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

Trial Summary

What is the purpose of this trial?

This study will test whether proactively connecting expectant parents with factual vaccination information during pregnancy can build confidence in vaccinations and lead to timely vaccinations during pregnancy and once their child is born.

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 data supports the effectiveness of the ADEPT treatment for vaccine hesitancy?

The research shows that web-based self-help can improve the effectiveness of therapy for depression, suggesting that similar approaches might help with vaccine hesitancy. Additionally, cognitive-behavioral therapy (CBT), which is part of many depression treatments, is effective for anxiety and depression, indicating that elements of ADEPT could be beneficial. ^{1 2 3 4 5}

Is the ADEPT Intervention for Vaccine Hesitancy safe for humans?

The safety of treatments like ketamine and esketamine, which may be related to ADEPT, has been studied in people with treatment-resistant depression. These studies generally report that the treatments are safe, with side effects consistent with known safety profiles. ^{6 7 8 9 10}

How is the ADEPT treatment for vaccine hesitancy different from other treatments?

ADEPT (Augmented Depression Therapy) is unique because it specifically targets anhedonia (reduced interest or pleasure) and wellbeing, which are often not adequately addressed by other therapies. This focus on enhancing pleasure and wellbeing could make it particularly effective for addressing vaccine hesitancy, as it may improve overall mental health and openness to vaccination. ^{2 3 11 12 13}

Research Team

Lavanya Vasudevan, PhD, MPH

Principal Investigator

Emory University

Eligibility Criteria

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

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

Not at known risk for preterm birth

Singleton pregnancy (excludes twins, triplets, etc.)

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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 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]

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 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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Perceptions of Cognitive-Behavioral Therapy and Antidepressant Medication for Depression After Brief Psychoeducation: Examining Shifts in Attitudes. [2019]

2. Canada 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. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Patients' attitudes toward conventional and herbal treatments for depression and anxiety: A cross-sectional Israeli survey. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Predicting treatment dropout after antidepressant initiation. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Has evidence-based psychosocial treatment for anxiety disorders permeated usual care in community mental health settings? [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Ketamine safety and tolerability in clinical trials for treatment-resistant depression. [2022]

7. England 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. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Low-dose ketamine for treatment resistant depression in an academic clinical practice setting. [2018]

9. England 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. [2023]

10. Ireland 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. [2021]

11. England 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. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Internet-based depression prevention over the life course: a call for behavioral vaccines. [2023]

13. Canada pubmed.ncbi.nlm.nih.gov

A Gamified Smartphone-Based Intervention for Depression: Randomized Controlled Pilot Trial. [2021]