Assessment of the effectiveness and acceptability of an online intervention for adapting well in the face of adversity, trauma, tragedy, threats or significant sources of stress
| ISRCTN | ISRCTN11866034 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11866034 |
| Secondary identifying numbers | AEIR2019 |
- Submission date
- 03/02/2019
- Registration date
- 20/03/2019
- Last edited
- 01/07/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
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
Contact information
Scientific
E-mental Health Research Group
School of Psychology
Trinity College Dublin
Dublin
D08 DR9P
Ireland
 ORCID ID |
0000-0003-0871-4078 |
|---|---|
| Phone | +353(0)879343678 |
| drichard@tcd.ie |
Public
E-mental Health Research Group
School of Psychology
Trinity College Dublin
Dublin
D02 PN40
Ireland
| ORCID ID |
0000-0003-0585-4008 |
|---|---|
| Phone | +353(0)879343678 |
| enriquea@tcd.ie |
Study information
| 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 |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Assessing the efficacy and acceptability of an Internet-delivered intervention for resilience: a pilot study for a randomised control trial |
| Study 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(s) | 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 |
| 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 |
| 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 study start date | 05/10/2018 |
| Overall study end date | 05/05/2019 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 75 |
| Total final enrolment | 82 |
| Participant inclusion criteria | 1. Over 18 years of age 2. Registered student at the University of Dublin, Trinity College Dublin |
| 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
Study participating centre
Dublin
D02 PN40
Ireland
Sponsor information
Industry
1 Stephens Street Upper
Dublin 8
Dublin
D08 DR9P
Ireland
| Phone | +353(0)1554 9771 |
|---|---|
| derek.richards@silvercloudhealth.com | |
| Website | https://www.silvercloudhealth.com |
"ROR" |
https://ror.org/05319p535 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/07/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Trial protocol publication, main results publication, conferences and webinars. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 11/11/2020 | 14/01/2021 | Yes | No |
| Protocol article | 01/09/2019 | 01/07/2022 | Yes | No |
Editorial Notes
01/07/2022: Publication reference added.
14/01/2021: Publication reference added.
15/05/2020: The intention to publish date was changed from 30/09/2019 to 31/07/2020.
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.
