Technology-enhanced Therapy: the SilverCloud Study

January 7, 2014 updated by: Cecily Morrison, University of Cambridge

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:

  • 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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Cambridgeshire, Peterborough and Mid-Essex, United Kingdom
        • Cambridgeshire Peterborough Foundation Trust: Improving Access to Psychological Therapies (IAPT)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Decrease in the Beck Depression Inventory Score
Time Frame: Change from baseline after 8 reviews have been completed in the online intervention
Change from baseline after 8 reviews have been completed in the online intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Decrease in the Patient Health Questionnaire Score
Time Frame: Change from baseline after 8 reviews have been completed in the online intervention
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
Change from baseline after 8 reviews have been completed in the online intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cambridge

Collaborators

National Institute for Health Research, United Kingdom
Cambridgeshire and Peterborough NHS Foundation Trust

Investigators

  • Principal Investigator: Cecily Morrison, PhD, University of Cambridge

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

December 14, 2011

First Submitted That Met QC Criteria

December 20, 2011

First Posted (Estimate)

December 23, 2011

Study Record Updates

Last Update Posted (Estimate)

January 8, 2014

Last Update Submitted That Met QC Criteria

January 7, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 609/M/C/791

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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