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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 is a NA study that has completed, run by Duke University. The registered enrollment target is 372 participants.
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-
Interventions
- BEHAVIORAL Habituation
- BEHAVIORAL Habituation Reminder Training
- BEHAVIORAL Habituation Reminder
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 372 participants |
| Start Date | 2012-08 |
| Est. Completion | 2016-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01653548
The ClinicalTrials.gov registry entry for NCT01653548 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 372 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Habituation is the first listed.
NCT01653548 reports 0 study locations.
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.
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