Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT01653548 · ClinicalTrials.gov registry record · NA

Evaluating a Novel Method of Generalizing Emotion Regulation

A NA study, sponsored by Duke University.

Completed
Registry status
NA
Development phase
372
Enrollment target

NCT01653548: Completed NA study, sponsored by Duke University.

NCT01653548 is a NA study that has completed, run by Duke University. The registered enrollment target is 372 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT01653548, a NA study, has completed, sponsored by Duke University.

COMPLETED
Registry status
NA
Development phase
372 participants
Enrollment target

Study Summary

The aim of the present project is to develop and evaluate a novel and brief method of generalizing habituation (i.e., calming down after being upset) from an original learning context in the laboratory to other contexts inside and outside the laboratory. Specifically, the primary aim of this project is to evaluate whether novel habituation reminders (HRs) introduced following personally-relevant emotional stressors reduce acute negative emotions and psychological distress outside of an original learning context. Using a team of basic and applied scientists, over 4 years the investigators expect to screen 420 adult outpatients to enroll 250 study participants who have extreme difficulties with emotion regulation. These 250 participants will be randomly assigned to one of eight experimental groups, with the experimental design leading them through 1 or 2 of 3 project experiments. Actual enrollment: 372 adult outpatients signed consent and enrolled into the study. 222 participants were eligible and began the study. Out of the 222, 210 completed the study (as opposed to the desired 250). Experiment 1 will evaluate whether novel auditory HRs following personally-relevant emotional stressors differentially reduce psychological distress and negative emotions (via self-report and psychophysiology), compared to no HRs, within the same and different lab contexts after a 1 week delay. Experiment 2 will evaluate whether HRs differentially reduce negative emotions, psychological distress, difficulties with emotion regulation, and psychiatric symptoms, compared to sham sounds outside the laboratory across a 1 week period, using 8x daily assessments of distress and emotions and automated HRs/shams when acute negative emotions are present. An automated server and cellular phone system will be used to assess distress and emotional states and to deliver HRs/shams. Experiment 3 will examine the feasibility, acceptability, and preliminary effect size estimates when participants self-

Primary Outcome

The investigators will examine psychophysiological and self-report measures of emotional stress.

Interventions

  • BEHAVIORAL Habituation
  • BEHAVIORAL Habituation Reminder Training
  • BEHAVIORAL Habituation Reminder

Trial Details

FieldValue
Enrollment Target 372 participants
Start Date 2012-08
Est. Completion 2016-05
Phase NA
Duke University

1,725 total trials

What the finished NCT01653548 record still lists

NCT01653548 is an interventional study that assigns participants to a tested intervention. The registered 372 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (74% lower).

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

NCT01653548 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01653548 about?

NCT01653548 is a clinical study titled "Evaluating a Novel Method of Generalizing Emotion Regulation". The aim of the present project is to develop and evaluate a novel and brief method of generalizing habituation (i.e., calming down after being upset) from an original learning context in the laboratory to other contexts inside and outside the laboratory. Specifically, the primary aim of this project...

What is the current status of trial NCT01653548?

This trial is currently completed. It is a NA study. The enrollment target is 372 participants. The study started on 2012-08. Estimated completion is 2016-05.

What interventions are being tested in trial NCT01653548?

The interventions under investigation include: Habituation (BEHAVIORAL), Habituation Reminder Training (BEHAVIORAL), Habituation Reminder (BEHAVIORAL).

Who is sponsoring clinical trial NCT01653548?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01653548's enrollment target sits among peer trials

372 280th of 2000 higher than 1,720 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

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT04801589 · 372 participants · Phase 3

    Goal-Directed Sedation in Mechanically Ventilated Infants and Children

  • NCT04879329 · 372 participants · Phase 2

    A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2

  • NCT05318105 · 372 participants · NA

    Ultrafiltration Versus IV Diuretics in Worsening Heart Failure

  • NCT06797635 · 372 participants · Phase 2

    Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT01653548, the US trial registry maintained by the National Library of Medicine. NCT01653548 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.