Hajarian Abhari 2021.

Study characteristics
Methods	Study design: RCT Duration of study: the study was conducted in 2018. Country: Iran Income classification: upper‐income country in 2018 Geographical scope: Mashhad Healthcare setting: health centres
Participants	1. Age: 18‐35 [mean age 23.3 years (SD 3.9) for intervention group and 24.4 (SD 4.4) years for control group] 2. Gender: female 3. Socioeconomic background: 76.7% of the sample reported unsatisfactory income level. 4. Educational background: 40‐43% had a diploma. Inclusion criteria: a. Iranian and residency in Mashhad; b. primiparous women; c. age range of 18‐35 years; d. basic literacy; e. gestational age of 35 weeks; f. singleton pregnancy; g. intentional pregnancies; h. no high‐risk pregnancy; i. absence of foetal anomalies and disorders based on ultrasonography; j. no history of medical and psychological disorders or use of psychiatric medications; k. no drug or alcohol addiction; l. no history of infertility; m. absence of Post‐Traumatic Stress Disorder (PTSD) and severe depression, anxiety, and stress based on Depression, Anxiety and Stress Scale—21 Items (DASS‐21) (score less than 20 for depression, less than 14 for anxiety and less than 25 for stress), and no causes for C‐section. Exclusion criteria: a. absence in the counselling programme for more than one session; b. occurrence of high‐risk complications during pregnancy, during/after delivery; c. occurrence of stressful events during the study. Note: at baseline, the intervention and control group scores for the DASS‐21 were, respectively, 8.7 (1.7) and 8.7 (1.8). Stated purpose: to assess the effect of counselling based on Gamble's approach on postpartum anxiety in primiparous women
Interventions	Name: midwife‐led individual counselling based on Gamble's approach Title/name of PW and number: midwives (1 delivered the intervention but 5 midwife researchers in total) 1. Selection: not specified 2. Educational background: university (department of nursing and midwifery) 3. Training: not specified 4. Supervision: not specified 5. Incentives/remuneration: none Prevention type: indicated prevention – participants presented some level of distress as indicated by DASS‐21 scores, but all those who presented severe levels were excluded. Intervention details: counselling based on Gamble’s approach is designed based on the principles of cognitive‐behavioural therapy. In this counselling, it is believed that people's beliefs, thoughts, and attitudes affect their feelings and behaviour. Counselling based on Gamble’s approach involves 9 strategies, including the development of a midwife‐parturient woman medical relationship, acknowledgement of the maternal feeling about delivery, assisting mothers to reveal their emotions, eliminating mothers' ambiguities, connecting behaviours, emotions, and delivery, revision of the stages of delivery, developing social support, promoting maternal adaptation, encouraging positive maternal perceptions, and finding solutions. Control: usual care (routine prenatal care and training)
Outcomes	Participants’outcomes of interest for this review Anxiety symptoms – DASS‐21 Carers’ outcomes of interest for this review Nil Economic outcomes Nil Time points:  baseline, post‐intervention (< 1 month)
Notes	Source of funding: not specified Notes on validation of instruments (screening and outcomes): the questionnaire was validated in a study carried out by Sahebi 2005, and in the study by Effati‐Daryani 2017 for utilization during pregnancy and postpartum. In the current study, the Cronbach alpha reliability coefficient for the scales of depression, anxiety, and stress was reported as 0.82%, 0.74%, and 0.78%, respectively. Additional information: none Handling the data: not applicable Prospective trial registration number: IRCT20180520020039747N1