The main aim of the ZELF-i project is to investigate the effectiveness of self-monitoring and personalized feedback as an add-on tool in the treatment of depression. By starting directly after intake, patients can make the most out of the usual…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure to determine effectiveness of the intervention will
be change in depression symptom severity as measured by the self-report
Inventory of Depressive Symptomatology (IDS-SR, Rush et al., 1999) across 6
time points: pre-ESM, after 4 weeks of ESM and at 4 follow-ups at 4, 8, 12, and
24 weeks (post-ESM).
Secondary outcome
From a patient perspective, functional outcomes are at least as relevant as
clinical outcomes. Therefore, we will also assess change in psychosocial
functioning by means of the Outcome Questionnaire (OQ-45, Lambert et al.,
1996). Moreover, we will assess the extent to which individuals regain
self-esteem and take control over their own lives by means of the Dutch
Empowerment questionnaire (NEL; Boevink, Kroon, & Giesen, 2010). This
questionnaire has been developed by the Trimbos institute in collaboration with
individuals with psychiatric problems.
Other outcome measures:
Questionnaires regarding cost-effectiveness: PRODISQ, TiC-P, en Euroqol-5D
Baseline characteristics: demographics, LEIDS-R (Cognitive Reactivity), TAS-20
(Alexithymia)
Background summary
The leading cause of disability worldwide is depression, a common mental
disorder that is characterized by two core symptoms: depressed mood and/or
decreased interest or pleasure in activities. A pioneer Randomized Controlled
Trial (RCT) has shown that systematic self-monitoring and personalized feedback
on contextualized patterns of positive affect through the Experience Sampling
Method (ESM) could provide an empowering and effective add-on tool to treatment
as usual (TAU). While promising, the intervention was highly labor intensive,
including manual statistical analyses and an extensive face-to-face component.
In addition, the intervention targeted only one of depression*s core symptoms.
This project takes the next logical step: (re)examine the effectiveness of
ESM-derived personalized feedback in a format that is optimized for clinical
practice for two ESM variants, each targeted at one of depression*s core
symptoms. We expect that the use of ESM as a self-management tool will benefit
depressed patients not only by reducing depressive symptomatology, but also by
increasing psychosocial functioning and enhancing patients* feelings of
empowerment.
Study objective
The main aim of the ZELF-i project is to investigate the effectiveness of
self-monitoring and personalized feedback as an add-on tool in the treatment of
depression. By starting directly after intake, patients can make the most out
of the usual waiting list period, and commence subsequent treatment programs
with a kick-start.
Study design
RCT with three treatment arms: wait-list (WL), ESM *Do*-module, ESM *Think*-
module. Randomization (allocation ratio 1:1:1) will be stratified according to
the duration of antidepressant pharmacotherapy (new/switch vs. maintenance,
i.e. receiving antidepressant or mood stabilizing medication for less vs.
longer than 8 weeks prior to study entry), and current psychotherapy (yes or
no).
Intervention
28 days of systematic self-monitoring (5 times per day) with weekly
personalized feedback. The Do-module focuses on positive affect and activities,
the Think-module focuses on negative affect and thinking patterns.
Study burden and risks
There are no risks involved in participating in the study. The burden
associated with participation comprises: an instruction session and
questionnaires before the ESM period (2 hours), filling in a diary using a
mobile application five times a day for 28 days (~2 minutes per measurement), a
debriefing session and questionnaires after the ESM period (2 hours in total),
and 4 follow-up assessments (1 hour per assessment). Benefits are an increased
insight in (fluctuations in) one*s own mood states and person-specific factors
that may promote the increase of positive affect or reduction of negative
affect. The intervention could also increase feelings of empowerment, improve
(social) functioning, and help patients bridge the usual wait list in a
constructive way. The burden for the control group consists of an instruction
session and filling out the same questionnaires at the same time points as the
intervention groups. The control group does not fill out electronic diaries,
nor engage in a debriefing session after the intervention.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
- Depression treatment is indicated by the practitioner
- Aged between 18 and 65 years
- Written informed consent
Exclusion criteria
- Crisis intervention warranted (i.e. in the case of acute suicidality)
- Presence of psychotic or manic symptoms
- Inadequate Dutch language proficiency, significant auditory or visual
impairments or mental retardation
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
Other | 22968 (in behandeling bij NTR) |
CCMO | NL55319.042.15 |
OMON | NL-OMON29201 |