The objective is to study the cost-effectiveness of an adapted version of an American course (developed at UCSF), the online 'Mothers and Babies' intervention (Dutch name: "Positief zwanger"), by comparing it to a no intervention…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the difference between the intervention group and the
control group in changes in depressive symptoms from baseline to follow-up
measurements (8 weeks and 4, 8 and 12 months). Depressive symptoms will be
measured with the CES-D.
Secondary outcome
An economical evaluation will be executed to study the cost-effectiveness of
the intervention compared to the controle group.
Costs that will be taken in considerations are those from:
- health care use
- the intervention
- production losses
Questionnaires that will be administered for this goal are (relevant parts) of:
- Tic-P
- PRODISQ
- EQ-5D
Also, the intervention group will be asked to evaluate the intervention.
Background summary
Women have the highest risk on a first episode of depression during child
bearing years (Weissman & Jensen, 2002). Particularly among pregnant
Turkish/Moroccan women the prevalence of depressive symptoms and depressive
disorder is relatively high (Goedhart et al., 2010; De Wit et al., 2008).
Maternal depression can interfere with the early bonding and attachment process
between mother and baby. Children of mothers with depression are known to be at
risk for behavior problems, and are also at high risk for depression or other
mood disorders in later childhood and adolescence (Beardslee et al., 1983).
Furthermore, maternal depressive symptoms are an important risk factor for
perinatal morbidity (Goedhart, 2010). Preventing maternal depression during
pregnancy and postpartum would benefit both the mothers and their newborns.
Therefore, a Dutch version of the online "Mothers and Babies" (Le et al, 2010;
Muñoz, 2007) course will be developed and the cost-effectiveness of this
intervention will be studied.
Study objective
The objective is to study the cost-effectiveness of an adapted version of an
American course (developed at UCSF), the online 'Mothers and Babies'
intervention (Dutch name: "Positief zwanger"), by comparing it to a no
intervention control group. For this goal the course will be made suitable for
Turkish and Moroccan women in the Netherlands and thereafter the study will
take place.
Research questions are:
Primary: are there differences between the course group and the control group
in the change in depressive symptoms / complaints from baseline to follow-up
measurements?
Secundary: Is the intervention cost-effective compared to a no preventive
intervention control group?
Study design
The design is a randomized controlled trial with three arms:
1) The online course .
2) A no intervention control group. This group has access to care as usual, but
does not receive an active intervention in this study.
Intervention
The psychosocial preventive intervention includes 6 modules / lessons.
The intervention is directed at:
- increasing engagement in activities, individually or with others, that result
in greater experiences of reward (pleasure or mastery),
- decreasing engagement in activities that are unpleasant or result in negative
consequences / feelings, and
- solve problems or learning to cope with problems that limit access to
positive feelings.
The online course participants in addition receive e-mails to help them work
their way through the course and will be stimulated to monitor their mood and
course related activities online.
Study burden and risks
The study entails:
- cooperating in a screening by means of a screening questionnaire
- filling in questionnaires at the start, after 8 weeks and after 4, 8 and 12
months.
Filling in the questionnaires will take about 20 minutes each.
- For those offered the online intervention: There are 6 lessons with a time
investment about 30 minutes per lesson and 1 hour for homework assignments per
lesson.
The course is psychoeducation in nature and does not pose any risks.
Questionnaires that will be used:
- sociodemografics (at baseline only)
- symptoms of depression (CES-D)
- health care services use, productivity and quality of life (see secundary
outcomes)
- evaluation of the course (intervention group only)
Use of the intervention will be gathered automatically in an online database
and does not require any efforts of the participants.
DA COSTAKADE 45
UTRECHT 3521 VS
NL
DA COSTAKADE 45
UTRECHT 3521 VS
NL
Listed location countries
Age
Inclusion criteria
Women who (a) are at least 18 years of age; (b) are between 12 to 30 weeks pregnant; (c) have a CES-D score >= 16 but (d) are not heavily impaired in daily functioning; (e) do not have frequent suicidal thoughts; (f) have Turkish/Moroccan ethnicity; (g) have Internet access and and e-mail address; (i) gave informed consent (j) completed the baseline questionnaire.
Exclusion criteria
1) Suicidal thoughs and concrete plans and 2) impairment in daily functioning because of depressive complaints.
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 | NL39196.041.13 |