DepressionNCT02214732
Mindfulness Based Cognitive Therapy for Psychological Distress in Pregnancy
A study testing Mindfulness Based Cognitive Therapy in people with Depression and Anxiety, run by University of Calgary at 2 sites in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Depression, Anxiety, Stress
- What is being tested?
- Mindfulness Based Cognitive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 2 sitesCanada
- Study dates
- Aug 2014to Sep 2017
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Riley Park Maternity Clinic
Calgary, Alberta, T2N 1B9
University Of Calgary
Calgary, Alberta, T2N 1N4
About this study
Official title: A Randomized Controlled Trial of Mindfulness Based Cognitive Therapy for Psychological Distress in Pregnancy
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.
- Conditions
- Depression, Anxiety, Stress
- Being tested
- Mindfulness Based Cognitive Therapy
- Keywords
- Pregnancy, Postpartum, Mindfulness Based Cognitive Therapy, Depression, Anxiety, Stress, MBCT, Actigraphy
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Cognitive TherapyBehavioural
Also called MBCT
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mindfulness Based Cognitive Therapy |
| Treatment as Usual (TAU) | No intervention | Participants in the TAU group access community resources for pregnant women experiencing psychological distress. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum (3 months after the birth of a person's baby)
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionApr 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Centre for Child, Family & Community Research, Alberta Family Wellness Initiative
- Responsible party
- Principal investigator, Lianne Tomfohr-Madsen, University of Calgary
- Investigators
- Lianne Tomfohr-Madsen, PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02214732
- Sponsor's protocol ID
- REB13-0860
- Status last verified
- Sep 2018
- First submitted
- 7 Aug 2014
- Last updated
- 14 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27737714
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Mindfulness Based Cognitive Therapy for Psychological Distress in Pregnancy
- ClinicalTrials.gov ID
- NCT02214732
- Acronym / sponsor ID
- REB13-0860
- Conditions
- Depression, Anxiety, Stress
- Keywords
- Pregnancy, Postpartum, Mindfulness Based Cognitive Therapy, Depression, Anxiety, Stress, MBCT, Actigraphy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Alberta Centre for Child, Family & Community Research, Alberta Family Wellness Initiative
- Study start
- Aug 2014
- Primary completion
- Apr 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 12 Aug 2014 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBCT + Treatment as Usual (TAU) | Experimental | Behavioral: Mindfulness Based Cognitive TherapyBehavioural: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
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 TherapyAlso: MBCTThe 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. | Behavioural | MBCT + Treatment as Usual (TAU) |
Primary outcome
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.
7 secondary outcomes
Change in Pregnancy Related Anxiety Measure scores from baseline to post-treatment
Time frame: Baseline (Week 1), Post-Treatment (Week 10)
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
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
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
Change in salivary cortisol profile from baseline to 3 months
Time frame: Baseline (Week 1), Post-Treatment (Week 10), 3 months follow-up postpartum
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
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
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 14 Sep 2018.
- Derived from this study: PubMed 27737714Tomfohr-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.
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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.
Lianne Tomfohr-Madsen, PhD principal investigator
University of Calgary
2 sites 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 Depression and Anxiety, run by University of Calgary at 2 sites in Canada.
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 3 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 14 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02214732, which also lists 1 linked publication.
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 14 Sep 2018.