Early intervention to prevent adverse child emotional and behavioural development following maternal depression in pregnancy: study protocol for a randomised controlled trial.

BACKGROUND: Substantial evidence indicates that maternal depression during pregnancy (i.e., antenatal depression) is associated not only with maternal wellbeing but also with child emotional and behavioural development. Children of antenatally depressed women are at risk of emotional and behavioural problems, including internalising problems (e.g., anxiety and depression) and externalising problems (e.g., attention problems), that may last at least to adolescence. These enduring effects also constitute an enormous economic cost. Despite the seriousness of this problem, until recently there existed very few controlled studies evaluating whether active psychological treatment for antenatal depression can prevent adverse child outcomes. Our previous pilot randomised controlled trial (RCT) exploring the effect of cognitive behavioural therapy (CBT) for antenatal depression on child outcomes showed promising results. We aim to assess whether treating antenatal depression with an evidence-based 8-week structured CBT program can prevent or ameliorate adverse child developmental outcomes at 2 years of age. METHODS: Pregnant women ≤ 30 weeks gestation diagnosed with a depressive disorder are recruited and randomised to CBT or treatment as usual (TAU). The target sample size is 230 and the primary outcome measure is the infant Internalising scale of the Child Behaviour Checklist (CBCL) at 24 months of age. Secondary infant outcome measures at 24 months are the Externalising scale of the CBCL and the motor and cognitive development subscales of the Ages & Stages Questionnaire (ASQ-3). Additional secondary outcome measures are subscales of the Revised Infant Behaviour Questionnaire (IBQ-R), ASQ-3 and the ASQ-Socio-Emotional (ASQ-SE) at 3 and 12 months of age and the quality of mother-infant interaction at 3 and 24 months. Maternal measures, including demographic data, depression diagnosis, depressive and anxiety symptoms, perceived stress and parenting stress, are collected across all time points. DISCUSSION: The trial is ongoing and recruitment was slowed due to the COVID-19 pandemic. If results suggest a beneficial effect of antenatal depression treatment on infant outcomes, the project could have repercussions for standard antenatal care, for maternal and infant health services and for preventing the intergenerational transmission of mental health disorders. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Register: ACTRN12618001925235 Date Registered: 27 November 2018.

Web-based treatment for depression in pregnancy: a feasibility study of Mum2BMoodBooster.

BACKGROUND: Depression in pregnancy is prevalent, under-treated, and has serious impacts on the wellbeing of women and on child development. Internet programs can reach women who may not access traditional treatments due to distance, stigma or concern about taking medication. We adapted our online postnatal depression program, MumMoodBooster, for antenatal use. We aimed to trial feasibility, acceptability, and potential efficacy of the new Mum2BMoodBooster intervention with depressed pregnant women. METHODS: Twenty-seven pregnant women with Edinburgh Postnatal Depression Scale score > 11 used the program in a feasibility trial. Twenty-one had current diagnoses of major or minor depression on the Structured Clinical Interview for the DSM-IV. Assessment of symptoms occurred at screening/baseline, post-test (8 weeks post-enrollment), and at follow-up (3 months postpartum) using the Patient Health Questionnaire (PHQ-9) and the Depression Anxiety Stress Scales (DASS-21). RESULTS: In this feasibility trial, depression scores on both the PHQ-9 and the DASS-21, showed significant reductions representing large effects, with average symptom scores reduced by > 50%, and maintained in the 'minimal or no depression' range at 3 month follow-up. Anxiety scores also decreased significantly. Program usage was high with 74% of women visiting all six sessions. Program acceptability ratings were moderate to high. CONCLUSIONS: Findings paralleled the magnitude of symptom reductions seen in randomised trials of the postnatal MumMoodBooster program, suggesting that Mum2BMoodBooster is an effective treatment for depressed pregnant women. Effective internet therapies are likely to become increasingly important as the COVID-19 pandemic continues to make face-to-face access to health care problematic during 'lockdowns'.

Lessons Learned Recruiting and Retaining Pregnant and Postpartum Individuals in Digital Trials: Viewpoint.

In an increasingly connected world and in the midst of a global pandemic, digital trials offer numerous advantages over traditional trials that rely on physical study sites. Digital trials have the potential to improve access to research and clinical treatments for the most vulnerable and minoritized, including pregnant and postpartum individuals. However, digital trials are underutilized in maternal and child health research, and there is limited evidence to inform the design and conduct of digital trials. Our research collaborative, consisting of 5 research teams in the U.S. and Australia, aimed to address this gap. We collaborated to share lessons learned from our experiences recruiting and retaining pregnant and postpartum individuals in digital trials of social and behavioral interventions. We first discuss the promise of digital trials in improving participation in research during the perinatal period, as well as the unique challenges they pose. Second, we present lessons learned from 12 completed and ongoing digital trials that have used platforms such as Ovia, Facebook, and Instagram for recruitment. Our trials evaluated interventions for breastfeeding, prenatal and postpartum depression, insomnia, decision making, and chronic pain. We focus on challenges and lessons learned in 3 key areas: (1) rapid recruitment of large samples with a diversity of minoritized identities, (2) retention of study participants in longitudinal studies, and (3) prevention of fraudulent enrollment. We offer concrete strategies that we pilot-tested to address these challenges. Strategies presented in this commentary can be incorporated, as well as formally evaluated, in future studies.

Internet and Face-to-face Cognitive Behavioral Therapy for Postnatal Depression Compared With Treatment as Usual: Randomized Controlled Trial of MumMoodBooster.

BACKGROUND: Previous research has confirmed that symptoms of postnatal depression (PND) can be ameliorated through internet-delivered psychological interventions. Advantages of internet-delivered treatment include anonymity, convenience, and catering to women who are unable to access face-to-face (FTF) treatments. To date, no research has examined the efficacy of such interventions compared directly with FTF treatments in women clinically diagnosed with PND. OBJECTIVE: This study aims to compare the efficacy of one of the first web-based cognitive behavioral therapy (CBT) interventions (internet CBT+coach calls) for PND (MumMoodBooster [MMB]) with FTF-CBT in a randomized controlled trial (RCT). METHODS: In this study, 116 postnatal women with a Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition (DSM-IV) diagnosis of major or minor depression were randomized to MMB (39/116, 33.6%), FTF-CBT (39/116, 33.6%), or a treatment-as-usual (TAU) control condition (38/116, 32.8%). Diagnostic status was determined at baseline and at 21-week follow-up using the Structured Clinical Interview for the DSM-IV. Severity of anxiety and depressive symptoms was evaluated using the Depression Anxiety Stress Scales and the revised Beck Depression Inventory at baseline, 12-week follow-up (after treatment), and 21-week follow-up. RESULTS: Of the 116 participants, 107 (92.2%) had a diagnosis of major depression at baseline. Rates of remission from a major or minor depressive episode at 21 weeks in both the FTF-CBT and MMB groups were superior to that of the TAU group (56.6% and 47.7% less likely to be depressed, respectively) and they were not significantly different from each other. Although remission rates differed between TAU and FTF-CBT, growth models showed that, in terms of symptom reduction across time, the FTF-CBT treatment was not significantly better than TAU. By comparison, MMB was statistically superior to both TAU and FTF-CBT in reducing symptoms of depression, anxiety, and stress from baseline to the 21-week follow-up (large and moderate effect sizes). Thus, after 21 weeks, the average symptom scores for depression and anxiety of women receiving MMB were approximately half those of women in both the TAU and FTF-CBT groups. CONCLUSIONS: In this RCT, MMB was at least as effective as FTF-CBT in achieving remission from a diagnosed PND episode. MMB was superior to TAU and FTF-CBT in encouraging and maintaining reduction of symptom severity over the 21-week follow-up for depressed postnatal women. These findings replicate results of prior studies on MMB that showed clinically significant improvements in depressive symptoms, and they provide direct empirical support that internet-delivered treatment for depressed postnatal women is a viable alternative to FTF treatment. The generalizability of the results needs to be examined in future research, as RCTs of internet-based versus FTF treatments necessarily involve a subset of people who are willing to undertake either modality of treatment. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry (ANZCTR) ACTRN12613000881730; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364683&isReview=true.

Dismantling, optimising, and personalising internet cognitive behavioural therapy for depression: a systematic review and component network meta-analysis using individual participant data.

BACKGROUND: Internet cognitive behavioural therapy (iCBT) is a viable delivery format of CBT for depression. However, iCBT programmes include training in a wide array of cognitive and behavioural skills via different delivery methods, and it remains unclear which of these components are more efficacious and for whom. METHODS: We did a systematic review and individual participant data component network meta-analysis (cNMA) of iCBT trials for depression. We searched PubMed, PsycINFO, Embase, and the Cochrane Library for randomised controlled trials (RCTs) published from database inception to Jan 1, 2019, that compared any form of iCBT against another or a control condition in the acute treatment of adults (aged ≥18 years) with depression. Studies with inpatients or patients with bipolar depression were excluded. We sought individual participant data from the original authors. When these data were unavailable, we used aggregate data. Two independent researchers identified the included components. The primary outcome was depression severity, expressed as incremental mean difference (iMD) in the Patient Health Questionnaire-9 (PHQ-9) scores when a component is added to a treatment. We developed a web app that estimates relative efficacies between any two combinations of components, given baseline patient characteristics. This study is registered in PROSPERO, CRD42018104683. FINDINGS: We identified 76 RCTs, including 48 trials contributing individual participant data (11 704 participants) and 28 trials with aggregate data (6474 participants). The participants' weighted mean age was 42·0 years and 12 406 (71%) of 17 521 reported were women. There was suggestive evidence that behavioural activation might be beneficial (iMD -1·83 [95% credible interval (CrI) -2·90 to -0·80]) and that relaxation might be harmful (1·20 [95% CrI 0·17 to 2·27]). Baseline severity emerged as the strongest prognostic factor for endpoint depression. Combining human and automated encouragement reduced dropouts from treatment (incremental odds ratio, 0·32 [95% CrI 0·13 to 0·93]). The risk of bias was low for the randomisation process, missing outcome data, or selection of reported results in most of the included studies, uncertain for deviation from intended interventions, and high for measurement of outcomes. There was moderate to high heterogeneity among the studies and their components. INTERPRETATION: The individual patient data cNMA revealed potentially helpful, less helpful, or harmful components and delivery formats for iCBT packages. iCBT packages aiming to be effective and efficient might choose to include beneficial components and exclude ones that are potentially detrimental. Our web app can facilitate shared decision making by therapist and patient in choosing their preferred iCBT package. FUNDING: Japan Society for the Promotion of Science.

An Australian perspective on treating perinatal depression and anxiety: a brief review of efficacy and evidence-based practice in screening, psychosocial assessment and management.

Australia is at the forefront of developing screening practices, interventions and national public health policy for perinatal women with depression and anxiety. For the last two decades Australian mental health experts and public health administrators have conducted population-wide feasibility studies on screening and incorporated these in national guidelines. This chapter outlines the wider evidence base supporting current Australian practice. Key recommendations include use of the Edinburgh Postnatal Depression Scale or the Patient Health Questionnaire-9 early in pregnancy and at 6-12 weeks postpartum, followed by psychosocial assessment. Positive depression screens need to be followed by diagnostic assessment, and clear treatment pathways must be available. Milgrom and colleagues' cognitive behavioural treatment is the only Australian program with a solid evidence base demonstrating its effectiveness for depression and associated anxiety. The face-to-face treatment has been further developed into an online program, MumMoodBooster, funded by the Federal government and available to Australian women.

Improving the mother-infant relationship following postnatal depression: a randomised controlled trial of a brief intervention (HUGS).

Postnatal depression (PND) disrupts the crucial mother-infant relationship on which optimal child development depends. However, few well-evaluated, brief mother-infant interaction interventions exist. This randomised controlled trial (RCT) aimed to evaluate the effect of a 4-session, group-based mother-infant interaction intervention ('HUGS'), compared to a control playgroup, both following cognitive-behavioural therapy for PND, on mother-infant relationships and early child development. It was hypothesised that dyads receiving the HUGS intervention would show larger improvements than control dyads. Mothers (n = 77; M age = 32 years) diagnosed with major or minor depressive disorder using the Structured Clinical Interview for the DSM-IV participated with their infants (<12 months). Primary outcomes were observed mother-infant interactions using the Parent Child Early Relational Assessment (ERA) and maternal parenting stress using the Parenting Stress Index (PSI). Data were collected at baseline, post-PND treatment, post-HUGS intervention and 6-month post-HUGS follow-up. Seventy-four percent of HUGS dyads attended at least half of the HUGS sessions (≥2). Significant group differences emerged at the 6-month follow-up (but were not significant immediately post-HUGS). At 6-month follow-up, HUGS dyads showed significantly improved parental positive affective involvement and verbalisation (ERA; F1, 47 = 4.96, p = .03, ηp2 = .10) and less impaired bonding (F1, 45 = 4.55, p = .04, ηp2 = .09) than control dyads. No differences were found on the PSI or on child development outcomes. Both groups improved substantially (around 30 points) on the PSI following PND treatment, so that average scores were below the clinically significant threshold when beginning HUGS and the control playgroup. Findings suggest that incorporating HUGS intervention following PND treatment is effective for improving mother-infant relationships. A longer-term follow-up and larger sample size may be needed for improved mother-infant relationships to show an impact on observable child developmental outcomes. Registered with the Australian New Zealand Clinical Trials Registry (ACTRN12612001110875).

Interventions for Perinatal Depression and Anxiety in Fathers: A Mini-Review.

BACKGROUND AND OBJECTIVES: Up to 10% of fathers experience perinatal depression, often accompanied by anxiety, with a detrimental impact on the emotional and behavioural development of infants. Yet, few evidence-based interventions specifically for paternal perinatal depression or anxiety exist, and few depressed or anxious fathers engage with support. This mini-review aims to build on the evidence base set by other recent systematic reviews by synthesising more recently available studies on interventions for paternal perinatal depression and anxiety. Secondarily, we also aimed to identify useful information on key implementation strategies, if any, that increase the engagement of men. METHODS: We drew upon three major previous systematic reviews and performed an updated search of PubMed/Medline; Psycinfo; Cochrane Database; Embase and Cinahl. The search was limited to trials, feasibility studies or pilot studies of interventions published between 2015 and 2020 that reported on fathers' perinatal mental health. We included psychological, educational, psychosocial, paternal, couple-focused, or group therapies, delivered face-to-face, via telephone and/or online that reported on either paternal depression, anxiety or both. RESULTS: Eleven studies satisfied search criteria (5 of which were not included in previous reviews). The majority were randomised controlled trials. Most interventions incorporated counselling, therapy or psychoeducation and took an indirect approach to perinatal mental health through antenatal or postnatal education and were couple-focused. No studies reported a presence of diagnosed depression or anxiety at baseline, although five studies reported a positive effect on sub-threshold symptoms. DISCUSSION: There was some evidence that these approaches may be useful in the initial engagement of fathers with perinatal supports and improve depression and anxiety scores. No studies targeted the explicit treatment of clinically depressed or anxious men, and this remains the most substantial gap in the peer-reviewed evidence base. Our results highlight the need to deliver perinatal interventions specifically designed for men and evaluate them in populations with clinical levels of depressive and anxious symptomatology.

Cognitive Behavioral Therapy for Antenatal Depression in a Pilot Randomized Controlled Trial and Effects on Neurobiological, Behavioral and Cognitive Outcomes in Offspring 3-7 Years Postpartum: A Perspective Article on Study Findings, Limitations and Future Aims.

PURPOSE OF ARTICLE: In a previous pilot randomized controlled trial including 54 pregnant women with depression, maternal mood improved after Cognitive Behavioural Therapy (CBT) compared to treatment as usual (TAU), showing medium to large effect sizes. The effect persisted up to 9 months postpartum, with infant outcomes also showing medium to large effects favoring CBT in various child domains. This perspective article summarizes the results of a follow-up that was performed approximately 5 years later in the same cohort, assessing the effects of antenatal Cognitive Behavioural Therapy for depression and anxiety on child buccal cell DNA-methylation, brain morphology, behavior and cognition. FINDINGS: Children from the CBT group had overall lower DNA-methylation compared to children from the TAU group. Mean DNA-methylation of all NR3C1 promoter-associated probes did not differ significantly between the CBT and TAU groups. Children from the CBT group had a thicker right lateral occipital cortex and lingual gyrus. In the CBT group, Voxel-Based-Morphometry analysis identified one cluster showing increased gray matter concentration in the right medial temporal lobe, and fixel-based analysis revealed reduced fiber-bundle-cross-section in the Fornix, the Optical Tract, and the Stria Terminalis. No differences were observed in full-scale IQ or Total Problems Score. When the total of hypotheses tests in this study was considered, differences in DNA-methylation and brain measurements were no longer significant. SUMMARY: Our explorative findings suggest that antenatal depression treatment decreases overall child DNA-methylation, increases cortical thickness, and decreases white matter fiber-bundle cross-section in regions involved in cognitive function and the stress response. Nevertheless, larger studies are warranted to confirm our preliminary conclusion that CBT in pregnancy alters neurobiological outcomes in children. Clinical relevance remains unclear as we found no effects of antenatal CBT on child behavior or cognition (yet).

Perinatal anxiety and depression: Awareness and attitudes in Australia.

BACKGROUND: Better community mental health literacy is associated with positive help-seeking behaviours and reduced stigma. There are relatively few published surveys of perinatal mental health literacy. AIMS: To provide a profile of current awareness, knowledge and attitudes in relation to the mental health of women and men in the perinatal period. METHOD: A cross-sectional online survey (n = 1,201) of adults (⩾ 18 years) in each state and territory of Australia was conducted in early 2016. Survey questions were based on a previous 2009 survey, with the addition of several novel items designed to assess knowledge around both perinatal anxiety and men's perinatal mental health. RESULTS: Depression (including postnatal depression) was the most frequently cited general health problem for women in the first postnatal year (52% of spontaneous first responses). Over 70% of adults believed that postnatal depression requires specialised treatment and checks for depressive symptoms should occur routinely in pregnancy and the first postnatal year. Women identified postnatal depression at a higher rate than men. Most commonly, postnatal depression was perceived as having a biological rather than psychosocial etiology (34.5%). Men and women differed in their knowledge about the symptoms of postnatal depression with more women correctly identifying core depressive symptoms. The specific term 'perinatal depression' was not well recognised. Although not well recognised as a general health issue, when prompted, 39% of respondents were aware of anxiety as a specific perinatal mental health issue. Most adult Australians (60%) were unaware that perinatal depression and anxiety could be experienced by men. CONCLUSION: Awareness of postnatal depression appeared high. However, areas including anxiety, antenatal mental health, and men's mental health were less well-understood. There remains considerable scope, and a need for, continued awareness-raising around anxiety, mental health in pregnancy and men's mental health.

Brain Magnetic Resonance Imaging Findings in Children after Antenatal Maternal Depression Treatment, a Longitudinal Study Built on a Pilot Randomized Controlled Trial.

Antenatal depression is associated with an increased risk of offspring neuro-developmental disorders, potentially as a consequence of an altered brain development in utero. We hypothesized that reducing maternal depression by Cognitive Behavioral Therapy (CBT) during pregnancy may ameliorate the offspring's brain (micro)structural outcomes. 54 pregnant women with a diagnosed clinical depression were randomly allocated to CBT or Treatment as Usual (TAU), showing moderate to large depression symptom improvements after CBT. In 16 of their children (69% boys, N(TAU) = 8, N(CBT) = 8, mean age = 5.9 years, range = 3.9-7.1 years) brain Magnetic Resonance Imaging (MRI) scans were conducted. Children from the CBT group had a thicker right lateral occipital cortex (difference: 0.13 mm, 95% CI = 0.005-0.26) and lingual gyrus (difference: 0.18 mm, 95% CI = 0.01-0.34). In the CBT group, Voxel-Based Morphometry analysis identified one cluster showing increased gray matter concentration in the right medial temporal lobe at p < 0.05 uncorrected, and fixel-based analysis revealed reduced fiber-bundle cross-section in the Fornix, the Optical Tract, and the Stria Terminalis at p < 0.01 uncorrected. However, none of the results survived correction for multiple testing. Our explorative analyses provided some indication that antenatal CBT for depression may ameliorate offspring's brain (micro)structural outcomes, but the sample size was extremely small, and our results should be cautiously interpreted. Larger studies are warranted to confirm our preliminary conclusions that CBT for antenatal depression affects brain development in children.

Behavioural and cognitive outcomes following an early stress-reduction intervention for very preterm and extremely preterm infants.

BACKGROUND: The landmark findings of the Mother-Infant Transaction Program (MITP) showing improved neurodevelopment of preterm infants following parent-sensitivity training delivered in the neonatal intensive care unit have not been consistently replicated. This study evaluated an MITP-type intervention in terms of neurobehavioural development to preschool age. METHODS: A randomised controlled trial involved 123 very preterm and extremely preterm infants allocated to either a parent-sensitivity intervention (PremieStart, n = 60) or to standard care (n = 63). When children were 2 and 4.5 years corrected age, parents completed the Child Behavior Checklist (CBCL). General development was assessed at 2 years with the Bayley Scales of Infant Development (Bayley-III). At 4.5 years, cognitive functioning was assessed with the Wechsler Preschool and Primary Scale of Intelligence (WPPSI-III) and executive functioning with the NEPSY-II. RESULTS: There were no significant between-group differences in behaviour problems at 2 or 4.5 years, general development at 2 years, or cognitive and executive functioning at 4.5 years. CONCLUSION: Advances in the quality of neonatal intensive care may mean that MITP-type interventions now have limited additional impact on preterm infants' long-term neurobehavioural outcomes. The gestational age of infants and the exact timing of intervention may also affect its efficacy.

A 7-year follow-up of antenatal depression treatment with cognitive behavioral therapy: A case report of maternal and child outcomes.

There are few studies of cognitive behavioral therapy for women with antenatal depression including qualitative and quantitative data, and yet, individual cases can provide valuable information on personal experiences of treatment effectiveness and acceptability. The purpose of this case report is to explore the long-term qualitative outcomes following cognitive behavioral therapy for antenatal depression. A pregnant woman with a Diagnostic and Statistical Manual of Mental Disorders diagnosis of depression was allocated to receive seven sessions of cognitive behavioral therapy in a randomized controlled trial. We describe her experiences and mood during treatment, at 12 weeks, 9 months, 2 years, and 7 years postpartum, as well as markers of her child's development. The woman's mood symptoms were dramatically improved after treatment and remained in the mild to moderate range until 7 years postpartum. Her child showed overall age-appropriate development, with strengths highlighted in his nonverbal and problem-solving ability. Relative weaknesses were in the communication domain and his processing speed. This case report suggests that psychological treatment for depression during pregnancy can be both acceptable to women and potentially protective in the long term.

Social Support-A Protective Factor for Depressed Perinatal Women?

Social support before and after childbirth is a possible protective factor for perinatal depression. Currently, there is a lack of longitudinal studies beyond the first year postpartum exploring the relationship of social support with depression and anxiety. Social support is also a possible protective factor for adverse child development, which is a known consequence of perinatal depression. The present study followed up a cohort of depressed women (n = 54) from a randomised controlled trial of psychological treatment for antenatal depression. We examined the trajectory of the relationships between perceived social support (Social Provisions Scale), depression (Beck Depression Inventory), and anxiety (Beck Anxiety Inventory) twice in pregnancy and twice postpartum up to two years. The influence of social support on child development and parenting-related stress was also explored. Two aspects of social support, Reassurance of Worth and Reliable Alliance, were strongly related to perinatal depression and anxiety, particularly when predicting symptoms in late pregnancy. However, the effect of postnatal depression on child development at 9 and 24 months post-birth was not mediated by social support. These results suggest the importance of adjusting current interventions for depressed perinatal women to focus on social support in late pregnancy and the first six months postpartum.

Exploring the effect of antenatal depression treatment on children's epigenetic profiles: findings from a pilot randomized controlled trial.

BACKGROUND: Children prenatally exposed to maternal depression more often show behavioral and emotional problems compared to unexposed children, possibly through epigenetic alterations. Current evidence is largely based on animal and observational human studies. Therefore, evidence from experimental human studies is needed. In this follow-up of a small randomized controlled trial (RCT), DNA-methylation was compared between children of women who had received cognitive behavioral therapy (CBT) for antenatal depression and children of women who had received treatment as usual (TAU). Originally, 54 women were allocated to CBT or TAU. A beneficial treatment effect was found on women's mood symptoms. FINDINGS: We describe DNA methylation findings in buccal swab DNA of the 3-7-year-old children (CBT(N) = 12, TAU(N) = 11), at a genome-wide level at 770,668 CpG sites and at 729 CpG sites spanning 16 a priori selected candidate genes, including the glucocorticoid receptor (NR3C1). We additionally explored associations with women's baseline depression and anxiety symptoms and offspring DNA methylation, regardless of treatment. Children from the CBT group had overall lower DNA methylation compared to children from the TAU group (mean Ƨ = - 0.028, 95% CI - 0.035 to - 0.022). Although 68% of the promoter-associated NR3C1 probes were less methylated in the CBT group, with cg26464411 as top most differentially methylated CpG site (p = 0.038), mean DNA methylation of all NR3C1 promoter-associated probes did not differ significantly between the CBT and TAU groups (mean Ƨ = 0.002, 95%CI - 0.010 to 0.011). None of the effects survived correction for multiple testing. There were no differences in mean DNA methylation between the children born to women with more severe depression or anxiety compared to children born to women with mild symptoms of depression or anxiety at baseline (mean Ƨ (depression) = 0.0008, 95% CI - 0.007 to 0.008; mean Ƨ (anxiety) = 0.0002, 95% CI - 0.004 to 0.005). CONCLUSION: We found preliminary evidence of a possible effect of CBT during pregnancy on widespread methylation in children's genomes and a trend toward lower methylation of a CpG site previously shown by others to be linked to depression and child maltreatment. However, none of the effects survived correction for multiple testing and larger studies are warranted. TRIAL REGISTRATION: Trial registration of the original RCT: ACTRN12607000397415 . Registered on 2 August 2007.

A THERAPEUTIC PLAYGROUP FOR DEPRESSED MOTHERS AND THEIR INFANTS: FEASIBILITY STUDY AND PILOT RANDOMIZED TRIAL OF COMMUNITY HUGS.

Symptoms of depression negatively impact on mother-infant relationships and child outcomes. We evaluated a novel, 10-session mother-infant therapeutic playgroup-Community HUGS (CHUGS)-which combines cognitive and experiential components through psychoeducation, play, music, and movement. Participants were mothers experiencing a range of postnatal mental health difficulties, including depression, with infants ≤12 months of age. However, the aim was not to treat maternal depression but to ameliorate associated problems in the mother-infant interaction. In the feasibility study, all participants received CHUGS. In the pilot randomized controlled trial (RCT), participants were randomized between intervention and a wait-list. Outcomes were the Parenting Stress Index (PSI; R.R. Abidin, 1995), Parenting Sense of Competency Scale (Self-Efficacy subscale; J. Gibaud-Wallston & L.P. Wandersman, 1978), and the Depression, Anxiety, Stress Scales (P.F. Lovibond & S.H. Lovibond, 1995). In the feasibility study (n = 74), PSI scores dropped on all subscales, all ps < .01. Depression, p < .001, anxiety, p = .01, stress, p = .01, and self-efficacy, p < .001, all showed improvements, as did observer-rated mother-infant interactions, p < .001. In the RCT, depression, p < .001, anxiety, p = .005, and stress, p < .001, symptoms were significantly reduced for intervention participants (n = 16), as compared to wait-list participants (n = 15). The CHUGS program had high participant satisfaction and produced improvements in self-efficacy, depression, anxiety, stress, and mother-infant interactions that supported the program's acceptability and the utility of further rollout.

Improving help-seeking for postnatal depression and anxiety: a cluster randomised controlled trial of motivational interviewing.

Low uptake of treatment by women with symptoms of postnatal depression and anxiety is consistently reported. This study examined whether a brief motivational interviewing (MI) intervention delivered by Maternal and Child Health Nurses (MCHNs) during routine emotional health assessments improves help-seeking following childbirth. In this parallel two-group cluster randomised controlled trial, MCHNs delivered a MI intervention ('PRIMER', n = 20) or Routine Care (n = 20) at women's (n = 541) postnatal consultations. The primary outcome was help-seeking over the 12 months post-birth. Other outcomes were emotional distress measured by the Edinburgh Postnatal Depression Scale, Beck Depression Inventory-Revised and Depression Anxiety Stress Scales, and barriers to help-seeking obtained by self-report via a checklist of potential barriers that was presented to women to select from if applicable. 27.4% of the sample experienced emotional distress over the 12 months post-birth. When comparing women who experienced emotional distress with those who did not, odds of seeking help were 4.0 times higher for the MI condition than Routine Care (p = .004). Of the women who sought help from a psychologist, 47.6% in the MI condition attended 6 + sessions versus 20.0% in Routine Care (numbers too small for reliable significance test). There was a non-significant trend of lower depression, anxiety and stress in the MI condition. Three risk factors for postnatal depression predicted help-seeking: antenatal anxiety (OR = 2.8, p = .002), depression history (OR = 2.5, p = .002) and self-esteem (OR = 0.7, p = .04). Common barriers to seeking help were thinking that one would or should be able to manage without help (endorsed by 11.1%). Treatment uptake for postnatal distress can be increased with MI. Training MCHNs in MI was feasible and valued. Given the devastating effects of depression, further research is needed to ascertain whether MI can improve mental health outcomes. Australian New Zealand Clinical Trials Registry (ACTRN12611000635965), 22 June 2011.

Internet Cognitive Behavioral Therapy for Women With Postnatal Depression: A Randomized Controlled Trial of MumMoodBooster.

BACKGROUND: There are few published controlled trials examining the efficacy of Internet-based treatment for postnatal depression (PND) and none that assess diagnostic status (clinical remission) as the primary outcome. This is despite the need to improve treatment uptake and accessibility because fewer than 50% of postnatally depressed women seek help, even when identified as depressed. OBJECTIVE: In a randomized controlled trial (RCT), we aimed to test the efficacy of a 6-session Internet intervention (the MumMoodBooster program, previously evaluated in a feasibility trial) in a sample of postnatal women with a clinical diagnosis of depression. The MumMoodBooster program is a cognitive behavioral therapy (CBT) intervention, is highly interactive, includes a partner website, and was supported by low-intensity telephone coaching. METHODS: This was a parallel 2-group RCT (N=43) comparing the Internet CBT treatment (n=21) to treatment as usual (n=22). At baseline and at 12 weeks after enrollment, women's diagnostic status was assessed by telephone with the Standardized Clinical Interview for DSM-IV (SCID-IV) and symptom severity with the Beck Depression Inventory (BDI-II). Depression symptoms were measured repeatedly throughout the study period with the Patient Health Questionnaire (PHQ-9). RESULTS: At the end of the study, 79% (15/19) of women who received the Internet CBT treatment no longer met diagnostic criteria for depression on the SCID-IV (these outcome data were missing for 2 intervention participants). This contrasted with only 18% (4/22) remission in the treatment as usual condition. Depression scores on the BDI-II showed a large effect favoring the intervention group (d=.83, 95% CI 0.20-1.45). Small to medium effects were found on the PHQ-9 and on measures of anxiety and stress. Adherence to the program was very good with 86% (18/21) of users completing all sessions; satisfaction with the program was rated 3.1 out of 4 on average. CONCLUSIONS: Our results suggest that our Internet CBT program, MumMoodBooster, is an effective treatment option for women clinically diagnosed with PND. This is one of only two controlled evaluations of specialized online psychological treatment among women clinically diagnosed with PND. MumMoodBooster appears to be a feasible, effective treatment option, which is potentially accessible to large numbers of women in metropolitan, rural, and remote areas. Future work might be focused profitably on establishing comparability with face-to-face treatments and purely self-guided delivery. We have commenced a larger RCT comparing MumMoodBooster with face-to-face CBT. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry (ANZCTR): ACTRN12613000113752; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=363561 (Archived by WebCite® at http://www.webcitation.org/6f64kuyLf).

Feasibility study and pilot randomised trial of an antenatal depression treatment with infant follow-up.

Substantial evidence links antenatal depression, anxiety and stress with negative effects on foetal development, resulting in enduring problems in child development. Despite this, there is a paucity of research on intervention programmes designed to address depression and anxiety, and none that include infant outcomes. We aimed to evaluate the efficacy of a brief treatment for maternal depression and anxiety in pregnancy in a sample of women with a diagnosed depressive disorder. We developed a cognitive behavioural therapy treatment for antenatal depression and anxiety and evaluated it in a feasibility trial. This was followed by a pilot randomised controlled trial (RCT) which collected data on the efficacy of the brief intervention and follow-up data on infants. The feasibility study (n = 25) yielded promising results for adherence, acceptability and improvements in depression and anxiety (Beck Depression Inventory and Beck Anxiety Inventory). The RCT (n = 54) again showed excellent adherence and acceptability and supported the efficacy of the treatment. Strong reductions in anxiety were observed during pregnancy, and improvements in depression were maintained at 9 months representing a moderately large effect size. Nine-month infant outcomes showed several medium to large effects favouring the intervention in domains including problem solving, self-regulation and stress reactivity, which were independent of maternal postnatal mood. Treating severe depression and anxiety during pregnancy with a brief cognitive behavioural therapy (CBT) intervention appears feasible and worthwhile. To reliably detect clinically meaningful effects on infant outcomes, larger RCTs are likely to be required.