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

NCT06046456 | Unknown

• 1 other identifier: R7-A182
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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 study also involves a low-risk group (n=146), although these individuals are not part of the intervention trial but are merely followed up with the same assessments for background comparisons.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.

Conditions

Postpartum Depression; Emotional Regulation; Cognitive Function 1, Social; Pregnancy Related; Mother-Child Relations

Outcome Measures

Primary Outcomes (1)

• The incidence of PPD during the first six months after birth, assessed with the Present State Examination (PSE), which is a part of Schedules for Clinical Assessment in Neuropsychiatry (SCAN)

  The primary outcome is the difference between mothers receiving PACT versus CAU in the incidence of PPD during the first six months after birth, assessed by a clinician blind to group status with the Present State Examination (PSE), which is a part of Schedules for Clinical Assessment in Neuropsychiatry (SCAN)

  Six months after birth

Secondary Outcomes (3)

• Change in negative cognitive bias

  In third trimester of pregnancy

• Self-rated depressive symptoms

  Within six weeks after birth

• Self-rated parental stress

  Six months after birth

Other Outcomes (3)

• Infant development

  Eight - eighteen months after birth

• Mother-child interaction

  Eight - eighteen months after birth

• Change in affective cognition

  Third trimester of pregnancy

Study Arms (2)

PACT

EXPERIMENTAL

Receive the intervention

Other: Prenatal Affective CogntiiveTraining

CAU

NO 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

Interventions

Prenatal Affective CogntiiveTraining OTHER

A psychological intervention using computer- and virtual reality based exercises to modify negative cognitive bias and improve emotion regulation

PACT

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Second or third trimester pregnancy.
• Age ≥ 18 years.
• Ability to speak and read Danish.
• 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).
• Absence of a personal or family history of mental illness.
• Absence of negative bias.
• Three or fewer of the additional risk factors mentioned above.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: lead
• University of Copenhagen: collaborator

Study Sites (1)

Mental Health Services in The Capital Region of Denmark

Copenhagen, 2000, Denmark

RECRUITING

Related Publications (1)

• Bjertrup AJ, Kofoed J, Egmose I, Wendelboe K, Southgate V, Vaever MS, Miskowiak KW. Prenatal affective cognitive training to reduce the risk of postpartum depression (PACT): study protocol for a randomized controlled trial. Trials. 2024 Jul 15;25(1):478. doi: 10.1186/s13063-024-08316-1.

  PMID: 39010232 DERIVED

MeSH Terms

Conditions

Depression, Postpartum; Emotional Regulation

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Study Officials

• Kamill W Miskowiak, DMsc

  Mental Health Services in the Capital Region of Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne J Bjertrup, PhD

CONTACT

27134839; anne.juul.bjertrup@regionh.dk

Anne Bjertrup

CONTACT

27134839; anne_bjertrup@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: September 21, 2023
• Study Start: January 10, 2023
• Primary Completion: February 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 8, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)