DepressionNCT01498107
Technology-enhanced Therapy: the SilverCloud Study
A study testing SilverCloud Platform in people with Depression, run by University of Cambridge at 1 site in United Kingdom.
Trial summary
This pilot study investigates a new platform for supporting online interventions for common mental health problems called SilverCloud. It was developed from insights into interactive system design to address the problem of high attrition rates and poor engagement with online interventions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- SilverCloud Platform
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2012to Oct 2012
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of depression with no co-morbidity of anxiety
- Appropriate for guided self-help in a primary care setting as determined by current IAPT procedures
- Owns a computer and has access to broadband internet
- Chooses to participate
- Gives consent to take part in the research
Who cannot join
- Are not comfortable reading in English
- Do not have adequate reading ability to use a guided self-help intervention
- Have had a CBT intervention within the past year
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cambridgeshire Peterborough Foundation Trust: Improving Access to Psychological Therapies (IAPT)
Cambridgeshire, Peterborough and Mid-Essex
About this study
Official title: A Pilot Study Evaluating Engagement With a Platform Supporting Online Interventions for Common Mental Health Problems
This pilot study investigates a new platform for supporting online interventions for common mental health problems called SilverCloud. It was developed from insights into interactive system design to address the problem of high attrition rates and poor engagement with online interventions. Through a range of methods, the study considers the role of four design strategies in engaging users in cognitive behavioural therapy. A service-based study, it concentrates on a clinical population with mild or moderate depression. Clinical outcome measures will be taken pre and post intervention use; demographic data of who did and did not choose the intervention collected, patterns of usage will be extracted from the log data and analysed; and qualitative interviews will be done to understand the relationship between patterns of usage and levels of engagement. The findings will be used to inform further developments of this and other online interventions and contribute to the development of methods for assessing online interventions.
The objectives of the pilot study are:
Read more
- To evaluate engagement with the online intervention in a realistic primary mental health care setting
- Assess engagement from multiple perspectives, including clinical efficacy and interaction design
- Contribute to further development of the online intervention
- Support preparation for a full-scale clinical trial
Research questions include:
- Does the online intervention decrease symptoms of depression?
- Who chooses to use the online intervention?
- What are the patterns of use of the online intervention?
- How successful are the four design principles, personal, interactive, supportive and social, in supporting engagement?
Read the detailed description
INTERVENTION DESCRIPTION
SilverCloud platform SilverCloud is a platform on which to quickly build online interventions for common mental health problems. It utilises four design strategies that have been drawn from research in human-computer interaction: personal, interactive, supportive and social. SilverCloud is unusual among online interventions for its utilisation of current interactive design approaches.
- Personal: Users are encouraged to draw together all strands of the programme and build their own plan or "toolbox" for staying well and managing current and future mood difficulties.
- Interactive: Users can engage with the range of media, such as interactive quizzes, video presentation, online exercises and activities, homework, and mobile diary-keeping. These are meant to encourage reflection and personalization of the information.
- Supportive: Though mainly self-directed, each user in the programme will be assigned a therapist who will support them and provide feedback at specified intervals throughout the intervention on the activities that the user has chosen to share.
- Social: Users can gain a sense of other people using the system be seeing how many people liked an activity, or by sharing answers to an activity that are visible to all after moderation.
Mindbalance programme Mind Balance is a six-module programme built on the SilverCloud platform, incorporating psycho-educational and therapeutic elements of managing difficulties with low mood and depression. The programme draws primarily on the principles of cognitive behavioural therapy (CBT) and incorporates elements of mindfulness.
Service-based use The SilverCloud online intervention will be used as part of IAPT: Improving Access to Psychological Therapies. IAPT is a recent, centrally-developed, nationally- implemented, service model to implement National Institute for Clinical Excellent (NICE) guidelines for common mental health problems in primary care in the UK. It provides high throughput talking therapies at two levels of intensity to the adult population. The higher level provides therapy with a clinical psychologist and the lower level, guided self-help with a trained IAPT worker. The SilverCloud online intervention will be provided at the lower level of intensity as an alternative to manual-based guided self-help. Participants will receive up to eight reviews on a weekly or fortnightly basis as agreed with their IAPT worker with the intervention running not more than three months.
- Conditions
- Depression
- Being tested
- SilverCloud Platform
- Keywords
- online intervention, computerized CBT, e-health
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SilverCloud PlatformBehavioural
The SilverCloud online intervention will be provided as an alternative choice to paper manuals to support guided self-help for depression in a primary care mental health service. Participants will receive up to eight progress reviews on a weekly or fortnightly basis as agreed with their therapist with the intervention running not more than three months.
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in the Beck Depression Inventory Score
Measured: Change from baseline after 8 reviews have been completed in the online intervention
Secondary outcomes (2)
Decrease in the Patient Health Questionnaire Score
Measured: Change from baseline after 8 reviews have been completed in the online intervention
Decrease in the Work and Social Adjustment Scale Score
Measured: Change from baseline after 8 reviews have been completed in the online intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionJul 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Collaborators
- Cambridgeshire and Peterborough NHS Foundation Trust, National Institute for Health Research, United Kingdom
- Responsible party
- Principal investigator, Cecily Morrison, University of Cambridge
- Investigators
- Cecily Morrison, PhD, Principal investigator, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01498107
- Sponsor's protocol ID
- 609/M/C/791
- Status last verified
- Jan 2014
- First submitted
- 14 Dec 2011
- Last updated
- 8 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Evaluating Engagement With a Platform Supporting Online Interventions for Common Mental Health Problems
- ClinicalTrials.gov ID
- NCT01498107
- Acronym / sponsor ID
- 609/M/C/791
- Conditions
- Depression
- Keywords
- online intervention, computerized CBT, e-health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Collaborators
- Cambridgeshire and Peterborough NHS Foundation Trust, National Institute for Health Research, United Kingdom
- Study start
- Jan 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 23 Dec 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.
This pilot study investigates a new platform for supporting online interventions for common mental health problems called SilverCloud. It was developed from insights into interactive system design to address the problem of high attrition rates and poor engagement with online interventions. Through a range of methods, the study considers the role of four design strategies in engaging users in cognitive behavioural therapy. A service-based study, it concentrates on a clinical population with mild or moderate depression. Clinical outcome measures will be taken pre and post intervention use; demographic data of who did and did not choose the intervention collected, patterns of usage will be extracted from the log data and analysed; and qualitative interviews will be done to understand the relationship between patterns of usage and levels of engagement. The findings will be used to inform further developments of this and other online interventions and contribute to the development of methods for assessing online interventions.
The objectives of the pilot study are:
- To evaluate engagement with the online intervention in a realistic primary mental health care setting
- Assess engagement from multiple perspectives, including clinical efficacy and interaction design
- Contribute to further development of the online intervention
- Support preparation for a full-scale clinical trial
Research questions include:
- Does the online intervention decrease symptoms of depression?
- Who chooses to use the online intervention?
- What are the patterns of use of the online intervention?
- How successful are the four design principles, personal, interactive, supportive and social, in supporting engagement?
Detailed description
INTERVENTION DESCRIPTION
SilverCloud platform SilverCloud is a platform on which to quickly build online interventions for common mental health problems. It utilises four design strategies that have been drawn from research in human-computer interaction: personal, interactive, supportive and social. SilverCloud is unusual among online interventions for its utilisation of current interactive design approaches.
- Personal: Users are encouraged to draw together all strands of the programme and build their own plan or "toolbox" for staying well and managing current and future mood difficulties.
- Interactive: Users can engage with the range of media, such as interactive quizzes, video presentation, online exercises and activities, homework, and mobile diary-keeping. These are meant to encourage reflection and personalization of the information.
- Supportive: Though mainly self-directed, each user in the programme will be assigned a therapist who will support them and provide feedback at specified intervals throughout the intervention on the activities that the user has chosen to share.
- Social: Users can gain a sense of other people using the system be seeing how many people liked an activity, or by sharing answers to an activity that are visible to all after moderation.
Mindbalance programme Mind Balance is a six-module programme built on the SilverCloud platform, incorporating psycho-educational and therapeutic elements of managing difficulties with low mood and depression. The programme draws primarily on the principles of cognitive behavioural therapy (CBT) and incorporates elements of mindfulness.
Service-based use The SilverCloud online intervention will be used as part of IAPT: Improving Access to Psychological Therapies. IAPT is a recent, centrally-developed, nationally- implemented, service model to implement National Institute for Clinical Excellent (NICE) guidelines for common mental health problems in primary care in the UK. It provides high throughput talking therapies at two levels of intensity to the adult population. The higher level provides therapy with a clinical psychologist and the lower level, guided self-help with a trained IAPT worker. The SilverCloud online intervention will be provided at the lower level of intensity as an alternative to manual-based guided self-help. Participants will receive up to eight reviews on a weekly or fortnightly basis as agreed with their IAPT worker with the intervention running not more than three months.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of depression with no co-morbidity of anxiety
- Appropriate for guided self-help in a primary care setting as determined by current IAPT procedures
- Owns a computer and has access to broadband internet
- Chooses to participate
- Gives consent to take part in the research
Key exclusion criteria (3 listed)
- Are not comfortable reading in English
- Do not have adequate reading ability to use a guided self-help intervention
- Have had a CBT intervention within the past year
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 |
|---|---|---|
| SilverCloud PlatformThe SilverCloud online intervention will be provided as an alternative choice to paper manuals to support guided self-help for depression in a primary care mental health service. Participants will receive up to eight progress reviews on a weekly or fortnightly basis as agreed with their therapist with the intervention running not more than three months. | Behavioural | – |
Primary outcome
Decrease in the Beck Depression Inventory Score
Time frame: Change from baseline after 8 reviews have been completed in the online intervention
2 secondary outcomes
Decrease in the Patient Health Questionnaire Score
Time frame: Change from baseline after 8 reviews have been completed in the online intervention
Decrease in the Work and Social Adjustment Scale Score
Time frame: Change from baseline after 8 reviews have been completed in the online intervention
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 8 Jan 2014.
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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.
Cecily Morrison, PhD principal investigator
University of Cambridge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SilverCloud Platform in people with Depression, run by University of Cambridge 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 5 inclusion and 3 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 8 Jan 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.
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?
Decrease in the Beck Depression Inventory Score (time frame: Change from baseline after 8 reviews have been completed in the online intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jan 2014.