Mindfulness Based Cognitive Therapy for Psychological Distress in Pregnancy

Study Overview
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Brief Summary
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Anxiety, stress and depression are common during pregnancy and in the postpartum period. The lack of empirically supported, non-pharmaceutical interventions for psychological distress in pregnancy is a significant gap in the literature, especially given many pregnant women's preference for non-pharmaceutical treatments. This study will evaluate the efficacy of Mindfulness Based Cognitive Therapy (MBCT) program in reducing measures of psychological distress (e.g., symptoms of stress, depression and anxiety) in a group of pregnant women endorsing high levels of distress.

Official Title
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A Randomized Controlled Trial of Mindfulness Based Cognitive Therapy for Psychological Distress in Pregnancy

Conditions
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Depression, Anxiety, Stress

Intervention / Treatment
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* Behavioral: Mindfulness Based Cognitive Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible women for this study are between 12 and 28 weeks of gestation, are experiencing psychological distress (elevated perinatal anxiety, mild depressive symptoms, or high-levels of self-reported stress) Exclusion Criteria: current suicidality current substance abuse or dependence experience a current major depressive episode have been diagnosed with bipolar disorder or other disorders that have a psychotic, dissociative, hallucinatory, or delusional component taking prescribed medications that affect sleep or mood

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MBCT + Treatment as Usual (TAU)<br>Behavioural: Mindfulness Based Cognitive Therapy Participants in the MBCT group attend an 8 week course of a modified MBCT program for pregnant women, delivered by a licensed clinical psychologist. | Behavioral: Mindfulness Based Cognitive Therapy<br>* The modified MBCT program for pregnant women is an 8-session group intervention that aims to help women change their relationship to the thoughts, feelings, and bodily sensations that can lead to psychological distress. Participants are guided to recognize and disengage from unhelpful mind states characterized by self-perpetuating patterns of ruminative thought. The intervention was modified to address pregnant women's physical and emotional needs, as well as their risk of perinatal mood episodes.<br>* Other names: MBCT;|
| No Intervention: Treatment as Usual (TAU)<br>Participants in the TAU group access community resources for pregnant women experiencing psychological distress. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Edinburgh Postpartum Depression Scale scores from baseline to 3 months follow-up postpartum | Symptoms of depression will be assessed using the 10-item, self-report Edinburgh Postpartum Depression Scale (EPDS). The EPDS has been validated against interview schedules and other self-report instruments. | Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum (3 months after the birth of a person's baby) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pregnancy Related Anxiety Measure scores from baseline to post-treatment | The Pregnancy Anxiety Measure, a 10-item instrument will be used to examine the extent to which women are worried about their own and baby's health, labour, delivery and caring their new baby. | Baseline (Week 1), Post-Treatment (Week 10) | 
| Change in Perceived Stress Scale (PSS-10) scores from baseline to 3 months | This questionnaire will be used in assessing the perception of stress. The questions are in regards to participant's feelings and thoughts during the previous month. It was designed to be used in community samples. The items are assessing perceived helplessness and self-efficacy. | Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum | 
| Change in Pittsburgh Sleep Quality Index (PSQI) scores from baseline to 3 months | The PSQI instrument will be used in assessing participant's sleep quality. There are seven components of the PSQI and these are subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications and daytime dysfunction. | Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum | 
| Change in objective measures of sleep using Wrist Actigraphy from baseline to 3 months | Actigraphy monitoring provides objective information on circadian rhythm amplitude, acrophase, as well as indices of sleep efficiency, sleep latency, total sleep time, and number and frequency of awakenings. The use of actigraphy has been demonstrated sensitive to treatment effects, while being less costly and intrusive than polysomnography. | Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum | 
| Change in salivary cortisol profile from baseline to 3 months | All samples are assayed for salivary cortisol using a highly sensitive enzyme immunoassay. | Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum | 
| Change in measures of blood pressure (BP) from baseline to 3 months | BP data will be collected using an automatic, calibrated, oscillometric BP monitor and a BP cuff on the upper part of the dominant arm. | Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum | 
| Changes in measures of heart rate variability from baseline to 3 months | Measures of heart rate (bpm) will be recorded noninvasively using a HIC-2000 Bio-electric Impedance Cardiograph and the Cardiac Output Program, developed by Bio-Impedance Technology. | Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Postpartum, Mindfulness Based Cognitive Therapy, Depression, Anxiety, Stress, MBCT, Actigraphy