Technology-enhanced Therapy: the SilverCloud Study

NCT01498107 | Completed

• 1 other identifier: 609/M/C/791
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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?

Conditions

Depression

Keywords

online intervention; computerized CBT; e-health

Outcome Measures

Primary Outcomes (1)

• Decrease in the Beck Depression Inventory Score

  Change from baseline after 8 reviews have been completed in the online intervention

Secondary Outcomes (2)

• Decrease in the Patient Health Questionnaire Score

  Change from baseline after 8 reviews have been completed in the online intervention

• Decrease in the Work and Social Adjustment Scale Score

  Change from baseline after 8 reviews have been completed in the online intervention

Interventions

SilverCloud Platform BEHAVIORAL

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cambridge: lead
• Cambridgeshire and Peterborough NHS Foundation Trust: collaborator
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Cambridgeshire Peterborough Foundation Trust: Improving Access to Psychological Therapies (IAPT)

Cambridgeshire, Peterborough and Mid-Essex, United Kingdom

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Cecily Morrison, PhD

  University of Cambridge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate

Study Record Dates

• First Submitted: December 14, 2011
• First Posted: December 23, 2011
• Study Start: January 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: October 1, 2012
• Last Updated: January 8, 2014

Record last verified: 2014-01

Locations

GB (1)