NCT05725863

Brief Summary

Objectives: Research on the effect of mindfulness-based cognitive therapy (MBCT) applied to postpartum mothers on the mother's mood and mother-infant interaction is a new and promising feld of research. However, the evidence on whether MBCT reduces stress and postpartum blues and improves mother-infant attachment and breastfeeding is inconclusive. The present study addresses this research question. Design: A two-arm randomized controlled trial was conducted in 90 postpartum mothers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 2, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 3, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2023

Completed
Last Updated

June 26, 2023

Status Verified

June 1, 2023

Enrollment Period

11 months

First QC Date

February 3, 2023

Last Update Submit

June 22, 2023

Conditions

Keywords

PostpartumStressPostpartum bluesMother-infant attachmentBreastfeeding

Outcome Measures

Primary Outcomes (4)

  • Stress evaluated using the Perceived Stress Scale

    The PSS-10, is a 14 items scale that was developed (Cohen et al., 1983) to assess perceived stress like the feelings and thoughts of one's life as uncontrollable, unpredictable, and overloaded over the last month with a five-point Likert (0: never, 4: very often) (e.g. "In the last month, how often have participants felt that things were going ones way?"). Scores on the PSS can range from 0 to 56 and higher scores indicate higher perceived stress. The scale was adapted to Turkish by Eskin and his colleagues (Eskin et al., 2013). During the adaptation to Turkish, the psychometric properties of the short-form of the 10-item and the 4-item scale, as well as the 14-item total scale, were tested. The internal consistency coefficients of the 14-item, 10-item, and 4-item forms of the scale were 0.84, 0.82, and 0.66; and test-retest reliability coefficients measured at one-month intervals were 0.87, 0.88, and 0.72, respectively. In this study, a ten-item short form of the scale was used.

    change from before implamentation patent and after 2 months of practice.

  • Postpartum blues evaluated using the Edinburgh Postpartum Depression Scale

    This scale, which was developed to determine the risk of PPD, has been adapted to Turkish (Cox et al., 1987; Engindeniz et al., 1996). The scale consists of 10 items with 4 - point Likert-type responses. Each item is scored from 0-3, and the total score is obtained as the total of the item scores (min: 0 - max: 30). The cutoff point for the scale in Turkey has been calculated as 12/13 points (Engindeniz et al., 1996). In the current study, postpartum mothers with an EPDS score of ≥ 13 points were referred to the Psychiatry Department.

    change from before implamentation patent and after 2 months of practice.

  • Mother-infant attachment evaluated using the Maternal Attachment Scale

    The MAS was developed by Müller (1994) and adapted to Turkish by Kavlak and Şirin (2009), was used to determine the level of the bond between mother and infant. The MAS includes 26 statements that people can use to express their feelings. Depending on the severity of the feelings of mothers against their babies, statements were calculated as 'Always=4 points, Frequently=3 points, Sometimes=2 points and Never=1 point'. An overall score was obtained from the sum of all items. High score indicates that maternal attachment is high. The scores obtained from the scale range from a minimum of 26 to a maximum of 104 points. The reliability coefficient of the MAS, which was adapted to Turkish by Kavlak and Şirin (2009), was found to be 0.77 in mothers with 1-month old newborn and 0.82 in mothers with 4-month old infant.

    change from before implamentation patent and after 2 months of practice.

  • Breastfeeding blues evaluated using the Bristol Breastfeeding Assessment Scale

    The BBAS, which was developed by Ingram et al. (2014) and adapted into Turkish by Dolgun et al. (2018), was used in the study. The scale consists of 4 items (positioning, holding, sucking and swallowing) with 3 - point Likert-type responses. Each item is scored from 0-2 (0 poor, 1 moderate, 2 good), and the total score is obtained as the total of the item scores (min: 0 - max: 8). A high score indicates an effective breastfeeding or vice versa.

    change from before implamentation patent and after 2 months of practice.

Study Arms (2)

Control

NO INTERVENTION

No psychological intervention was offered. Postpartum mothers in the control condition were informed that they would receive MBCT after a waiting period of 2 months.

MBCT

EXPERIMENTAL

Mindfulness-Based Cognitive Therapy (MBCT) consisted of eight weekly 2.5-hr sessions and one 3-hr silent session. First, psycho-education focused on the importance of recognizing personal feelings and the relationship between stress, postpartum blues, mother-infant attachment and breastfeeding symptoms, and stress management, stress, postpartum blues, mother-infant attachment and breastfeeding. Additionally, postpartum mothers' experiences of stress, postpartum blues, mother-infant attachment, and breastfeeding were central during the study and were a recurring topic for the purpose of the study in general. Postpartum mothers were given homework assignments, including audio CDs with formal exercises, and were asked to practice for 30 min per day.

Other: Mindfulness-Based Cognitive Therapy

Interventions

Mindfulness-Based Cognitive Therapy (MBCT) is a structured group intervention developed by Segal et al. (2002). The intervention consisted of eight weekly 2.5-hr sessions and one 3-hr silent session. First, psycho-education focused on the importance of recognizing personal feelings and the relationship between stress, postpartum blues, mother-infant attachment and breastfeeding symptoms, and stress management, stress, postpartum blues, mother-infant attachment and breastfeeding. Additionally, postpartum mothers' experiences of stress, postpartum blues, mother-infant attachment, and breastfeeding were central during the study and were a recurring topic for the purpose of the study in general. Postpartum mothers were given homework assignments, including audio CDs with formal exercises, and were asked to practice for 30 min per day.

MBCT

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPostpartum mothers
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Volunteer to participate in the research,
  • Over 18 years old,
  • Participated in group sessions for 2,5 hours once a week for eight weeks,
  • Mothers could read, write and speak Turkish.

You may not qualify if:

  • Over 49 years old,
  • The presence of serious cognitive, neurological, and psychiatric disorders that may preclude participation of postpartum mothers or require other treatment,
  • Particularly psychotic complaints or a diagnosis of schizophrenia, neurological disorders including severe cognitive limitations,
  • Substance use disorder, and acute suicidal thoughts or behaviors that may stress the mother,
  • The presence of any congenital anomaly in the baby.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turkey, Trakya University

Edirne, 22030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 3, 2023

First Posted

February 13, 2023

Study Start

April 2, 2022

Primary Completion

March 2, 2023

Study Completion

May 10, 2023

Last Updated

June 26, 2023

Record last verified: 2023-06

Locations