Dataset Information

Online singing interventions for postnatal depression in times of social isolation: a feasibility study protocol for the SHAPER-PNDO single-arm trial.

ABSTRACT:

Background

Postnatal depression (PND) affects 13% of new mothers, with numbers rising during the COVID-19 pandemic. Despite this prevalence, many women have difficulty with or hesitancy towards accessing pharmacological and/or psychological interventions. Group-based mother-baby activities, however, have a good uptake, with singing improving maternal mental health and the mother-infant relationship. The recent lockdowns highlight the importance of adapting activities to an online platform that is wide-reaching and accessible.

Aims

The SHAPER-PNDO study will primarily analyse the feasibility of a 6-week online singing intervention, Melodies for Mums (M4M), for mothers with PND who are experiencing barriers to treatment. The secondary aim of the SHAPER-PNDO study will be to analyse the clinical efficacy of the 6-week M4M intervention for symptoms of postnatal depression.

Methods

A total of 120 mothers and their babies will be recruited for this single-arm study. All dyads will attend 6 weekly online singing sessions, facilitated by Breathe Arts Health Research. Assessments will be conducted on Zoom at baseline and week 6, with follow-ups at weeks 16 and 32, and will contain interviews for demographics, mental health, and social circumstances, and biological samples will be taken for stress markers. Qualitative interviews will be undertaken to understand the experiences of women attending the sessions and the facilitators delivering them. Finally, data will be collected on recruitment, study uptake and attendance of the programme, participant retention, and acceptability of the intervention.

Discussion

The SHAPER-PNDO study will focus on the feasibility, alongside the clinical efficacy, of an online delivery of M4M, available to all mothers with PND. We hope to provide a more accessible, effective treatment option for mothers with PND that can be available both during and outside of the pandemic for mothers who would otherwise struggle to attend in-person sessions, as well as to prepare for a subsequent hybrid RCT.

Trial registration

ClinicalTrials.gov Identifier: NCT04857593 . Registered retrospectively on 22 April 2021. The first participants were recruited on 27 January 2021, and the trial is ongoing.

SUBMITTER: Bind RH

PROVIDER: S-EPMC9289358 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundPostnatal depression (PND) affects over 12% of mothers, with numbers rising during COVID-19. Singing groups can support mothers with PND; however, online delivery has never been evaluated. SHAPER-PNDO, a single-arm clinical trial, evaluated the feasibility, clinical efficacy, and well-being outcomes of a 6-week online version of Breathe Melodies for Mums (M4M) singing intervention developed for mothers with PND during COVID-19 lockdowns.MethodsThe primary objective of this study was to assess the feasibility of a group online singing intervention for new mothers with postnatal depression. This was ascertained through recruitment rates, study retention rates, attendance rates to the singing sessions, and study completion rates. The secondary objective of the study was to assess the clinical efficacy and well-being outcomes of the singing intervention. Specifically, we measured change in Edinburgh Postnatal Depression Scale (EPDS), State-Trait Anxiety Inventory (STAI), Perceived Stress Scale (PSS), and Office for National Statistics Wellbeing Scale (ONS) scores from baseline to end-of-intervention (week 6); follow-up assessments were completed at weeks 3, 16, and 32. Mothers were eligible if they scored ≥10 on the baseline EPDS.ResultsEighty-seven percent of the 37 recruited mothers completed the study, attending, on average, 5 of the 6 group singing sessions. With regard to secondary outcomes, at end-of-treatment, mothers experienced significant reductions in depression (EPDS, 16.6 ± 3.7 to 11.2 ± 5.3, 95% CI [0.79,1.65]), anxiety (STAI-S, 48.4 ± 27.1 to 41.7 ± 26.8, 95% CI [4.96, 17.65]) and stress (PSS, 29.0 ± 5.7 to 19.7 ± 5.3, 95% CI [1.33, 7.07]); and, furthermore, significant improvements in life satisfaction (ONS, 50.5 ± 23.0 to 72.8 ± 11.7, 95% CI [- 39.86, - 4.64]) and feelings of worthwhileness (ONS, 51.7 ± 30.4 to 78.6 ± 15.1, 95% CI [- 52.79, - 0.85]). Reduction on the EPDS correlated with a reduction on the BDI and the STAI-S and maternal childhood maltreatment was predictive of a smaller treatment response.ConclusionsM4M online was feasible to mothers who partook in the programme. Furthermore, M4M online supports the mental health and well-being of new mothers experiencing PND, especially when barriers to in-person treatment are present.Trial registrationClinicalTrials.gov NCT04857593 . Registered 22 April 2021, retrospectively registered.

Project description:IntroductionPostpartum depression (PPD) affects around one in seven women globally, with these women in need of non-pharmaceutical treatment strategies. There is a long history of the benefits of singing for maternal mental health, and promising research exists showing the clinical effectiveness of group singing. Group singing interventions are being scaled up to support new mothers in the United Kingdom, but we do not know if such an intervention may benefit women in different cultural contexts. This protocol focuses on exploring the feasibility of implementation and perceived impact of a 10-week group singing intervention for new mothers in Romania and Denmark eliciting signs of PPD.Methods and analysisData will be collected from up to 48 women with a score ≥10 on the Edinburgh Postnatal Depression Scale (EPDS) participating in a 10-week group singing intervention in Denmark or Romania, as well as a range of project stakeholders. The singing classes will take place in person and be facilitated by professional singing leaders. Feasibility of implementation will be analysed through qualitative data (eg, focus groups, interviews) and quantitative data (eg, the Feasibility of Intervention Measure). Perceived impact will be explored via surveys that include mental health measures (EPDS, Multidimensional Scale of Perceived Social Support, WHO Five Well-Being Index) from singing intervention participants (at weeks 1, 6, 10) and focus groups. Descriptive statistics, repeated measures analysis of variance and analysis of covariance will be used to analyse quantitative data. Framework method and thematic analysis will be used to analyse qualitative data.Ethics and disseminationThe national ethics committees in Romania (IRB-PH Protocol #2021-211217-012) and Denmark (case number 1-10-72-274-21) have approved the study, as has the Ethics Review Committee at the World Health Organization (ERC.0003714). All participants will be required to provide informed consent. Results will be disseminated by reports published by the WHO Regional Office for Europe, peer-reviewed publications and at conferences.

Project description:IntroductionPostpartum depression and anxiety (PPDA) is experienced by up to 20% of families in the first year. The condition impacts not only parents but also their developing child. While mindfulness-based interventions (MBI) have shown to be beneficial for this population, many parents do not have access to treatment or find it challenging to commit or complete the treatment. The COVID-19 pandemic has heightened some of the challenges that parents face. The ability to find time for needed self-care and health interventions is also affected by limited childcare support. The opportunity to attend a group online may significantly improve the accessibility to group MBI but may also bring challenges. This study aims to examine the feasibility and acceptability of online MBI groups for parents in families affected with PPDA.Methods and analysisIn this feasibility study, participants will include mothers diagnosed with PPDA and their partners. Two online MBI groups will run simultaneously for 8 weeks: one for mothers with PPDA and another one for their partners. The primary outcome will be feasibility of conducting the online groups, assessed from the facilitators' perspective, participants' perspective and attrition throughout the study. The participants' perspectives on feasibility will be assessed by questions including how difficult it was for them to make it to the sessions, specific obstacles encountered and their scheduling preferences. The facilitators' perspective will be assessed by frequency of technical difficulties encountered, of disruptions in the online sessions and of episodes where parents leave the screen (eg, to calm their child). Secondary outcomes will include mental health, couple relationship, satisfaction and acceptability which will also be evaluated through participant questionnaires.Ethics and disseminationThe study has received ethics approval from the University of British Columbia Children's and Women's Research Ethics Board. Study results will be disseminated through peer-reviewed journals and conferences.Trial registration numberNCT04617132.

Project description:ObjectivesPilot feasibility randomised controlled trial (RCT) for the singing groups for people with aphasia (SPA) intervention to assess: (1) the acceptability and feasibility of participant recruitment, randomisation and allocation concealment; (2) retention rates; (3) variance of continuous outcome measures; (4) outcome measure completion and participant burden; (5) fidelity of intervention delivery; (6) SPA intervention costs; (7) acceptability and feasibility of trial and intervention to participants and others involved.DesignA two-group, assessor-blinded, randomised controlled external pilot trial with parallel mixed methods process evaluation and economic evaluation.SettingThree community-based cohorts in the South-West of England.ParticipantsEligible participants with post-stroke aphasia were randomised 1:1 to SPA or control.InterventionThe manualised SPA intervention was delivered over 10 weekly singing group sessions, led by a music facilitator and assisted by an individual with post-stroke aphasia. The intervention was developed using the Information-Motivation-Behavioural skills model of behaviour change and targeted psychosocial outcomes. Control and intervention participants all received an aphasia information resource pack.Outcome measuresCollected at baseline, 3 and 6 months post-randomisation, candidate primary outcomes were measured (well-being, quality of life and social participation) as well as additional clinical outcomes. Feasibility, acceptability and process outcomes included recruitment and retention rates, and measurement burden; and trial experiences were explored in qualitative interviews.ResultsOf 87 individuals screened, 42 participants were recruited and 41 randomised (SPA=20, control=21); 36 participants (SPA=17, control=19) completed 3-month follow-up, 34 (SPA=18, control=16) completed 6-month follow-up. Recruitment and retention (83%) were acceptable for a definitive RCT, and participants did not find the study requirements burdensome. High fidelity of the intervention delivery was shown by high attendance rates and facilitator adherence to the manual, and participants found SPA acceptable. Sample size estimates for a definitive RCT and primary/secondary outcomes were identified.ConclusionsThe SPA pilot RCT fulfilled its objectives, and demonstrated that a definitive RCT of the intervention would be both feasible and acceptable.Trial registration numberNCT03076736.

Project description:BackgroundPostpartum depression (PPD) has a 20% 3-month prevalence rate. The consequences of PPD are significant for the mother, infant, and the family. There is a need for preventive interventions for PPD, which are effective and accessible; however, many barriers exist for women who attempt to access perinatal depression prevention programs. Internet interventions for the treatment and prevention of depression are widely accepted as efficacious and may overcome some of the issues pertaining to access to treatment barriers perinatal women face. However, internet interventions offered without any human support tend to have low adherence but positive outcomes for those who do complete treatment. Internet support groups often have high levels of adherence but minimal data supporting efficacy as a treatment for depression. Taken together, these findings suggest that combining the treatment components of individual interventions with the support provided by an internet support group might create an intervention with the scalability and cost-effectiveness of an individual intervention and the better outcomes typically found in supported interventions.ObjectivesThis study aimed to describe the development of a cognitive behavioral therapy (CBT) internet intervention with peer support to prevent PPD and examine preliminary depression and site usage outcomes.MethodsUser-centered design groups were used to develop the internet intervention. Once the intervention was developed, women who were 20 to 28 weeks pregnant with symptoms of depression (Patient Health Questionnaire-8 scores of 5-14) but who had no major depression diagnosis were enrolled in a randomized controlled trial (RCT) to compare 8 weeks of a CBT-based internet intervention with peer support to an individual internet intervention designed to prevent PPD. Assessments took place at baseline, 4 weeks, 8 weeks (end of treatment), and then 4 weeks and 6 weeks postpartum.ResultsA total of 25 women were randomized. Of these, 24 women completed the RCT. Patient Health Questionnaire-9 scores at 6 weeks postpartum remained below the clinical threshold for referral for treatment in both groups, with depression measures showing a decrease in symptoms from baseline to postpartum. At 6 weeks postpartum, only 4% (1/24) met the criteria for PPD. There was no difference between groups in adherence to the intervention, with an average of 14.55 log-ins over the course of treatment.ConclusionsResults suggest women were responsive to both peer support and individual internet interventions to prevent PPD and that peer support may be a useful feature to keep participants adherent.Trial registrationClinicalTrials.gov NCT02121015; https://clinicaltrials.gov/ct2/show/NCT02121015 (archived by WebCite at http://www.webcitation.org/765a7qBKy).