Promoting resilience and coping skills in people at risk of developing adjustment disorders
| ISRCTN | ISRCTN13856522 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13856522 |
| Secondary identifying numbers | ICARE-R2016 |
- Submission date
- 27/07/2016
- Registration date
- 28/07/2016
- Last edited
- 30/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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)
Contact information
Scientific
Avenida Vicent Sos Baynat S/N
Castellon de la Plana
12006
Spain
 ORCID ID |
0000-0001-8783-6959 |
|---|
Scientific
Avenida Blasco Ibañez 21
Valencia
46010
Spain
| ORCID ID |
0000-0003-0626-7665 |
|---|
Study information
| Study design | Multi-country randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | ICare-R: Integrating Technology into Mental Health Care Delivery in Europe - Resilience Trial |
| Study acronym | ICare-R |
| Study objectives | 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(s) | Ethics approval Universitat Juame I: Comisión Deontológica de la Universitat Jaume I (Ethical Committee of the Jaume I University), 02/06/2016 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/09/2015 |
| Completion date | 31/07/2019 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | N= 464: I-CARE group= 232; Control group: 232 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 30/09/2016 |
| Date of final enrolment | 31/07/2018 |
Locations
Countries of recruitment
- Germany
- Spain
- Switzerland
Study participating centres
12071
Spain
46010
Spain
3012
Switzerland
8031
Switzerland
91054
Germany
Sponsor information
University/education
Avenida Vicent Sos Baynat S/N
Castellon de la Plana
12006
Spain
| Website | http://www.uji.es |
|---|---|
"ROR" |
https://ror.org/02ws1xc11 |
University/education
Avenida Blasco Ibañez 21
Valencia
46010
Spain
| Website | http://www.uv.es |
|---|
University/education
Fabrikstrasse 8
Bern
3012
Switzerland
University/education
Konradstrasse 32
Zurich
8031
Switzerland
University/education
Nägelsbachstraße 25a
Erlangen
90152
Germany
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- European Union, Comisión Europea, Europäische Kommission, EU-Kommissionen, Euroopa Komisjoni, Ευρωπαϊκής Επιτροπής, Европейската комисия, Evropské komise, Commission européenne, Choimisiúin Eorpaigh, Europskoj komisiji, Commissione europea, La Commissione europea, Eiropas Komisiju, Europos Komisijos, Európai Bizottságról, Europese Commissie, Komisja Europejska, Comissão Europeia, Comisia Europeană, Európskej komisii, Evropski komisiji, Euroopan komission, Europeiska kommissionen, EC, EU
Results and Publications
| Intention to publish date | 30/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 22/03/2018 | 11/05/2021 | Yes | No |
Editorial Notes
30/08/2024: The intention to publish date was changed from 30/05/2020 to 30/12/2024.
11/05/2021: Publication reference added.
06/03/2020: The intention to publish date was changed from 30/09/2019 to 30/05/2020.
05/03/2018: The following changes were made:
1. Recruitment end date was changed from 31/01/2018 to 31/01/2018.
2. Overall trial end date was changed from 31/01/2018 to 31/07/2019.
3. Intention to publish date was changed from 31/01/2019 to 30/09/2019.
25/09/2017: Internal review.
