Condition category
Mental and Behavioural Disorders
Date applied
03/02/2019
Date assigned
20/03/2019
Last edited
09/04/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
College students have a high prevalence of depression and anxiety. Starting at college is considered a stress factor. Therefore, it is particularly relevant to develop interventions specifically addressed to students to foster supportive environments and resilient communities. This study aims to assess the effectiveness and acceptability of an Internet-based intervention programme for adapting well in the face of adversity, trauma, tragedy, threats or significant sources of stress (resilience), based on princliples of positive psychology to promote resilience and well-being among college students.

Who can participate?
Any registered student at the University of Dublin, Trinity College Dublin over 18 years of age can participate

What does the study involve?
We will compare the Internet-delivered intervention with human support; the Internet-delivered intervention with automated support; and a waiting-list control group who will receive the Internet-delivered intervention after the first 8 weeks of the study

What are the possible benefits and risks of participating?
Participation in a psychological intervention (the efficacy of which is currently unknown) and disclosure of information of a sensitive nature may be upsetting for some participants, therefore potentially posing a risk of psychological distress. However, it is not anticipated that the study will involve any physical harm to participants. If a member of the research team or a supporter are made aware of any physical harm, they will remind the participant that they do not have to continue participating in the study, ascertain whether the participant would like to continue participating and provide them with a list of support services.
Participants will benefit from the programme as part of promoting a mentally healthy lifestyle as a relevant component to promote resilience. These components included interactive tools to aim is to increase self-compassion and self-esteem, to improve social relationships and communication style. Also, the participants can benefit from exercises of gratitude and balanced optimism. The programme intervention is based in positive psychology, and also include physical aspects of resilience: exercise, sleep and diet.

Where is the study run from?
Student Counselling Service, Trinity College Dublin, Dublin, D02 PN40

When is the study starting and how long is it expected to run for?
The study will start in February 2019 and run for approximately 6 weeks

Who is funding the study?
SilverCloud Health (Ireland)

Who is the main contact?
Dr. Derek Richards, drichard@tcd.ie

Trial website

Contact information

Type

Scientific

Primary contact

Dr Derek Richards

ORCID ID

http://orcid.org/0000-0003-0871-4078

Contact details

E-mental Health Research Group
School of Psychology
Trinity College Dublin
Dublin
D08 DR9P
Ireland
+353(0)879343678
drichard@tcd.ie

Type

Public

Additional contact

Dr Angel Enrique

ORCID ID

http://orcid.org/0000-0003-0585-4008

Contact details

E-mental Health Research Group
School of Psychology
Trinity College Dublin
Dublin
D02 PN40
Ireland
+353(0)879343678
enriquea@tcd.ie

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

AEIR2019

Study information

Scientific title

Assessing the efficacy and acceptability of an Internet-delivered intervention for resilience: a pilot study for a randomised control trial

Acronym

AEIR

Study hypothesis

The current study sought to examine the acceptability and efficacy of an internet-delivered programme for resilience with automated or human support compared to a waiting list group in a sample of college students. The hypothesis is that the intervention Space for Resilience programme would be efficacious, with significant changes within the treatment group and differences post-treatment between the active treatment groups (human support group and automated support group) and the waiting list control.

Ethics approval

Approved 29/01/2019, Trinity College Dublin School of Psychology REC (Room 1.42, Trinity College Dublin, College Green, Dublin 2, Ireland; +353(0)1896 2428; psych.ethics@tcd.ie), ref: SPREC112018-12

Study design

The study is a randomised controlled trial to examine the efficacy and acceptability of the Internet-delivered intervention for resilience. Participants will be randomised into three groups: (a) the internet-delivered intervention with human support, (b) the internet-delivered intervention with automated support and (c) a waiting-list control group.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Resilience, which is defined in this study as a dynamic mental health adaptation, which individuals are able to face and recover from significant distress or trauma.

Intervention

The present research will use a three-armed pilot randomised controlled trial (RCT) design. Independent variables include group (K=3; intervention with automated support, intervention with human support and waiting list control group) and time of testing (K=2; pre-intervention and post-intervention).

Human support: Participants in the intervention with human support group will be assigned to a supporter from the TCD student counselling service. Supporters will be receive training in how to use the SilverCloud Health platform and the intervention programme prior to starting their role as a supporter and will be supervised by an experienced clinical psychologist. The role of the supporter is to motivate participants and provide asynchronous feedback to programme users. Participants in the human support group will receive fortnightly support from their supporter via the platform

Automated support: Participants in the automated support group will receive support through automated e-mails sent over the course of the eight weeks. This will include a welcome message and information on modules and tools Participants in the automatic support group will receive fortnightly automatic messages by email.

Waiting list control group: Participants in the waiting list control group will begin the intervention after eight weeks when participants in the active treatment groups (intervention with human or automated support) have completed the intervention

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Resilience measured using the Connor-Davidson Resilience Scale (CD-RISC) at baseline and post-treatment (8 weeks)
2. Happiness measured using the Pemberton Happiness Index (PHI) at baseline and post-treatment (8 weeks)




Secondary outcome measures

1. Gender, age, education, occupation, socioeconomic status, and clinical history measured using the Sociodemographic & History Questionnaire at baseline.
2. Depression measured using the Patient Health Questionnaire – 4 items (PHQ-4) at baseline and post-treatment (8 weeks)
3. Self-esteem measured using the Rosenberg Self-Esteem Scale (RSE) at baseline and post-treatment (8 weeks)
4. Stress measured using the Perceived Stress Scale – 4 items (PSS-4) at baseline and post-treatment (8 weeks)
5. Satisfaction with treatment measured using the Satisfaction with Treatment (SAT) scale at baseline and post-treatment (8 weeks)

Overall trial start date

05/10/2018

Overall trial end date

05/05/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Over 18 years of age
2. Registered student at the University of Dublin, Trinity College Dublin

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

75

Total final enrolment

82

Participant exclusion criteria

1. Psychotic or bipolar disorder
2. Risk of suicide
3. Currently in psychotherapy

Recruitment start date

04/02/2019

Recruitment end date

13/03/2019

Locations

Countries of recruitment

Ireland

Trial participating centre

Trinity College Dublin
Student Counselling Service, Trinity College Dublin
Dublin
D02 PN40
Ireland

Sponsor information

Organisation

SilverCloud Health

Sponsor details

1 Stephens Street Upper
Dublin 8
Dublin
D08 DR9P
Ireland
+353(0)1554 9771
derek.richards@silvercloudhealth.com

Sponsor type

Industry

Website

https://www.silvercloudhealth.com

Funders

Funder type

Industry

Funder name

SilverCloud Health

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Trial protocol publication, main results publication, conferences and webinars.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request

Intention to publish date

30/09/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

09/04/2019: The following changes were made to the trial record: 1. The total final enrolment number was added. 2. The recruitment end date was changed from 22/03/2019 to 13/03/2019. 26/02/2019: Trial’s existence confirmed by IRB.