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"Zlotnick, Caron"
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Analysis of implementation processes in a hybrid effectiveness-implementation trial of interpersonal psychotherapy (IPT) for major depressive disorder in prisons: Training, supervision, and recommendations
by
Wiltsey-Stirman, Shannon
,
Johnson, Jennifer E.
,
Zlotnick, Caron
in
Adult
,
Analysis
,
Biology and Life Sciences
2024
There are 10 million admissions to U.S. prisons and jails each year. More than half of those admitted have mental health problems. The goal of this article is to inform: (1) implementation of evidence-based mental health treatments in prisons and jails, an important effort that needs more evidence to guide it; (2) psychotherapy and interpersonal psychotherapy (IPT) training efforts, especially in low-resource settings.
A randomized hybrid effectiveness-implementation trial of group IPT for major depressive disorder (MDD) in state prisons found that IPT increased rates of MDD remission and lowered posttraumatic stress disorder symptoms relative to prison treatment as usual. The trial used prison counselors, only some of whom had prior psychotherapy training/experience, to deliver IPT. IPT treatment adherence was high (96%), but trial training and supervision were too costly to be scalable outside the trial. The current article reports results from a planned qualitative analysis of 460 structured implementation and supervision documents in that trial to describe training and supervision processes and lessons learned, inform training recommendations, and facilitate future work to optimize training and supervision for under-resourced settings.
Themes identified in implementation and supervision process notes reflected: work on psychotherapy basics (reflective listening, focusing on emotions, open-ended questions, specific experiences), IPT case conceptualization (forming a conceptualization, what is and is not therapeutic work, structure and limit setting, structure vs. flexibility), IPT techniques (enhancing social support, role plays, communication analysis), psychotherapy processes (alliance repair, managing group processes), and managing difficult situations (avoidance, specific clients, challenging work settings). Counselors were receptive to feedback; some relied on study supervisors for support in managing stressful prison working conditions.
Findings can be used to make future training and supervision more efficient. Based on our results, we recommend that initial and refresher training focus on IPT case conceptualization, steps for addressing each IPT problem area, and reflective listening. We also recommend supervision through at least counselors' first two rounds of groups. More low-cost, scalable training methods are needed to get mental health treatment to individuals who need it most, who are often served in challenging, low-resource settings such as prisons. This is a mental health access and equity issue.
The trial was registered at clinicaltrials.gov (NCT01685294).
Journal Article
MOSAIC (MOthers’ AdvocateS In the Community) for pregnant women and mothers of children under 5 with experience of intimate partner violence: A pilot randomized trial study protocol
by
Johnson, Jennifer E.
,
Zlotnick, Caron
,
Hailemariam, Maji
in
Abused women
,
Acceptability
,
Advocacy
2022
Pregnancy and motherhood increase the risk for long-term exposure to physical, psychological and sexual intimate partner violence (IPV; sexual or physical violence by current or former partners). Pregnant women and mothers with children under 5 who have experienced IPV exhibit poor physical and mental health and obstetric outcomes. Depression and posttraumatic stress disorder (PTSD) are the two most common mental health consequences of IPV. There is good evidence that women with good social support have better mental health and IPV outcomes.
This study will develop MOthers' AdvocateS In the Community (MOSAIC) Plus intervention for pregnant women and mothers with children under the age of 5. MOSAIC uses trained mentor mothers and has been found to reduce subsequent IPV. This study will blend the original MOSAIC intervention with principles of interpersonal psychotherapy (IPT) to address symptoms of depression, PTSD, and prevent subsequent risk of IPV. We will conduct a pilot randomized trial of the MOSAIC Plus intervention compared to the traditional MOSAIC intervention to determine its feasibility and acceptability. Study samples include focus groups (n = 36), open trial (n = 15), and a randomized pilot trial including 40 pregnant women and mothers with children under 5 who report current/recent of IPV and elevated symptoms of maternal depression and/or PTSD. The study's primary outcome will be changes in maternal depressive and PTSD symptoms. Secondary outcomes will include reduction in subsequent IPV, improvement in functioning, changes in social support and effectiveness in obtaining resources.
This is a formative study evaluating the feasibility and acceptability of a mentor mother intervention for pregnant women and mothers with children under 5. Promising results of this study will be used for a larger, fully-powered randomized trial evaluating the effectiveness of a mentor mother intervention in preventing subsequent IPV and reducing depressive and PTSD symptoms in this population.
Journal Article
Intimate Partner Violence and Coerced Unprotected Sex Among Young Women Attending Community College
by
Zlotnick, Caron
,
Orchowski, Lindsay M.
,
Yusufov, Miryam
in
Advertisements
,
Advertising
,
Assertiveness
2020
The present study examined the mediating role of sexual assertiveness in the relationship between psychological, physical, and sexual intimate partner violence (IPV) victimization and unprotected sex as a result of condom use resistance among sexually active young women attending community college. Women reported engagement in unprotected sex as a result of a partner’s use of one of 32 forms of condom use resistance (e.g., physical force, deception, or other forms of coercion to avoid using a condom during intercourse). Women ages 18–24 years (
N
= 212) attending community college were recruited through paper advertisements to complete assessments of social and dating behavior in the campus computer laboratory. Only the women with a history of sexual intercourse (
N
= 178; 84% of the sample) were included in analyses. More frequent engagement in unprotected sex as a result of a partner’s condom use resistance was associated with physical, psychological, and sexual IPV victimization. Sexual assertiveness mediated the relationship between physical IPV victimization and the frequency of unprotected sex as a result of condom use resistance. Efforts to prevent dating violence and enhance the sexual health of community college women may benefit from focusing on targeting sexual assertiveness as a protective factor.
Journal Article
Computer-based intervention for residents of domestic violence shelters with substance use: A randomized pilot study
2023
Intimate Partner Violence (IPV) is a significant public health problem often associated with serious mental health and physical health implications. Substance use disorders (SUDs) are one of the most common comorbidities among women with IPV, increasing risk of subsequent IPV.
The current study examined the feasibility, acceptability, and preliminary effectiveness of a brief computerized intervention to reduce alcohol and drug use among women with IPV. Fifty women with recent IPV and alcohol and drug use risk were recruited from domestic violence shelters and randomized to the experimental computerized intervention or to an attention and time control condition. The primary outcome was percent heavy drinking or drug using days in 3 month increments over the 6 months after leaving the shelter. Receipt of substance use services and IPV severity were evaluated as secondary outcomes.
The computerized intervention was feasible and acceptable, with high (n = 20, 80%) completion rates, engagement with the intervention, and satisfaction scores. As expected in this pilot trial, there were no significant differences between conditions in percent heavy drinking/drug using days or receipt of substance use services and large individual differences in outcomes. For example, receipt of substance use services decreased by a mean of 0.05 times/day from the baseline to the 6-month time period in the control condition (range -1.00 to +0.55) and increased by a mean of 0.06 times/day in the intervention condition (range -0.13 to +0.89). There were large decreases in IPV severity over time in both conditions, but directions of differences favored the control condition for IPV severity.
A computerized intervention to reduce the risk of alcohol/drug use and subsequent IPV is feasible and acceptable among residents of a domestic violence shelter. A fully powered trial is needed to conclusively evaluate outcomes.
Journal Article
Computerized Intervention in Primary Care for Women Veterans with Sexual Assault Histories and Psychosocial Health Risks: a Randomized Clinical Trial
by
Creech, Suzannah K
,
Zlotnick Caron
,
Orchowski Lindsay M
in
Aggression
,
Chi-square test
,
Clinical trials
2022
ImportanceSexual assault is a public health concern for women and is associated with subsequent psychosocial health risks of posttraumatic stress disorder (PTSD), hazardous drinking, and intimate partner violence (IPV). Sexual assault is associated with social stigma and other barriers shown to inhibit one from seeking mental health care. Digital health technologies may overcome these barriers.ObjectiveTo test the impact of a brief computerized intervention delivered in primary care to reduce health risks and increase mental health treatment utilization among women with histories of sexual assault and current health risks.Design, Setting, and ParticipantsThe Safe and Healthy Experiences (SHE) program was tested in a randomized controlled trial with N = 153 women veterans at a Veterans Health Administration (VHA) medical center, and they completed assessments at baseline, 2 months, and 4 months.InterventionSHE is a brief motivational interviewing and psychoeducation-based computerized intervention. SHE was compared to a screen and referral-only control condition.Main MeasuresHealth risks were measured via validated self-report instruments. Treatment initiation and utilization were measured via self-report and chart review.ResultsSHE did not impact women’s number of health risks (all p’s > .05). However, women randomized to SHE showed significantly greater increases in treatment use compared to women in the control group, as measured by chart review (χ2 (1, n = 153) = 4.38, p = .036, rs = .16), and self-report (χ2 (1, n = 130) = 5.89, p = .015, rs = .21). SHE was found to be an acceptable intervention.ConclusionsSHE was effective in improving mental health treatment initiation and utilization compared to a control group. Computer-based interventions to address sexual trauma and its consequences are acceptable, are highly scalable, and can add value to primary care with little cost or increase in provider time.Trial RegistrationClinicaltrials.gov identifier NCT02957747.
Journal Article
Outcomes of the ROSE Sustainment (ROSES) Study, a sequential multiple assignment randomized implementation trial to determine the minimum necessary intervention to sustain a postpartum depression prevention program in agencies serving low-income pregnant people
by
Wiltsey-Stirman, Shannon
,
Johnson, Jennifer E.
,
Sikorskii, Alla
in
Adult
,
Collaboration
,
Cost analysis
2025
Background
This Sequential Multiple Assignment Randomized Trial (SMART) was conducted to determine minimum implementation support needed for agencies serving pregnant people on public assistance to adopt and sustain the ROSE (Reach Out, Stay Strong, Essentials for mothers of newborns) postpartum depression (PPD) prevention program.
Methods
Enrolled prenatal agencies (
N
=98) received thorough initial implementation support (initial training + written sustainment planning). Agencies were identified as at risk for non-sustainment within the first 15 months (
N
=56) were randomized to: (1) no additional implementation support (
N
=12), or (2) quarterly implementation support (coaching and feedback;
N
=44). If agencies receiving quarterly implementation supports were still at risk and within the first 15 months (
N
=29), they were randomized to: (1) continued quarterly support (
N
=14), or (2) monthly implementation support (
N
=15). No implementation support occurred after 18 months. Follow-ups occurred quarterly and then at 18, 24, and 30 months. Outcomes included sustainment of core program elements, agency PPD rates, reach, and costs/cost-effectiveness of each sustainment step.
Results
Twice as many agencies as expected (41 of 98; 42%) delivered ROSE with fidelity for 15+ months after receiving thorough initial implementation support only. For agencies at risk for non-sustainment, no effects of adding quarterly implementation supports were observed. However, adding monthly supports (versus quarterly) for agencies still at risk resulted in higher monthly percent of core ROSE elements sustained and more months ROSE was sustained with fidelity with large (Cohen’s d = 0.73 and 0.80) effect sizes, and improved reach over 30 months. Many agencies did not consistently collect PPD rates, making results difficult to interpret. Mean implementation costs (including implementation support and agency staff time) per agency were $1,849 (SD $1,429) for agencies receiving initial implementation support only, $2,699 (SD $1,837) for those receiving initial and quarterly implementation support, and $4,059 (SD $1,763) for those receiving initial, quarterly, and ultimately monthly implementation support.
Conclusions
The cost of agency-wide ROSE implementation is far less than the cost of a single untreated case of PPD ($33,484). We suggest implementing ROSE through thorough training and written sustainment planning. For agencies not sustaining, adding monthly support can promote sustainment and improve reach.
Trial registration
Registered June 14, 2018 at clinicaltrials.gov, NCT03267563 (
https://clinicaltrials.gov/study/NCT03267563
).
Journal Article
Correction to: Intimate Partner Violence and Coerced Unprotected Sex Among Young Women Attending Community College
by
Zlotnick, Caron
,
Orchowski, Lindsay M.
,
Yusufov, Miryam
in
Behavioral Science and Psychology
,
Correction
,
Psychology
2020
There is an error in one of the affiliations presented for co-author Caron Zlotnick.
Journal Article
Protocol for the ROSE sustainment (ROSES) study, a sequential multiple assignment randomized trial to determine the minimum necessary intervention to maintain a postpartum depression prevention program in prenatal clinics serving low-income women
by
Wiltsey-Stirman, Shannon
,
Johnson, Jennifer E.
,
Sikorskii, Alla
in
Ambulatory Care Facilities
,
Analysis
,
Child
2018
Background
More research on sustainment of interventions is needed, especially return on investment (ROI) studies to determine cost-benefit trade-offs for effort required to sustain and how much is gained when effective programs are sustained. The ROSE sustainment (ROSES) study uses a sequential multiple assignment randomized (SMART) design to evaluate the effectiveness and cost-effectiveness of a stepwise approach to sustainment of the ROSE postpartum depression prevention program in 90 outpatient clinics providing prenatal care to pregnant women on public assistance. Postpartum depression (PPD) is common and can have lasting consequences. Outpatient clinics offering prenatal care are an opportune place to provide PPD prevention because most women visit while pregnant. The ROSE (Reach Out, Stay Strong, Essentials for mothers of newborns) program is a group educational intervention to prevent PPD, delivered during pregnancy. ROSE has been found to reduce cases of PPD in community prenatal settings serving low-income pregnant women.
Methods
All 90 prenatal clinics will receive enhanced implementation as usual (EIAU; initial training + tools for sustainment). At the first time at which a clinic is determined to be at risk for failure to sustain (i.e., at 3, 6, 9, 12, and 15 months), that clinic will be randomized to receive either (1) no additional implementation support (i.e., EIAU only), or (2) low-intensity coaching and feedback (LICF). If clinics receiving LICF are still at risk at subsequent assessments, they will be randomized to either (1) EIAU + LICF only, or (2) high-intensity coaching and feedback (HICF). Additional follow-up interviews will occur at 18, 24, and 30 months, but no implementation intervention will occur after 18 months. Outcomes include (1) percent sustainment of core program elements at each time point, (2) health impact (PPD rates over time at each clinic) and reach, and (3) ROI (costs and cost-effectiveness) of each sustainment step. Hypothesized mechanisms include sustainment of capacity to deliver core elements and engagement/ownership.
Discussion
This study is the first randomized trial evaluating the ROI of a stepped approach to sustainment, a critical unanswered question in implementation science. It will also advance knowledge of implementation mechanisms and clinical care for an at-risk population.
Trial registration
Clinicaltrials.gov,
NCT03267563
. Registered June 14, 2018.
Journal Article
Efficacy and moderators of cognitive behavioural therapy versus interpersonal psychotherapy for adult depression: study protocol of a systematic review and individual participant data meta-analysis
2025
IntroductionCognitive behavioural therapy (CBT) and interpersonal psychotherapy (IPT) are both efficacious treatments for depression, but it is less clear how both compare on outcome domains other than depression and in the longer term. Moreover, it is unclear which of these two psychotherapies works better for whom. This article describes the protocol for a systematic review and individual participant data (IPD) meta-analysis that aims to compare the efficacy of CBT and IPT for adults with depression on a range of outcomes in both the short and long term, and to explore moderators of the treatment effect. This study can enhance our understanding of treatments for depression and inform treatment personalisation.Methods and analysisSystematic literature searches will be conducted in PubMed, PsycINFO, EMBASE and the Cochrane Library from inception to 1 January 2026, to identify randomised clinical trials (RCTs) comparing CBT and IPT for adult depression. Researchers of eligible studies will be invited to contribute their participant-level data. One-stage IPD meta-analyses will be conducted with mixed-effects models to examine (a) treatment efficacy on all outcome measures that are assessed at post-treatment or follow-up in at least two studies, and (b) various baseline participant characteristics as potential moderators of depressive symptom level at treatment completion.Ethics and disseminationEthical approval is not required for this study since it will be based on anonymised data from RCTs that have already been completed. The findings of the present study will be disseminated through a peer-reviewed journal or conference presentation.
Journal Article
Protocol for the Healing After Loss (HeAL) Study: a randomised controlled trial of interpersonal psychotherapy (IPT) for major depression following perinatal loss
2022
IntroductionThis protocol describes a study testing the efficacy of interpersonal psychotherapy (IPT) for major depressive disorder following perinatal loss (early and late fetal death and early neonatal death). Perinatal loss is associated with elevated risk of major depressive disorder and post-traumatic stress disorder (PTSD). Perinatal loss conveys specific treatment needs. The trial will be the first fully powered randomised trial of treatment for any psychiatric disorder following perinatal loss.Methods and analysisA sample of 274 women in Flint and Detroit areas in Michigan who experience a major depressive episode following a perinatal loss will be randomised to group IPT for perinatal loss or to group coping with depression. We anticipate that 50% of the sample will have co-occurring PTSD. Assessments occur at baseline, mid-treatment (8 weeks), post-treatment (16 weeks) and follow-up (28 weeks). Clinical outcomes include time to recovery from major depressive episode (primary), depressive symptoms, PTSD symptoms and time to recovery from PTSD. Additional outcomes include social support, social role functioning (including parental functioning for those with living children), well-being, grief (including complicated grief and fault beliefs) and fear of subsequent pregnancies. Social support and grief are hypothesised mediators of IPT effects on time to recovery from major depressive episode.Ethics and disseminationThe trial was approved by Michigan State University’s Biomedical Institutional Review Board. It has a data and safety monitoring board and has been submitted to the community-based organisation partners community ethics review board. Written operating procedures outline methods for protecting confidentiality, monitoring and recording adverse events, and safeguarding participants. We will share study results with research and clinical communities, community organisations through which we recruited, and will offer results to study participants. Deidentified datasets will be available through the National Institute of Mental Health Data Archive and to qualified investigators on request.Trial registration numberNCT04629599.
Journal Article