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NCT03509181 · ClinicalTrials.gov registry record · NA

Augmenting Hospitalization for Serious Mental Illness: Cognitive Bias Modification

A NA study, sponsored by Mclean Hospital.

Completed
Registry status
NA
Development phase
68
Enrollment target

NCT03509181 is a NA study that has completed, run by Mclean Hospital. The registered enrollment target is 68 participants.

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The verdict

NCT03509181, a NA study, has completed, sponsored by Mclean Hospital.

COMPLETED
Registry status
NA
Development phase
68 participants
Enrollment target

Study Summary

Approximately 4.1% of the adult US population meets the criteria for SMI, a mental disorder associated with significant functional impairment. Even when effective, pharmacologic and psychological treatments often leave individuals with SMI with residual symptoms, impairment, and at risk for re-hospitalization and suicide. The month following hospitalization is a particularly risky time; thus, augmentation treatments that can speed up improvement during brief hospital stays, as well as provide a bridge to outpatient care are urgently needed. Thus, the investigators propose to develop an augmentation to psychiatric hospital care (called "I-Change") that can be continued at home following discharge. I-Change targets interpretation bias, the tendency to resolve ambiguous situations negatively. Interpretation bias is a well-established cognitive vulnerability for psychopathology and is associated with poor emotion regulation, rumination, symptom severity, and suicidal ideation. For example, in a psychiatric hospital sample, interpretation bias upon admission accounted for 28% of the variance in treatment response, and predicted suicidal ideation at discharge, controlling for ideation at admission. Although some existing treatments target this mechanism, most notably Cognitive Behavioral Therapy (CBT), they require individuals to be able to recognize their automatic interpretations and use complex techniques to reappraise them. Individuals with SMI who are experiencing symptoms acute enough to require hospitalization are often treatment refractory and may experience particular difficulty applying these techniques. It is therefore critical to more efficiently and effectively engage this target. Over the past 14 years, the Principal Investigator has developed and validated a training task that utilizes repetition and feedback to reinforce a healthier interpretive style. The computer-delivered version of the task was acceptable to an SMI population and led to better treatmen

Interventions

  • BEHAVIORAL I-Change
  • BEHAVIORAL Symptom Tracking

Trial Details

FieldValue
Enrollment Target 68 participants
Start Date 2019-01-24
Est. Completion 2021-12-01
Phase NA

Sponsor

Mclean Hospital

140 total trials

What the Registry Record Tells You About NCT03509181

The ClinicalTrials.gov registry entry for NCT03509181 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mclean Hospital, which has 140 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which I-Change is the first listed.

NCT03509181 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03509181 about?

NCT03509181 is a clinical study titled "Augmenting Hospitalization for Serious Mental Illness: Cognitive Bias Modification". Approximately 4.1% of the adult US population meets the criteria for SMI, a mental disorder associated with significant functional impairment. Even when effective, pharmacologic and psychological treatments often leave individuals with SMI with residual symptoms, impairment, and at risk for re-hospi...

What is the current status of trial NCT03509181?

This trial is currently completed. It is a NA study. The enrollment target is 68 participants. The study started on 2019-01-24. Estimated completion is 2021-12-01.

What interventions are being tested in trial NCT03509181?

The interventions under investigation include: I-Change (BEHAVIORAL), Symptom Tracking (BEHAVIORAL).

Who is sponsoring clinical trial NCT03509181?

This trial is sponsored by Mclean Hospital, which has 140 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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