Back to resultsPrenatal Affective Cognitive Training to Reduce the Risk of Postpartum Depression (PACT) (PACT)
Primary Purpose
Postpartum Depression, Emotional Regulation, Cognitive Function 1, Social
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Prenatal Affective CogntiiveTraining
Sponsored by
About this trial
This is an interventional prevention trial for Postpartum Depression
Eligibility 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).
Sites / Locations
- Mental Health Services in The Capital Region of DenmarkRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
PACT
CAU
Arm Description
Receive the intervention
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
Outcomes
Primary Outcome Measures
Post partum depression
Occurence of depression and depression severity during the first six months after birth
Secondary Outcome Measures
Affective cognition
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.
Full Information
NCT ID
NCT06046456
First Posted
September 14, 2023
Last Updated
September 25, 2023
Sponsor
Mental Health Services in the Capital Region, Denmark
Collaborators
University of Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT06046456
Brief Title
Prenatal Affective Cognitive Training to Reduce the Risk of Postpartum Depression (PACT)
Acronym
PACT
Official Title
Prenatal Affective Cognitive Training to Reduce the Risk of Postpartum Depression (PACT): Study Protocol for a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2023 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mental Health Services in the Capital Region, Denmark
Collaborators
University of Copenhagen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression, Emotional Regulation, Cognitive Function 1, Social, Pregnancy Related, Mother-Child Relations
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
146 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PACT
Arm Type
Experimental
Arm Description
Receive the intervention
Arm Title
CAU
Arm Type
No Intervention
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Prenatal Affective CogntiiveTraining
Intervention Description
A psychological intervention using computer- and virtual reality based exercises to modify negative cognitive bias and improve emotion regulation
Primary Outcome Measure Information:
Title
Post partum depression
Description
Occurence of depression and depression severity during the first six months after birth
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Affective cognition
Description
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.
Time Frame
Ten months
Other Pre-specified Outcome Measures:
Title
Mother-infant measures
Description
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.
Time Frame
Ten months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne J Bjertrup, PhD
Phone
27134839
Email
anne.juul.bjertrup@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Bjertrup
Phone
27134839
Email
anne_bjertrup@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kamill W Miskowiak, DMsc
Organizational Affiliation
Mental Health Services in the Capital Region of Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mental Health Services in The Capital Region of Denmark
City
Copenhagen
ZIP/Postal Code
2000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne J Bjertrup, PhD
Phone
27134839
Email
anne.juul.bjertrup@regionh.dk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prenatal Affective Cognitive Training to Reduce the Risk of Postpartum Depression (PACT)
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