The purpose of the overall project is to adapt an existing self management tool for adults to the needs of young people and how to implement the adapted app within the youth mental health. The overall project consists of three different phases with…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study outcome is depression. Depressive symptoms are assessed with
a Dutch translation of the Inventory of Depressive Symptoms-Self-Report
(IDS-SR; Rush et al., 1986, 1996). This survey has 30 items which measure
depressive symptoms in the last seven days.
Secondary outcome
The Boost My Mood (BMM) app is an application for smartphones with which
youngsters are able to work towards decreasing their depressive symptoms. The
BMM app has four themes: better mood, better sleep, less rumination, and less
stress. For each theme, the app provides tips, psycho-education, and exercises
(derived from interventions proven effective) and testimonials (based on
interviews with youngsters). Also, the app provides a diary for daily
self-monitoring, via which youngsters can monitor their symptoms. In the dairy,
the youngsters evaluate their experienced mood, quality of sleep, amount of
rumination and stress with a mark. The diary also provides an opportunity to
monitor (social) activities that have been undertaken. All diary input is
summarized in an overview, via which the youngsters gain insight into whether
certain themes of app content contribute to a decrease in their symptoms. The
app also sends positive and encouraging notifications and push-messages,
provided that the youngsters agreed to receive these messages. The goal of
these messages is e.g. to stimulate app use, to stimulate completing exercises
that have been started, and to provide feedback.
The primary study outcome is depression. Depressive symptoms are assessed with
a Dutch translation of the Inventory of Depressive Symptoms-Self-Report
(IDS-SR; Rush et al., 1986, 1996). This survey has 30 items which measure
depressive symptoms in the last seven days.
In addition to items tapping into depressive symptoms, the survey will contain
questions about sleep, ruminations, anxiety and stress.
Sleep will be assessed with a Dutch translation of the Glasgow Sleep Effort
Scale (GSES; Broomfield & Espie, 2005). The GSES has 7 items which measure the
extent to which youngsters worry about their sleep.
Rumination will be assessed with a Dutch translation of the Penn State Worry
Questionnaire (PSWQ; Meyer et al., 1990; van Rijsoort et al., 1997). The PSWQ
is a self-report to measure one*s inclination to ruminate. The survey has 16
items tapping into the amount, intensity and loss of control over rumating.
Experienced stress will be assessed with a Dutch translation of the Perceived
Stress Scale (PSS; Cohen et al., 1983). The PSS has 14 items which measure the
extent to which youngsters experienced stress in the last month.
Anxiety will be assessed with the state-anxiety scale of the Dutch
Zelf-Beoordelings vragenlijst (Self-evaluation questionnaire; Van der Ploeg,
2000). The state-anxiety scale has 20 items which assess the amount of
experienced anxiety during a specific moment.
Background summary
Nearly one out of five Dutch persons between 18 and 65 years old has been
depressed at least once. A depression leads to a person not or hardly being
able to function in daily life. Depressions often follow a recurring pattern:
more than half of the people with depression experiences another depression
later on. Most depressions develop during adolescence. Therefore, it is highly
important that depression in adolescents is recognized and treated early, and
that relapse is prevented. These efforts will have a positive influence on the
course of the depression and will decrease the likelihood of another episode.
Unfortunately, most adolescents with depression do not currently receive
treatment. They only turn to treatment when they have severe problems.
Youngsters have little trust in regular treatment and they prefer to deal with
their problems independently, by themselves. Also, available treatments do not
always fit the needs of the youngster, leading to them terminating the
treatment prematurely. New and easy accessible forms of treatment are therefore
warranted. Mobile-health (m-health) provides youngsters the opportunity to deal
with their problems individually. In the current era, in which information and
communication is increasingly digitally provided, integrating m-health in the
current range of treatment and prevention programs is a logical step.
In the current project, an app has been developed for youngsters (16-21 years
old) with depressive symptoms or depressive disorders. With the app, these
youngsters will work independently towards decreasing their symptoms. This
newly developed app will be implemented and evaluated in three different phases
within the chain of care: as early intervention, as intervention for youngsters
placed on waiting lists to receive treatment for depressive disorders, and as a
relapse prevention intervention.
Study objective
The purpose of the overall project is to adapt an existing self management tool
for adults to the needs of young people and how to implement the adapted app
within the youth mental health. The overall project consists of three
different phases with own sub-goals:
Phase 1: making the app suitable for young people
1.) To determine the main complaints and determinants of depression in young
people
2.) To determine the goals of the adapted app for youth
3.) To Determine the extent to which the existing app meets the needs of young
people
4.) Customize the app to the needs of young people
Phase 2: setting up implementation strategy
1.) To determine which people have a role in the implementation of the adapted
app in three different phases of the treatment trajectory (early intervention,
addition to the treatment and relapse prevention)
2.) Setting implementation goals in the three different stages of the treatment
trajectory
3.) Drafting implementation plans for the three different stages of the
treatment trajectory
4.) To develop implementation tools.
Phase 3: test implementation and pilot research
1.) To implement the adapted app in three different phases of the treatment
trajectory (early intervention, addition to the treatment and relapse
prevention)
2.) To determine the quality of implementation and to identify areas for
improvement in the implementation process for future consolidation and
upscaling.
3.) To determine the usefulness and efficacy of the app
Study design
Ad fase 3, objective 2: A process evaluation
Ad fase 3, objective 3: A naturalistic evaluation study (pre-test and two
post-test measurements, after 1 and 3 months with 60 youngsters who have used
the app as early intervention and as relapse prevention intervention), and a
stepped-wedge study (30 youngsters start using the app 1, 2 or 3 weeks after
being placed on a treatment waiting list)
Intervention
The Boost My Mood (BMM) app is an application for smartphones with which
youngsters are able to work towards decreasing their depressive symptoms. The
BMM app has four themes: better mood, better sleep, less rumination, less
stress. Each theme consists of several parts: a diary (self-monitoring) via
which youngsters can monitor their symptoms, background information about
depressive complaints and tips to address these complaints (psycho education),
several methods derived from the principles of cognitive behavioral therapy and
other evidence based interventions, stories based on the experiences of
youngsters with depressive symptoms (recognition and support), and testimonials
from real life characters to encourage the user to try out exercises (modeling)
and tips of other users of the app.
Thus, the app is used for the prevention, monitoring and relief of an illness
(in this case a depressive disorder). This means that the app is consistent
with the definition of a medical device, as described in the Dutch Wet op de
medische hulpmiddelen.
Study burden and risks
Participants are requested to use the app for at least four weeks. Beneficial
effects of the app on mood, sleep, rumination and stress are expected. The
youngsters themselves decide which parts of the app they use and intensity of
use. The part of the study in which youngsters use the app as early
intervention or as relapse prevention intervention includes one pre-test and
two post-test measurements (online surveys). Completing these surveys will take
about 35 minutes. The youngsters who use the app while being placed on a
waiting list, complete four questionnaires: one pre-test and three measurement
during the period of app-use. In addition, youngsters are asked daily to
evaluate the severity of depressive symptoms on a visual scale. In all cases,
the BMM app will be introduced to youngsters by a (mental) health professional.
Youngsters can turn to these professionals in cases of an increase in
depressive symptoms. In the case the self-monitoring tool, the diary, shows
that the youngster is not doing well, the app sends out an automatic
notification with an advice to contact the (mental) health professional.
Youngsters with an acute suicide risk will excluded.
Da Costakade 45
Utrecht 3521VS
NL
Da Costakade 45
Utrecht 3521VS
NL
Listed location countries
Age
Inclusion criteria
-16-21 years old
-Depressive symptoms (early intervention), depressive disorder (waiting list) or completed treatment of depressive disorder (relapse prevention);
- Signed Informed Consent form
- Ability and willingness to download the app on a personal mobile device
- Ability and willingness to use the app
- Ability and willingness to participate in the study
Exclusion criteria
-Severe depressive symptoms (exclusion for the early intervention group),
-Suicide risk
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL65545.041.18 |