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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.

Objectives: Internet-based interventions are often hampered by high dropout rates. The number of individuals who decline to participate or dropout are reported, but reasons for dropout are not. Identification of barriers to participation and predictors of dropout may help improve the efficacy of internet-based clinical trials. The aim was to investigate a large number of possible predictors for non-participation and dropout in a randomised controlled trial for women with a negative birth experience and/or post-traumatic stress following childbirth.

Setting: A childbirth clinic at a university hospital in Sweden.

Participants: The sample included 1523 women who gave birth between September 2013 and February 2018. All women who rated an overall negative birth experience on a Likert scale, and/or had an immediate caesarean section (CS), and/or severe postpartum haemorrhage (& GE; 2000 mL) were eligible.

Methods: Demographic, antepartum, and labour-related/postpartum predictors were investigated for non-participation (eligible but denied participation), pre-treatment dropout (prior to intervention start), treatment dropout, and loss to follow-up. Descriptive statistics and logistic regression were used in the data analysis.

Results: A majority (80.3 %) were non-participants. Non-participation was predicted by lower level of education, being foreign-born, no experience of counselling for fear of childbirth, multiparity, vaginal delivery (vs CS and vacuum-assisted delivery) and absence of: preeclampsia, anal sphincter injury and intrapartum fetal distress. Pretreatment dropout was predicted by the absence of severe haemorrhage. Treatment dropout was predicted by vaginal delivery (vs immediate CS), vertex presentation and good overall birth experience. Loss to follow-up was predicted by vaginal delivery (vs immediate CS or vacuum-assisted delivery) and absence of intrapartum fetal distress.

Conclusions: Mothers with no obstetric complications were more likely to not participate and dropout at different time points. Both demographic, antepartum and obstetrical variables are important to attend to while designing procedures to maximise participation in internet-delivered cognitive-behavioral therapy.

Background: Giving birth is often a positive experience, but 7-44% have negative experiences and about 4% develop posttraumatic stress disorder following childbirth (PTSD FC). This randomized controlled trial (RCT) investigated the effect of internet-based cognitive behaviour therapy (iCBT) for women with negative birth experiences and/or at risk for PTSD FC.

Methods: This was a superiority nonblinded multicentre RCT comparing iCBT combined with treatment as usual (TAU) with TAU only. Data were collected through questionnaires at baseline, at 6 weeks, 14 weeks and 1 year after randomization. The RCT was conducted at four delivery clinics in Sweden and participants were recruited from September 2013 until March 2018. Women who rated their childbirth experience as negative on a Likert scale, and/or had an immediate caesarean section or a haemorrhage of > 2000 ml were eligible. Primary outcomes were symptoms of posttraumatic stress (Traumatic Event Scale, TES) and symptoms of depression (Edinburgh Postnatal Depression Scale, EPDS). Secondary outcomes were satisfaction with life (Satisfaction With Life Scale, SWLS) and coping (Ways of Coping Questionnaire, WCQ).

Results: Out of 1810 eligible women, 266 women were randomised to iCBT+TAU (n = 132) or to TAU (n = 134). In the iCBT+TAU group 59 (45%) completed the treatment. ICBT+TAU did not reduce PTSD FC at 6 weeks, at 14 weeks, or at 1 year follow-up compared with TAU, according to the TES. Both the ITT and completer analyses showed significant time and quadratic time effects due to reduction of symptoms in both groups on the TES (re-experience subscale) and on the EPDS, and significant time effect on the self-controlling subscale of the WCQ (which increased over time). There was also a significant main effect of group on the SWLS where the TAU group showed higher initial satisfaction with life. Exploratory subgroup analyses (negative birth experience, immediate caesarean section, or severe haemorrhage) showed significant time effects among participants with negative birth experience on re-experience, arousal symptoms and depressive symptoms.

Conclusions: The ICBT intervention did not show superiority as both groups showed similar beneficial trajectories on several outcomes up to 1 year follow-up. This intervention for women with negative birth experiences and/or at risk for PTSD FC was feasible; however, the study suffered from significant drop out rate. Future studies with more narrow inclusion criteria and possibly a modified intervention are warranted.

Objective: To investigate the effect of internet-based cognitive behaviour therapy (iCBT) on partner relationships and bonding in women with negative birth experiences and/or at risk of posttraumatic stress disorder following childbirth.

Methods: In a superiority multicentre randomised controlled trial conducted in Sweden 2013–2018, 266 women were randomised to iCBT+treatment as usual (TAU) (n=132) or TAU (n=134). The outcome measures were 1) partner communication, 2) quality of partner relationship and 3) mother-infant bonding. Data were collected at baseline, 6 weeks, 14 weeks and one year after randomisation. Mixed-model repeated measures analysis was used.

Results: The trial suffered from a high dropout rate. About 45% (n=59) of women in the intervention group completed the iCBT. In the intention-to-treat analyses, women in both groups reported fewer positive feelings and attitudes toward their partner over time. Partner satisfaction and cohesion declined over time. Mother-infant bonding showed initial improvement, but this later changed into decline over time. In the completer analyses, similar significant time effects were found for both groups. However, there were no significant group or interaction effects on any of the outcome measures in the intention-to-treat or completer analyses. 

Conclusions: In this study, we could not identify any effect of iCBT. However, we observed changes over time for both the intervention and TAU group with decreased quality of partner relationship over time, and initial improvement in mother-infant bonding, which then decreased.