Evidence map›Paper›PMID 30285758›Full record

Trial reportBMC pregnancy and childbirth2018

A longitudinal, multi-centre, superiority, randomized controlled trial of internet-based cognitive behavioural therapy (iCBT) versus treatment-as-usual (TAU) for negative experiences and posttraumatic stress following childbirth: the JUNO study protocol.

Josefin Sjömark, Thomas Parling, Maria Jonsson, Margareta Larsson, Agneta Skoog Svanberg

Abstract readMulticenter StudyRandomized Controlled TrialEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC pregnancy and childbirth, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Article
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

5 authors.

Josefin SjömarkDepartment of Women's and Children's Health, Uppsala University, Akademiska sjukhuset, SE-751 85, Uppsala, Sweden. josefin.sjomark@kbh.uu.se.ORCID http://orcid.org/0000-0002-4093-7346
Thomas ParlingDepartment of Women's and Children's Health, Uppsala University, Akademiska sjukhuset, SE-751 85, Uppsala, Sweden.
Maria JonssonDepartment of Women's and Children's Health, Uppsala University, Akademiska sjukhuset, SE-751 85, Uppsala, Sweden.
Margareta LarssonDepartment of Women's and Children's Health, Uppsala University, Akademiska sjukhuset, SE-751 85, Uppsala, Sweden.
Agneta Skoog SvanbergDepartment of Women's and Children's Health, Uppsala University, Akademiska sjukhuset, SE-751 85, Uppsala, Sweden.

Funding

The Regional Research Council (Regionala Forskningsrådet; http://www.researchweb.org/is/sverige 368901, 308451, 480141
6 · The paper itself

Abstract

backgroundAbout one-third of women report their childbirth as traumatic and up to 10% have severe traumatic stress responses to birth. The prevalence of Posttraumatic stress disorder following childbirth (PTSD FC) is estimated to 3%. Women with PTSD FC report the same symptoms as other patients with PTSD following other types of trauma. The effect of psychological treatment for women with PTSD FC has only been studied in a few trials. Similarly, studies on treatment needs for women not diagnosed as having PTSD FC but who nevertheless face psychological problems are lacking. METHODS/

designWomen who rate their overall birth experience as negative on a Likert scale, and/or had an immediate caesarean section and/or a major postpartum haemorrhage are randomized to either internet delivered cognitive behaviour therapy (iCBT) plus treatment as usual (TAU) or TAU. The iCBT is to be delivered in two steps. The first step consists of six weekly modules for both the woman and her partner (if they wish to participate) with minimal therapeutic support. Step 2 consists of eight weekly modules with extended therapeutic support and will be offered to participants whom after step 1 report PTSD FC. Assessments will be made at baseline, 6 weeks, 14 weeks, and at follow-ups at 1, 2, 3 and 4 years after baseline. The primary outcome measures are symptoms of posttraumatic stress and depression. Secondary outcomes are quality of life, parent-child bonding, marital satisfaction, coping strategies, experience regarding the quality of care received, health-related quality of life, number of re-visits to the clinic and number of appointments for counselling during the 4 years' period after the negative childbirth experience, time until the woman gets pregnant again, and the type of birth in the subsequent pregnancy. A health economic evaluation in the form of a cost utility analysis will be conducted. DISCUSSION: This study protocol describes a randomized controlled trial that will provide information about the effectiveness of iCBT in women with negative experiences, posttraumatic stress, and PTSD FC.

trial registrationISRCTN39318241 . Date for registration 12/01/2017, retrospectively registered.

Indexed as

AdultCognitive Behavioral TherapyDelivery, ObstetricDepression, PostpartumFemaleHumansLongitudinal StudiesParturitionQuality of LifeResearch DesignStress Disorders, Post-TraumaticTherapy, Computer-AssistedYoung AdultiCBTImmediate caesarean sectionNegative birth experiencePostpartum haemorrhagePosttraumatic stress following childbirthPTSDPTSD following childbirthStudy protocol

Identifiers

PMID30285758
PMCPMC6167807

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Registered trials

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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.