The primary aim of the proposed study is to evaluate the effectiveness and cost-effectiveness of a DST for patients with anxiety and/or mood disorders in comparison to UC.The secondary aims are: 1) to identify what works for whom by identifying…
ID
Source
Brief title
Condition
- Other condition
- Anxiety disorders and symptoms
Synonym
Health condition
angst en depressie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoints are the effectiveness and cost-effectiveness of the DST.
The effectiveness of the DST will be measured by analyzing anxiety and
depression symptoms, general mental-health-related symptoms and functioning,
and quality of life. To determine the cost-effectiveness, we will look at the
costs related to the intervention, the use of healthcare resources (e.g., the
use of medication), and productivity losses.
Secondary outcome
- Acceptability of DST (CSQ-8)
- Feasibility of DST (usage data)
- Patient-centered care (therapeutic working alliance [WAI-SF], shared decision
making from patient perspective [collaboRATE survey]
- Patient empowerment [NEL]
- Client functioning (OMQ, SMQ)
Background summary
Mood and anxiety disorders affect 20% of adults and are among the top disorders
causing health loss in the Netherlands. These two disorders harm the patient*s
quality of life and lead to increasing work disability and absenteeism,
resulting in high economic costs. Although therapy with evidence-based
protocols is effective, not all clients benefit. The drop-out rate of therapy
is high and recurrence and relapse are common. Moreover, clients are looking
for modern ways of therapy, such as blended therapy - combining face-to-face
sessions with online therapy or digital tools - or treatment supplemented with
digital tool(s) such as a platform or app that allows them to take charge of
their mental health issues in their own time and environment. The
data-supported treatment (DST) through NiceDay is such a treatment concept,
combining the smart use of technology with evidence-based interventions.
NiceDay is a treatment platform for organizations and therapists offering
personalized and accessible mental healthcare treatment for various mental
health issues. The literature shows promising results regarding the
effectiveness and efficiency of the DST. Preliminary data suggests that the DST
is superior to usual care (UC) with reduced treatment time, but a rigorous
scientific evaluation of both effectiveness and cost-effectiveness is lacking.
Study objective
The primary aim of the proposed study is to evaluate the effectiveness and
cost-effectiveness of a DST for patients with anxiety and/or mood disorders in
comparison to UC.
The secondary aims are: 1) to identify what works for whom by identifying
potential moderators of treatment response to a DST for patients with anxiety
and/or mood in comparison to UC, 2) to examine the acceptability of a DST, 3)
to examine the feasibility of a DST, and 4) to examine whether the DST
facilitates patient-centered care.
Study design
A multicenter randomized controlled superiority trial with two treatment arms,
comparing the DST with UC in the Netherlands, with a 1-year follow-up. The
study will use a concurrent mixed-methods approach, combining quantitative data
from self-reported questionnaires and usage data (i.e., data on the utilization
of various DST features), with qualitative data obtained through
semi-structured interviews with patients and therapists.
Intervention
The DST is a new treatment concept for (digital) mental healthcare, made
available by Niceday Healthcare Nederland B.V. NiceDay is a treatment platform
for organizations and therapists offering personalized and accessible mental
healthcare for various mental health issues. It is co-created with therapists
and former patients and certified with ISO 27001 and NEN 7515. The platform
consists of a NiceDay web portal for therapists and the NiceDay mobile
application for patients. NiceDay includes the following features that
therapists can provide to their patients: online communication via chat or
(video) calls, an intervention toolbox, self-reported trackers, feedback
questionnaires, administrative features, and other therapeutic resources. The
DST treatment concept combines the use of the NiceDay features with
evidence-based interventions and treatment principles: Cognitive Behavioral
Therapy (CBT), Experience Sampling Assessment and Intervention (EMA/EMI), and
feedback-informed treatment. The NiceDay features will enable therapists to
apply EMA, EMI, and feedback-informed treatment principles in the patient*s
treatment.
Study burden and risks
Regarding time investment, all participating patients will be asked to complete
a set of questionnaire at baseline and 12, 24, 36, and 52 weeks after baseline
(T0-T4). Filling out the questionnaires will take approximately 40-45 minutes
per timepoint. Patients who have completed all the questionnaires (T0-T4) will
receive a gift voucher worth 15 euro. In addition, a subsample of minimal 10
patients will participate in a semi-structured interview lasting approximately
45-60 minutes. They will be reimbursed with a gift voucher of 20 euro. A
minimum of 5 therapists will participate in a semi-structured interview lasting
approximately 45-60 minutes. They will be reimbursed with a gift voucher of 20
euro. No direct risks were reported in the three previous studies on the DST or
came across while treatment centers used the NiceDay platform. Patients in both
treatment arms will be treated by experienced therapists who will monitor their
mental health during treatment and take precautions in case necessary. Hence,
the risks related to the DST through NiceDay will be comparable to UC conform
national guidelines. If the DST proves to be more effective compared to UC,
participating patients can benefit from improved health outcomes.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
• >= 18 years of age
• Main diagnosis of anxiety disorder (social anxiety disorder (300.23), panic
disorder (300.01), agoraphobia (300.22), generalized anxiety disorder (300.02),
other specified anxiety disorder (300.9), obsessive-compulsive
disorder/hoarding disorder (300.3), and illness anxiety disorder (300.7)),
and/or depressive disorder (major depressive disorder with single or recurrent
episodes (296.20 - 296-36) and other specified depressive mood disorders (311))
• Being able to understand, read, and speak Dutch or English
• Having access to the internet and a smartphone
Exclusion criteria
• Known severe psychiatric comorbidity (e.g., psychosis, (severe) addiction
that interferes with daily functioning, diagnosis of Bipolar Disorder I or II,
eating disorder, Personality Disorders, traumatic brain injury, Intellectual
Disability and/or General Medical Conditions with a life expectancy of less
than one year)
• Severe or very severe level of Suicidality (preparing for suicide, recent
suicide attempt)
• Having received psychological treatment in the prior 6 months for the same
anxiety or mood disorder (except for short-term treatment provided by POH-GGZ
or student psychologist)
• Therapist judges that the patient is not suitable for receiving DST
• Not being able to complete the entire treatment at once (e.g., due to
pregnancy).
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
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In other registers
| Register | ID |
|---|---|
| CCMO | NL87390.058.24 |