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Cochrane Database of Systematic Reviews Protocol - Intervention

Psychosocial interventions for preventing postpartum depression

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Abstract

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:

The primary objective of this review is to assess the effects, on mothers and their families, of preventive psychosocial interventions compared with usual antepartum, intrapartum, or postpartum care to reduce the risk of postpartum depression.

Secondary objectives are to examine:
1. the effectiveness of individual versus group‐based interventions;
2. the effectiveness of face‐to‐face versus telephone‐based interventions;
3. the differences between professional versus lay interventions;
4. the effects of timing and duration of the interventions;
5. whether psychosocial interventions are more effective in women with specific risk factors than the general population.

Background

Mood disorders following childbirth range in severity from the mild and transient "baby blues" experienced by 50‐80% of women to postpartum psychosis, a serious condition which affects less than 1% of mothers and usually requires hospitalization (Evins 1997). Along this spectrum is postpartum depression (PPD), a condition often exhibiting the disabling symptoms of uneasiness, irritability, confusion and forgetfulness, fatigue, insomnia, anxiety, guilt, inability to cope, and suicidal ideation. Frequently exacerbating these symptoms are low self‐esteem, lack of confidence, and unrealistic expectations of motherhood. The development of PPD is greatest in the first three months postpartum with duration frequently dependent on severity (Cox 1993). Residual depressive symptoms are common and if left untreated, PPD often continues past the first year postpartum (Cooper 1998).

PPD is a major health issue for many women. Longitudinal and epidemiological studies have yielded varying prevalence rates, ranging from 3% to more than 25% of women in the first year after delivery; these rates fluctuate due to measurement and theoretical issues including sample size, timing of assessment, and differing diagnostic criteria. Frequently cited estimates range between 10‐15% and a meta‐analysis of 58 studies reported the incidence of postpartum depression to be 13% (O'Hara 1996).

This morbidity has well documented public health consequences for the mother, child, and family. While women who have suffered from PPD are twice as likely to experience future episodes of depression over a five year period (Cooper 1995), infants and children are particularly vulnerable. PPD has been linked directly and indirectly to negative maternal‐infant interactions and perceptions of infant behaviour (Campbell 1995; Mayberry 1993), cognitive and emotional developmental delay (Cogill 1986; Murray 1992), and child neglect/abuse (Buist 1998). Behavioural difficulties in older siblings (Williams 1985) and marital stress resulting in separation or divorce (Boyce 1994) are other reported outcomes linked to PPD.

The etiology of PPD remains unclear and there is little evidence to support a biological basis (O'Hara 1997). Despite considerable research, no single causative factor has been isolated. However, consistent findings suggest the importance of psychosocial variables (Cooper 1998; O'Hara 1997). In particular, stressful life events (Bernazzani 1997; O'Hara 1991), marital conflict (Bernazzani 1997; O'Hara 1991; O'Hara 1986), and the lack of social support (Bernazzani 1997; Brugha 1998; Cooper 1998; O'Hara 1986; Small 1994; Stein 1989; Stuchbery 1998) have been found to significantly increase the risk of PPD. The saliency of social support was especially highlighted in a predictive study of several thousand women where mothers who lacked social support were approximately two times more likely to develop PPD than mothers with sufficient support (Cooper 1996). It is noteworthy that there is little evidence to support the existence of PPD in non‐industrialized societies (Romito 1989).

To address this issue, a variety of psychosocial interventions have been developed to treat PPD. For example, randomized controlled trials evaluating cognitive‐behavioural counselling with antidepressants (Appleby 1997), cognitive‐behavioural therapy and non‐directive counselling (Cooper 1997), and health visitor‐led non‐directive counselling (Holden 1989; Wickberg 1996) have all demonstrated the amenability of PPD to treatment (Ray 2001). However, it is theoretically possible that psychosocial interventions may prevent PPD as many of the known risk factors for PPD are present during pregnancy and the immediate postpartum period. Furthermore, a number of studies have suggested that there is an overlap between antenatal and postpartum depression, in that there are significant correlations among Edinburgh Postnatal Depression Scale scores at varying antenatal and immediate postnatal time periods (Appleby 1994; Hannah 1992; Lane 1997; Yamashita 2000). While psychosocial interventions may be effective treatment strategies (Ray 2001), they may also be used in pregnancy and the early postpartum period to prevent postpartum depression.

Objectives

The primary objective of this review is to assess the effects, on mothers and their families, of preventive psychosocial interventions compared with usual antepartum, intrapartum, or postpartum care to reduce the risk of postpartum depression.

Secondary objectives are to examine:
1. the effectiveness of individual versus group‐based interventions;
2. the effectiveness of face‐to‐face versus telephone‐based interventions;
3. the differences between professional versus lay interventions;
4. the effects of timing and duration of the interventions;
5. whether psychosocial interventions are more effective in women with specific risk factors than the general population.

Methods

Criteria for considering studies for this review

Types of studies

All published or unpublished randomized or quasi‐randomized controlled trials that address the primary and secondary objectives. Specific inclusion criteria: controlled trial comparing a psychosocial intervention by a professional or lay individual with usual care; random allocation to treatment and control groups; violations of allocated management insufficient to materially affect outcomes; loss to follow‐up insufficient to materially affect the comparison; and data available in a form suitable for analysis.

Types of participants

Pregnant women and new (< 6 weeks postpartum) mothers including those at no known risk and those identified as high‐risk to develop PPD.

Types of interventions

A variety of non‐pharmaceutical interventions, including psychoeducational strategies, cognitive‐behavioural or non‐directive counselling, various supportive interactions, and tangible assistance, delivered via telephone, home or clinic visits, or individual or group sessions antenatally and/or within the first month postpartum by a professional (nurse, midwife, childbirth educator, physician) or lay person (a specially trained woman from the community, a student) with the primary or secondary outcome the reduction of risk to develop postpartum depression compared with women who receive any form of standard or usual care. Psychotherapeutic interventions involving a specific type of psychotherapy delivered by a psychiatrist or psychologist will be excluded.

Types of outcome measures

Maternal outcomes:
1. postpartum depression symptomatology (as variously defined and measured by trialists);
2. postpartum psychosis;
3. major postpartum depression (defined as a score greater than 12 on the Edinburgh Postnatal Depression Scale (EPDS) or as diagnosis by a psychiatric interview);
4. mild postpartum depression (defined as a score greater than nine on the EPDS or as diagnosis by a psychiatric interview);
5. maternal mortality and serious morbidity including self‐harm, suicide attempts;
6. health service utilization including outpatient and inpatient use of psychiatric unit, other health services;
7. use of anti‐depressant medication;
8. maternal‐infant attachment;
9. maternal attitudes towards motherhood;
10. maternal anxiety, stress;
11. maternal confidence, competence, esteem;
12. general health;
13. maternal dissatisfaction with intervention;
14. need for electroconvulsive therapy.

Infant outcomes:
1. breastfeeding duration at 1, 3, 6 months postpartum;
2. breastfeeding level (exclusive, almost exclusive, high, partial, token, bottle‐feeding);
3. infant health parameters including immunization, accidental injury, nonaccidental injury;
4. infant developmental assessments (variously defined);
5. child abuse and/or neglect;
6. neonatal/infant mortality;
7. neonatal/infant morbidity;
8. quality of mothering (variously defined).

Family outcomes:
1. marital discord;
2. marital separation/divorce.

Search methods for identification of studies

This review will draw on the search strategy developed for the Pregnancy and Childbirth Group as a whole. The full list of journals and conference proceedings as well as the search strategies for the electronic databases, which are searched by the Group on behalf of its reviewers, are described in detail in the 'Search strategies for the identification of studies' within the editorial information about the Cochrane Pregnancy and Childbirth Group. Briefly, the Group searches on a regular basis MEDLINE, the Cochrane Controlled Trials Register and reviews the Content tables of a further 38 relevant journals via ZETOC, an electronic current awareness service. Relevant trials, which are identified through the Group's search strategy, are entered into the Group's Specialised Register of Controlled Trials. Please see Review Group's details for more detailed information. From the Group's specialised Register of Controlled Trials, relevant trials for this review will be identified.

Relevant trials will also be identified using the Cochrane Collaboration Depression, Anxiety and Neurosis search strategy and specialized Register of Controlled Trials. Secondary references will be scanned and relevant studies obtained. Contact will be made with experts in the field to identify other published or unpublished trials.

Data collection and analysis

Selection of Trials
Titles and abstracts of the electronic searches will be reviewed by both reviewers. Trials under consideration will be evaluated by both reviewers independently for methodological quality and appropriateness for inclusion, without consideration of their results. In the case of uncertainties regarding the appropriateness for inclusion, resolvement will be established through discussion and consensus.

Methodological Quality Assessment
Quality assessment of trial validity will be carried out by both reviewers. Details of randomization, concealment allocation, blinding, and exclusions from data analyses will be recorded and evaluated. Unbiased methods of randomization that will be considered acceptable include random numbers generated by computer or sequentially numbered opaque sealed envelopes containing random allocation. Both reviewers will assign a rating to each trial according to criteria described by Clarke 2000. Only trials in categories A or B will be included in this review. Results will be compared and differences discussed until agreement is obtained. Reasons for exclusion of any apparently eligible trial will be clearly described.

Data Extraction
Data will be extracted independently from trial reports by both reviewers using a pilot‐tested data extraction form. Wherever necessary, unpublished or missing data will be requested from the trial contact author. In addition, data will be sought to allow an 'intent to treat' analysis. Data will be entered into RevMan 2000 by one reviewer and all entries will be checked by the other reviewer.

Data Synthesis
Trials using different treatments will be analysed separately and the results combined only if there is no reason to think that they differ in relevant ways. While the primary meta‐analysis will be based on the occurrence of postpartum depression or not (however measured by trialists), a variety of depression rating scales will be incorporated with some trials using more than one scale on participants. To address the potential measurement differences, where possible, direct comparisons using a fixed effect model will be made between trials using the same rating scales. In trials where participants were assessed using more than one rating scale, all data will be presented. Odds ratios and 95% confidence intervals will be calculated for categorical and dichotomous (depressed/not depressed) data. Continuous data will be pooled as weighted mean differences. An assessment will be made of the extent to which there are between‐study differences including variations in the population or intervention. In the event of significant clinical or statistical heterogeneity, the results will not be combined in a meta‐analysis. Sensitivity analysis will be used where appropriate to determine the effects of the trials' methodological quality on the results. Wherever possible, sub‐group analyses will be undertaken based on maternal factors such as parity, marital status, availability/perceived availability of support, multiple pregnancy, preterm birth, previous depressive episode (including depression independent of childbirth), age, mode of delivery, domestic violence, and socioeconomic status. In addition, relevant narratives from participants will be included as a qualitative commentary.