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NCT04642898 · ClinicalTrials.gov registry record · NA

Increasing Treatment Efficacy Using SMART Methods for Personalizing Care

A NA study, sponsored by Shannon E. Sauer-Zavala.

Completed
Registry status
NA
Development phase
61
Enrollment target

NCT04642898: Completed NA study, sponsored by Shannon E. Sauer-Zavala.

NCT04642898 is a NA study that has completed, run by Shannon E. Sauer-Zavala. The registered enrollment target is 61 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04642898, a NA study, has completed, sponsored by Shannon E. Sauer-Zavala.

COMPLETED
Registry status
NA
Development phase
61 participants
Enrollment target

Study Summary

The proposed study will determine the feasibility, tolerability, and acceptability of a study that tests: 1) personalized treatment delivery (i.e., module sequencing and treatment discontinuation timing) aimed at increasing the efficiency of care, and 2) the research protocol designed to evaluate the effects of this personalized care. A sample of 60 participants with heterogeneous anxiety disorders (and comorbid conditions, including depression) will be enrolled in a pilot sequential multiple assignment randomized trial (SMART). Patients will be randomly assigned to one of three sequencing conditions: transdiagnostic treatment administered in its standard module order, module sequences that prioritize capitalizing on relative strengths, and module sequences that prioritize compensating for relative weaknesses. Next, after 6 sessions, participants will be randomly assigned to either continue or discontinue treatment to evaluate post-treatment change at varying levels of target engagement. This proposal will enable us to 1) test the feasibility, acceptability, and tolerability of the research protocol, treatment sequencing conditions, and early treatment discontinuation, 2) determine whether a preliminary signal that capitalization or compensation module sequencing improves treatment efficiency exists, and 3) explore preliminary associations between core process engagement at treatment discontinuation and later symptom improvement. The proposed study, and the subsequent research it will support, will inform evidence-based decision rules to make existing treatments more efficient, ultimately reducing patient costs and increasing the mental health service system's capacity to address the needs of more individuals.

Primary Outcome

Clinical severity will be measured using the Diagnostic Interview for Anxiety, Mood, and Obsessive Compulsive and Related Neuropsychiatric Disorders (DIAMOND) dimensional clinician ratings. Scores range from 1-7; higher scores indicate greater severity. Negative scores indicate symptom improvement.

Interventions

  • BEHAVIORAL Standard UP Treatment
  • BEHAVIORAL Capitalization UP Treatment
  • BEHAVIORAL Compensation UP Treatment

Trial Details

FieldValue
Enrollment Target 61 participants
Start Date 2021-06-22
Est. Completion 2024-06-15
Phase NA
Shannon E. Sauer-Zavala

5 total trials

What the finished NCT04642898 record still lists

NCT04642898 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 3 interventions - of which Standard UP Treatment is the first listed.

NCT04642898 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04642898 about?

NCT04642898 is a clinical study titled "Increasing Treatment Efficacy Using SMART Methods for Personalizing Care". The proposed study will determine the feasibility, tolerability, and acceptability of a study that tests: 1) personalized treatment delivery (i.e., module sequencing and treatment discontinuation timing) aimed at increasing the efficiency of care, and 2) the research protocol designed to evaluate th...

What is the current status of trial NCT04642898?

This trial is currently completed. It is a NA study. The enrollment target is 61 participants. The study started on 2021-06-22. Estimated completion is 2024-06-15.

What interventions are being tested in trial NCT04642898?

The interventions under investigation include: Standard UP Treatment (BEHAVIORAL), Capitalization UP Treatment (BEHAVIORAL), Compensation UP Treatment (BEHAVIORAL).

Who is sponsoring clinical trial NCT04642898?

This trial is sponsored by Shannon E. Sauer-Zavala, which has 5 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04642898's enrollment target sits among peer trials

61 1164th of 2000 higher than 837 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04642898, the US trial registry maintained by the National Library of Medicine. NCT04642898 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.