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Treating postnatal depressive symptoms in primary care: a randomised controlled trial of GP management, with and without adjunctive counselling.

ABSTRACT: Postnatal depression (PND) is under-diagnosed and most women do not access effective help. We aimed to evaluate comparative management of (PND) following screening with the Edinburgh Postnatal Depression Scale, using three best-practice care pathways by comparing management by general practitioners (GPs) alone compared to adjunctive counselling, based on cognitive behavioural therapy (CBT), delivered by postnatal nurses or psychologists.This was a parallel, three-group randomised controlled trial conducted in a primary care setting (general practices and maternal & child health centres) and a psychology clinic. A total of 3,531 postnatal women were screened for symptoms of depression; 333 scored above cut-off on the screening tool and 169 were referred to the study. Sixty-eight of these women were randomised between the three treatment groups.Mean scores on the Beck Depression Inventory (BDI-II) at entry were in the moderate-to-severe range. There was significant variation in the post-study frequency of scores exceeding the threshold indicative of mild-to-severe depressive symptoms, such that more women receiving only GP management remained above the cut-off score after treatment (p = .028). However, all three treatment conditions were accompanied by significant reductions in depressive symptoms and mean post-study BDI-II scores were similar between groups. Compliance was high in all three groups. Women rated the treatments as highly effective. Rates of both referral to the study (51%), and subsequent treatment uptake (40%) were low.Data from this small study suggest that GP management of PND when augmented by a CBT-counselling package may be successful in reducing depressive symptoms in more patients compared to GP management alone. The relatively low rates of referral and treatment uptake, suggest that help-seeking remains an issue for many women with PND, consistent with previous research.

SUBMITTER: Milgrom J

PROVIDER: S-EPMC3121669 | biostudies-literature | 2011 May

REPOSITORIES: biostudies-literature

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Treating postnatal depressive symptoms in primary care: a randomised controlled trial of GP management, with and without adjunctive counselling.

Milgrom Jeannette J Holt Christopher J CJ Gemmill Alan W AW Ericksen Jennifer J Leigh Bronwyn B Buist Anne A Schembri Charlene C

BMC psychiatry 20110527

<h4>Background</h4>Postnatal depression (PND) is under-diagnosed and most women do not access effective help. We aimed to evaluate comparative management of (PND) following screening with the Edinburgh Postnatal Depression Scale, using three best-practice care pathways by comparing management by general practitioners (GPs) alone compared to adjunctive counselling, based on cognitive behavioural therapy (CBT), delivered by postnatal nurses or psychologists.<h4>Methods</h4>This was a parallel, thr ...[more]

PMID: 21615968

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Project description:ImportanceImmune-metabolic disturbances have been implicated in the pathophysiology of major depressive disorder and may be more prominent in individuals with treatment-resistant depression (TRD). Preliminary trials suggest that lipid-lowering agents, including statins, may be useful adjunctive treatments for major depressive disorder. However, no adequately powered clinical trials have assessed the antidepressant efficacy of these agents in TRD.ObjectiveTo assess the efficacy and tolerability of adjunctive simvastatin compared with placebo for reduction of depressive symptoms in TRD.Design, setting, and participantsThis 12-week, double-blind, placebo-controlled randomized clinical trial was conducted in 5 centers in Pakistan. The study involved adults (aged 18-75 years) with a Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) major depressive episode that had failed to respond to at least 2 adequate trials of antidepressants. Participants were enrolled between March 1, 2019, and February 28, 2021; statistical analysis was performed from February 1 to June 15, 2022, using mixed models.InterventionParticipants were randomized to receive standard care plus 20 mg/d of simvastatin or placebo.Main outcomes and measuresThe primary outcome was the difference between the 2 groups in change in Montgomery-Åsberg Depression Rating Scale total scores at week 12. Secondary outcomes included changes in scores on the 24-item Hamilton Rating Scale for Depression, the Clinical Global Impression scale, and the 7-item Generalized Anxiety Disorder scale and change in body mass index from baseline to week 12. C-reactive protein and plasma lipids were measured at baseline and week 12.ResultsA total of 150 participants were randomized to simvastatin (n = 77; median [IQR] age, 40 [30-45] years; 43 [56%] female) or placebo (n = 73; median [IQR] age, 35 [31-41] years; 40 [55%] female). A significant baseline to end point reduction in Montgomery-Åsberg Depression Rating Scale total score was observed in both groups and did not differ significantly between groups (estimated mean difference for simvastatin vs placebo, -0.61; 95% CI, -3.69 to 2.46; P = .70). Similarly, there were no significant group differences in any of the secondary outcomes or evidence for differences in adverse effects between groups. A planned secondary analysis indicated that changes in plasma C-reactive protein and lipids from baseline to end point did not mediate response to simvastatin.Conclusions and relevanceIn this randomized clinical trial, simvastatin provided no additional therapeutic benefit for depressive symptoms in TRD compared with standard care.Trial registrationClinicalTrials.gov Identifier: NCT03435744.

Project description:BackgroundPatients continue to suffer from medically unexplained symptoms otherwise referred to as persistent physical symptoms (PPS). General practitioners (GPs) play a key role in the management of PPS and require further training. Patients are often frustrated with the care they receive. This study aims to assess the acceptability of an 'integrated GP care' approach which consists of offering self-help materials to patients with PPS and offering their GPs training on how to utilise cognitive behavioural skills within their consultations, as well as assessing the feasibility of conducting a future trial in primary care to evaluate its benefit.MethodsA feasibility cluster randomised controlled trial was conducted in primary care, South London, UK. GP practices (clusters) were randomly allocated to 'integrated GP care plus treatment as usual' or 'treatment as usual'. Patients with PPS were recruited from participating GP practices before randomisation. Feasibility parameters, process variables and potential outcome measures were collected at pre-randomisation and at 12- and 24-weeks post-randomisation at cluster and individual participant level.ResultsTwo thousand nine hundred seventy-eight patients were identified from 18 GP practices. Out of the 424 patients who responded with interest in the study, 164 fully met the eligibility criteria. One hundred sixty-one patients provided baseline data before cluster randomisation and therefore were able to participate in the study. Most feasibility parameters indicated that the intervention was acceptable and a future trial feasible. 50 GPs from 8 GP practices (randomised to intervention) attended the offer of training and provided positive feedback. Scores in GP knowledge and confidence increased post-training. Follow-up rate of patients at 24 weeks was 87%. However estimated effect sizes on potential clinical outcomes were small.ConclusionsIt was feasible to identify and recruit patients with PPS. Retention rates of participants up to 24 weeks were high. A wide range of health services were used. The intervention was relatively low cost and low risk. This complex intervention should be further developed to improve patients'/GPs' utilisation of audio/visual and training resources before proceeding to a full trial evaluation.Trial registrationNCT02444520 (ClinicalTrials.gov).

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Treating postnatal depressive symptoms in primary care: a randomised controlled trial of GP management, with and without adjunctive counselling.

Publications

Treating postnatal depressive symptoms in primary care: a randomised controlled trial of GP management, with and without adjunctive counselling.

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