N/A
N=97
Hostile Interpretation Bias Training to Treat Irritability
Irritable Mood · Mood Disorders
Bottom Line
View on ClinicalTrials.gov: NCT03592368 ↗Enrolled (actual)
97
Serious AEs
1.0%
Results posted
Apr 2024
Primary outcome: Primary: Change in Interpretation Bias — 1.53; 0.55 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- IBT (Device)
- Age
- Pediatric · 13+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Interpretation Bias |
1.53; 0.55 | <0.001 sig |
| PRIMARY Neural Response in Threat Learning System. |
16; 18 | — |
| SECONDARY Learning Rate |
0.019; 0.017 | 0.32 |
| SECONDARY Irritability |
-2.04; -1.44 | 0.12 |
Summary
Hostile interpretation bias may be a feature of severe, chronic irritability in children, one of the most common psychiatric symptoms of childhood. Interpretation bias training (IBT) is a computer-based training program that may reduce irritability in youths. This trial lays the groundwork for a test IBT on irritability.
Eligibility Criteria
Inclusion Criteria
- Adolescents in mental health treatment, with at least:
- mild, clinically significant irritability, and
- typical intellectual functioning (IQ>80)
Exclusion Criteria
- Any of the following mental health diagnoses:
- current post-traumatic stress
- lifetime bipolar I or II disorder
- lifetime cyclothymic disorder
- lifetime psychotic disorder
- lifetime autism spectrum disorder
- Major medical problems, including head trauma.
- MRI-specific safety exclusions for the MRI arms.
- Clinical instability.
Data sourced from ClinicalTrials.gov (NCT03592368). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.