Study design

Parallel two-arm pilot randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Internet

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Low mood./depression

Intervention

The study will test the delivery of an online educational life skills package (LLTTF4). The course teaches key life skills and is based on an existing CBT model with a strong educational focus. It contains a series of e-books - together with linked online modules that focus on the following topics:
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
Each is accompanied by colourful worksheets. Participants will work through the LLTTF4 online sessions at their own pace (1 session per week is recommended). All participants will be allocated a support worker (trained in delivering support for the online intervention) who will deliver 6 weeks of support via email or telephone. The support will be offered by Action on Depression (support workers, who have delivered similar content before online or in classes.

Control group: Students will receive access to the intervention after a 3-month delay. During these three months, participants in this group are advised to continue with their treatment as usual, whatever that may be, ex. antidepressant medication. We will not provide a usual care package while they wait.

Intervention type

Other

Phase

Drug names

Primary outcome measures

In this pilot study, the main aim will be to investigate take-up, drop-out and completion rates of the online course, and the completion rates for data collection.

Secondary outcome measures

Secondary outcomes will be mood ratings at 3 months. We will use changes in the Patient Health Questionnaire 9 (PHQ-9) score to provide data relating to the effect of the intervention on depression levels. This will give an indication of efficacy, and together with the drop-out/retention rate, will be used to provide a power calculation for the future substantive RCT; providing evidence that a change in depression levels between the intervention and control groups can be observed. Anxiety, social adjustment and satisfaction with the intervention will also be assessed.

Overall trial start date

01/08/2015

Overall trial end date

01/08/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 or over
2. Living in the UK
3. Ability to understand the written and spoken English language
4. Regular access to a computer with sound card and broadband connection
5. Score of 10 or more on PHQ9

Participant type

Other

Age group

Adult

Gender

Not Specified

Target number of participants

The aim is to recruit up to 50 participants.

Participant exclusion criteria

1. High rating of suicidality (i.e. scoring 2 or 3 on PHQ-9 item 9)
2. Currently receiving any psychological intervention such as counselling or psychotherapy
3. No new or altered dose of antidepressant in the last month
4. Taking part in other research

Recruitment start date

01/08/2015

Recruitment end date

01/02/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Glasgow
Administration Building Gartnavel Royal Hospital 1055 Great Western Road
Glasgow
G12 0XH
United Kingdom

Sponsor information

Organisation

University of Glasgow

Sponsor details

c/o Deirdre Kelliher
University of Glasgow
R114 Level 1
R&E
11 The Square
Glasgow
G12 8QQ
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Hospital/treatment centre

Funder name

NHS Greater Glasgow and Clyde

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

2016 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/27121090

Publication citations

Additional files

Editorial Notes

04/05/2016: Publication reference added.