Methods |
Study design: RCT
Study grouping: parallel
Unit of randomisation: individuals
Power (power & sample size calculation, level of power achieved): not specified in trial registration
Imputation of missing data: not specified |
Participants |
Country: Spain, Argentina and Mexico
Setting: web‐based intervention
Age: not specified
Sample size (randomised): 324 (estimated enrolment)
Sex: not specified
Comorbidity (mean (SD) of respective measures in indicated, if available) at baseline: not specified
Population description: Spanish‐speaking university students
Inclusion criteria: 1) age: 18 ‐ 60 years; 2) university students with a SD score below the sample mean on the CD‐RISC‐25; 3) adequate knowledge to understand and read Spanish and/or be Spanish‐speaking; 4) internet access and computer skills Exclusion criteria: 1) university students who are on a waiting list for psychotherapy or who are or have been undergoing psychotherapy in the last 12 months; 2) individuals with a current or past psychotic or bipolar disorder; 3) individuals at risk of suicide
Attrition (withdrawals and exclusions): not specified
Reasons for missing data: not specified |
Interventions |
Intervention: Unguided web‐based resilience intervention (CORE; n = 108 planned)
delivery: internet‐based; includes multimedia elements (videos, audios, vignettes, images)
providers: not specified
duration of treatment period and timing: 6 weekly modules
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description:
main objective is to teach coping skills and strategies to cope with stressful everyday situations in order to improve resilience, promote self‐efficacy and increase well‐being
6 interactive modules designed for weekly sessions
organised in 6 dimensions: autonomy, self‐acceptance, environmental mastery, purpose in life, positive relationships, and personal growth
Each module includes exercises to practice the proposed skills
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6 weekly modules:
Welcome: introduction module to the programme, with an explanation about the tools and the way to use CORE
psycho‐education: explanation of psychological well‐being and the concept of resilience
autonomy, building my way: enhancement of autonomy
mindfulness and self‐compassion: training in mindfulness, savouring, and an attitude of self‐compassion
overcoming obstacles: development of coping strategies to deal with daily difficulties in life
connecting to others: acknowledge the relevance of relationships and how they can be helpful in the construction of well‐being
purpose in life and personal growth: approach the future with a positive attitude, planning goals for the future.
compliance: not specified
integrity of delivery: not specified
economic information: not specified
theoretical basis: Cognitive Behavioral Therapy
Control 1: active control; Healthy lifestyle psycho‐educational programme; HLP; n = 108 planned)
delivery: not specified
providers: not specified
duration of treatment period and timing: not specified
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description:
provides information to promote a healthy lifestyle, on issues related to physical and mental health and physical activity, as well as diet and sleep management
beginning of a lifestyle change: The participant will learn to identify healthy and risky behaviours and recognise obstacles that prevent them from adopting a healthy lifestyle
physical activity: The importance of "moving on" and activating behaviour will be taught through regular exercise information to improve mood
diet: This module is dedicated to teaching the importance of diet for good physical and mental health. The Mediterranean diet will be taken as an example of a balanced diet, because it does not differ from the habits of other countries
sleep: The importance of good sleep will be addressed with information and strategies for understanding the relationship between sleep and overall health
compliance: not specified
integrity of delivery: not specified
economic information: not specified
theoretical basis: components of psycho‐education based on the intervention protocol for depression (Castro 2015); based on low‐intensity psychological intervention models for mild or moderate depressive symptoms in primary care (García‐Herrera 2011; NICE 2009; Nieuwsma 2012)
Control 2: wait‐list control (n = 108 planned)
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Outcomes |
Outcomes collected and reported: Primary outcome:
Secondary outcomes:
well‐being ‐ Ryff Scales of PWB ‐ 29 items
depression ‐ PHQ
responses to positive affect states ‐ Responses to Positive Affect questionnaire
positive affect ‐ PANAS
negative affect ‐ PANAS
anxiety ‐ GADQ
perceived stress ‐ PSS‐4
self‐compassion ‐ SCS ‐ Short Form
personality ‐ 10‐Item Big Five Inventory
patient expectations and credibility about treatment ‐ CEQ
client satisfaction with health services ‐ Client Satisfaction Questionnaire
therapeutic alliance between the technological tool and the patient ‐ Working Alliance Inventory for Technology Based Interventions
frequency and severity of anxiety symptoms ‐ Overall Anxiety Severity and Impairment Scale
depression severity and impairment ‐ Overall Depression Severity and Impairment Scale
expectations and positive affectivity towards the future ‐ Openness to the future Scale
Other outcomes:
Outcomes reported not specified
Time points measured: 1) pre‐intervention; 2) post‐intervention; 3) 6‐month follow‐up; 4) 12‐month follow‐up; time points reported not specified
Adverse events: not specified |
Notes |
Contact with authors: We contacted the authors to ask if the trial also included healthcare students, but only received the response from the authors that they were starting the analysis for the project (Herrero 2019 [pers comm]). Study start/end date: November 2018 ‐ November 2020 (estimated study completion data)
Funding source: Universitat Jaume I
Declaration of interest: not specified Ethical approval needed/obtained for study: not specified
Comments by study authors: not relevant Miscellaneous outcomes by the review authors: unclear if healthcare students were also included in the trial; trial status according to trial registration: enrolling by invitation; last updated in April 2019
Correspondence: study director: Cristina Botella, PhD; University Jaume I, Castellon, Spain |