Condition category
Mental and Behavioural Disorders
Date applied
13/10/2008
Date assigned
20/11/2008
Last edited
05/04/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

https://www.onlineassessment.org.uk/lowmoodresearch/index.pl

Contact information

Type

Scientific

Primary contact

Dr Paul Farrand

ORCID ID

Contact details

School of Psychology
University of Exeter
Room 235
Washington Singer Laboratories
Perry Road
Exeter
EX4 4QG
United Kingdom
+44 (0)1392 262497
P.A.Farrand@exeter.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ASRB4082

Study information

Scientific title

Effectiveness of two types of support for low mood: a randomised controlled trial and economic analysis

Acronym

LIVELIFE

Study hypothesis

Compared to the treatment as usual (TAU) by general practitioner (GP) and continued monitoring control group alone, patients receiving NHS Direct telephone support for free to use web-based cognitive behavioural therapy (CBT) self help (Living Life to the Full) will have:
1. Improved mood measured on the Beck Depression Inventory (BDI-II)
2. Improved symptoms and social functioning measured on the 9-item Patient Health Questionnaire (PHQ-9) (depression), 7-item Generalised Anxiety Disorder (GAD-7) (anxiety), and Work And Social Adjustment Scale (WASAS) for social functioning questionnaires
3. Lower health care costs (EQ-5D and Client Services Receipt Interview [CSRI])
4. Improved mental health literacy
5. Improved acceptability

Ethics approval

Devon and Torbay Research Ethics Committee gave approval on the 5th March 2008 (ref: 08/H0202/31)

Study design

Single centre, randomised, phase III, controlled trial with single blinding on the study, research and analysis teams

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Patient information material found at: https://www.onlineassessment.org.uk/lowmoodresearch/index.pl?p=1

Condition

Mild to moderate depression, with or without anxiety

Intervention

Status of trial amended to 'stopped' as of 05/04/2013 due to notification of lack of resources.

Intervention:
Up to 60 minutes of telephone support for a free to use cognitive behavioural self help web site called Living Life to the Full with treatment as usual from General Practitioner.

Control:
Continued monitoring and treatment as usual from General Practioner.

Duration of treatment is up to 60 minutes of telephone support. Duration of follow up for both arms is dictated by time taken to complete the follow up questionnaires which would be about 45 minutes in total over all follow-up sessions.

Intervention type

Other

Phase

Phase III

Drug names

Primary outcome measures

Beck Depression Inventory II at 4 months follow up.

Secondary outcome measures

1. Beck Depression Inventory II at 8 weeks, 4 months and 1 year
2. PHQ-9 depression measure at 8 weeks, 4 months and 1 year
3. GAD-7 anxiety measure at 8 weeks, 4 months and 1 year
4. Work And Social Adjustment Scale (WASAS) questionnaire at 8 weeks, 4 months and 1 year
5. Modified (shortened) EQ5D at 4 months and 1 year
6. Modified (shortened) version of the Client Service Receipt Inventory (CSRI) at 4 months and 1 year
7. Single item satisfaction scale at 8 weeks, 4 months and 1 year
8. Four items assessing mental health literacy at 8 weeks, 4 months and 1 year

Overall trial start date

20/10/2008

Overall trial end date

28/02/2011

Reason abandoned

Lack of staff/facilities/resources

Eligibility

Participant inclusion criteria

1. Aged 16 and above, either sex
2. Currently experiencing mild to moderately severe levels of depression - or depression and anxiety as defined by a score of 5 - 19 on the Patient Health Questionnaire 9 (PHQ-9)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

184

Participant exclusion criteria

1. Aged under 16 years
2. Do not wish to adopt a self-help format
3. Cannot read/understand the written and audio content
4. Do not have a telephone and computer
5. Do not have access to broadband
6. Have active suicidal intent (defined as a score of 2 or more on the BDI-II suicide item)
7. Have more severe depression (a score greater than 19 on the PHQ)
8. An alcohol intake above 31 and 22 units for men and women respectively
9. People with drug dependency defined as using street drugs every day
10. A history of bipolar disorder
11. Psychosis and depression
12. Currently or have in the last 6 months been referred for supported self-help
13. Those who have started or changed antidepressant type in the last month

Recruitment start date

20/10/2008

Recruitment end date

28/02/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

School of Psychology
Exeter
EX4 4QG
United Kingdom

Sponsor information

Organisation

University of Exeter (UK)

Sponsor details

Washington Singer Laboratories
Perry Road
Exeter
EX4 4QG
United Kingdom

Sponsor type

University/education

Website

http://www.exeter.ac.uk/

Funders

Funder type

Government

Funder name

NHS Direct (UK) - competitive funding (ref: ASRB4082)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes