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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: Completed NA study, sponsored by Mclean Hospital.
NCT03509181 is a NA study that has completed, run by Mclean Hospital. The registered enrollment target is 68 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Self-reported improvement rating. Outcome is number of participants who reported feeling much or very much improved.
Interventions
- BEHAVIORAL I-Change
- BEHAVIORAL Symptom Tracking
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2019-01-24 |
| Est. Completion | 2021-12-01 |
| Phase | NA |
What the finished NCT03509181 record still lists
NCT03509181 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which I-Change is the first listed.
NCT03509181 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03509181's enrollment target sits among peer trials
68 1133rd of 2000 higher than 862 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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