Primary objective: To map the effectiveness and working mechanisms of e-health modules on worrying and self-esteem in reducing subclinical anxiety symptoms among students
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Anxiety: State Trait Anxiety Inventory (STAI - trait)
• Worry: Penn State Worry Questionnaire (PSWQ)
Secondary outcome
• Self-esteem: Rosenberg Self-Esteem Scale (RSES)
• Metacognitions: Metacognitions Questionnaire (MCQ)
• Psychological well-being: Mental Health Continuum - Short Form (MHC-SF)
• Positive emotions: Modified Differential Emotions Scale (mDES)
• Depressive symptoms: Beck Depression Inventory (BDI)
• Exposure tendency: Self-reported Engagement in Exposure exercises
Questionnaire (SEEQ)
• Avoidance: Fear Questionnaire (FQ)
Background summary
The current research focuses on the effectiveness of e-health interventions to
reduce anxiety among students and increase their well-being. Student life is a
turbulent time, in which young adults are expected to become increasingly
independent, while the challenges increase. Students therefore regularly suffer
from fears, whereby complaints such as worrying and doubts about their own
ability occur regularly. E-health interventions can offer a good opportunity to
combat such complaints. It is known from the literature on generalized anxiety
disorder that fears can be 'treated' through interventions aimed at worrying
and self-image. Both ways seem to be effective. However, most e-health
interventions for healthy subjects are somewhat general, in order to be able to
treat the largest possible target group. This may miss an opportunity to
respond to specific mechanisms that play a role in anxiety symptoms (i.e.,
meta-cognitions and self-esteem).
In addition, even less is known about the effective mechanisms of e-health
interventions, and - more generally - of psychotherapy. Most e-health studies
focus on treatment effectiveness and have too few measurement moments to
determine to what extent different e-health interventions work in different
ways. More knowledge about the effective mechanisms of e-health interventions
can help us to understand how e-health interventions work, so that they can be
improved in the future and more targeted recommendations can be made for
individuals ('personalized medicine').
Study objective
Primary objective: To map the effectiveness and working mechanisms of e-health
modules on worrying and self-esteem in reducing subclinical anxiety symptoms
among students
Study design
Randomized controlled trial (RCT). Tilburg University students with increased
anxiety symptoms are randomly assigned to one of three conditions: a
self-esteem e-health module, a worrying e-health module or a control waiting
list, in which no intervention is offered.
Intervention
Participants who are assigned to an intervention follow either an online worry
module (https://mirro.nl/module/piekeren/) or an online self-image module
(https://mirro.nl/module/zelfbeeld/). Both modules take 4 weeks to complete.
Study burden and risks
The modules may have beneficial effects for participants, because participants
can complete an e-health module free of charge that is intended to reduce
complaints and improve well-being, but this is not certain. The modules are
already offered online and are freely accessible to everyone. The modules have
been developed by New Health Collective/Mirro in collaboration with
psychologists. For this reason, we expect that the modules will not have any
adverse effects on the participants. The only possible burden we foresee is
that the modules could be confronting for some participants. However,
participation is voluntary and participants may withdraw from the study at any
time.
Warandelaan 2
Tilburg 5037 AB
NL
Warandelaan 2
Tilburg 5037 AB
NL
Listed location countries
Age
Inclusion criteria
- Adults (18 years or older)
- Students of Tilburg University
- GAD-7 score of 5 or higher (generalized anxiety disorder diagnosis is
permitted)
Exclusion criteria
- Presence of severe psychopathology (other than generalized anxiety disorder)
or addiction
- Simultaneous psychological care or (e-)treatment
- A medical condition that affects psychological well-being
- High suicide risk (acute planning or severe suicidal ideation)
- Acute grief
- Medication use is allowed, but must have been stable in the past 3 months and
must (probably) remain stable in the next 3 months
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL79374.028.21 |