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

Abstract

Background: About 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/design: Women 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 registration: ISRCTN39318241 . Date for registration 12/01/2017, retrospectively registered.

Keywords: Immediate caesarean section; Negative birth experience; PTSD; PTSD following childbirth; Postpartum haemorrhage; Posttraumatic stress following childbirth; Study protocol; iCBT.

Fig. 1

JUNO flow diagram

Fig. 2

JUNO flow diagram. Note. TAU treatment as usual; iCBT=internet delivered cognitive behavior therapy TES The Traumatic Event Scale, EPDS Edinburgh Postnatal Depression Scale, SWLS The Satisfaction with Life Scale, WCQ The Ways of coping questionnaire, ENRICH The communication subscale from the Evaluation and Nurturing Relationship Issues, Communication and Happiness, RDAS The Revised Dyadic Adjustment Scale, PBQ The Postpartum Bonding Questionnaire, EQ-5D EuroQol 5D, SF-36 Short Form Health Survey – 36, HADS Hospital Anxiety and Depression Scale, National register data = The medical birth register, the national patient register, the Swedish prescribed drug register, QPP Quality from the patient’s perspective, Health history = Information about previous pregnancies and births are collected at baseline; Obstetric data regarding pregnancy = childbirth, the post partum period and other medical data concerning the current childbirth X¹ approximately 6-8 weeks after giving birth, this includes assessment of depression (EPDS)