| Methods |
Study design: RCT
Study grouping: parallel group
Unit of randomisation: individuals
Power (power & sample size calculation, level of power achieved): Taking a conservative approach, they expect a small effect size for well‐being outcomes (d = 0.2), based on a meta‐analysis of RCTs on positive psychology interventions; taking an equally conservative approach, at the minimum they anticipate a similar effect size for resilience outcomes. Therefore, given a small expected effect size of 0.2 for resilience and well‐being outcomes and recent guidelines for estimating sample size for pilot RCTs designed with 90% power and 2‐sided 5% significance, based on a non‐central t‐distribution approach, a sample size of 75 was determined (25 per arm)
Imputation of missing data: not specified, but all analyses will be based on the intention‐to‐treat principle according to study protocol |
| Interventions |
Intervention 1: internet‐delivered intervention for resilience with human support (Space for Resilience; n planned = 25)
delivery: delivered on Web 2.0 platform using interactive content; each module follows structured format (videos, informational content, interactive activities, mindfulness meditations, homework suggestions, summaries); personal stories and accounts from others incorporated into presentation of material providers: supporters = counsellors or trainee counselling staff working at the university's student counselling service who have already widely used the SilverCloud depression and anxiety interventions; have access to participant levels of engagement with the programme through online platform and provide individualised reviews to participants duration of treatment period and timing (frequency, duration of each session): 8 weeks -
description:
compliance: not specified integrity of delivery: The online system will automatically record information about the programme usage. All user activity within the programme (i.e. clicking through the content, updating an activity, saving a journal entry) is recorded with a time stamp. Thus, a session is defined as any time that the user logs on to the platform and the length of the session is determined by subtracting the time of the last time stamp of that session, to the time of the login. Total time spent in the programme is therefore calculated by adding the total time that the user spent in each session. The system also tracks the number of activities completed, the percentage of programme viewed and the number of reviews offered by the supporter (in the human support condition) economic information : not specified in trial registration or study protocol theoretical basis: based primarily on positive psychology and comprises cognitive components previously incorporated in other resilience interventions, including cognitive flexibility, optimism,challenging negative self‐talk, behavioural activation and active coping , as well as information on social support, lifestyle factors and values
Intervention 2: internet‐delivered intervention for resilience with automated support (Space for Resilience; n planned = 25)
delivery: delivered on Web 2.0 platform using interactive content; each module follows structured format (videos, informational content, interactive activities, mindfulness meditations, homework suggestions, summaries); personal stories and accounts from others incorporated into presentation of material; automated support/reviews sent by messages on online platform providers:automated support = generic, precast reviews, i.e. no individualised reviews based on each participant's level of engagement; messages pre‐written by clinicians with many years of clinical experience and knowledge of delivering online support; all messages follow similar structure duration of treatment period and timing: 8 weeks -
description:
receive 4 reviews during 8‐week period (reviews scheduled to be sent at moment of sign‐up, week 2, week 4, and week 7) -
7 modules:
1) building resilience: introduces the concept of resilience and allows the user to analyse their current levels of resilience and set goals for the programme; practice of mindfulness and its relevance for resilience is also introduced 2) purpose: focuses on purpose, meaning and values; user is encouraged to identify their values, what matters most to them in life and their passions, and find ways to incorporate these into the key life roles they undertake 3) self: focuses on self‐esteem and self‐compassion; user is encouraged to identify their strengths and align them to their values and passions; users are also invited to challenge their negative self‐talk and replace it with more compassionate statements 4) connections: supports users in reflecting on their social networks and improving their relationships and communities; information about communication styles is provided and the user is given tips for improving their communication skills 5) body: focuses on creating a healthy lifestyle by developing positive habits for sleep, diet and exercise; behavioural activation techniques are provided and the user can track their daily lifestyle choices and observe how they impact on their mood 6) mind: focuses on thoughts and offers balanced optimism and gratitude as alternatives to negative or distorted thinking 7) moving forward: looks at active coping methods for dealing with problems, and prepares the user for coming to the end of the programme; users have the opportunity to review their progress since starting the programme and set goals for the future
compliance: not specified in trial registration or study protocol integrity of delivery: The online system will automatically record information about the programme usage. All user activity within the programme (i.e. clicking through the content, updating an activity, saving a journal entry) is recorded with a time stamp. Thus, a session is defined as any time that the user logs on the platform and the length of the session is determined by subtracting the time of the last time stamp of that session, to the time of the login. Total time spent in the programme is therefore calculated by adding the total time that the user spent in each session. The system also tracks the number of activities completed, the percentage of programme viewed and the number of reviews offered by the supporter (in the human support condition). economic information: not specified in trial registration or study protocol theoretical basis: based primarily on positive psychology and comprises cognitive components previously incorporated in other resilience interventions, including cognitive flexibility, optimism,challenging negative self‐talk, behavioural activation and active coping, as well as information on social support, lifestyle factors and values
Control: wait‐list control (n planned = 25) |
| Notes |
Contact with authors: We contacted the authors for information about the inclusion of healthcare students, but received no response
Study start/end date: see trial registration: October 2018 to May 2019
Funding source: funded by joint resources provided from SilverCloud Health and Student Counselling Service, Trinity College Dublin
Declaration of interest: 4 authors are employees of SilverCloud Health, 2 of them are members of the e‐mental health research group, School of Psychology, Trinity College Dublin
Ethical approval needed/obtained for study: approved by the research ethics committee at the School of Psychology, Trinity College Dublin (Approval ID: SPREC112018‐12; 27th November 2018)
Comments by study authors: trial registration: ISRCTN11866034
Miscellaneous outcomes by the review authors: according to trial registration: no longer recruiting, overall trial status: completed, unpublished trial (last update in April 2019); inclusion of healthcare students unclear
Correspondence: A. Enrique; E‐Mental Research group, School of Psychology, Trinity College Dublin, Ireland and Clinical Research & Innovation, SilverCloud Health, Dublin, Ireland; corresponding author: D. Richards; E‐Mental Research group, School of Psychology, Trinity College Dublin; Ireland; derek.richards@tcd.ie |
