DepressionPhase 1NCT01469689
Raising Awareness of Online Therapies for Depression: Pilot Study
A Phase 1 study testing Google Adwords and Local organisation websites in people with Depression, run by University of Plymouth at 1 site in United Kingdom.
Trial summary
Web based cognitive behavioural therapy (webCBT) for depression is recommended by NICE but analysis of the geographic distribution of one webCBT site showed 15-fold variation in use across Britain. Such variation is unlikely to be from differences in prevalence. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Google Adwords and Local organisation websites
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,231 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2011to Dec 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- people living in Britain searching for online help for depression
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Web based cognitive behavioural therapy (webCBT) for depression is recommended by NICE but analysis of the geographic distribution of one webCBT site showed 15-fold variation in use across Britain. Such variation is unlikely to be from differences in prevalence. Raising awareness of webCBT could benefit many people with depression but it is not clear how direct-to-patient promotion online or via the media, compares with GP centred methods. This pilot cluster randomised controlled trial will explore the use of online methods to raise awareness in preparation for subsequent study comparing different approaches.
In a pilot cluster randomised trial the investigators will explore the feasibility and likely impact of online methods of raising awareness of webCBT, assessing how many people with depression respond to geographically restricted Google and local website advertisements. The investigators will explore costs of recruitment and define and document the best online methods that might subsequently be used in a definitive trial comparing online with mass media and GP centred methods for raising awareness. The investigators will compare intervention with control areas to estimate impact on registration levels and compare rate of completion of webCBT of these 'additional' registrants with other registrants. Recommendations will be made for a subsequent trial comparing online with other methods.
- Conditions
- Depression
- Being tested
- Google Adwords, Local organisation websites
- Keywords
- People, living, community
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Google AdwordsOther
The investigators will display Google Adwords advertising the investigators' website offering online help for depression
Local organisation websitesOther
The investigators will place adverts on local organization websites with links to the investigators' project website offering online help for depression
| Study group | Role | What they receive |
|---|---|---|
| Google Adwords only | Experimental | In these areas,the investigators will display online adverts using Google Adwords, with links to the investigators' project website, and from there to four other websites for depression. Receives: Other: Google Adwords |
| Local organisation websites | Experimental | In these areas, the investigators will try to place adverts on the websites of local organizations, with links to the investigators' project website, and from there to four other websites for depression. Receives: Other: Local organisation websites |
| Google Ads and local websites | Experimental | In these areas, the investigators will place Google Adwords and also try to place adverts on the websites of local organizations, with links to the investigators' project website, and from there to four other websites for depression. Receives: Other: Google Adwords; Other: Local organisation websites |
| Control | No intervention | Control areas. No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Registration on Living Life To The Full website
This is a cluster trial with primary outcome the number of registrations for given geographical areas on a website (Living Life to The Full) offering cognitive behaviuoural therapy for depression.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8,231 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Plymouth
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Principal investigator, Ray Jones, University of Plymouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01469689
- Sponsor's protocol ID
- RR103348-101
- Status last verified
- May 2014
- First submitted
- 8 Nov 2011
- Last updated
- 30 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Jones RB, Goldsmith L, Hewson P, Williams CJ. Recruitment to online therapies for depression: pilot cluster randomized controlled trial. J Med Internet Res. 2013 Mar 5;15(3):e45. doi: 10.2196/jmir.2367.
PubMed 23462072Jones RB, Goldsmith L, Williams CJ, Kamel Boulos MN. Accuracy of geographically targeted internet advertisements on Google AdWords for recruitment in a randomized trial. J Med Internet Res. 2012 Jun 20;14(3):e84. doi: 10.2196/jmir.1991.
PubMed 22718043Jones RB, Goldsmith L, Hewson P, Kamel Boulos MN, Williams CJ. Do adverts increase the probability of finding online cognitive behavioural therapy for depression? Cross-sectional study. BMJ Open. 2012 Apr 16;2(2):e000800. doi: 10.1136/bmjopen-2011-000800. Print 2012.
PubMed 22508957
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Raising Awareness of Online Therapies for Depression: Pilot Study
- ClinicalTrials.gov ID
- NCT01469689
- Acronym / sponsor ID
- RR103348-101
- Conditions
- Depression
- Keywords
- People, living, community
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,231 participants (actual)
- Lead sponsor
- University of PlymouthUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- Mar 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 10 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Web based cognitive behavioural therapy (webCBT) for depression is recommended by NICE but analysis of the geographic distribution of one webCBT site showed 15-fold variation in use across Britain. Such variation is unlikely to be from differences in prevalence. Raising awareness of webCBT could benefit many people with depression but it is not clear how direct-to-patient promotion online or via the media, compares with GP centred methods. This pilot cluster randomised controlled trial will explore the use of online methods to raise awareness in preparation for subsequent study comparing different approaches.
In a pilot cluster randomised trial the investigators will explore the feasibility and likely impact of online methods of raising awareness of webCBT, assessing how many people with depression respond to geographically restricted Google and local website advertisements. The investigators will explore costs of recruitment and define and document the best online methods that might subsequently be used in a definitive trial comparing online with mass media and GP centred methods for raising awareness. The investigators will compare intervention with control areas to estimate impact on registration levels and compare rate of completion of webCBT of these 'additional' registrants with other registrants. Recommendations will be made for a subsequent trial comparing online with other methods.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Google Adwords only | Experimental | Other: Google AdwordsIn these areas,the investigators will display online adverts using Google Adwords, with links to the investigators' project website, and from there to four other websites for depression. |
| Local organisation websites | Experimental | Other: Local organisation websitesIn these areas, the investigators will try to place adverts on the websites of local organizations, with links to the investigators' project website, and from there to four other websites for depression. |
| Google Ads and local websites | Experimental | Other: Google Adwords, Other: Local organisation websitesIn these areas, the investigators will place Google Adwords and also try to place adverts on the websites of local organizations, with links to the investigators' project website, and from there to four other websites for depression. |
| Control | No intervention | –Control areas. No Intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- people living in Britain searching for online help for depression
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Google AdwordsThe investigators will display Google Adwords advertising the investigators' website offering online help for depression | Other | Google Ads and local websites, Google Adwords only |
| Local organisation websitesThe investigators will place adverts on local organization websites with links to the investigators' project website offering online help for depression | Other | Google Ads and local websites, Local organisation websites |
Primary outcome
Registration on Living Life To The Full website
Time frame: 9 months
This is a cluster trial with primary outcome the number of registrations for given geographical areas on a website (Living Life to The Full) offering cognitive behaviuoural therapy for depression.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2014.
- Derived from this study: PubMed 23462072Jones RB, Goldsmith L, Hewson P, Williams CJ. Recruitment to online therapies for depression: pilot cluster randomized controlled trial. J Med Internet Res. 2013 Mar 5;15(3):e45. doi: 10.2196/jmir.2367.
- Derived from this study: PubMed 22718043Jones RB, Goldsmith L, Williams CJ, Kamel Boulos MN. Accuracy of geographically targeted internet advertisements on Google AdWords for recruitment in a randomized trial. J Med Internet Res. 2012 Jun 20;14(3):e84. doi: 10.2196/jmir.1991.
- Derived from this study: PubMed 22508957Jones RB, Goldsmith L, Hewson P, Kamel Boulos MN, Williams CJ. Do adverts increase the probability of finding online cognitive behavioural therapy for depression? Cross-sectional study. BMJ Open. 2012 Apr 16;2(2):e000800. doi: 10.1136/bmjopen-2011-000800. Print 2012.
- University of Plymouth (Sponsoring organisation)Link provided by the sponsor.
- Collaborating centreLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Google Adwords and Local organisation websites in people with Depression, run by University of Plymouth at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Registration on Living Life To The Full website (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01469689, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2014.