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Pilot Randomized Controlled Trial of a Novel Web-Based Intervention to Prevent Posttraumatic Stress in Children Following Medical Events.

ABSTRACT: To assess feasibility and estimate effect size of a self-directed online intervention designed to prevent persistent posttraumatic stress after acute trauma.Children aged 8-12 years with a recent acute medical event were randomized to the intervention (N = 36) or a 12-week wait list (N = 36). Posttraumatic stress, health-related quality of life, appraisals, and coping were assessed at baseline, 6, 12, and 18 weeks.Most children used the intervention; half completed it. Medium between-group effect sizes were observed for change in posttraumatic stress severity from baseline to 6 weeks (d = -.68) or 12 weeks (d = -.55). Exploratory analyses suggest greatest impact for at-risk children, and a small effect for intervention initiated after 12 weeks. Analysis of covariance did not indicate statistically significant group differences in 12-week outcomes.This pilot randomized controlled trial provides preliminary evidence that a self-directed online preventive intervention is feasible to deliver, and could have an effect in preventing persistent posttraumatic stress.

SUBMITTER: Kassam-Adams N

PROVIDER: S-EPMC4723670 | biostudies-literature | 2016 Jan-Feb

REPOSITORIES: biostudies-literature

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Pilot Randomized Controlled Trial of a Novel Web-Based Intervention to Prevent Posttraumatic Stress in Children Following Medical Events.

Kassam-Adams Nancy N Marsac Meghan L ML Kohser Kristen L KL Kenardy Justin J March Sonja S Winston Flaura K FK

Journal of pediatric psychology 20150618 1

<h4>Objective</h4>To assess feasibility and estimate effect size of a self-directed online intervention designed to prevent persistent posttraumatic stress after acute trauma.<h4>Methods</h4>Children aged 8-12 years with a recent acute medical event were randomized to the intervention (N = 36) or a 12-week wait list (N = 36). Posttraumatic stress, health-related quality of life, appraisals, and coping were assessed at baseline, 6, 12, and 18 weeks.<h4>Results</h4>Most children used the intervent ...[more]

PMID: 26089554

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Project description:BackgroundMothers who identify as Black or African American are more likely to report depressed moods in late pregnancy and early postpartum and have the lowest rates of human milk feeding compared with all other racial groups in the United States. Internet interventions offer the potential to extend preventative and supportive services as they address key barriers, particularly for those navigating the complex and vulnerable early postpartum period. However, there is limited evidence on the feasibility of such interventions for preventing perinatal mental health disorders and improving human milk feeding outcomes in Black mothers.ObjectiveThis pilot study aimed to assess the feasibility and preliminary findings of a web-based cognitive behavioral therapy-based internet intervention, with and without human milk feeding education and support, to prevent perinatal depression and promote human milk feeding in Black mothers.MethodsParticipants were Black-identifying individuals between 20 and 28 weeks of pregnancy with human milk feeding intention and mild to moderate depressive symptoms (Patient Health Questionnaire scores 5-14). Participants were randomized to either Sunnyside, a 6-week cognitive behavioral therapy-based web-based intervention, or Sunnyside Plus, which included additional education and support to promote human milk feeding. Assessments occurred at baseline, third trimester (end of antenatal treatment), 6 weeks postpartum (end of postpartum treatment), and 12 weeks postpartum. The primary focus of this randomized pilot trial was the feasibility and preliminary outcomes of mental health and human milk feeding.ResultsA total of 22 tertiary-educated participants were randomized. The mean number of log-ins was 7.3 (SD 5.3) for Sunnyside and 13.8 (SD 10.5) for Sunnyside Plus. Scores of depression and anxiety measures remained below the clinical threshold for referral to treatment in both groups. All the participants initiated human milk feeding (18/18, 100%). Most participants reported at least some human milk feeding at both 6 and 12 weeks postpartum (6/7, 86%; 11/11, 100%, or 10/10, 100%, for Sunnyside and Sunnyside Plus, respectively).ConclusionsThe results suggest that tertiary-educated Black mothers at risk for perinatal depression and who intended to human milk feed were receptive to and satisfied with a web-based cognitive behavioral therapy-based internet intervention, with and without human milk feeding education and support. Preliminary findings indicate that both Sunnyside and Sunnyside Plus interventions have the potential to affect symptoms of depression, anxiety, and human milk feeding outcomes.Trial registrationClinicalTrials.gov NCT04128202; https://www.clinicaltrials.gov/ct2/show/NCT04128202.

Project description:BackgroundCardiac surgery is a frequently performed procedure. However, pain after cardiac surgery may become chronic (lasting >3 months) in adults. Once discharged from the hospital, patients are at greater risk of developing chronic postsurgical pain (CPSP) and of prolonged opioid use, as they need to self-manage their pain. Psychological risk and protective factors such as pain-related catastrophic thoughts and pain acceptance determine their ability to cope and their use of opioids, which is crucial for self-management of pain. Studies on mindfulness-based cognitive therapy (MBCT) have multiplied their potential effects on pain acceptance and catastrophic thoughts. However, web-based MBCT for the prevention of CPSP has not yet been examined.ObjectiveThe aim of this study is to pilot test a 4-week-long web-based MBCT intervention for adults following discharge from the hospital by assessing the acceptability or feasibility of the intervention and examining preliminary effects on pain intensity, pain interference with activities and opioid use, and pain acceptance and catastrophic thoughts in the 6 months following surgery.MethodsA double-blinded pilot randomized controlled trial will be used to assess a web-based MBCT intervention. Patients will be selected according to the following criteria: age ≥18 years; first-time elective cardiac surgery via a median sternotomy; worst pain in the past week score ≥4/10; ability to understand and complete questionnaires in English; and ability to use an electronic device such as a smartphone, computer, or tablet. After baseline measures, 32 participants will be randomized into two groups: one receiving both the brief, 4-week-long web-based MBCT intervention and usual care (experimental group) and the other receiving only one standardized, web-based educational session with weekly reminders and usual care (attention control group). Peer-reviewed competitive funding was received from Florida State University's Council on Research & Creativity in January 2021, as well as research ethics approval from Florida State University's institutional review board.ResultsRecruitment began in June 2021. Unfortunately, because of the current COVID-19 pandemic, recruitment is not progressing as expected. Recruitment strategies are constantly monitored and updated according to latest data and restrictions surrounding the pandemic.ConclusionsThis research is significant because it targets the trajectory of CPSP, a leading cause of disability and opioid misuse. This is the first study to assess MBCT for the prevention of CPSP after cardiac surgery in the recovery phase. This approach is innovative because it promotes self-management of pain through the modulation of individual factors. If successful, the intervention could be expanded to numerous populations at risk of chronic pain.International registered report identifier (irrid)DERR1-10.2196/30951.

Project description:PurposeTo evaluate post-treatment efficacy of DARWeb (online psychosocial intervention for children with functional abdominal pain) using a randomized clinical trial design and combining quantitative and qualitative data.Patients and methodsTwenty-five families with children with FAP in the experimental group (EG: accessed to DARWeb) and 36 in the control group (CG: wait-list) were compared. Children and parents completed measures of abdominal pain severity (primary outcome), quality of life, and satisfaction. Moreover, children completed measures of depression, functional disability, catastrophizing and coping strategies; parents completed measures about parental responses to their children's pain. Families also answered open questions and were interviewed.ResultsA higher percentage of children in the EG achieved a significant clinical change in abdominal pain severity from the parents' perspective (28% in the EG vs 8.33% in the CG). There was a significantly greater reduction in pain frequency in the EG compared to the CG (both from the children's and parents' perspectives) from mixed repeated-measures analyses of variance (there was not a significant interaction in total scores of pain severity). A higher percentage of children in the EG improved in quality of life and depression compared to the CG (results from mixed methods repeated-measures analyses of variances were not significant). However, there were no differences for disability, pain catastrophizing or the coping strategies assessed from the children's perspective; neither from the parents' assessment of quality of life. There were significant interactions for parents' solicitousness responses and promotion of well behaviors in the expected directions. Families were quite satisfied with the intervention, and the qualitative results confirmed an improvement in pain and having learned important coping strategies.ConclusionOur results support the efficacy of our intervention, but future studies are needed with different profiles of initial severity of the pain problem, longer follow-ups, and other conditions.

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Pilot Randomized Controlled Trial of a Novel Web-Based Intervention to Prevent Posttraumatic Stress in Children Following Medical Events.

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Pilot Randomized Controlled Trial of a Novel Web-Based Intervention to Prevent Posttraumatic Stress in Children Following Medical Events.

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