ADEPT Intervention for Vaccine Hesitancy

(ADEPT Trial)

Overseen By Beverly Gray, MD

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Emory University

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

770 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether providing expectant parents with accurate vaccine information during pregnancy can increase their confidence in vaccines and ensure timely vaccination for their children. The study includes two groups: one receives the ADEPT intervention (Augmented Depression Therapy) with additional information and support, while the other receives standard prenatal care. This trial suits first-time parents with a single pregnancy, no known complications, and who receive prenatal care at participating practices. As an unphased trial, it offers a unique opportunity to contribute to important research that could enhance prenatal care practices.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the ADEPT intervention is safe for expectant parents?

Research has shown that treatments like ADEPT do not cause serious negative effects for participants. In past studies, participants in ADEPT trials did not report unexpected or harmful outcomes directly related to the treatment, indicating it is generally well-tolerated.

It's important to note that ADEPT is not a drug or medical procedure. It involves providing information and support, which typically carries very low risk. Therefore, participants need not worry about the side effects often associated with new medications or surgeries.

Participants in similar programs have not experienced significant negative effects, making ADEPT a safe choice for those considering joining this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ADEPT intervention for vaccine hesitancy because it offers a fresh approach to understanding and addressing the concerns of expectant parents. Unlike the standard of care, which typically involves providing general vaccine information, ADEPT is designed to be a more personalized and engaging method. It focuses on building trust and directly addressing individual concerns, potentially leading to higher vaccine acceptance rates. By tailoring communication strategies to the specific hesitations of individuals, ADEPT aims to bridge the gap between healthcare providers and patients, fostering a more supportive environment for vaccine discussions.

What evidence suggests that the ADEPT intervention is effective for vaccine hesitancy?

Research shows that providing expectant parents with clear and accurate information about vaccines can boost their confidence in vaccinating their children. Studies have found that one-on-one counseling increases openness to vaccines, particularly among those who are unsure. In this trial, participants in the ADEPT intervention arm will receive the ADEPT program, designed for prenatal care, which aims to ensure timely vaccinations by giving parents important facts before their baby is born. Early results suggest that these proactive steps can lead to timely vaccinations in early childhood. This method could be especially helpful in promoting vaccinations during pregnancy and after birth. ^{1 6 7 8 9}

Who Is on the Research Team?

Lavanya Vasudevan, PhD, MPH

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for expectant parents with a single pregnancy, no prior live births, and no known fetal issues. They must be in the early third trimester and getting prenatal care at a participating practice. Those at risk for preterm birth cannot join.

Inclusion Criteria

Not at known risk for preterm birth

My unborn baby does not have any known birth defects or genetic issues.

Singleton pregnancy (excludes twins, triplets, etc.)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of ADEPT intervention in prenatal care settings, including provider trainings and recommendations to pregnant individuals.

28-32 weeks gestation

Multiple visits (in-person and virtual)

Adaptive Intervention

Vaccine-hesitant individuals receive educational materials and phone consultations with a vaccine navigator.

8-12 weeks

Follow-up

Assessment of children's vaccination outcomes at birth, 2, 4, 6, and 12 months using NCIR data.

12 months post birth

What Are the Treatments Tested in This Trial?

Interventions

• ADEPT

Trial Overview The study tests if giving factual vaccine information to expectant parents during pregnancy can increase their confidence in childhood vaccines and ensure their child gets vaccinated on time.

How Is the Trial Designed?

Group I: ADEPT Experimental Treatment 1 Intervention

Individuals receiving prenatal care at a practice that was randomized to deliver the ADEPT intervention.

Group II: Standard of Care Active Control 1 Intervention

Individuals receiving prenatal care at a practice that was randomized to deliver the standard of care.

ADEPT is already approved in United Kingdom for the following indications:

Approved in United Kingdom as Augmented Depression Therapy for:

• Anhedonic Depression

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Published Research Related to This Trial

Technology-based approaches for preventing depression provide significant advantages such as easy access and increased patient autonomy, making them a valuable alternative to traditional face-to-face interventions.

The authors propose a 'behavioral vaccine model' for Internet interventions, which integrates effective community-based strategies to enhance the delivery and efficacy of online depression prevention programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-based depression prevention over the life course: a call for behavioral vaccines. Van Voorhees, BW., Mahoney, N., Mazo, R., et al.[2023]

In a study of 229 patients, adding a Web-based self-help program (Deprexis) to multimodal inpatient psychotherapy significantly reduced depressive symptoms, anxiety, and improved quality of life and self-esteem at a 6-month follow-up.

Participants using the Web-based self-help were nearly three times more likely to achieve remission compared to those receiving only standard information, highlighting the effectiveness of this digital intervention as an adjunct to traditional therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the Course of Depressive Symptoms After Inpatient Psychotherapy Using Adjunct Web-Based Self-Help: Follow-Up Results of a Randomized Controlled Trial. Zwerenz, R., Baumgarten, C., Becker, J., et al.[2020]

The OPTIMUM study is a large-scale clinical trial involving 1,500 older adults (aged 60 and above) who have not responded to two or more antidepressant treatments, aiming to compare the effectiveness and safety of medication augmentation versus switching therapies for treatment-resistant depression.

Initial challenges faced in the study include participant recruitment, managing polypharmacy risks, standardizing adverse event reporting, and effectively disseminating results, which highlight the complexities of conducting research in older populations with depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing Outcomes of Treatment-Resistant Depression in Older Adults (OPTIMUM): Study Design and Treatment Characteristics of the First 396 Participants Randomized. Cristancho, P., Lenard, E., Lenze, EJ., et al.[2023]

In a study of 23 adults with treatment-resistant depression, 91.8% reported significant improvements in emotional and daily functioning after using esketamine nasal spray (ESK) alongside an oral antidepressant (OAD).

Patients noted key benefits of ESK treatment, including its effectiveness, rapid onset of action, and a side-effect profile consistent with existing safety data, leading to high satisfaction rates (100% reported satisfaction).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-reported review of the value of esketamine in patients with treatment-resistant depression: Understanding the patient experience in the STRIVE Study. Starr, HL., Abell, J., Larish, A., et al.[2021]

Providing psychoeducation about cognitive-behavioral therapy (CBT) significantly improved participants' perceptions of its credibility and expectancy, indicating that people may be more open to this treatment after learning about it.

However, while perceptions of CBT improved, acceptability did not change as much, suggesting that more extensive interventions may be needed to increase the willingness to try CBT among those who typically prefer antidepressant medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions of Cognitive-Behavioral Therapy and Antidepressant Medication for Depression After Brief Psychoeducation: Examining Shifts in Attitudes. Beshai, S., Watson, LM., Meadows, TJS., et al.[2019]

A study of 582 patients with anxiety disorders at a public outpatient clinic revealed that most received pharmacological treatment, but very few accessed effective cognitive behavioral therapy (CBT) that included exposure components, which are crucial for optimal treatment.

The findings highlight a significant gap in the delivery of evidence-based psychosocial treatments for anxiety, as most patients received only supportive therapy instead of the more effective CBT, indicating a need to address barriers to accessing proper care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Has evidence-based psychosocial treatment for anxiety disorders permeated usual care in community mental health settings? Wolitzky-Taylor, K., Zimmermann, M., Arch, JJ., et al.[2018]

The gamified smartphone-based intervention, mentalis Phoenix (MT-Phoenix), was tested in a pilot trial with 77 participants and showed a significant reduction in depressive symptoms compared to a waitlist control, with a large effect size (d=1.02).

Participants engaged with the intervention for an average of 46% of the days over a 14-day period, and the positive effects on depression were sustained at a 3-month follow-up, indicating both efficacy and potential for long-term benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Gamified Smartphone-Based Intervention for Depression: Randomized Controlled Pilot Trial. Lukas, CA., Eskofier, B., Berking, M.[2021]

Augmented Depression Therapy (ADepT) shows promise in improving both depression and wellbeing compared to Cognitive Behavioural Therapy (CBT), with a pilot study involving 82 participants indicating favorable outcomes for ADepT at both 6 and 18 months.

The study reported no significant treatment-related adverse events, suggesting that ADepT is a safe intervention, and it demonstrated a high probability of being cost-effective, supporting further research into its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary clinical and cost effectiveness of augmented depression therapy versus cognitive behavioural therapy for the treatment of anhedonic depression (ADepT): a single-centre, open-label, parallel-group, pilot, randomised, controlled trial. Dunn, BD., Widnall, E., Warbrick, L., et al.[2023]

In a study involving 97 participants with treatment-resistant depression, ketamine infusions showed a 67% response rate, indicating significant antidepressant effects.

The treatment was found to be safe and well-tolerated, with only a 3.1% attrition rate and no cases of persistent adverse effects, although some participants experienced temporary side effects like drowsiness and dissociation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ketamine safety and tolerability in clinical trials for treatment-resistant depression. Wan, LB., Levitch, CF., Perez, AM., et al.[2022]

In a study of 269 patients with treatment-resistant depression (TRD) using esketamine (ESK) intranasal spray, 61.3% completed the recommended induction phase, indicating good adherence to treatment.

Post-initiation of ESK, there was a trend of reduced mental health-related inpatient and emergency department costs, suggesting potential economic benefits alongside clinical outcomes for patients with TRD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment patterns, healthcare utilization, and costs of patients with treatment-resistant depression initiated on esketamine intranasal spray and covered by US commercial health plans. Joshi, K., Pilon, D., Shah, A., et al.[2023]

A study of 51,683 patients found that using electronic health records to analyze patient history can significantly improve predictions of unplanned treatment discontinuation when starting antidepressants, with a mean predictive accuracy (AUC) of 0.69.

The study revealed that paroxetine had the highest discontinuation rate at 27.71%, while venlafaxine had the lowest at 20.78%, highlighting the importance of considering tolerability alongside efficacy when personalizing antidepressant treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting treatment dropout after antidepressant initiation. Pradier, MF., McCoy, TH., Hughes, M., et al.[2021]

A survey of 591 Jewish Israeli adults with depression or anxiety revealed that many patients prefer herbal treatments over conventional medications, with 39% not using prescription drugs at all, highlighting a significant barrier to effective treatment.

Patients' concerns about adverse effects from conventional treatments were linked to a greater willingness to consider herbal alternatives, suggesting that understanding cultural and personal attitudes is crucial for improving treatment acceptance and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' attitudes toward conventional and herbal treatments for depression and anxiety: A cross-sectional Israeli survey. Burstein, O., Shamir, A., Abramovitz, N., et al.[2022]

A study of 41 adults with treatment-resistant depression (TRD) showed that a single sub-anesthetic infusion of ketamine significantly reduced depression scores within 24 hours, with over half of the patients experiencing a 50% reduction in symptoms.

The treatment was well tolerated, with only mild side effects reported, and a majority of responders maintained their improvement for at least a week, indicating both efficacy and safety in a real-world setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-dose ketamine for treatment resistant depression in an academic clinical practice setting. Feifel, D., Malcolm, B., Boggie, D., et al.[2018]

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A Spatial Analysis Across Two Time Periods This study investigates the impact of COVID-19 case rates, vaccination rates, and socioeconomic factors on severe depression rates across 1470 counties in the ...

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COVID Vaccine Hesitancy and Long-Term Traffic Risks Those who had not received a COVID vaccine had a 58% higher risk than those who had received a COVID vaccine (6983 vs 4438 per million, P < .001). The increased ...