The main objectives are to investigate whether our product is suitable for the target group, to identify barriers to wider implementation in mainstream care, and to gather patient experience and feedback. We want to know if patients perceive theā¦
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
- Psychiatric disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Structured interviews and questionnaires will be conducted to collect
qualitative data on the feasibility of the intervention, including insights
into the process, advantages and disadvantages, and patients' experiences of
the application.
Secondary outcome
Additional questionnaires are administered on comorbid symptoms (depressive
symptoms (IDS) and anxiety symptoms (STAI), general functioning (OQ-45), and
quality of life (WHODAS). This will allow us to investigate whether specific
subgroups may influence feasibility and whether these scores change clinically.
Furthermore, the trial will examine the extent to which traumatic events evoke
no or significantly reduced emotional reactions in the patient, as measured by
the PTSD Checklist (PCL-5), allowing for a conservative assessment of efficacy.
Background summary
A significant percentage (9-21%) (Stramrood et al., 2011) of births are
experienced as traumatic, with 3.2-4% leading to post-traumatic stress disorder
(PTSD) in young mothers, and up to 18.5% in those with additional risk factors
(Grekin & O*Hara, 2014). Postnatal PTSD has negative consequences for both
mother and child, impacting attachment (mother-child bonding), breastfeeding
and future pregnancies (Kopmeiners et al., 2023). Moreover, it significantly
increases the risk of postpartum depression (20-75%) which prolonged negative
effects on mother and the newborn (Dutch Society for Obstetrics & Gynaecology,
2019). Early and effective treatment is therefore essential. Research shows
that the standard treatment, Eye Movement Desensitization and Reprocessing
(EMDR), is effective (Dutch Society for Obstetrics & Gynaecology, 2019), but
unfortunately has limited availability and is difficult to combine with young
motherhood, resulting in long waiting times. E-health solutions can address
this gap by providing effective treatment with a low-barrier of entry.
Study objective
The main objectives are to investigate whether our product is suitable for the
target group, to identify barriers to wider implementation in mainstream care,
and to gather patient experience and feedback. We want to know if patients
perceive the added value of our treatment and how we can improve it. The trial
will also provide insight into early efficacy, an estimate of the number of
treatment sessions required, feasibility within specific subgroups, and
preliminary insights into clinical changes in comorbid symptoms, overall
functioning, and quality of life.
Study design
Interventional Single-Arm Clinical Feasibility Study
Intervention
The intervention consists of a maximum of 4 EMDR sessions of 45 minutes each
using an e-Health intervention based on traditional EMDR. The sessions take
place over a period of 3 weeks, with a 1-week interval between sessions. On
non-response, conventional EMDR will be offered to participants.
Study burden and risks
In this study, there will be a potential benefit to participants as a result of
the EMDR therapy. The therapy can elicit short-term emotions during the
sessions as part of the therapeutic process. However, these emotions would also
be present if left untreated due to the subjective unit of distress (SUD) being
addressed in the present moment. If left untreated, the emotions may persist
for a longer duration and potentially intensify. The goal of an EMDR session is
to achieve a lower SUD score at the end compared to the beginning, as a result
of the treatment*s effectiveness.
Participants will take part in a maximum of four 45-minute EMDR sessions and
complete questionnaires three times, each taking approximately 20 minutes.
Additionally, 30 minutes will be required for intake, 30 minutes for closing,
and 15 minutes for follow-up.
Reinier Postlaan 4
Nijmegen 6525 GC
NL
Reinier Postlaan 4
Nijmegen 6525 GC
NL
Listed location countries
Age
Inclusion criteria
Women (>=18 years) who have recently given birth at Radboudumc or are currently
in care at Radboudumc's POP clinic, and who have a negative or traumatic
childbirth experience within the first +-6 to 12 weeks postpartum.
Exclusion criteria
Current or past psychotic disorder
Design
Recruitment
Medical products/devices used
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 | NL85436.000.24 |