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Prenatal Affective Cognitive Training to Reduce the Risk of Postpartum Depression (PACT) (PACT)

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ClinicalTrials.gov Identifier: NCT06046456
Recruitment Status : Recruiting
First Posted : September 21, 2023
Last Update Posted : September 28, 2023
Sponsor:
Collaborator:
University of Copenhagen
Information provided by (Responsible Party):
Mental Health Services in the Capital Region, Denmark

Study Description
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Brief Summary:

Many pregnant women face the risk of experiencing depression after giving birth, especially if they've previously dealt with depression.

The goal of this study, is to test if our newly developed Prenatal Affective Cognitive Training (PACT) intervention, can decrease the likelihood of post partum depression. In the study, 226 pregnant women, some of whom are considered high risk due to past mental illness or psycho-social risk factors, will participate. The high-risk women will be divided into two groups. One group will undergo the PACT training, which involves computer and virtual reality exercises spanning five weeks, designed to improve mood and emotional regulation. The other group will receive usual care. The main aim is to observe whether the women who undergo PACT intervention are less prone to depression after childbirth compared to those who do not.

This study has potential to offer a simple, non-invasive method to bolster mental health in expectant mothers, which could also positively impact their infants.


Condition or disease Intervention/treatment Phase
Postpartum Depression Emotional Regulation Cognitive Function 1, Social Pregnancy Related Mother-Child Relations Other: Prenatal Affective CogntiiveTraining Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prenatal Affective Cognitive Training to Reduce the Risk of Postpartum Depression (PACT): Study Protocol for a Randomized Controlled Trial
Actual Study Start Date : January 10, 2023
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: PACT
Receive the intervention
 Other: Prenatal Affective CogntiiveTraining
A psychological intervention using computer- and virtual reality based exercises to modify negative cognitive bias and improve emotion regulation
No Intervention: CAU
Receive care as usual, i.e., the standard care provided to pregnant women without any additional experimental interventions. It typically involves routine prenatal care, which may include regular check-ups, medical assessments, and general support from healthcare professionals


Outcome Measures
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Primary Outcome Measures :
  1. Post partum depression [ Time Frame: Six months ]
    Occurence of depression and depression severity during the first six months after birth


Secondary Outcome Measures :
  1. Affective cognition [ Time Frame: Ten months ]
    The reduction in negatively biased cognitive processing of infant stimuli from baseline to follow-up during pregnancy, as well as the self-rated parental stress after birth.


Other Outcome Measures:
  1. Mother-infant measures [ Time Frame: Ten months ]
    Tertiary outcomes involve assessing differences in infant development, mother-infant interaction measures (e.g., sensitivity, intrusiveness, dyadic reciprocity), and changes in facial expressions and visual attention towards infant stimuli (during pregnancy) between the PACT and CAU groups.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for General Pregnant Population:

  • Second or third trimester pregnancy.
  • Age ≥ 18 years.
  • Ability to speak and read Danish.

Inclusion Criteria for High-Risk Pregnant Group:

  • Either:
  • Negative cognitive bias in emotional reactivity to infant distress (cut-off > 96 on a scale from 0-100).
  • High-risk status according to the Antenatal Risk Questionnaire (ANRQ) which means:
  • Personal history of severe mental illness.
  • Experienced childhood emotional, physical, or sexual abuse.
  • Total score on psycho-social risk factors is above the cut-off (> 23).

Inclusion Criteria for Low-Risk Pregnant Group:

  • Absence of a personal or family history of mental illness.
  • Absence of negative bias.
  • Three or fewer of the additional risk factors mentioned above.

General Exclusion Criteria:

  • Schizophrenia.
  • Current substance use disorder.
  • Score of 9 or more on the Hamilton Depression Rating Scale-6 items (HDRS-6), indicating moderate depression.
  • Pregnant women diagnosed with a personality disorder (note: they will still be included at baseline and follow-up after birth but will be excluded from randomization).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06046456


Contacts
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Contact: Anne J Bjertrup, PhD 27134839 anne.juul.bjertrup@regionh.dk
Contact: Anne Bjertrup 27134839 anne_bjertrup@hotmail.com

Locations
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Denmark
Mental Health Services in The Capital Region of Denmark Recruiting
Copenhagen, Denmark, 2000
Contact: Anne J Bjertrup, PhD    27134839    anne.juul.bjertrup@regionh.dk   
Sponsors and Collaborators
Mental Health Services in the Capital Region, Denmark
University of Copenhagen
Investigators
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Principal Investigator: Kamill W Miskowiak, DMsc Mental Health Services in the Capital Region of Denmark
More Information
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Responsible Party: Mental Health Services in the Capital Region, Denmark
ClinicalTrials.gov Identifier: NCT06046456    
Other Study ID Numbers: R7-A182
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: September 28, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression, Postpartum
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
 Mental Disorders
Puerperal Disorders
Pregnancy Complications
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases