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Feasibility and Acceptability of a Web-Based Treatment with Telephone Support for Postpartum Women With Anxiety: Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Postpartum anxiety can have adverse effects on the mother and child if left untreated. Time constraints and stigma are common barriers to postpartum treatment. Web-based treatments offer potential flexibility and anonymity. What Am I Worried About (WaWa) is a self-guided treatment based on cognitive-behavioral and mindfulness principles for women experiencing postpartum anxiety. WaWa was developed in Australia and consists of 9 modules with optional weekly telephone support. WaWa was adapted to a Web-based version for use in England (Internet-based What Am I Worried About, iWaWa). OBJECTIVE:This study aimed to investigate the feasibility (engagement and usability) and acceptability (usefulness, satisfaction, and helpfulness) of iWaWa among English postpartum women with anxiety. METHODS:Postpartum (<12 months) women with mild-to-severe anxiety were recruited anonymously via social media during an 8-week period. Participants were randomized to the iWaWa treatment (8 weeks) or wait-list control group. Treatment and study feasibility and acceptability were assessed after the treatment, and anxiety symptoms were assessed at baseline, 8 weeks postrandomization, and 12 weeks postrandomization (treatment group only) using Web-based questionnaires. Semistructured telephone interviews were carried out after the treatment period for a more in-depth exploration of treatment acceptability and feasibility. RESULTS:A total of 89 eligible women were recruited through social media and randomized into the treatment (n=46) or wait-list control group (n=43). Women were predominantly Caucasian, well-educated, married, on maternity leave, first-time mothers and reported moderate levels of anxiety. Dropout rates were high, especially in the treatment group (treatment: 82%, 38/46; wait-list control: 51%, 22/43). A total of 26 women started iWaWa with only 2 women completing all 9 modules. Quantitative and qualitative data suggest iWaWa was experienced as generally useful and helpful. Participants enjoyed iWaWa's accessibility, anonymity, and weekly reminders, as well as the introduction to the principles of cognitive-behavioral therapy (CBT) and mindfulness. However, iWaWa was also experienced as not user-friendly enough, too long, and not smartphone-friendly. Parts of the content were experienced as not always relevant and appropriate. Participants felt that iWaWa could be improved by having it in a smartphone app format and by making the content more concise and inclusive of different parenting styles. CONCLUSIONS:Despite interest in iWaWa, the results suggest that both the study and iWaWa were not feasible in the current format. However, this first trial provides useful evidence about treatment format and content preferences that can inform iWaWa's future development, as well as research and development of Web-based postpartum anxiety treatments, in general, to optimize adherence. TRIAL REGISTRATION:ClinicalTrials.gov NCT02434406; https://clinicaltrials.gov/ct2/show/NCT02434406 (Archived by WebCite at http://www.webcitation.org/6xTq7Bwmd).

SUBMITTER: Ashford MT

PROVIDER: S-EPMC5938691 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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Feasibility and Acceptability of a Web-Based Treatment with Telephone Support for Postpartum Women With Anxiety: Randomized Controlled Trial.

Ashford Miriam T MT Olander Ellinor K EK Rowe Heather H Fisher Jane Rw JR Ayers Susan S

JMIR mental health 20180420 2

<h4>Background</h4>Postpartum anxiety can have adverse effects on the mother and child if left untreated. Time constraints and stigma are common barriers to postpartum treatment. Web-based treatments offer potential flexibility and anonymity. What Am I Worried About (WaWa) is a self-guided treatment based on cognitive-behavioral and mindfulness principles for women experiencing postpartum anxiety. WaWa was developed in Australia and consists of 9 modules with optional weekly telephone support. W ...[more]

PMID: 29678804

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Project description:ObjectiveWith a period prevalence of 21.9% in the year after birth, depression is a common complication of childbearing. We assessed the impact of telephone-delivered depression care management (DCM) on symptom levels, health service utilization, and functional status 3, 6, and 12 months postpartum.MethodsThe randomized controlled trial was conducted at the University of Pittsburgh, Pittsburgh, Pennsylvania, from March 2006 through September 2010. Women (N = 628) who screened positive for depression (a score of 10 or greater on the Edinburgh Postnatal Depression Scale) 4 to 6 weeks postpartum were evaluated with the Structured Clinical Interview for DSM-IV-TR Axis I Disorders, Research Version, Patient Edition With Psychotic Screen and enrolled in a randomized trial of DCM compared to enhanced usual care (EUC). Clinicians conducted telephone contacts to educate, assist with treatment decisions, monitor symptoms, facilitate access to services, and encourage links to community resources. Independent evaluators collected symptom scores, functional status, and health services use at 3, 6, and 12 months postpartum. Primary outcome was reduction of symptoms as measured by the Structured Interview Guide for the Hamilton Depression Rating Scale with Atypical Depression Supplement.ResultsMean depressive symptom and function scores significantly improved (by greater than 50%) in both groups of women but did not differ by DCM versus EUC assignment. Health services use was similar in women randomly assigned to DCM compared to EUC. Women with childhood sexual abuse responded significantly more favorably to DCM on depression and functional measures (all P values < .02).ConclusionsBoth DCM and EUC favorably impacted depression symptom levels and function. The subgroup of women with childhood sexual abuse benefited significantly more from DCM compared to the EUC condition. Regular telephone availability of a clinician is a resource that appears to be particularly therapeutic to women with childhood sexual abuse.Trial registrationClinicalTrials.gov identifier: NCT00282776.

Project description:BackgroundPregnant patients with overweight or obesity are at high risk for perinatal complications. Excess gestational weight gain (GWG) further exacerbates this risk. Mobile health (mHealth) lifestyle interventions that leverage technology to facilitate self-monitoring and provide just-in-time feedback may motivate behavior change to reduce excess GWG, reduce intervention costs, and increase scalability by improving access.ObjectiveThis study aimed to test the acceptability and feasibility of a pilot mHealth lifestyle intervention for pregnant patients with overweight or obesity to promote moderate intensity physical activity (PA), encourage guideline-concordant GWG, and inform the design of a larger pragmatic cluster randomized controlled trial.MethodsWe conducted a mixed methods acceptability and feasibility randomized controlled trial among pregnant patients with a prepregnancy BMI of 25 to 40 kg/m2. Patients with singletons at 8 to 15 weeks of gestation who were aged ≥21 years and had Wi-Fi access were recruited via email from 2 clinics within Kaiser Permanente Northern California and randomized to receive usual prenatal care or an mHealth lifestyle intervention. Participants in the intervention arm received wireless scales, access to an intervention website, activity trackers to receive automated feedback on weight gain and activity goals, and monthly calls from a lifestyle coach. Surveys and focus groups with intervention participants assessed intervention satisfaction and ways to improve the intervention. PA outcomes were self-assessed using the Pregnancy Physical Activity Questionnaire, and GWG was assessed using electronic health record data for both arms.ResultsOverall, 33 patients were randomly assigned to the intervention arm, and 35 patients were randomly assigned to the usual care arm. All participants in the intervention arm weighed themselves at least once a week, compared with 20% (7/35) of the participants in the usual care arm. Participants in the intervention arm wore the activity tracker 6.4 days per week and weighed themselves 5.3 times per week, and 88% (29/33) of them rated the program "good to excellent." Focus groups found that participants desired more nutrition-related support to help them manage GWG and would have preferred an app instead of a website. Participants in the intervention arm had a 23.46 metabolic equivalent of task hours greater change in total PA per week and a 247.2-minute greater change in moderate intensity PA per week in unadjusted models, but these effects were attenuated in adjusted models (change in total PA: 15.55 metabolic equivalent of task hours per week; change in moderate intensity PA: 199.6 minutes per week). We found no difference in total GWG (mean difference 1.14 kg) compared with usual care.ConclusionsThe pilot mHealth lifestyle intervention was feasible, highly acceptable, and promoted self-monitoring. Refined interventions are needed to effectively affect PA and GWG among pregnant patients with overweight or obesity.Trial registrationClinicalTrials.gov NCT03936283; https://clinicaltrials.gov/ct2/show/NCT03936283.

Project description:BackgroundNovel interventions tailored to blue collar workers are needed to reduce the disparities in smoking rates among occupational groups.ObjectiveThe main objective of this study was to evaluate the efficacy and usage of the Web-enhanced "Tobacco Tactics" intervention targeting operating engineers (heavy equipment operators) compared to the "1-800-QUIT-NOW" telephone line.MethodsOperating engineers (N=145) attending one of 25 safety training sessions from 2010 through 2012 were randomized to either the Tobacco Tactics website with nurse counseling by phone and access to nicotine replacement therapy (NRT) or to the 1-800-QUIT-NOW telephone line, which provided an equal number of phone calls and NRT. The primary outcome was self-reported 7-day abstinence at 30-day and 6-month follow-up. The outcomes were compared using chi-square tests, t tests, generalized mixed models, and logistic regression models.ResultsThe average age was 42 years and most were male (115/145, 79.3%) and white (125/145, 86.2%). Using an intent-to-treat analysis, the Tobacco Tactics website group showed significantly higher quit rates (18/67, 27%) than the 1-800-QUIT NOW group (6/78, 8%) at 30-day follow-up (P=.003), but this difference was no longer significant at 6-month follow-up. There were significantly more positive changes in harm reduction measures (quit attempts, number of cigarettes smoked per day, and nicotine dependence) at both 30-day and 6-month follow-up in the Tobacco Tactics group compared to the 1-800-QUIT-NOW group. Compared to participants in the 1-800-QUIT NOW group, significantly more of those in the Tobacco Tactics website group participated in the interventions, received phone calls and NRT, and found the intervention helpful.ConclusionsThe Web-enhanced Tobacco Tactics website with telephone support showed higher efficacy and reach than the 1-800-QUIT-NOW intervention. Longer counseling sessions may be needed to improve 6-month cessation rates.Trial registrationClinicaltrials.gov NCT01124110; http://clinicaltrials.gov/ct2/show/NCT01124110 (Archived by WebCite at http://www.webcitation.org/6TfKN5iNL).

Project description:BACKGROUND:During the postpartum visit, health care providers address issues with short- and long-term implications for maternal and child health. Women with Medicaid insurance are less likely to return for a postpartum visit compared with women with private insurance. Behavioral economics acknowledges that people do not make exclusively rational choices, rather immediate gratification, cognitive and psychological biases, and social norms influence decision making. Drawing on insights from decision science, behavioral economists have examined how these biases can be modulated through carefully designed interventions. We have developed a Web-based tool, Healthy Beyond Pregnancy, that incorporates empirically derived concepts of behavioral economics to improve adherence rates to the postpartum visit. OBJECTIVES:The primary objectives of this pilot study were to (1) refine and assess the usability of Healthy Beyond Pregnancy and (2) assess the feasibility of a randomized controlled trial (RCT) of the intervention. METHODS:We used a multistep process and multidisciplinary team of maternal-fetal medicine physicians, a behavioral economist, and researchers with expertise in behavioral interventions to design Healthy Beyond Pregnancy. We assessed the usability of the program with the Post-Study System Usability Questionnaire (PSSUQ), a validated 7-point scale, and semistructured interviews with postpartum women. We then conducted a feasibility trial to determine the proportion of eligible women who were willing to participate in an RCT of Healthy Beyond Pregnancy and the proportion of women willing to complete the Web-based program. Exploratory outcomes of the pilot trial included attendance at the postpartum visit, uptake of long-acting reversible contraception, and uptake of any contraception. RESULTS:The median PSSUQ score for Healthy Beyond Pregnancy was 6.5 (interquartile range: 6.1-7) demonstrating high usability. Semistructured interviews (n=10) provided in-depth comments about users' experience and further improved the program. A total of 34 postpartum women with Medicaid insurance were approached for the pilot trial, and 30 (88%) were consented and randomized. All women randomized to Healthy Beyond Pregnancy completed the Web-based program, had text-enabled cell phones, and were willing to receive text messages from the study team. Women in the Healthy Beyond Pregnancy arm were more likely to return for a postpartum visit compared with women in the control arm with 85% of women in Healthy Beyond Pregnancy returning versus 53% in the control arm (odds ratio in the Healthy Beyond Pregnancy group: 5.3; 95% CI 0.9-32.0; P=.06). CONCLUSIONS:We have developed a highly usable and acceptable Web-based program designed to increase attendance at the postpartum visit. Our pilot trial demonstrates that women are willing and able to participate in a randomized trial of a Web-based program and text messaging system. TRIAL REGISTRATION:Clinicaltrials.gov NCT03296774; https://clinicaltrials.gov/ct2/show/NCT03296774 (Archived by WebCite at http://www.webcitation.org/6tpgXFzyk).

Project description:ObjectiveTo assess the feasibility of implementing a dedicated feeding support team on a postnatal ward and pilot the potential effectiveness and cost-effectiveness of team (proactive) and woman-initiated (reactive) telephone support after discharge.DesignRandomised controlled trial embedded within a before-and-after study. Participatory approach and mixed-method process evaluation.SettingA postnatal ward in Scotland.SampleWomen living in disadvantaged areas initiating breast feeding.MethodsEligible women were recruited to a before-and-after intervention study, a proportion of whom were independently randomised after hospital discharge to intervention: daily proactive and reactive telephone calls for ≤14 days or control: reactive telephone calls ≤ day 14. Intention-to-treat analysis compared the randomised groups on cases with complete outcomes at follow-up.Main outcome measuresPrimary outcomeany breast feeding at 6-8 weeks assessed by a telephone call from a researcher blind to group allocation.Secondary outcomesexclusive breast feeding, satisfaction with care, NHS costs and cost per additional woman breast feeding.ResultsThere was no difference in feeding outcomes for women initiating breast feeding before the intervention (n=413) and after (n=388). 69 women were randomised to telephone support: 35 intervention (32 complete cases) and 34 control (26 complete cases). 22 intervention women compared with 12 control women were giving their baby some breast milk (RR 1.49, 95% CI 0.92 to 2.40) and 17 intervention women compared with eight control women were exclusively breast feeding (RR 1.73, 95% CI 0.88 to 3.37) at 6-8 weeks after birth. The incremental cost of providing proactive calls was £87 per additional woman breast feeding and £91 per additional woman exclusively breast feeding at 6-8 weeks; costs were sensitive to service organisation.ConclusionsProactive telephone care delivered by a dedicated feeding team shows promise as a cost-effective intervention for improving breastfeeding outcomes. Integrating the FEeding Support Team (FEST) intervention into routine postnatal care was feasible.Trial registration numberISRCTN27207603. The study protocol and final report are available on request.

Project description:BackgroundPostpartum depression and anxiety are the 2 most common perinatal mental health disorders, with prevalence rates higher among women living in the Middle East than in most Western countries. The negative outcomes associated with postpartum depression and anxiety are profound and include less responsive parenting and compromised infant and young child development. Although interventions exist to prevent postpartum depression and anxiety, to date, there have been no studies that have attempted to prevent postpartum depression or anxiety among Arabic-speaking women in the Middle East, including Qatar.ObjectiveThe purpose of this study is to conduct a randomized controlled trial (RCT) of an evidence-based postpartum depression preventive intervention-Mothers and Babies (MB)-culturally adapted for use with Arabic-speaking women in Doha, Qatar. MB is guided by a cognitive behavioral therapy framework that focuses on increasing pleasant activities, promoting healthy thought patterns, and increasing the type and frequency of personal contacts. MB is tailored to specific needs and issues related to pregnancy and the postpartum period.MethodsA multidisciplinary and multiethnic investigator team adapted MB to promote cultural and contextual fit for Arabic-speaking women. Intervention concepts were reviewed to ensure core content would be understood by Arabic-speaking women in Qatar. Subsequently, images, activities, and examples in the intervention manuals were adapted, as needed, to make the content more relevant to Arab culture. To deliver the adapted intervention, 30 Arabic-speaking individuals with mental health backgrounds were trained. The adapted intervention was subsequently pilot-tested with 10 pregnant women receiving prenatal care at Sidra Hospital in Doha. We are now conducting an RCT to examine the effectiveness of the adapted intervention. We plan to enroll 210 pregnant individuals who are Arabic-speaking, with 1:1 randomization to the MB intervention or usual prenatal care. Among the enrolled participants, a stratified subsample of 40 pregnant women with diabetes is being recruited. Data collection will take place at baseline and a 6-month follow-up. The primary outcomes are depressive and anxiety symptoms and perceived stress. Diabetes self-care is the exploratory outcome for the subsample of individuals with diabetes. Intervention implementation will be assessed via client and provider surveys during and after intervention delivery. Power and sample size were calculated using a 2-sided 5% effort rate and assumed analyses on the individual level, accounting for attrition of 20%.ResultsThe cultural adaptation and pilot study of the adapted MB intervention are completed. A total of 157 women have been enrolled in the RCT as of March 31, 2023.ConclusionsThis study is highly innovative, as it is the first study to our knowledge to examine the effectiveness of an evidence-based postpartum depression preventive intervention in the Middle East. Limitations include a single follow-up time point and a small subsample of individuals with diabetes.Trial registrationClinicalTrials.gov NCT04442529; https://www.clinicaltrials.gov/study/NCT04442529.International registered report identifier (irrid)DERR1-10.2196/11623.

Project description:BackgroundExercise referral schemes (ERSs) are recommended for patients with health conditions or risk factors. Evidence points to the initial effectiveness and cost-effectiveness of such schemes for increasing physical activity, but effects often diminish over time. Techniques such as goal setting, self-monitoring, and personalized feedback may support motivation for physical activity and maintenance of effects. Wearable technologies could provide an opportunity to integrate motivational techniques into exercise schemes. However, little is known about acceptability to exercise referral populations or implementation feasibility within exercise referral services.ObjectiveTo determine the feasibility and acceptability of implementing an activity-monitoring device within the Welsh National ERS to inform a decision on whether and how to proceed to an effectiveness trial.MethodsWe conducted a feasability randomized controlled trial with embedded mixed-methods process evaluation and an exploratory economic analysis. Adults (N=156) were randomized to intervention (plus usual practice; n=88) or usual practice only (n=68). Usual practice was a 16-week structured exercise program. The intervention group additionally received an accelerometry-based activity monitor (MyWellnessKey) and associated Web platform (MyWellnessCloud). The primary outcomes were predefined progression criteria assessing acceptability and feasibility of the intervention and proposed evaluation. Postal questionnaires were completed at baseline (time 0:T0), 16 weeks (T1), and 12 months after T0 (T2). Routine data were accessed at the same time-points. A subsample of intervention participants and scheme staff were interviewed following the initiation of intervention delivery and at T2.ResultsParticipants were on average aged 56.6 (SD 16.3) years and mostly female (101/156, 64.7%) and white (150/156, 96.2%). Only 2 of 5 progression criteria were met; recruitment and randomization methods were acceptable to participants, and contamination was low. However, recruitment and retention rates (11.3% and 67.3%, respectively) fell substantially short of target criteria (20% and 80%, respectively), and disproportionally recruited from the least deprived quintile. Only 57.4% of intervention participants reported receipt of the intervention (below the 80% progression threshold). Less than half reported the intervention to be acceptable at T2. Participant and staff interviews revealed barriers to intervention delivery and engagement related to the device design as well as context-specific technological challenges, all of which made it difficult to integrate the technology into the service. Routinely collected health economic measures had substantial missing data, suggesting that other methods for collecting these should be used in future.ConclusionsTo our knowledge, this is the first study to evaluate short- and long-term feasibility and acceptability of integrating wearable technologies into community-based ERSs. The findings highlight device- and context-specific barriers to doing this in routine practice, with typical exercise referral populations. Key criteria for progression to a full-scale evaluation were not met.Trial registrationISRCTN Registry ISRCTN85785652; http://www.isrctn.com/ISRCTN85785652.

Project description:ObjectiveTo assess the feasibility, acceptability and fidelity of a feeding team intervention with an embedded randomised controlled trial of team-initiated (proactive) and woman-initiated (reactive) telephone support after hospital discharge.DesignParticipatory approach to the design and implementation of a pilot trial embedded within a before-and-after study, with mixed-method process evaluation.SettingA postnatal ward in Scotland.SampleWomen initiating breast feeding and living in disadvantaged areas.MethodsQuantitative data: telephone call log and workload diaries. Qualitative data: interviews with women (n=40) with follow-up (n=11) and staff (n=17); ward observations 2 weeks before and after the intervention; recorded telephone calls (n=16) and steering group meetings (n=9); trial case notes (n=69); open question in a telephone interview (n=372). The Framework approach to analysis was applied to mixed-method data.Main outcome measuresQuantitative: telephone call characteristics (number, frequency, duration); workload activity. Qualitative: experiences and perspectives of women and staff.ResultsA median of eight proactive calls per woman (n=35) with a median duration of 5 min occurred in the 14 days following hospital discharge. Only one of 34 control women initiated a call to the feeding team, with women undervaluing their own needs compared to others, and breast feeding as a reason to call. Proactive calls providing continuity of care increased women's confidence and were highly valued. Data demonstrated intervention fidelity for woman-centred care; however, observing an entire breast feed was not well implemented due to short hospital stays, ward routines and staff-team-woman communication issues. Staff pragmatically recognised that dedicated feeding teams help meet women's breastfeeding support needs in the context of overstretched and variable postnatal services.ConclusionsImplementing and integrating the FEeding Support Team (FEST) trial within routine postnatal care was feasible and acceptable to women and staff from a research and practice perspective and shows promise for addressing health inequalities.Trial registrationISRCTN27207603. The study protocol and final report is available on request.

Project description:BackgroundChronic or persistent pain affects one's ability to work or be productive at work, generating high societal and economic burden. However, the provision of work-related advice and support for people with chronic pain is variable or lacking. The Pain-at-Work (PAW) Toolkit was cocreated with people who live with pain, health care professionals, and employers. It aims to increase knowledge about employee rights and how to access support for managing a painful chronic condition in the workplace and provides advice on lifestyle behaviors that facilitate the management of chronic pain.ObjectiveWe aimed to establish the feasibility of conducting a definitive cluster randomized controlled trial comparing access to the PAW Toolkit and telephone support calls from an occupational therapist (PAW) with treatment as usual (ie, standard support from their employer). Our primary outcomes are establishing parameters of feasibility, acceptability, usability, and safety of this digital workplace health intervention. We will assess the candidate primary and secondary outcomes' feasibility and test research processes for a definitive trial.MethodsThis is an open-label, parallel 2-arm pragmatic feasibility cluster randomized controlled trial with exploratory health economics analysis and a nested qualitative interview study. We aim to recruit 120 participants from at least 8 workplace clusters (any type, >10 employees) in England. The recruitment of workplaces occurs via personal approach, and the recruitment of individual participants is web based. Eligible participants are vocationally active adults aged ≥18 years with internet access and self-reporting chronic pain interfering with their ability to undertake or enjoy productive work. A restricted 1:1 cluster-level randomization is used to allocate employment settings to PAW or treatment as usual; participants are unblinded to group allocation. Following site- and individual-level consent, participants complete a web-based baseline survey (time 0), including measures of work capacity, health and well-being, and health care resource use. Follow-up is performed at 3 months (time 1) and 6 months (time 2). Feasibility outcomes relate to recruitment; intervention fidelity (eg, delivery, reach, uptake, and engagement); retention; and follow-up. Qualitative evaluation (time 2) is mapped to the Capability, Opportunity, Motivation-Behavior model and will explore intervention acceptability to employees and employers, along with individual and contextual factors influencing the delivery and uptake of the intervention.ResultsEthics approval was obtained in March 2023. Trial recruitment began in June 2023.ConclusionsThe PAW Toolkit is the first evidence-based digital health intervention aimed at supporting the self-management of chronic or persistent pain at work. This study will inform the design of a definitive trial, including sample size estimation, approaches to cluster site identification, primary and secondary outcomes' selection, and the final health economic model. Findings will inform approaches for the future delivery of this digital health intervention.Trial registrationClinicalTrials.gov NCT05838677; https://clinicaltrials.gov/study/NCT05838677.International registered report identifier (irrid)DERR1-10.2196/51474.

Dataset Information

Feasibility and Acceptability of a Web-Based Treatment with Telephone Support for Postpartum Women With Anxiety: Randomized Controlled Trial.

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Feasibility and Acceptability of a Web-Based Treatment with Telephone Support for Postpartum Women With Anxiety: Randomized Controlled Trial.

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