To assess the effects of Cognitive Behavioral Therapy (CBT) in pregnant women with symptoms of anxiety or depression on the child*s behavioral/emotional problems. In addition, we aim to study its effects on the child*s development, maternal mental…
ID
Source
Brief title
Condition
- Neonatal and perinatal conditions
- Psychiatric and behavioural symptoms NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Behavioral/emotional problems at age 1.5 as assessed by the total problems
scale of the Child Behavior Check List 1.5 - 5 years.
Secondary outcome
- Mental, psychomotor and behavioral development of the child at age 18 months
according to the Bayley scales
- Maternal anxiety and depression during pregnancy and 6 weeks postnatal
- Maternal attachment style
- Neonatal outcomes: birth weight, gestational age and Apgar score
- Health care consumption and general health status (economic evaluation).
Background summary
There is ample evidence from observational prospective studies that maternal
depression or anxiety during pregnancy is a risk factor for adverse
psychosocial outcomes in the offspring. To date, however, no previous study has
demonstrated that treatment of depressive or anxious symptoms in pregnancy
actually could prevent psychosocial problems in children. Preventing
psychosocial problems in children will eventually bring down the huge public
health burden of mental disease.
Study objective
To assess the effects of Cognitive Behavioral Therapy (CBT) in pregnant women
with symptoms of anxiety or depression on the child*s behavioral/emotional
problems. In addition, we aim to study its effects on the child*s development,
maternal mental health, and neonatal outcomes, as well as the
cost-effectiveness of CBT relative to usual care.
Study design
A randomized controlled single-blind trial in primary, secondary and tertiary
obstetric care.
Intervention
The cognitive behavioral therapy consists of 10-14 individual sessions, 6-10
sessions during pregnancy and 4-8 sessions after delivery (once a week). The
CBT will be conducted by registered psychologists, specialized in conducting
CBT.
The first session will focus on the rationale of cognitive behavioral therapy,
i.e. the influence of (irrational or dysfunctional) cognitions and attitudes on
feelings and behaviors. Additionally, goal setting will be initiated. These
therapy goals will be unique for each patient. Subsequent sessions will be
targeted at identifying and amending irrational cognitions and attitudes
related to pregnancy, delivery, concerns about the (unborn) child and the
future family situation. Each session will address specific pregnancy-related
cognitions. Additionally, patients will be taught how dysfunctional cognitions
and attitudes affect adversely feelings and behaviors. These dysfunctional
cognitions and attitudes will be challenged and replaced by functional
cognitions and attitudes. After each session, patients will be given home work.
For example, patients will be asked to register negative experiences, and
accompanying cognitions, feelings and behaviors. Finally, in the last two to
four sessions, the newly learned cognitions and attitudes will be consolidated.
Study burden and risks
There are no risks associated with participating in this study.
Women will be asked to fill in some questionnaires; 9 questionnaires of which a
few will have to be filled in a few times spread over 2 years. Besides that,
the child born from this pregnancy will be tested on psychosocial development
at the age of 1.5.
Postbus 30001
9700 RB Groningen
NL
Postbus 30001
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
Having at least moderate depression and/or anxiety symptoms during pregnancy.
Exclusion criteria
Women fulfilling one or more of the following criteria will be excluded from participation:
1. High suicidal risk according to the suicidality subscale score on the MINI (defined as a positive response on the question on concrete suicide plans)
2. Presently receiving psychotherapy at a higher than twice a month rate
3. Substantial physical disease or illegal substance abuse
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 | NL29578.042.09 |