Condition category
Mental and Behavioural Disorders
Date applied
24/09/2007
Date assigned
25/10/2007
Last edited
05/03/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rebeca Martinez

ORCID ID

Contact details

Gartnavel Royal Hospital
1055 Great Western Road
Glasgow
G12 0XH
United Kingdom
-
r.martinez@clinmed.gla.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

FM05006

Study information

Scientific title

A pilot research project into the use of online resources for low mood and anxiety in the voluntary sector

Acronym

Study hypothesis

Anxiety and stress are common and cause difficulties in everyday life. It has been estimated that around one in two people who experience these problems choose to seek help on their own or through the voluntary services.

The National Phobics Society already works to relieve and support those living with anxiety disorders by providing information, support and understanding via an extensive range of services, including one-to-one email and telephone support services. Many people have overlapping difficulties of low mood and anxiety. The offer of support through the voluntary sector offers a very attractive option for people who wish to seek help for their difficulties but may find it difficult to do so through mainstream health services.

"Living Life to the Full" is a free, web based life skills site (supported by the Scottish Executive Health Department) aimed at low mood and anxiety, which is based on the Cognitive Behaviour Therapy model. The written version of these materials on which this website is based on, have proven to be very effective in the treatment of low mood in a primary care population (effect size: 1.27, CSO CZH 461).

In the current study we intend to pilot and evaluate the use of Living Life to the Full, which can be accessed free of charge from a persons' home or local library with the support of the voluntary sector agency: National Phobics Society (NPS) - the UK's predominant anxiety charity. The recruitment for this study is from the voluntary sector, and does not involve any recruitment within the NHS. We aim to recruit people with anxiety or anxiety and low mood who contact the National Phobics Society (NPS). The form of support will be offered by email support by trained NPS volunteers.

Hypotheses:
1. Take-up, retention and drop-out in the two arms
2. The relative effect size of the interventions
3. The acceptability of the approach to participants and self-help support workers
4. Effect that the severity of symptoms has on people's use and benefit from the use of the active intervention

Ethics approval

University of Glasgow (UK) Ethics Committee, 05/09/2007, ref: FM05006

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Depression, anxiety

Intervention

This is a pilot randomised controlled trial comparing an online life skills package, Living Life To The Full (LLTTF) which is based on the Cognitive Behaviour Therapy model, delivered with brief email support (at least one email per week), compared with matched email support in the other arm of the study. The support will be within the time frame specified for brief interventions (i.e. approximately 60 minutes in total delivered over 6 weeks - the time used per participant will be recorded and the reasons for using more time will be explored), for people experiencing significant symptoms of anxiety and/or low mood.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Beck Anxiety Inventory (BAI) score at 4 months
2. Beck Depression Inventory (BDI-II) score at 4 months

Secondary outcome measures

1. Work And Social Adjustment Scale (WASAS)
2. Single item satisfaction scale
3. Four-items assessing mental health literacy

All outcomes will be measured at 6 weeks and 4 months.

Overall trial start date

01/10/2007

Overall trial end date

01/05/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 16 and above
2. Living in the UK
3. Currently experiencing significant anxiety and or low mood as indicated by a nine-item Patient Health Questionnaire (PHQ-9) score above 10 or a seven-item PHQ (PHQ-7) score above 10
4. Have online access and an active email address
5. Wish to work in this way to address their difficulties

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. No access to broadband internet, soundcard and speakers either at home or the local library
2. Cannot read/understand the written and audio content
3. Active suicidal intent (as defined by a score of 2 or more on the suicide item questionnaire)

Recruitment start date

01/10/2007

Recruitment end date

01/05/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Gartnavel Royal Hospital
Glasgow
G12 0XH
United Kingdom

Sponsor information

Organisation

Glasgow Institute of Psychosocial Interventions (GIPSI) (UK)

Sponsor details

Gartnavel Royal Hospital
The Academic Centre
1055 Great Western Road
Glasgow
G12 0XH
United Kingdom
-
chris.williams@clinmed.gla.ac.uk

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

Glasgow Institute of Psychosocial Interventions (GIPSI) (UK)

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