Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Alberta Centre for Child, Family & Community Research | OTHER |
| Alberta Family Wellness Initiative | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MBCT + Treatment as Usual (TAU) | Experimental | 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. |
|
| Treatment as Usual (TAU) | No Intervention | Participants in the TAU group access community resources for pregnant women experiencing psychological distress. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Based Cognitive Therapy | Behavioral | 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. |
| 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) |
| 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) |
Not provided
Inclusion Criteria:
Eligible women for this study
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lianne Tomfohr-Madsen, PhD | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riley Park Maternity Clinic | Calgary | Alberta | T2N 1B9 | Canada | ||
| University Of Calgary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27737714 | Derived | Tomfohr-Madsen LM, Campbell TS, Giesbrecht GF, Letourneau NL, Carlson LE, Madsen JW, Dimidjian S. Mindfulness-based cognitive therapy for psychological distress in pregnancy: study protocol for a randomized controlled trial. Trials. 2016 Oct 13;17(1):498. doi: 10.1186/s13063-016-1601-0. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000099025 | Mindfulness-Based Cognitive Therapy |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| 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 |
| Calgary |
| Alberta |
| T2N 1N4 |
| Canada |
| D004191 |
| Behavioral Disciplines and Activities |