To search for personalized early warning signals of critical transitions in depressive symptoms within single individuals with a history of depression who wish to taper their antidepressant medication.
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is a within-person critical transition towards higher
levels of depressive symptoms.
Secondary outcome
Secundary study parameters are daily affect, behavior, context, Heart Rate
Variability, and physical activity.
Background summary
There is a need for a more accurate assessment of personalized risk of
transitions towards higher levels of depressive symptoms. It has been suggested
that depression may behave like a complex dynamical system, in which sudden
transitions can occur between alternative stable states (i.e., no/mild symptoms
versus severe symptoms). Transitions in a complex dynamical system may be
anticipated by early warning signals (EWS). If transitions in depressive
symptoms indeed behave according to complex dynamical system principles, this
would mean that there is an alternative route to getting precise and
person-specific information on vulnerability, likelihood, and timing of
transitions to new episodes of depressive symptoms.
Study objective
To search for personalized early warning signals of critical transitions in
depressive symptoms within single individuals with a history of depression who
wish to taper their antidepressant medication.
Study design
The study concerns an observational study in which a repeated single-subject
intensive time-series design is adopted.
Study burden and risks
There are no risks involved in study participation. The burden associated with
participation consists of: an introductory interview before the diary
assessments (1,5 hour), filling in diary questions (2 minutes) on a smartphone
5 times a day (thus in total: 10 minutes per day) for a period of 4 months,
conducting Heart Rate Variability (HRV) measurements for 5 minutes 2 times a
day, wearing an accelerometer on their body for a period of 4 months,
completing a weekly depressive symptom scale once a week (5 minutes a week) for
a period of 6 months, and an evaluation interview at the end of the study (1,5
hour).
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
- age >= 18
- fulfil the criteria of a past depressive episode according to DSM-IV criteria
- having made a shared decision with a mental health care provider (general practitioner, psychiatrist or a mental health care provider that is supervised by a general practitioner or psychiatrist) to taper the current dose of antidepressant medication
- having made a tapering scheme or plan with a mental health care provider
Exclusion criteria
- current depressive episode according to the DSM-IV criteria
- presence of bipolar disorder or a psychotic disorder
- reported diagnosis of a personality disorder
- start of any other antidepressant treatment
- inability to work with a smartphone
- not giving informed consent on checking the tapering scheme or plan with the mental health care provider
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 | NL58469.042.16 |