Mindfulness Based Cognitive Therapy for Psychological Distress in Pregnancy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02214732|
Recruitment Status : Completed
First Posted : August 12, 2014
Last Update Posted : September 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Depression Anxiety Stress||Behavioral: Mindfulness Based Cognitive Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Randomized Controlled Trial of Mindfulness Based Cognitive Therapy for Psychological Distress in Pregnancy|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||April 2017|
|Actual Study Completion Date :||September 2017|
Experimental: MBCT + Treatment as Usual (TAU)
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
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.
Other Name: MBCT
No Intervention: Treatment as Usual (TAU)
Participants in the TAU group access community resources for pregnant women experiencing psychological distress.
- Change in Edinburgh Postpartum Depression Scale scores from baseline to 3 months follow-up postpartum [ Time Frame: Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum (3 months after the birth of a person's baby) ]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.
- Change in Pregnancy Related Anxiety Measure scores from baseline to post-treatment [ Time Frame: Baseline (Week 1), Post-Treatment (Week 10) ]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.
- Change in Perceived Stress Scale (PSS-10) scores from baseline to 3 months [ Time Frame: Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum ]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.
- Change in Pittsburgh Sleep Quality Index (PSQI) scores from baseline to 3 months [ Time Frame: Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum ]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.
- Change in objective measures of sleep using Wrist Actigraphy from baseline to 3 months [ Time Frame: Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum ]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.
- Change in salivary cortisol profile from baseline to 3 months [ Time Frame: Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum ]All samples are assayed for salivary cortisol using a highly sensitive enzyme immunoassay.
- Change in measures of blood pressure (BP) from baseline to 3 months [ Time Frame: Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum ]BP data will be collected using an automatic, calibrated, oscillometric BP monitor and a BP cuff on the upper part of the dominant arm.
- Changes in measures of heart rate variability from baseline to 3 months [ Time Frame: Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02214732
|Riley Park Maternity Clinic|
|Calgary, Alberta, Canada, T2N 1B9|
|University Of Calgary|
|Calgary, Alberta, Canada, T2N 1N4|
|Principal Investigator:||Lianne Tomfohr-Madsen, PhD||University of Calgary|