No registrations found.
ID
Source
Brief title
Health condition
Major Depressive Disorder
Sponsors and support
Intervention
Outcome measures
Primary outcome
The most important outcome measure of this study is “Speed of remission ”, which is a measure of the speed with which symptom reduction takes place as a result of the therapy. Since the costs of the applied interventions are known at the level of minutes, it is possible to calculate the costs of remote digital therapy.
Secondary outcome
Apart from psychometrics, we measure Quality Of Life and (to a limited extent) physical health parameters.
Background summary
Behavioral activation is an evidence-based effective treatment for unipolar depression. The patient is motivated to reach daily goals such as eat, sleep and social rhythms, adequate amounts of physical exercise, outdoor activities and emotional awareness. The effect of behavioral activation is comparable to that of Cognitive Behavioral Therapy (CBT).
Until now, patients were motivated to reach their activation goals by psychologists and psychiatrists within an office building, or even behind a desk. However, in our current digital era, we can use a smartphone application (app) that allows for the automation and intensification of behavioral activation. By using mobile communication technology, it is possible to relay the effects of behavioral activation directly to the patient, at the precise time and location that is most relevant to the problem at hand (this is called ‘direct feedback’). Direct feedback shortens the delay between the expression of certain (healthy) behavior and the (positive) reinforcement of that behavior. This reduces stimulus contingency and clarifies the relationships between certain types of behavior and the consequences of that behavior.
Because of this, we expect 'digital therapy' to show a greater efficiency and efficacy than behavioral activation as usual.
Objectives of the study:
- To investigate the clinical course of depressive symptoms during digital outpatient therapy and follow up, both within-patient and between patients.
- To provide a health economic evaluation for digital outpatient treatment in routine mental healthcare.
- To explore the association of patient characteristics and specific therapeutic components with clinical progression or outcome.
- To explore the patient-therapist interaction during digital outpatient treatment.
This study will be conducted at various settings within PsyQ and does not involve a multicenter trial.
Study objective
We hypothesise that digital remote treatment for patients with major depressive disorder is effective in reducing symptoms.
Study design
1-3-2021: start of inclusion
Intervention
NA
Inclusion criteria
Participants are eligible if they are/have:
- 18 years or older
- unipolar moderate to severe depressive disorder (criteria DSM-5);
- possessing a smartphone.
Exclusion criteria
Patients cannot participate if they:
- do not speak Dutch;
- have incompetent skills to manage smartphone (applications);
- have severe psychiatric comorbidities, i.e. psychosis, personality disorders, intoxications / addictions (axis II);
- have severe physical comorbidities (axis III);
- have severe psychosocial and environmental problems (axis IV)
- use drugs or medication which interferes with the use of the smartphone application (i.e. cannabis, strong sedatives / pain killers, alcohol abuse)
Design
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL7494 |
| CCMO | NL522562.058.15 |