The primary aim of ICT4D is to design an intelligent monitoring and selfhelpsystem for use in Primary Care (Moodbuster). In this pilot study the feasibility and the usability if this intervention is tested among patients suffering from minor and…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility of Moodbuster:
Time needed to include the participants
Willingness of participants to cooperate with the study after being informed by
the assistent of the GP
Compliance to the protocol of Moodbuster
Usibility of Moodbuster:
System Usability Scale (SUS; Brooke, 1996)
Client Satisfaction Questionnaire-8 (CSQ-8: De Brey, 1983).
Clinical outcome:
Depressive symptoms: Beck Depression Inventory II (BDI-II).
In order to explore the experiences of patients with Moodbuster in a more
qualitative way, we also will perform semistructured interviews with patients
and assistents of the GP.
Secondary outcome
Expectations toward the intervention:
Credibility/Expectancy Questionnaire (CEQ) of Devilly en Borkovec (Devilly &
Borkovec, 2000)
Anxietysymptoms: Hospital Anxiety Depression Scale (HADS-A) (Zigmond & Snaith,
1983).
Mastery: Mastery-scale (Pearlin, 1978)
Quality of life: EuroQol (EuroQol Group, 1990)
Background summary
Depressive disorders are highly prevalent in the general population (Kessler et
al., 1994; ESEMED, 2004) and have a serious impact on the quality of life of
patients and their family (Ustun et al., 2004; Saarni et al., 2007). Also,
depression is associated with a large economic burden to society (Berto et al.,
2000; Greenberg & Birnbaum, 2005; Smit et al., 2006). Most patients with
depressive disorders are treated in primal health care (Bijl & Ravelli, 2000).
Although effective treatment excist, such as medication and psychotherapy
(Cuijpers et al., 2009), further improvements remain necessary.
ICT4Depression (ICT4D) is an European project, in which an innovative programme
called Moodbuster is being designed. Moodbuster is an online selfhelp
programme, consisting of internet interventions, as well as the use of a
smartphone and a wireless pillbox. Patients are able to monitor their symptoms
on a daily basis by use of the smartphone. The use of the wireless pillbox, for
those patients that already use medication, reminds the patients of proper
intake.
Particiating members to the project are the Free University Amsterdam,
GGZinGeest (Netherlands), University of Linköping (Sweden), INESC and Plux
(Portugal), de University of Limerick (Ireland) and the Aardexgroup (Swiss).
Study objective
The primary aim of ICT4D is to design an intelligent monitoring and
selfhelpsystem for use in Primary Care (Moodbuster). In this pilot study the
feasibility and the usability if this intervention is tested among patients
suffering from minor and major depressive disorder who are being treated in
Primary care.
Study design
To evaluate the feasibility and usability of Moodbuster, a pilot study
consisting of one sample of 25 patients will be performed. These patients are
invited for a screening interview, followed by a baseline assesment and
follow-up measurements after 6 weeks and 3 months. Also, semistructured
interviews will be carried out in order to inventarisise the expectations and
experiences of the participants.
Study burden and risks
De burden for participants consists of the following tasks:
* Wearing sensor devices (glove and heart rate strep) for two parts of a day
during 6 weeks.
* Telephonic diagnostic interview which takes about 45 minutes
* Three measurements: at baseline, after 6 weeks and after 3 months.
* For some participants a face-to-face interview which takes about 1 hour about
their experiences with Moodbuster.
* Daily measurement (7 times per day) of mood, sleep and anxiety via the mobile
phone during 6 weeks.
The risks associated with participation are small. De safety of the sensor
devices is garanteed. However, as the devices don't have a CE-quality mark, a
contract will be made with an insurance company.
vd Boechorststraat 1
Amsterdam 1081 BT
NL
vd Boechorststraat 1
Amsterdam 1081 BT
NL
Listed location countries
Age
Inclusion criteria
1) Patients of GP with a DSM-IV minor or major depression
2) 18 years or older
3) acces to internet
4)motivated to use bio sensors
Exclusion criteria
suicidal risk
bipolar of psychotic disorder
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 | NL41822.029.12 |