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A randomized controlled trial of a computer-based brief intervention for victimized perinatal women seeking mental health treatment.

ABSTRACT: Intimate partner victimization (IPV) during the perinatal period is associated with adverse outcomes for the woman, her developing fetus, and any children in her care. Maternal mental health concerns, including depression and anxiety, are prevalent during the perinatal period particularly among women experiencing IPV. Screening and interventions for IPV targeting women seeking mental health treatment are lacking. In the current study, we examine the feasibility, acceptability, and the preliminary efficacy of a brief, motivational computer-based intervention, SURE (Strength for U in Relationship Empowerment), for perinatal women with IPV seeking mental health treatment. The study design was a two-group, randomized controlled trial with 53 currently pregnant or within 6-months postpartum women seeking mental health treatment at a large urban hospital-based behavioral health clinic for perinatal women. Findings support the acceptability and feasibility of the SURE across a number of domains including content, delivery, and retention. All participants (100%) found the information and resources in SURE to be helpful. Our preliminary results found the degree of IPV decreased significantly from baseline to the 4-month follow-up for the SURE condition (paired t-test, p?

SUBMITTER: Zlotnick C

PROVIDER: S-EPMC6367105 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature

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A randomized controlled trial of a computer-based brief intervention for victimized perinatal women seeking mental health treatment.

Zlotnick Caron C Tzilos Wernette Golfo G Raker Christina A CA

Archives of women's mental health 20180807 3

Intimate partner victimization (IPV) during the perinatal period is associated with adverse outcomes for the woman, her developing fetus, and any children in her care. Maternal mental health concerns, including depression and anxiety, are prevalent during the perinatal period particularly among women experiencing IPV. Screening and interventions for IPV targeting women seeking mental health treatment are lacking. In the current study, we examine the feasibility, acceptability, and the preliminar ...[more]

PMID: 30088145

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Project description:BackgroundUnmet pediatric mental health (MH) needs are growing as rates of pediatric depression and anxiety dramatically increase. Access to care is limited by multiple factors, including a shortage of clinicians trained in developmentally specific, evidence-based services. Novel approaches to MH care delivery, including technology-leveraged and readily accessible options, need to be evaluated in service of expanding evidence-based services to youths and their families. Preliminary evidence supports the use of Woebot, a relational agent that digitally delivers guided cognitive behavioral therapy (CBT) through a mobile app, for adults with MH concerns. However, no studies have evaluated the feasibility and acceptability of such app-delivered relational agents specifically for adolescents with depression and/or anxiety within an outpatient MH clinic, nor compared them to other MH support services.ObjectiveThis paper describes the protocol for a randomized controlled trial evaluating the feasibility and acceptability of an investigational device, Woebot for Adolescents (W-GenZD), within an outpatient MH clinic for youths presenting with depression and/or anxiety. The study's secondary aim will compare the clinical outcomes of self-reported depressive symptoms with W-GenZD and a telehealth-delivered CBT-based skills group (CBT-group). Tertiary aims will evaluate additional clinical outcomes and therapeutic alliance between adolescents in W-GenZD and the CBT-group.MethodsParticipants include youths aged 13-17 years with depression and/or anxiety seeking care from an outpatient MH clinic at a children's hospital. Eligible youths will have no recent safety concerns or complex comorbid clinical diagnoses; have no concurrent individual therapy; and, if on medications, are on stable doses, based on clinical screening and as well as study-specific criteria.ResultsRecruitment began in May 2022. As of December 8, 2022, we have randomized 133 participants.ConclusionsEstablishing the feasibility and acceptability of W-GenZD within an outpatient MH clinical setting will add to the field's current understanding of the utility and implementation considerations of this MH care service modality. The study will also evaluate the noninferiority of W-GenZD against the CBT-group. Findings may also have implications for patients, families, and providers looking for additional MH support options for adolescents seeking help for their depression and/or anxiety. Such options expand the menu of supports for youths with lower-intensity needs as well as possibly reduce waitlists and optimize clinician deployment toward more severe cases.Trial registrationClinicalTrials.gov NCT05372913; https://clinicaltrials.gov/ct2/show/NCT05372913.International registered report identifier (irrid)DERR1-10.2196/44940.

Project description:BackgroundSexually transmitted infections (STIs) are an increasingly critical and costly health problem for American childbearing women. Pregnant women who misuse substances are more likely to engage in risky sexual behavior that leads to STIs. Substance use and risky sex during pregnancy are both associated with numerous negative consequences for the woman and the developing fetus.Study designA two-group, randomized controlled trial.ParticipantsRecruitment of 50 pregnant women (30% Latina; 24.4 years old [SD = 5.31]) with an average of 13 weeks gestation (SD = 4.5 weeks) was conducted at a prenatal clinic in a large inner-city hospital. Recruitment took place between 2015 and 2016, and data analysis took place in 2016.InterventionA computer-delivered, single-session brief motivational intervention plus booster session addressing both substance use and STI risk.ObjectiveTo assess participants' perceptions of the intervention and to examine the preliminary efficacy in reduction of substance use and risky sex at 4-month follow-up assessment.ResultsThere were consistently very high ratings of acceptability of the intervention, ranging between 6.3 and 6.8 on a 1-7 scale. At the 4-month follow-up, participants in the intervention arm reported a significantly larger reduction (54%) in any marijuana or alcohol use compared with participants in the control group (16%) (p = 0.015) based on two-group clustered logistic regression using a generalized estimating equations approach. There was a higher reduction in condomless vaginal sex at follow-up in the health checkup for expectant moms (HCEM) arm than control (27% vs. 5%), although this was not significant (p = 0.127).ConclusionsThe results of this pilot study are encouraging with respect to the acceptability and preliminary efficacy of an intervention in reducing alcohol/marijuana use and condomless sex during pregnancy, supporting the next step of testing the intervention in a larger sample.

Project description:Internet-based interventions for heavy drinkers show promising results, but existing research is characterized by few studies in nonstudent adult populations and few comparisons with appropriate control groups.To test whether a fully automated Internet-based brief personalized feedback intervention and a fully automated Internet-based personalized brief advice intervention in a non-treatment-seeking population of heavy drinkers would result in a reduced alcohol intake.We conducted a 3-arm parallel randomized controlled trial in a general population-based sample of heavy drinkers. The 54,157 participants (median age of 58 years) were screened for heavy drinking. Of the 3418 participants who had a weekly alcohol consumption above 14 drinks for women and 21 drinks for men, 1380 (619 women) consented to take part in the trial and were randomly assigned to an Internet-based brief personalized feedback intervention group (normative feedback, n = 476), an Internet-based personalized brief advice intervention group (n = 450), or a nonintervention control group (n = 454). Follow-up after 6 and 12 months included 871 and 1064 participants, respectively, of all groups combined. The outcome measure was self-reported weekly alcohol consumption. We analyzed the data according to the intention-to-treat principle. To examine changes over time and to account for the multiple time measurements, we used a multilevel linear mixed model. To take attrition into account, we used multiple imputation to address missing data.The intervention effect of the Internet-based brief personalized feedback intervention, determined as the mean additional difference in changes in alcohol consumption in the Internet-based brief personalized feedback intervention compared with the control group, was -1.8 drinks/week after 6 months and -1.4 drinks/week after 12 months; these effects were nonsignificant (95% confidence interval -4.0 to 0.3 at 6 months, -3.4 to 0.6 at 12 months). The intervention effect of the Internet-based personalized brief advice intervention was -0.5 drinks/week after 6 months and -1.2 drinks/week after 12 months; these effects were nonsignificant (95% confidence interval -2.7 to 1.6 at 6 months, -3.3 to 0.9 at 12 months).In this randomized controlled trial we found no evidence that an Internet-based brief personalized feedback intervention was effective in reducing drinking in an adult population of heavy drinkers.ClinicalTrials.gov NCT00751985; http://clinicaltrials.gov/ct2/show/NCT00751985 (Archived by WebCite at http://www.webcitation.org/68WCRLyaP).

Project description:BackgroundLittle empirical evidence is available to support the effectiveness and cost-effectiveness of internet interventions to increase help-seeking behavior for mental health in young adults.ObjectiveThe aim of this study was to evaluate the cost-effectiveness of a Web-based mental health help-seeking navigation tool (Link) in comparison with usual help-seeking strategies.MethodsA cost-utility analysis alongside the main randomized trial of Link was conducted from the Australian health care sector perspective. Young adults aged 18 to 25 years were randomized to the Link intervention (n=205) or usual care (n=208) with 1- and 3-month follow-ups. The primary outcome of this study was quality-adjusted life years (QALYs) measured by the assessment of quality of life-4D. Costs were calculated based on the self-reported resource use questionnaire and were reported in 2015 Australian dollars. Primary analyses were conducted as intention-to-treat and reported as incremental cost-effectiveness ratios. Completer analyses were conducted in a sensitivity analysis.ResultsSignificantly more QALYs were gained in the intervention group than the control group (0.15 vs 0.14; P<.001). The intervention was associated with significantly lower health professional consultation costs at 1-month follow-up (mean costs Aus $98 vs Aus $162; P<.05). Costs of hospital services were lower at 3 months in the intervention arm (mean costs Aus $47 vs Aus $101); however, there was insufficient sample size to detect a significant difference between the groups. There were no statistically significant differences in the total costs between the 2 arms. Relative to the control group, those who received the intervention experienced 0.01 more QALYs (0.00-0.02) and had lower total health sector costs of Aus -$81 (Aus -$348 to Aus $186) over 3 months. The intervention was found to be more effective and less costly compared with usual help-seeking strategies. The intervention was 100% likely to be cost-effective below a willingness-to-pay value-for-money threshold of Aus $28,033 per QALY. Results were robust in the sensitivity analysis.ConclusionsOur study found that the online youth mental health help-seeking Web service is a cost-effective intervention for young people aged 18 to 25 years compared with usual search strategies. Further research is required to confirm these results.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12614001223628; https://www.anzctr.org.au /Trial/Registration/TrialReview.aspx?id=366731.

Dataset Information

A randomized controlled trial of a computer-based brief intervention for victimized perinatal women seeking mental health treatment.

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A randomized controlled trial of a computer-based brief intervention for victimized perinatal women seeking mental health treatment.

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