A randomized controlled trial of a self-guided mobile app targeting repetitive negative thought to prevent depression in university students: study protocol of the Nurture-U Reducing Worry prevention trial.
Adolescent
Adult
Female
Humans
Male
Young Adult
Anxiety
/ prevention & control
Cognitive Behavioral Therapy
/ methods
Depression
/ prevention & control
Depressive Disorder, Major
/ prevention & control
Mobile Applications
Randomized Controlled Trials as Topic
Rumination, Cognitive
Single-Blind Method
Students
/ psychology
Universities
Depression
Mobile-health prevention
Randomised controlled trial
Rumination
University students
Well-being
Worry
Journal
BMC psychiatry
ISSN: 1471-244X
Titre abrégé: BMC Psychiatry
Pays: England
ID NLM: 100968559
Informations de publication
Date de publication:
02 Oct 2024
02 Oct 2024
Historique:
received:
27
05
2024
accepted:
12
09
2024
medline:
3
10
2024
pubmed:
3
10
2024
entrez:
2
10
2024
Statut:
epublish
Résumé
Tackling poor mental health in university students has been identified as a priority in higher education. However, there are few evidence-based prevention initiatives designed for students. Repetitive Negative Thought (RNT, e.g. worry, rumination) is elevated in university students and is a well-established vulnerability factor for anxiety and depression. Furthermore, there are now evidence-based cognitive-behavioural interventions to tackle RNT. A mobile self-help cognitive-behavioural app targeting RNT, adapted for students may therefore be an effective, scalable, and acceptable way to improve prevention in students. An online single blind, two-arm parallel-group Randomised Controlled Trial (RCT) to examine the incidence of major depression and symptoms of anxiety and depression across 12 months in university students aged over 16 who screen into the study with self-reported high levels of worry and/or rumination and no current diagnosis of major depression. Eligible participants will be randomised to the active intervention arm (usual practice plus using a self-guided mobile app targeting RNT) or to the control arm (usual practice). In total, 648 participants aged over 16, with no current major depression, bipolar disorder or psychosis will be recruited from UK universities. Assessments will take place at baseline (pre-randomisation), 3 months and 12 months post- randomisation. Primary endpoint and outcome is incidence of major depression as determined by self-reported diagnostic criteria at 12-month follow-up. Depressive symptoms, anxiety, well-being, health-related quality of life, functioning and academic outcomes are secondary outcomes. Compliance, adverse events, and potentially mediating variables will be carefully monitored. The trial aims to provide a better understanding of the causal role of tackling RNT (worry, rumination) using a self-help mobile app with respect to preventing depression in university students. This knowledge will be used to develop and disseminate innovative evidence-based, feasible, and effective mobile-health public health strategies for preventing common mental health problems. https://www.isrctn.com/ISRCTN86795807 Date of registration: 27 October 2022.
Sections du résumé
BACKGROUND
BACKGROUND
Tackling poor mental health in university students has been identified as a priority in higher education. However, there are few evidence-based prevention initiatives designed for students. Repetitive Negative Thought (RNT, e.g. worry, rumination) is elevated in university students and is a well-established vulnerability factor for anxiety and depression. Furthermore, there are now evidence-based cognitive-behavioural interventions to tackle RNT. A mobile self-help cognitive-behavioural app targeting RNT, adapted for students may therefore be an effective, scalable, and acceptable way to improve prevention in students.
METHODS
METHODS
An online single blind, two-arm parallel-group Randomised Controlled Trial (RCT) to examine the incidence of major depression and symptoms of anxiety and depression across 12 months in university students aged over 16 who screen into the study with self-reported high levels of worry and/or rumination and no current diagnosis of major depression. Eligible participants will be randomised to the active intervention arm (usual practice plus using a self-guided mobile app targeting RNT) or to the control arm (usual practice). In total, 648 participants aged over 16, with no current major depression, bipolar disorder or psychosis will be recruited from UK universities. Assessments will take place at baseline (pre-randomisation), 3 months and 12 months post- randomisation. Primary endpoint and outcome is incidence of major depression as determined by self-reported diagnostic criteria at 12-month follow-up. Depressive symptoms, anxiety, well-being, health-related quality of life, functioning and academic outcomes are secondary outcomes. Compliance, adverse events, and potentially mediating variables will be carefully monitored.
DISCUSSION
CONCLUSIONS
The trial aims to provide a better understanding of the causal role of tackling RNT (worry, rumination) using a self-help mobile app with respect to preventing depression in university students. This knowledge will be used to develop and disseminate innovative evidence-based, feasible, and effective mobile-health public health strategies for preventing common mental health problems.
TRIAL REGISTRATION
BACKGROUND
https://www.isrctn.com/ISRCTN86795807 Date of registration: 27 October 2022.
Identifiants
pubmed: 39358704
doi: 10.1186/s12888-024-06079-2
pii: 10.1186/s12888-024-06079-2
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
649Subventions
Organisme : Medical Research Council
ID : MR/W002442/1
Pays : United Kingdom
Organisme : Medical Research Council
ID : MR/W002442/1
Pays : United Kingdom
Organisme : Medical Research Council
ID : MR/W002442/1
Pays : United Kingdom
Organisme : Medical Research Council
ID : MR/W002442/1
Pays : United Kingdom
Organisme : Medical Research Council
ID : MR/W002442/1
Pays : United Kingdom
Organisme : Medical Research Council
ID : MR/W002442/1
Pays : United Kingdom
Organisme : Medical Research Council
ID : MR/W002442/1
Pays : United Kingdom
Informations de copyright
© 2024. The Author(s).
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