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New Cognitive Treatment for Peripartum Depression

Study acronym: MCT-DPP
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Re-verified, no change to tracked fieldsv3
  2. Notable Primary endpoint revisedv2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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The peripartum period is the period between the last month of pregnancy and up to a year after childbirth. It can be considered a difficult time for women, as it is a period of transition during which vulnerability to psychiatric disorders and in particular to major depressive disorder (MDD) (Vesga-Lopez, Blanco, Olfson, Grant \& Hasin, 2008). Depression with peripartum onset (PPD) is characterised by the fact that the onset of symptoms may occur during pregnancy or within four weeks of delivery, but may also persist for up to 12 months after delivery (American Psychiatric Association, 2013). PPD affects 10 to 20% of women who have given birth (Tebeka et al. 2021). In addition, the psychological distress experienced by the mother during the peripartum period can disrupt interactions with her newborn (Lefkovics et al. 2014). Depression during this period can therefore have long-term consequences, not only for the women who suffer it, but also for their children (Gavin et al. 2005). The investigators now know that women with PPD have deficits in metacognition. Metacognition is the body of knowledge, processes and practices that enable individuals to control and evaluate their own cognitive activities, thereby enabling them to regulate them (Flavell, 1976). Patients with PPD therefore have difficulty identifying, controlling and evaluating their own cognitive activities. These deficits may also represent a risk factor for the development of PPD if they are present at an early stage (Diop et al. 2022). In patients with PPD, metacognitive therapies appear to be effective in reducing symptoms. In 2013, Bevan, Wittkowski and Wells conducted a pilot study to test the effects associated with metacognitive therapy in depression. This was the first published study to evaluate the effects of metacognitive therapy on patients with depression in the peripartum period. It shows promising results which it would be interesting to replicate, as this is a pilot study. A metacognitive training program for depression (D-MCT) was developed by Jelinek, Hauschildt, Moritz and Dubreucq in 2016, it is a brief group intervention that is easy to manage to participants. To date, no study has yet tested this specific program in patients with PPD, but it has been able to show its effectiveness in reducing the metacognitive deficits. In the light of the scientific literature, the aims of this study are, firstly, to demonstrate the efficacy of D-MCT therapy in subjects with post-partum depression. Secondly, to examine the effects of this therapy on mother-child interactions. The investigators make the following assumptions: * Women in the experimental group showed a greater reduction in depressive symptoms and an improvement in metacognitive functioning than those in the control group. * Women in the experimental group showed a reduction in depressive symptoms after therapy (v2) and maintenance of this improvement (v3). * Improvement in the quality of mother-child bonding for women who took part in the program compared with those in the control group. * Improvement in the quality of mother-child bonding after the program (v2 and v3) for women in the experimental group compared with when they entered the program.
Trial Details
NCT Number NCT06253390
Lead Sponsor CHU de Reims
Conditions
(from sponsor)
Postnatal Depression
Related terms Depression, Postpartum
Enrollment 96 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov