LIVELIFE: effectiveness of two types of support for low mood

ISRCTN	ISRCTN65803720
DOI	https://doi.org/10.1186/ISRCTN65803720
Secondary identifying numbers	ASRB4082

Submission date: 13/10/2008
Registration date: 20/11/2008
Last edited: 05/04/2013

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Paul Farrand
Scientific

School of Psychology
University of Exeter
Room 235
Washington Singer Laboratories
Perry Road
Exeter
EX4 4QG
United Kingdom

Phone	+44 (0)1392 262497
Email	P.A.Farrand@exeter.ac.uk

Study information

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
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Patient information material found at: https://www.onlineassessment.org.uk/lowmoodresearch/index.pl?p=1
Scientific title	Effectiveness of two types of support for low mood: a randomised controlled trial and economic analysis
Study acronym	LIVELIFE
Study objectives	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(s)	Devon and Torbay Research Ethics Committee gave approval on the 5th March 2008 (ref: 08/H0202/31)
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	20/10/2008
Completion date	28/02/2011
Reason abandoned (if study stopped)	Lack of staff/facilities/resources

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	184
Key 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)
Key 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
Date of first enrolment	20/10/2008
Date of final enrolment	28/02/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

School of Psychology

Exeter
EX4 4QG
United Kingdom

Sponsor information

University of Exeter (UK)
University/education

Washington Singer Laboratories
Perry Road
Exeter
EX4 4QG
England
United Kingdom

Website	http://www.exeter.ac.uk/
"ROR"	https://ror.org/03yghzc09

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan