An interventional study of Standard Exposure and Exposure + Inhibitory Learning in Anxiety Disorders, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 7 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-12-17.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Treatment
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Among 23 studies in Anxiety Disorders by University of Colorado, Denver — 7 open to participants now, 9 under way, none of them phase 3. Anxiety Disorders · University of Colorado, Denver.
Among the 23 studies in Anxiety Disorders by University of Colorado, Denver, this one is the 17th largest by enrollment of the 22 interventional ones that give a count, is one of 4 that started in 2018, is one of 17 with no phase, and was the 7th registered.
7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
Browse Anxiety Disorders studies →7 of the 23 studies in Anxiety Disorders by University of Colorado, Denver are open now, in 1 country. Recruiting first, the newest first:
University of Colorado, Denver · Sites in United States
Women only
University of Colorado, Denver · Sites in United States
Ages 10–19
University of Colorado, Denver · Sites in United States
Ages 7–15 · Healthy volunteers
University of Colorado, Denver · Sites in United States
Ages 13–18
University of Colorado, Denver · Sites in United States
Ages 18–85 · Healthy volunteers
By country, each count listing its studies:
Of the 944 Anxiety Disorders studies recruiting now, 417 (44%) set no upper age limit and 460 (49%) stop at 75 or younger; 233 take children under 18; 317 take healthy volunteers.
This study: 7 Years to 17 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
23 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 3 · Phase 3 1 · Phase 4 1
First in 2008; this study’s year is marked. 4 started in 2018.
This study's enrollment of 28 is below the median of 80 across 6,062 interventional studies indexed under Anxiety Disorders.
Median enrollment 74 across the 22 interventional studies, 330 across the 1 observational. Of the 12 that completed or were terminated, 5 (42%) have results posted.
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University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.
Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
3 of the studies in Anxiety Disorders by University of Colorado, Denver that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05434130University of Colorado, DenverModulating Exercise Dosage to Improve Concussion Recovery | 2027-02-01 |
| NCT06949813University of Colorado, DenverPreventing Maternal Mood, Anxiety, and Trauma Symptoms After Cesarean Delivery | 2027-04-30 |
| NCT07082218University of Colorado, DenverMultidimensional Sleep Health Intervention to Optimize Concussion Recovery | 2027-05-01 |
Add all 3 to your calendar (.ics) → With an account.
Among the 23 studies in Anxiety Disorders by University of Colorado, Denver, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Recently, basic research conducted in adults has revealed that fear extinction, or the weakening of a learned fear response, may be best explained by principles of "inhibitory learning." New guidelines for the clinical practice of exposure therapy for anxiety disorders have arisen from research on inhibitory learning, but these guidelines have not yet been empirically tested in youth with anxiety disorders. The overall goal of this research is to investigate the acceptability, feasibility, and efficacy of conducting exposure therapy for anxiety disorders in youth according to clinical guidelines developed from basic research on inhibitory learning principles, using a pilot randomized controlled trial design.
Exposure therapy-which involves repeatedly exposing individuals to feared situations to change their fear responses to and beliefs about those situations--has been a mainstay of treatments for anxiety disorders since it was developed in the 1950s. Today, exposure therapy is the most commonly-occurring treatment technique included in well-supported treatments for anxiety disorders, and meta-analyses have indicated that exposure is more strongly associated with treatment gains in anxious youth compared to non-behavioral interventions. Despite its effectiveness, approximately 40% of anxious youth fail to achieve clinically significant benefit from exposure therapy. This indicates that further research is needed regarding strategies for optimizing exposure therapy so that it is effective for a greater proportion of youth.
There is clearly a need to optimize exposure therapy for youth, but at the same time very little empirical data exists regarding how exposure works or the best way to conduct exposures. Common wisdom about exposure, based on emotional processing theory, dictates that exposure works by breaking and eliminating conditioned fear responses through a process called habituation. This viewpoint dictates that exposure should be conducted until habituation occurs (i.e., until a physiological fear response reduces by at least 50%), and that habituation both during and between exposure sessions is necessary for improvement. As exposure therapy has evolved, other common practices have emerged that lack clear evidence supporting their efficacy. For example, it is common clinical practice to encourage youth to challenge their thoughts about a feared situation before and during an exposure (i.e., cognitive restructuring), even though clear evidence does not exist to support this practice. Additionally, it is common for clinicians to create a "fear ladder" or "hierarchy" with patients before beginning exposures. This hierarchy typically takes the form of a rank-ordered list of exposures or feared stimuli from least to most difficult, and clinicians move up this list systematically from the easiest to most difficult items during treatment. Again, there is little clear evidence to support this practice.
More recent research on fear extinction indicates that exposure therapy does not cause threat associations to disappear but rather leads to the formation of non-threat (i.e., inhibitory) associations that compete with and weaken older threat associations. The goal of exposure therapy, according to this model, is to strengthen these non-threat associations and weaken threat associations. Research on inhibitory learning has turned many of the long-standing exposure practices discussed in the previous paragraph on their head by providing new guidelines for optimizing exposure therapy. Many of these new guidelines differ significantly from common clinical practices and are designed to maximize learning of inhibitory associations. These guidelines are as follows:
In this study, the investigators plan to test these clinical practice guidelines derived from inhibitory learning against standard exposure practice. A few studies have empirically tested these and/or other clinical practice guidelines established based on inhibitory learning in clinical adult samples. However, no known studies have yet empirically tested the efficacy of an inhibitory learning approach to exposure therapy in youth with anxiety or other emotional disorders, nor have any known studies tested the acceptability or feasibility of such an approach. Therefore, in this study the investigators propose to conduct a small-scale, pilot randomized controlled trial (RCT) examining the feasibility, acceptability, and relative efficacy of applying an inhibitory learning approach to exposure in youth. Up to 20 youth will be randomized to one of two groups-standard exposure (SE) or exposure conducting according to inhibitory learning principles (E + IL). Given the small n for this study, the primary goal will be to assess feasibility and acceptability of an inhibitory learning approach to exposure, while establishing the efficacy of this approach relative to SE is exploratory. This study, along with planned larger-scale RCTs to follow, will help to inform clinical care guidelines for best practice of exposure therapy with anxious youth.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
This arm will receive exposure therapy conducted according to standard care practices.
Behavioral: Standard Exposure
This arm will receive exposure therapy conducted according to principles of inhibitory learning.
Behavioral: Exposure + Inhibitory Learning
Exposure therapy conducted according to standard clinical care practices
Exposure therapy conducted according to practice recommendations based derived from research on inhibitory learning theories of fear extinction
Change in Percentage of Exposure Refusals (Feasibility Measure)
Therapists will record the percentage of exposures the patient refused to complete during the session.
Time frame: Treatment weeks 5, 6, 7, and 8
Change in Latency to Initiating Exposure (Feasibility Measure)
Therapist will record the average amount of time the patient delayed before initiating each exposure in session
Time frame: Treatment weeks 5, 6, 7, 8
Early Treatment Termination (Feasibility Measure)
Information will be collected regarding whether the patient terminated treatment early (before session 9)
Time frame: Measure will be collected following the patient's termination from treatment
Change in Homework Completion (Feasibility Measure)
Therapist will record the number of exposure sessions for which the patient completed homework
Time frame: Treatment weeks 6, 7, 8, and 9
Client Satisfaction Questionnaire-8 (CSQ-8)
8-item measure of patient satisfaction with treatment. The measure is rated on a four-point scale, with possible scores ranging from 8-32.
Time frame: Week 9 (End of Treatment)
Change in Distress Tolerance Scale--Child (DTS-C)
A 15-item self-report measure of difficulties managing distress and related emotions. The measure is rated on a 5-point scale, with possible scores ranging from 15 to 65. Higher scores indicate greater ability to tolerate distress.
Time frame: Treatment Week 1, Week 5, and Week 9 (End of Treatment)
Change in Child Avoidance Measure, Self and Parent Report (CAMS/P)
The CAMS/P are 8-item child- and parent-report (respectively) measures of behavioral avoidance. The measure is rated on a 4-point scale, with possible scores ranging from 0 to 24. Higher scores indicate greater behavioral avoidance.
Time frame: Treatment Week 1, Week 5, and Week 9 (End of Treatment)
Change in Avoidance and Fusion Questionnaire--Youth (AFQ-Y)
A 17-item self-report measure of experiential avoidance and cognitive fusion. The measure is rated on a 4-point scale, with possible scores ranging from 0 to 68. Higher scores indicate greater cognitive fusion and experiential avoidance.
Time frame: Treatment Week 1, Week 5, and Week 9 (End of Treatment)
Change in Parent Acceptance and Action Questionnaire (PAAQ)
A 15-item measure of parent experiential avoidance, or parental actions intended to control the form and frequency of their child's emotional experiences. Items are rated on a 7-point scale, with possible scores ranging from 17 to 105. Higher scores indicate less parental experiential avoidance and less effort to control child emotional experiences.
Time frame: Treatment Week 1, Week 5, and Week 9 (End of Treatment)
Change in Screen for Child Anxiety Related Disorders (SCARED), Self and Parent Report
A 41-item child- and parent-report measure assessing symptoms of anxiety in youth ages 7 to 19. Items are rated on a 3-point scale, with scores ranging from 0 to 82. Higher scores indicate greater anxiety symptoms.
Time frame: Treatment Week 1, Week 5, Week 6, Week 7, Week 8, and Week 9 (End of Treatment)
Plan to share: Undecided
Ran from Jan 2018 to primary completion in Dec 2020, 34 months.
Of 3,841 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's 34 months is above that.
Counting every sponsor, half of 3,943 studies reached it within 12 months; a quarter within 5 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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University of Colorado, Denver →