Plain English Summary
Background and study aims
Adjustment disorder (AD) is a type of stress-related condition, in which a person has difficulty coping with, or adjusting to, a particular source of stress. The first year of university can be seen as a stressful situation, due to the increased work load and major life change it represents. It often shares some symptoms with clinical depression, such as feelings of hopelessness, loss of interest in work and activities, and anxiety. People with low resilience (the ability to recover quickly from difficulties) are more likely to develop AD. This study will look at a self-help internet-based program which aims to promote resilience called CORE. The aim of this study is to investigate the effectiveness and cost-effectiveness of the CORE program at improving resilience and wellbeing and reducing levels of depression and anxiety.
Who can participate?
First year university students aged 18 years and over with low resilience levels.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group take part in the CORE program for six weeks. The program includes a range of multimedia, including videos, audios, vignettes and images, as well as educational material designed to enhance resilience and coping skills, to promote self-empowerment and increase wellbeing. Those in the second group do not receive any additional treatment throughout the study period. After the study is over, they are given access to the CORE program. Participants in both groups complete a number of questionnaires at the start of the study and then after 4 weeks, 8 weeks, 6 months and 12 months, to test their resilience levels and mental wellbeing.
What are the possible benefits and risks of participating?
Participants who receive the CORE program may benefit from improved resilience and mental wellbeing. There are no notable risks of participating in this study.
Where is the study run from?
1. Universitat Jaume I (Spain)
2. Universitat de Valencia (Spain)
3. Universitaet Bern (Switzerland)
4. Universität Zürich (Switzerland)
5. Friedrich-Alexander-Imiversitaet Erlangen Nuernberg (Germany)
When is the study starting and how long is it expected to run for?
September 2015 to July 2019
Who is funding the study?
European Commission (Belgium)
Who is the main contact?
1. Professor Cristina Botella (scientific)
2. Professor Rosa Maria Baños Rivera (scientific)
Trial website
Contact information
Type
Scientific
Primary contact
Prof Cristina Botella
ORCID ID
http://orcid.org/0000-0001-8783-6959
Contact details
Avenida Vicent Sos Baynat S/N
Castellon de la Plana
12006
Spain
Type
Scientific
Additional contact
Prof Rosa Maria Baños Rivera
ORCID ID
http://orcid.org/0000-0003-0626-7665
Contact details
Avenida Blasco Ibañez 21
Valencia
46010
Spain
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ICARE-R2016
Study information
Scientific title
ICare-R: Integrating Technology into Mental Health Care Delivery in Europe - Resilience Trial
Acronym
ICare-R
Study hypothesis
The aim of this trial is to develop and test the effectiveness and cost-effectiveness of unguided Internet intervention program for promoting resilience and coping skills in people at risk of developing adjustment disorders (AD), such as students low in resilience confronting a crucial life-event like the first year of university. Specifically aims of the study are:
1. To provide a preventative online intervention for enhancing resilience (ICare-R), for decreasing symptoms of depression and anxiety and for increasing wellbeing
2. To evaluate the effectiveness and acceptability of ICare-R in a randomized controlled trial compared with care as usual (CAU)
3. To analyze feasible strategies to implement ICare-R and to identify possible implementation barriers from final users, professionals of University counseling services and the University authorities
Ethics approval
Ethics approval Universitat Juame I: Comisión Deontológica de la Universitat Jaume I (Ethical Committee of the Jaume I University), 02/06/2016
Study design
Multi-country randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Internet
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Adjustment disorders (AD)
Intervention
Participants will be randomized in a 1:1 ratio. Randomization will be stratified according to trial site.
ICare-R condition: Participants allocated to this condition will use a self-help programme named CORE. CORE is a 6-week Internet-based prevention program, which main objective is to teach skills and adaptive strategies to cope with daily life issues in order to enhance resilience and coping skills, to promote self-empowerment and increase wellbeing. CORE provides techniques based on cognitive behaviour therapy and positive psychology strategies (behavioural activation, cognitive restructuring, problem solving, mindfulness, self-compassion, among others). The program includes several multimedia elements: videos, audios, vignettes, images. Besides, each module includes exercises for practicing the different skills. CORE addresses several important dimensions related with wellbeing: self-acceptance, the establishment of quality ties to other, a sense of autonomy in thought and action, the ability to manage complex environments to suit personal needs and values, the pursuit of meaningful goals and a sense of purpose in life, continued growth and development as a person.
“Care as usual” condition: “ICare-R”-prevention model will be compared to care-as-usual (CAU). Since participants are part of the general population, it is not expected that they have serious mental disorders, but they will be monitored to detect if they engage in treatment (psychotherapy or medication treatment). Upon completion of the intervention period, the participants in the CAU condition will be debriefed about the study, and provided access to the “ICare-R” program intervention program.
Online- and telephone assessments will be conducted at pre- and post-intervention, and at 6- and 12-month follow-up.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measures
Resilience capacity is measured using the Connor-Davidson Resilience Scale (CD-RISC 25) at baseline, 8 weeks, 6 months and 12 months
Secondary outcome measures
1. Resilience capacity is measured using the Resilience Scale (RS-14) at baseline, 8 weeks, 6 months and 12 months
2. Depressive symptoms Patient Health Questionnaire (PHQ-9) at baseline, 4 weeks, 8 weeks, 6 months and 12 months
3. Personality traits are measured using the 10-Item Big Five Inventory (BFI-10) at baseline, 8 weeks, 6 months and 12 months
4. Anxiety symptoms are measured using the Generalized Anxiety Disorder Questionnaire (GAD-7) at baseline, 4 weeks, 8 weeks, 6 months and 12 months
5. Self-esteem is measured using the Rosenberg's Self-Esteem Scale (RSE) at baseline, 4 and 8 weeks
6. Alcohol use is measured using the Alcohol Use Disorders Identification Test (AUDIT-C) at baseline, 4 and 8 weeks
7. Positive and negative emotions frequency is measured using the Positive and Negative Affect Scale (PANAS) at baseline, 4 weeks, 8 weeks, 6 months and 12 months
8. Wellbeing is measured using the Psychological Wellbeing Ryff (PW-29) at baseline, 8 weeks, 6 months and 12 months
9. Self-compassion is measured using the Self-compassion Scale - Short Form (SCS-SF) at baseline, 8 weeks, 6 months and 12 months
10. Health service utilization is measured using the Client Service Receipt Inventory (CSRI) at baseline, 8 weeks, 6 months and 12 months
11. Stress is measured using the Perceived Stress Scale (PSS) at baseline, 8 weeks, 6 months and 12 months
12. Pleasant orientation is measured using the Enjoyment Orientation Scale (EOS) at baseline, 8 weeks, 6 months and 12 months
13. Expectations of the intervention are measured using the Credibility and Expectancy Questionnaire (CEQ) at baseline, 8 weeks, 6 months and 12 months
14. Alliance with technological intervention is measured using the Working Alliance Inventory (WAI-TECH) at baseline, 8 weeks, 6 months and 12 months
15. . Satisfaction with the intervention is measured using the Client Satisfaction Questionnaire (CSQ) at 8 weeks
Overall trial start date
01/09/2015
Overall trial end date
31/07/2019
Reason abandoned
Eligibility
Participant inclusion criteria
1. Freshmen university students
2. Scoring one standard deviation below the mean of the sample on the Connor-Davidson Resilience Scale (CD-RISC-25)
Participant type
Other
Age group
Other
Gender
Both
Target number of participants
N= 464: I-CARE group= 232; Control group: 232
Participant exclusion criteria
1. Individuals with a history of a Common Mental Disorder in the past 12 months
2. Individuals who are on a waiting list for psychotherapy or are currently or have been in psychotherapeutic treatment within the past 12 months for any kind of mental health problems
3. Individuals with a current or history of a psychotic or bipolar disorder
4. Individuals at risk for suicide
Recruitment start date
30/09/2016
Recruitment end date
31/07/2018
Locations
Countries of recruitment
Germany, Spain, Switzerland
Trial participating centre
Universitat Jaume I
Castellon de la Plana
12071
Spain
Trial participating centre
Universitat de Valencia
Valencia
46010
Spain
Trial participating centre
Universitaet Bern (UBERN)
Bern
3012
Switzerland
Trial participating centre
Universität Zürich (UZH)
Zürich
8031
Switzerland
Trial participating centre
Friedrich-Alexander-Imiversitaet Erlangen Nuernberg (FAU)
Erlangen
91054
Germany
Sponsor information
Organisation
Universitat Jaume I
Sponsor details
Avenida Vicent Sos Baynat S/N
Castellon de la Plana
12006
Spain
Sponsor type
University/education
Website
Organisation
Universitat de Valencia
Sponsor details
Avenida Blasco Ibañez 21
Valencia
46010
Spain
Sponsor type
University/education
Website
Organisation
Clinical Psychology and Psychotherapy, Universitaet Bern
Sponsor details
Fabrikstrasse 8
Bern
3012
Switzerland
Sponsor type
University/education
Website
Organisation
Swiss Research Institute for Public Health and Addictions (ISGF) - Universität Zürich
Sponsor details
Konradstrasse 32
Zurich
8031
Switzerland
Sponsor type
University/education
Website
Organisation
Clinical Psychology and Psychotherapy Friedrich-Alexander University of Erlangen-Nuremberg
Sponsor details
Nägelsbachstraße 25a
Erlangen
90152
Germany
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
European Commission
Alternative name(s)
EC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Results and Publications
Publication and dissemination plan
1. Planned publication in a high-impact peer reviewed journal around one year after the overall trial end date
2. Planned periodic dissemination in International and National congress: Botella, C., Baños, R., Herrero Camarano, R., Garcia Palacios, A., Quero, S., Etchemendy, E., Mira, A., & Corno, G. “ICARE-R: Una intervención online para promover la resiliencia en estudiantes universitarios”. Poster presentation at III Congreso de Psicología Positiva in collaboration with the Sociedad Española de Psicologia Positiva, 20-23 April 2016, Baeza, Spain.
Intention to publish date
30/09/2019
Participant level data
Available on request
Results - basic reporting
Publication summary