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| A pilot research project into the use of online resources for low mood and anxiety in the voluntary sector |
| Source of record | UK Trials |
| ISRCTN | ISRCTN71327173 |
| Date ISRCTN assigned | 25/10/2007 |
| Local reference number(s) | FM05006 |
| Public title | A pilot research project into the use of online resources for low mood and anxiety in the voluntary sector |
| Scientific title | |
| Acronym | N/A |
| Disease/condition/study domain | Depression, anxiety |
| 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 |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Ethics approval received from the University of Glasgow (UK) Ethics Committee on the 5th September 2007 (ref: FM05006). |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - 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) |
| Patient information material | |
| Anticipated start date | 01/10/2007 |
| Anticipated end date | 01/05/2008 |
| Status of trial | Ongoing |
| Target number of participants | 100 |
| Interventions | 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. |
| Primary outcome measure(s) | 1. Beck Anxiety Inventory (BAI) score at 4 months 2. Beck Depression Inventory (BDI-II) score at 4 months |
| Secondary outcome measure(s) | 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. |
| Sources of funding | Glasgow Institute of Psychosocial Interventions (GIPSI) (UK) |
| Sponsor name | Glasgow Institute of Psychosocial Interventions (GIPSI) (UK) |
| Sponsor details | Gartnavel Royal Hospital The Academic Centre 1055 Great Western Road Glasgow United Kingdom G12 0XH |
| Sponsor email | chris.williams@clinmed.gla.ac.uk |
| Contact name | Dr Rebeca Martinez |
| Contact details | Gartnavel Royal Hospital 1055 Great Western Road Glasgow United Kingdom G12 0XH |
| Contact email | r.martinez@clinmed.gla.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN71327173 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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