A pilot research project into the use of online resources for low mood and anxiety in the voluntary sector
| ISRCTN | ISRCTN71327173 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71327173 |
| Secondary identifying numbers | FM05006 |
- Submission date
- 24/09/2007
- Registration date
- 25/10/2007
- Last edited
- 07/07/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- 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
Contact information
Dr Rebeca Martinez
Scientific
Scientific
Gartnavel Royal Hospital
1055 Great Western Road
Glasgow
G12 0XH
United Kingdom
| r.martinez@clinmed.gla.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A pilot research project into the use of online resources for low mood and anxiety in the voluntary sector |
| Study objectives | 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). The aim of this study is 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. The aim is 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(s) | University of Glasgow (UK) Ethics Committee, 05/09/2007, ref: FM05006 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/10/2007 |
| Completion date | 01/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 100 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 01/10/2007 |
| Date of final enrolment | 01/05/2008 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Gartnavel Royal Hospital
Glasgow
G12 0XH
United Kingdom
G12 0XH
United Kingdom
Sponsor information
Glasgow Institute of Psychosocial Interventions (GIPSI) (UK)
Research organisation
Research organisation
Gartnavel Royal Hospital
The Academic Centre
1055 Great Western Road
Glasgow
G12 0XH
United Kingdom
| chris.williams@clinmed.gla.ac.uk | |
"ROR" |
https://ror.org/00vtgdb53 |
Funders
Funder type
Research organisation
Glasgow Institute of Psychosocial Interventions (GIPSI) (UK)
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 |
Editorial Notes
07/07/2017: No publications found, verifying study status with principal investigator.
