Evidence map›Paper›PMID 27737714›Full record

Trial reportTrials2016

Mindfulness-based cognitive therapy for psychological distress in pregnancy: study protocol for a randomized controlled trial.

Lianne M Tomfohr-Madsen, Tavis S Campbell, Gerald F Giesbrecht, Nicole L Letourneau, Linda E Carlson, Joshua W Madsen, Sona Dimidjian

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02214732 (A Randomized Controlled Trial of Mindfulness Based Cognitive Therapy for Psychological Distress in Pregnancy), which is not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
2.4field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02214732 nacompletednot on this map

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

TypeinterventionalSponsorUniversity of CalgaryRan2014 to 2017Enrolled61ConditionsDepression, Anxiety, StressArmsMindfulness Based Cognitive Therapy
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 46 citations in OpenAlex.

  1. Pooled it
  2. Sleeping for Two: a randomized controlled trial of cognitive behavioral therapy for insomnia in pregnancy.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 2 countries.

Lianne M Tomfohr-MadsenDepartment of Psychology, University of Calgary, Calgary, AB, Canada. ltomfohr@ucalgary.ca.
Tavis S CampbellDepartment of Psychology, University of Calgary, Calgary, AB, Canada.
Gerald F GiesbrechtDepartment of Psychology, University of Calgary, Calgary, AB, Canada.
Nicole L LetourneauFaculties of Nursing and Medicine (Pediatrics), University of Calgary, Calgary, AB, Canada.
Linda E CarlsonDepartment of Psychology, University of Calgary, Calgary, AB, Canada.
Joshua W MadsenDepartment of Psychology, University of Calgary, Calgary, AB, Canada.
Sona DimidjianDepartment of Psychology and Neuroscience, University of Colorado, Boulder, CO, USA.
University of Calgary · CAUniversity of Colorado Boulder · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundClinically significant psychological distress in pregnancy is common, with epidemiological research suggesting that between 15 and 25 % of pregnant women experience elevated symptoms of stress, anxiety, and depression. Untreated psychological distress in pregnancy is associated with poor obstetrical outcomes, changes in maternal physiology, elevated incidence of child physical and psychological disorders, and is predictive of maternal postpartum mood disorders. Despite the wide-ranging impact of antenatal psychological distress on mothers and their children, there is a gap in our knowledge about the most effective treatments that are available for psychological distress experienced in pregnancy. Additionally, no trials have focused on potential physiological changes that may occur as a result of receiving mindfulness training in pregnancy. The proposed trial will determine the effectiveness of an 8-week modified Mindfulness-based Cognitive Therapy (MBCT) intervention delivered during pregnancy.

methodsA randomized controlled trial (RCT) design with repeated measures will be used to evaluate the effectiveness of MBCT to treat psychological distress in pregnancy. A sample of 60 consenting pregnant women aged 18 years and above will be enrolled and randomized to the experimental (MBCT) or control (treatment as usual) condition. Primary (e.g., symptoms of stress, depression, and anxiety), secondary (cortisol, blood pressure (BP), heart rate variability (HRV), and sleep) and other outcome data (e.g., psychological diagnoses) will be collected via a combination of laboratory visits and at-home assessments from both groups at baseline (T DISCUSSION: The trial is expected to improve knowledge about evidence-based treatments for psychological distress experienced in pregnancy and to evaluate the potential impact of mindfulness-based interventions on maternal physiology.

trial registrationClinicalTrials.gov: NCT02214732 , registered on 7 August 2014. Protocol Version 2.0., 5 September 2016.

Indexed as

AlbertaBiomarkersBlood PressureBlood Pressure DeterminationClinical ProtocolsCognitive Behavioral TherapyElectrocardiographyFemaleHeart RateHumansHydrocortisoneMindfulnessNeuropsychological TestsPregnancyPregnancy ComplicationsResearch DesignBiomarkersHydrocortisone

Identifiers

PMID27737714
PMCPMC5064936
OpenAlexW2529962934

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.