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Published 15 January 2009, doi:10.1136/bmj.a3064
Cite this as: BMJ 2009;338:a3064
C-L Dennis, associate professor and Canada research chair in perinatal community health1,2, E Hodnett, professor and Heather M Reisman chair in perinatal nursing research1, L Kenton, trial coordinator1, J Weston, senior trial coordinator1, J Zupancic, assistant professor of paediatrics3, D E Stewart, university professor and Lillian Love chair in womens health2, A Kiss, biostatistician4
1 Lawrence S Bloomberg Faculty of Nursing, University of Toronto, Toronto, Canada, 2 Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, Canada, 3 Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA, 4 Department of Research Design and Biostatistics, Sunnybrook Health Sciences Centre, Toronto, Canada
Correspondence to: C-L Dennis cindylee.dennis{at}utoronto.ca
Design Multisite randomised controlled trial.
Setting Seven health regions across Ontario, Canada.
Participants 701 women in the first two weeks postpartum identified as high risk for postnatal depression with the Edinburgh postnatal depression scale and randomised with an internet based randomisation service.
Intervention Proactive individualised telephone based peer (mother to mother) support, initiated within 48-72 hours of randomisation, provided by a volunteer recruited from the community who had previously experienced and recovered from self reported postnatal depression and attended a four hour training session.
Main outcome measures Edinburgh postnatal depression scale, structured clinical interview-depression, state-trait anxiety inventory, UCLA loneliness scale, and use of health services.
Results After web based screening of 21 470 women, 701 (72%) eligible mothers were recruited. A blinded research nurse followed up more than 85% by telephone, including 613 at 12 weeks and 600 at 24 weeks postpartum. At 12 weeks, 14% (40/297) of women in the intervention group and 25% (78/315) in the control group had an Edinburgh postnatal depression scale score >12 (
2=12.5, P<0.001; number need to treat 8.8, 95% confidence interval 5.9 to 19.6; relative risk reduction 0.46, 95% confidence interval 0.24 to 0.62). There was a positive trend in favour of the intervention group for maternal anxiety but not loneliness or use of health services. For ethical reasons, participants identified with clinical depression at 12 weeks were referred for treatment, resulting in no differences between groups at 24 weeks. Of the 221 women in the intervention group who received and evaluated their experience of peer support, over 80% were satisfied and would recommend this support to a friend.
Conclusion Telephone based peer support can be effective in preventing postnatal depression among women at high risk.
Trial registration ISRCTN 68337727.
Although extensive research suggests the cause of postnatal depression is multifactorial, epidemiological studies and meta-analyses of predictive studies have consistently highlighted the importance of psychosocial variables.1 10 11 A recent Cochrane review showed that postnatal depression can be treated with psychosocial and psychological techniques.12 The results from another Cochrane review, however, pointed to the need for rigorous evaluations of preventive interventions.13
Detailed analyses of social support variables in predictive studies clearly show a significant increase in the risk of postnatal depression in women who do not have someone to talk openly with who has shared and understood a similar problem,14 lack an intimate confidant or friend,14 15 16 17 do not receive support without having to ask for it,14 and feel socially isolated.18 Depressed mothers participating in a population based study commonly said that they were depressed because of "lack of support" and "feeling isolated."19 When asked what advice they would give to new mothers with postnatal depression, the most common suggestion was "find someone to talk to." Another population based study found that depression scale20 scores were significantly correlated with maternal perceptions of support from other women with children.21 Thus, the provision of support from an experienced mother might be a simple intervention with the potential to prevent postnatal depression.
We evaluated the effect of telephone based peer (mother to mother) support on preventing postnatal depression among women identified as high risk within the first two weeks postpartum. Our hypothesis was that fewer women who received peer support would show evidence of postnatal depression at 12 weeks postpartum than those who did not receive peer support. We defined postnatal depression as a score >12 on the Edinburgh postnatal depression scale20 at 12 weeks postpartum, a measure and cut-off score used internationally by clinicians and researchers.22 23
Design and procedures
We carried out a multisite randomised controlled trial (figure
). After informed consent procedures, the trial coordinator obtained baseline data and randomised eligible participants. Randomisation was centrally controlled with a web based randomisation service (www.randomize.net), with stratification based on self reported history of depression, a known risk factor for postnatal depression.1 11 Women allocated to the control group had access to standard community postpartum care, which could have included, if available, the mother proactively seeking the services from public health nurses, physicians, other providers, and various community resources, including drop-in centres. Women allocated to the intervention group had access to all standard postpartum care in addition to being matched with a peer volunteer. Research nurses blinded to group allocation telephoned all participants at 12 and 24 weeks postpartum to assess trial outcomes. At 12 weeks, women in the intervention group answered questions regarding their experience with the peer volunteer via a mailed questionnaire.25 While trial participants and peer volunteers could not be blinded to group allocation, health professionals and service providers of standard community postpartum care were not informed of any mothers participation in the trial or group allocation.
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Peer volunteer recruitment and training—Through the distribution of flyers, ads in the local newspapers, and word of mouth, 204 women from the community volunteered and met the selection criteria: ability to speak and understand English and self reported history of and recovery from postnatal depression. Peer volunteers were recruited from all health regions and the number recruited was based on region size and ranged from 12 to 66. We employed a paid peer volunteer coordinator to organise recruitment of peer volunteers and obtain informed consent; conduct training sessions for peer volunteers; match women with an appropriate peer volunteer; and monitor implementation of the intervention. All peer volunteers participated in a four hour training session. The focus of the training was to develop skills required to provide effective telephone based support and to make referrals to health professionals as necessary; role playing was an important training strategy. A take-home 121 page training manual developed and piloted by the principal investigator25 was distributed to all new peer volunteers to guide the training session and intervention. During the training sessions, the peer volunteers were given activity logs to complete for each supported mother. Most peer volunteers who participated in the trial were married (n=168, 82%) and had some further education beyond high school (n=187, 91%); 61% (n=125) had had more than one pregnancy and 41% (n=85) were employed, either full time or part time, outside the home. Over half (n=93, 54%) self reported their ethnicity as non-Canadian. Each peer volunteer who actively participated in the trial and was matched with a participant (n=175) on average supported two women (mean 1.97, SD 1.50), with a range from one to seven.
Outcome measures
Postnatal depression was assessed using the Edinburgh postnatal depression scale20 and the structured clinical interview for depression (SCID).27 The depression scale is not diagnostic but is by far the most commonly used measure in research to assess symptoms of postnatal depression, including in treatment and prevention trials.22 23 28 29 The recommended cut-off score of >12 on the depression scale indicates probable depression20 and has been validated by standardised psychiatric interviews with large samples. This measure has well documented reliability and validity in many languages.30 The clinical interview is a diagnostic measure for depression and has excellent evidence of reliability and validity when administered face to face.31 Our secondary outcomes included the state-trait anxiety inventory,32 the short version UCLA loneliness scale,33 and the health service utilisation and cost of care questionnaire,34 which examined the use of 15 diverse health professionals and services (such as walk-in clinic, emergency department). Outcome assessors were trained in data collection procedures and all self reported measures were piloted and have good psychometric properties.25 35 36
Sample size
At the time we developed the trial, only one quasi-experimental postnatal depression prevention study previously identified women at risk by assessing depressive symptoms at baseline.37 Trials of treatment for postnatal depression that have included these assessments, however, have reported spontaneous recovery rates (score <13) in control groups of 25-40%.38 39 40 Furthermore, the difference in recovery rates between groups in these trials was 27-55%, with 66-80% of women in the intervention group being classified as not depressed at follow-up for the primary outcome. To calculate the sample size, we conservatively assumed that 30% of women in the control group who scored >9 at screening would have postnatal depression (score >12) at 12 weeks postpartum. We based our sample size on our ability to detect a moderate decrease of 10 percentage points to a rate of 20% among women in the intervention group. Thus, with 80% power, a two tailed
error of 0.05, and using a test of two independent proportions to find a 10% reduction in the rate of postnatal depression by 12 weeks postpartum, we required a sample size of 586 (293 per group). We therefore planned to enrol 700 to allow for losses to follow-up.
Statistical analysis
All data were collected by phone interview and were entered directly on a Microsoft Access database. Built in logic and range checks allowed for immediate correction of errors and insertion of missing data. Data were analysed with SAS version 9.1 and an intention to treat approach. The biostatistician completed an interim analysis of the primary outcome and provided results to the data safety monitoring committee, who had no safety concerns. We used a significance level of 0.05 for the primary outcome of postnatal depression and 0.01 for secondary outcomes to account for multiple comparisons. Continuous variables were analysed with two sample two sided t tests. For binary variables, we carried out
2 analyses and have presented odds ratios with 95% confidence intervals. To assess the change over time across groups (that is, a group by time interaction) for the primary outcome, we ran generalised estimating equation models, with one model looking at the change from baseline to 12 weeks and the second looking at the change from baseline to 24 weeks.
We used multiple logistic regression analysis to assess the effect of the intervention on postnatal depression at 12 weeks after controlling for baseline characteristics. Before analysis, we assessed the baseline variables for the presence of multicollinearity. We retained only one member of a correlated set (significant correlation coefficient >0.8) for the final model. To identify which variables offered a significant contribution to the prediction of depression scores, in addition to group status, the regression modelling technique41 involved looking initially at a model with only the key predictor variable of interest (group status) and the dependent variable (score >12 at 12 weeks postpartum). The parameter estimate signifying the relation between group status and the dependent variable was noted and then one of the covariates was added to this model. We noted whether this new covariate changed the parameter estimate for the key variable group status by more than 10%. If it did, we retained this variable for the final multivariable model. This procedure was repeated for each individual covariate, resulting in a reduced set of variables for the final logistic regression model.
Table 1 shows characteristics of the participants
. There were no clinically important differences between the two groups. The mean scores at baseline were 12.50 (SD 2.80) in the intervention group and 12.62 (SD 2.76) in the control group. At 12 weeks postpartum, 613 (87.4%) participants completed the follow-up telephone interview, decreasing slightly to 600 (85.6%) participants at 24 weeks. There were no baseline differences between women included in the analyses and those who were lost to follow-up at 12 weeks. To assess for blinding of the outcome assessor, at the end of the interview the data collection nurses indicated whether they thought the participant was in the control group or the intervention group or they did not know. At the 12 week interview, the data collection nurses had no opinion regarding which group 595 (97%) women were allocated to; a similar rate was found at the 24 week interview (n=588, 98%).
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2=12.5, P<0.001; number needed to treat 8.8, 5.9 to 19.6; relative risk reduction 0.46, 0.24 to 0.62). These results suggest women who received the peer support intervention were at half the risk of developing postnatal depression at 12 weeks postpartum than those in the control group. We found no significant group differences at 24 weeks (
2=2.53, P=0.11), when 11% (33/289) of women in the intervention group and 14% (43/311) in the control group had a score >12 (odds ratio 1.22, 0.75 to 1.98). This 24 week finding was expected considering that this was a prevention trial and for ethical reasons any participants identified at 12 weeks with severe depression or who had a score >20 were referred to their local public health department for treatment. Confirmation of referral for treatment was noted when women in the control group reported more home visits by a public health nurse at the 24 week assessment than those in the intervention group (4.45 (SD 3.49) v 3.02 (SD 2.54); t=2.21, P=0.03). The accuracy of our diagnostic data can be questioned. We might have underestimated the training needs of the data collection nurses in relation to completing the structured clinical interview over the telephone with our multiethnic sample. We also had to use a shortened version of the depression module because of the feasibility of administering a clinical interview via telephone with mothers of young infants. Only 37 (6%) women in the whole sample were identified with clinical depression at 12 weeks postpartum (14/297 (5%) in intervention group and 23/315 (7%) in control group). This prevalence is significantly lower than the overall 13% reported by OHara and Swain1 in a meta-analysis of 59 studies and the 12% rate found with interview based methods (31 studies), which included a 11% estimate based on research diagnostic criteria (19 studies). It is also inconsistent with research clearly suggesting women with depressive symptoms in the early postpartum period are at significantly higher risk of developing postnatal depression.20 24 42 43 44 45 46 47 48 The uncertain accuracy of our data should highlight the problems associated with using generalist nurses as data collectors administering the interview over the telephone with a multicultural sample and the need to use complete interview modules, despite feasibility issues.
At 12 weeks postpartum, 61 (21%) women in the intervention group had a score >44 on the state-trait anxiety inventory compared with 86 (27%) in the control group (odds ratio 1.44, 0.99 to 2.10;
2=3.66, P=0.055); we found no significant group differences at 24 weeks postpartum. Table 2 shows mean scores related to all trial outcomes including loneliness and total use of health services
. At 12 weeks comparable numbers of women in the intervention (n=11, 4%) and control (n=19, 6%) groups were taking antidepressants (
2=1.70, P=0.19). At 24 weeks there was no significant difference in antidepressant use between the groups (16 (6%) v 29 (10%),
2=3.05, P=0.08).
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2=16.16, P<0.001), not born in Canada (
2=13.93, P=0.002), and less than five years in Canada (
2=5.19, P=0.02). Multicollinearity was not a concern among the independent variables in the model before analysis. The modelling procedure resulted in a final model, which included the variables trial group status (P<0.001), history of depression (P<0.001), and no other individual to talk to who has a baby or young children (P<0.001) (table 3
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While there was no relation between screening depression scores and peer volunteer interactions, scores at 12 weeks postpartum were correlated to total number of peer volunteer contacts (r=0.25, P<0.001) and number of conversations (r=0.25, P<0.001). In particular, women who had a score >12 at 12 weeks had significantly more contacts with their peer volunteer than those with a score
12 (11.96 (SD 6.96) v 8.30 (SD 5.86); t=2.97, P=0.003); we found similar results with total number of conversations (t=3.61, P<0.001).
Maternal satisfaction with intervention
Two hundred and twenty one (63%) women in the intervention group returned mailed evaluations of their experiences with peer volunteers. Overall, 81% (n=161) of women were satisfied with their experience (table 4
). Maternal overall satisfaction was weakly correlated with total number of peer volunteer contacts (r=0.35, P<0.001), number of conversations (r=0.29, P=0.001), and number of messages left (r=0.29, P=0.001).
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Strengths and weaknesses
We used population based screening via a web based system and our participation rate was above 70%. The intervention was pilot tested and standardised through specific selection criteria for peer volunteers, formal training, and structured activities for the volunteer coordinator to ensure initiation of the intervention. Postnatal depression was assessed with the Edinburgh postnatal depression scale, the most commonly used measure in treatment and prevention trials to assess for symptoms of postnatal depression. All self reported outcome measures and procedures were pilot tested, the data collection nurses were trained and assessed for blinding to group allocation, and our losses to follow-up were below 15%. Women also evaluated their experience of peer support, providing valuable data on acceptance of the intervention. In relation to external validity, we recruited from seven health regions across the province with many participants identifying themselves as of non-Canadian ethnicity; around half of the women were not born in Canada and almost 20% had moved to Canada about five years previously. Thus, the generalisability of our results is good.
Despite the many strengths, our results are limited in that the clinical diagnostic data for postnatal depression might be questionable. While the structured clinical interview was developed to be administered face to face by a mental health specialist, in our trial it was feasible for the generalist nurses to administer only a shortened version of the depression module by telephone. This had not been formally validated. Furthermore, our sample was significantly more ethnically diverse than the sample in the one previous postnatal depression study that administered the interview by telephone.49 While we attempted to be the first postnatal depression prevention trial to administer a diagnostic interview, the depression rates are lower than previous prevalence rate data at 12 weeks postpartum.1 Conversely, the results of the Edinburgh postnatal depression scale were consistent with our power analysis, previous research,1 and recent work that supports the use of the scale in multiethnic samples.50 Additional research would determine how to obtain SCID clinical diagnostic data effectively in large, multisite trials in which face to face interviews are not feasible and the sample is multiethnic. Other limitations include the pragmatic exclusion of women who did not speak English and that for an appreciable proportion of women in the intervention group peer volunteers did not return activity logs. This might indicate that some women had limited interaction with their peer volunteer, despite our request for a minimum of four contacts. Furthermore, there is evidence that the intervention was not initiated in a few cases. These findings highlight the critical role of the peer volunteer coordinator in initiation of the intervention and compliance of volunteers.
Comparison with other research
Our results are consistent with those in a large Cochrane review, which suggests that interventions to prevent postnatal depression are more likely to be successful if they are individually based, initiated postnatally, and target high risk women.13 Our study is also one of the few trials that showed a preventative effect for postnatal depression,28 29 evaluated a secondary preventive intervention where women were screened for depressive symptoms in the first two weeks postpartum, and examined the effect of any peer/lay intervention in the prevention of postnatal depression. As such, this trial is original and makes an important contribution to research on postnatal depression. Furthermore, our findings could be applied in community based settings to devise policies regarding strategies to prevent postnatal depression.
Our results are also consistent with research linking depressive symptoms with smaller social networks, fewer close relationships, and lower perceived adequacy of social support.51 52 Furthermore, our findings provide evidence that lay people who have experienced a similar health problem or stressor can have a positive effect on psychological wellbeing.53 54 There are several possible explanations as to why the peer volunteers prevented depressive symptoms in the first 12 weeks postpartum. Members of a social network can exert a salutary influence on mental health by role modelling health relevant behaviours.55 Integration in a social network might also directly produce positive psychological states, including a sense of purpose, belonging, and recognition of self worth.54 These positive states, in turn, might benefit mental health because of an increased motivation for self care, as well as the modulation of the neuroendocrine response to stress.54 Being part of a broader social structure (such as involvement in social networks and immersion in close relationships) enhances the likelihood of accessing various forms of support, which in turn protects against distress.56 Finally, the perceived availability of social support in the face of a stressful event might have led to a more benign appraisal of the situation, thereby preventing a cascade of ensuing negative emotional and behavioural responses.57 While the causal pathway is unknown, theoretically all are viable options.
Anxiety often occurs with depression,58 and in our trial there was a trend for women in the intervention group to have lower levels of anxiety at 12 weeks postpartum. Fourteen independent prospective studies have shown a relation between antenatal maternal anxiety or stress and cognitive, behavioural, and emotional problems in the child.59 The continuity of antenatal anxiety into the postpartum period is also well documented,58 with postnatal anxiety being linked to poor maternal-infant interactions.60 Despite these findings, maternal anxiety has received little empirical attention,61 and further research examining the prevention and treatment of this condition is warranted.
Consistent with previous research, a history of depression was a significant risk factor for the development of postnatal depression.11 One unique finding, however, was the importance of self reported non-Canadian ethnicity and living in Canada for less than five years in the presentation of depressive symptoms in the immediate postpartum period. Among the few studies that have examined immigrant status, all have found this variable to be significantly related to postnatal depression.36 62 63 While scant research has been conducted as to why these women are at risk, investigations with general immigrant populations have clearly shown a link between the acculturation process and psychological problems.64 65 Acculturation refers to the process of adjusting to life modifications, and, depending on the disparity between the two cultures, acculturative stress is a common outcome often resulting in an increased risk of depression.64 66 While considerable attention has been paid to the importance of acculturative stress on depression among populations of immigrants25 66 67 68 69 70 71 and the impact of stressful life events on maternal mood,11 the relation between acculturation, acculturative stress, and postnatal depression has received scant attention.
The number of contacts with peer volunteers was significantly correlated with depression scores at 12 weeks, suggesting that mothers with depressive symptoms were receptive to the peer support intervention. This finding also indicates that the peer volunteers could identify potentially depressed mothers and respond to individual needs for support. Given that the aetiology of postnatal depression is multifactorial,1 11 it is not surprising that peer support was not protective for all women and that referrals to health professionals were required. Consistent with previous research,72 women positively evaluated their experience of telephone based peer support. Traditionally, support has been provided through groups, but these tend to be poorly attended by new mothers and those who are feeling depressed. Telephone based support interventions are not only flexible, private, and non-stigmatising but they also reduce differences related to socioeconomic status and traditional healthcare barriers such as accessibility because of transportation difficulties or geography.73 74 While in the past decade advances in technology, such as the use of email and the internet, have enhanced the range of options available for "home to home" support, the telephone remains the most accessible for most people.75
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Cite this as: BMJ 2009;338:a3064
Funding: This work was supported by the Canadian Institutes of Health Research grant number MCT 66874. This trial was conducted and data analysed with complete independence of the researchers from the Canadian Institutes of Health Research.
Competing interests: None declared.
Ethical approval: This study was approved by the University of Toronto ethics committee and ethical review boards of participating health regions. Informed consent was given by all participants.
Provenance and peer review: Not commissioned; externally peer reviewed.
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