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Increasing impact through technology: A randomized controlled trial to determine the effectiveness and cost-effectiveness of an innovative, data-supported, personalized treatment for anxiety and mood disorders.

Increasing impact through technology: A randomized controlled trial to determine the effectiveness and cost-effectiveness of an innovative, data-supported, personalized treatment for anxiety and mood disorders. - Innovative data-supported personalized treatment

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON57147
Enrollment
13
Registered
2024-07-09
Start date
2025-05-06
Completion date
Unknown
Last updated
2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety and depression Anxiety and depression

Interventions

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 person
feedback-informed treatment. The NiceDay features will enable therapists to apply EMA, EMI, and feedback-informed treatment principles in the patients' treatment.

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients: • >= 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 smartphoneTherapists: Therapists can participate in the surveys if they are treating participating patients as part of this study. Moreover, therapist can be included in the optional qualitative interview when they are willing to participate in both interviews (i.e., one in the beginning of the study and one 9 months thereafter).

Exclusion criteria

Exclusion criteria: Patients:• 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).Therapists: There are no specific exclusion criteria for therapists. 

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
- 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)

Countries

Netherlands

Contacts

Public ContactJ.J. Aardoom

Leids Universitair Medisch Centrum

j.j.aardoom@lumc.nl+31 70 52668444

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jun 21, 2026