Wahlbeck 2020.

Study characteristics
Methods	An open, randomised, controlled trial with 2 arms to compare treatment alternatives for severe FOC.
Participants	Setting: Participants were recruited between March 2011 and March 2017 from 10 antenatal clinics in southern Sweden. At these clinics, all women who register their pregnancy are asked to indicate, on a visual analogue scale, the extent of their fear of the approaching birth. Scores above 7 are considered high enough to require treatment and these women are referred to a specialist group at the obstetric unit at the regional hospital. When contact was made with the specialist group, these women were invited to join the study. Inclusion criteria: Scores above 7 are considered high enough to require treatment and these women are referred to a specialist group at the obstetric unit at the regional hospital. When contact was made with the specialist group, these women were invited to join the study. Statistics from the unit (unpublished) show that 4.3% of pregnant women were referred to the specialist group because of severe FOC during the data collection period. Exclusion criteria: Pregnant women who did not understand or speak Swedish, had physical hindrance for a vaginal birth or were diagnosed with obstetrical complications, a current depression requiring medical intervention, acute psychosis or current substance abuse were excluded from the study. Women who registered later than the 35th gestational week were also excluded since there was a risk that the treatment could not be finished before the birth.
Interventions	Experimental intervention (n = 55): midwife‐led counselling plus art therapy (AT). Women in the intervention group invited to 5 AT sessions. The aims were to reduce FOC and motivate more women to give vaginal birth. When only 1 participant was recruited, AT was provided individually. When more than 1 was recruited, participants could choose individual or group AT. A group was limited to 3 participants. 27 women were treated individually and 12 in the group. The sessions were given between 28 and 36 gestational weeks and held in a locality outside of the hospital surroundings. Painting was offered as a tool for self‐reflection to release feelings they were unable to express elsewhere, to strengthen the process of bonding with their baby, and to initiate the counselling component of AT. The sessions were given once per week and lasted between 90 and 120 minutes. The art therapist was a midwife and first author in this study. Comparator (n = 48): midwife‐led counselling only
Outcomes	Outcomes: Pregnant women whose FOC decreased from severe (≥ 100 W‐DEQ points) to any level below this (≤ 99 W‐DEQ points) after treatment in Study Group (SG) or Control Group (CG). Secondary outcomes: (1) comparison of changes in the mean W‐DEQ between measurements at recruitment and at the end of treatment for SG and CG; (2) comparison of number of Midwifery Counselling (MC) sessions required by SG and CG; (3) comparison of type of birth; normal vaginal birth versus all other types of birth between SG and CG; and (4) number of women with higher levels of FOC after treatment.
Notes	Sources of trial funding: This research received a grant of 2,500 US dollars from Procter and Gamble. The company had no commercial interest in the use of AT. Trial author declaration of interest: Nothing reported. First author was a midwife and conducted the art therapy sessions. Author (Kajsa Landgren) contacted for WDEQ A mean and SD on 13/11/20202 and data provided 16/11/2020
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	When the questionnaires were completed, randomisation was carried out via a computer‐generated randomisation chart and the individual was informed whether she had been randomised to the control group (CG) or the study group (SG). Randomisation was preceded by stratification.
Allocation concealment (selection bias)	High risk	When the questionnaires were completed, randomisation was carried out via a computer‐generated randomisation chart.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Open unblinded trial.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Outcomes were analysed with the on‐treatment technique using SPSS version 25. No mention of blinding of outcome assessors.
Incomplete outcome data (attrition bias) All outcomes	High risk	39/55 and 43/48 included in the analysis. Differential attrition and no indication that any statistical adjustment was made to account for missing data.
Selective reporting (reporting bias)	Low risk	All reported as specified in the paper and protocol.
Other bias	Unclear risk	Lead author was a midwife and delivered the art therapy sessions (intervention) ‐ unclear if author's involvement could have had any effect on outcomes.

CS: caesarean section; FOB: fear of birth; FOBS: Fear of Birth Scale; FOC: fear of childbirth; SG: Study Group; CG: Control Group;MC: Midwifery Counselling