Mindfulness-based Cognitive TherapyNCT05725863
Mindfulness-Based Cognitive Therapy Postpartum Mothers Stress, Postpartum Blues, Mother-Baby Attachment and Breastfeeding
A study testing Mindfulness-Based Cognitive Therapy in people with Mindfulness-based Cognitive Therapy, run by Trakya University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mindfulness-based Cognitive Therapy
- What is being tested?
- Mindfulness-Based Cognitive Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Apr 2022to 10 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mindfulness-Based Cognitive Therapy Applied to Postpartum Mothers on Stress, Postpartum Blues, Mother-Baby Attachment and Breastfeeding
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.
Read the detailed description
This two-arm randomized controlled trial (RCT) was conducted in the postpartum mothers located in Edirne, between April and December 2022. During the intake, postpartum mothers were informed about the goals and setup of the study and intervention, and assessed for eligibility by a brief standardized interview. Postpartum mothers who fulfilled our criteria received an information letter and informed consent form, as well as the baseline questionnaire. Those postpartum mothers that provided written informed consent for participation were included in the study. Assessments in both groups were performed before randomization (i.e., baseline) and directly after the intervention period (i.e., post-measurement, approximately 2 months after baseline).
Randomization: Postpartum mothers were randomly assigned to an 8-week MBCT or control condition. A research assistant not actively involved in the design and data analysis of the study created a random distribution sequence and assigned participants to one of the two conditions (1:1 ratio).
Intervention: Mindfulness-Based Cognitive Therapy (MBCT) is a structured group intervention developed. The intervention consisted of eight weekly 2.5-hr sessions and one 3-hr silent session. The main aspects of the program; It included group meditation, cognitive-behavioral exercises, psycho-education, and daily homework. The intervention in our study closely followed the original manual, with several adaptations for the study group and purpose. 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.
Control Condition: Postpartum mothers in the control condition were informed that they would receive MBCT after a waiting period of 2 months. Meanwhile, no psychological intervention was ofered.
Measures: The baseline questionnaire included questions about demographic, socioeconomic, obstetric, mood, and breastfeeding-specific information. Outcomes related to all stress, postpartum blues, mother-infant attachment, and breastfeeding were assessed at baseline and after therapy (on average, 2 months after baseline assessment).
Sample size calculation for the primary research question was performed based on a pilot study, which assessed pre- and post-measurement stres and depression levels in postpartum participating in a mindfulness program similar to MBCT, specifcally CALM Pregnancy as focused on training in formal mindfulness and informal mindfulness practices. The CALM Pregnancy program both involve eight weekly 2.5-hr sessions. Sessions included didactic presentations, group exercises, formal meditation practices, and leader-facilitated group inquiry and discussion. Formal practices included the body scan, mindful yoga, and sitting meditation. Informal mindfulness practices included mindfulness of everyday activities such as mindful eating and mindful walking. The intervention also incorporated the 3-min breathing space and cognitive approaches for developing alternative ways of responding to stress and anxiety symptoms. Given the similarities in the content, structure, and intensity of the two programs, the investigators used this pilot study for the sample size calculation. With a statistical power of 0.95 and an alpha of 0.05, 45 postpartum mothers patients were required per group (90 in total) to be able to detect diferences with an effect size of at least 0.50.
- Conditions
- Mindfulness-based Cognitive Therapy
- Being tested
- Mindfulness-Based Cognitive Therapy
- Keywords
- Postpartum, Stress, Postpartum blues, Mother-infant attachment, Breastfeeding
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Cognitive TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Mindfulness-Based Cognitive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: change from before implamentation patent and after 2 months of practice.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start2 Apr 2022
- Primary completion2 Mar 2023
- Study completion10 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mindfulness-based Cognitive TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu KUCUKKAYA, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725863
- Sponsor's protocol ID
- 2022/P004
- Status last verified
- Jun 2023
- First submitted
- 3 Feb 2023
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness-Based Cognitive Therapy Applied to Postpartum Mothers on Stress, Postpartum Blues, Mother-Baby Attachment and Breastfeeding
- ClinicalTrials.gov ID
- NCT05725863
- Acronym / sponsor ID
- 2022/P004
- Conditions
- Mindfulness-based Cognitive Therapy
- Keywords
- Postpartum, Stress, Postpartum blues, Mother-infant attachment, Breastfeeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 2 Apr 2022 (actual)
- Primary completion
- 2 Mar 2023 (actual)
- Study completion
- 10 May 2023 (actual)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This two-arm randomized controlled trial (RCT) was conducted in the postpartum mothers located in Edirne, between April and December 2022. During the intake, postpartum mothers were informed about the goals and setup of the study and intervention, and assessed for eligibility by a brief standardized interview. Postpartum mothers who fulfilled our criteria received an information letter and informed consent form, as well as the baseline questionnaire. Those postpartum mothers that provided written informed consent for participation were included in the study. Assessments in both groups were performed before randomization (i.e., baseline) and directly after the intervention period (i.e., post-measurement, approximately 2 months after baseline).
Randomization: Postpartum mothers were randomly assigned to an 8-week MBCT or control condition. A research assistant not actively involved in the design and data analysis of the study created a random distribution sequence and assigned participants to one of the two conditions (1:1 ratio).
Intervention: Mindfulness-Based Cognitive Therapy (MBCT) is a structured group intervention developed. The intervention consisted of eight weekly 2.5-hr sessions and one 3-hr silent session. The main aspects of the program; It included group meditation, cognitive-behavioral exercises, psycho-education, and daily homework. The intervention in our study closely followed the original manual, with several adaptations for the study group and purpose. 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.
Control Condition: Postpartum mothers in the control condition were informed that they would receive MBCT after a waiting period of 2 months. Meanwhile, no psychological intervention was ofered.
Measures: The baseline questionnaire included questions about demographic, socioeconomic, obstetric, mood, and breastfeeding-specific information. Outcomes related to all stress, postpartum blues, mother-infant attachment, and breastfeeding were assessed at baseline and after therapy (on average, 2 months after baseline assessment).
Sample size calculation for the primary research question was performed based on a pilot study, which assessed pre- and post-measurement stres and depression levels in postpartum participating in a mindfulness program similar to MBCT, specifcally CALM Pregnancy as focused on training in formal mindfulness and informal mindfulness practices. The CALM Pregnancy program both involve eight weekly 2.5-hr sessions. Sessions included didactic presentations, group exercises, formal meditation practices, and leader-facilitated group inquiry and discussion. Formal practices included the body scan, mindful yoga, and sitting meditation. Informal mindfulness practices included mindfulness of everyday activities such as mindful eating and mindful walking. The intervention also incorporated the 3-min breathing space and cognitive approaches for developing alternative ways of responding to stress and anxiety symptoms. Given the similarities in the content, structure, and intensity of the two programs, the investigators used this pilot study for the sample size calculation. With a statistical power of 0.95 and an alpha of 0.05, 45 postpartum mothers patients were required per group (90 in total) to be able to detect diferences with an effect size of at least 0.50.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Mindfulness-Based Cognitive TherapyMindfulness-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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Cognitive TherapyMindfulness-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. | Other | MBCT |
Primary outcome
Stress evaluated using the Perceived Stress Scale
Time frame: change from before implamentation patent and after 2 months of practice.
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.
Postpartum blues evaluated using the Edinburgh Postpartum Depression Scale
Time frame: change from before implamentation patent and after 2 months of practice.
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.
Mother-infant attachment evaluated using the Maternal Attachment Scale
Time frame: change from before implamentation patent and after 2 months of practice.
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.
Breastfeeding blues evaluated using the Bristol Breastfeeding Assessment Scale
Time frame: change from before implamentation patent and after 2 months of practice.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Cognitive Therapy in people with Mindfulness-based Cognitive Therapy, run by Trakya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress evaluated using the Perceived Stress Scale (time frame: change from before implamentation patent and after 2 months of practice.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2023.