search
Back to results

Test of an Inhibitory Learning Model of Extinction in Treatment of Anxious Youth

Primary Purpose

Anxiety Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Exposure
Exposure + Inhibitory Learning
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders

Eligibility Criteria

7 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Primary or secondary diagnosis of an anxiety disorder
  2. Ability of both child and caregiver to read and understand English
  3. Ability of child and at least one caregiver to attend weekly sessions

Exclusion Criteria:

  1. Diagnosis of autism spectrum disorder, intellectual development disorder, or limited cognitive functioning (i.e., documented Intelligence Quotient [IQ]<80).
  2. Diagnosis of a psychotic disorder or bipolar disorder
  3. Severe and current suicidal ideation, history of suicide attempt in past six months, or frequent and persistent self-injurious behavior
  4. Diagnosis of a substance use disorder or significant, recent substance use
  5. Any youth receiving concurrent individual therapy will also be excluded from the study.

Sites / Locations

  • Children's Hospital Colorado

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Exposure

Exposure + Inhibitory Learning

Arm Description

This arm will receive exposure therapy conducted according to standard care practices.

This arm will receive exposure therapy conducted according to principles of inhibitory learning.

Outcomes

Primary Outcome Measures

Change in Percentage of Exposure Refusals (Feasibility Measure)
Therapists will record the percentage of exposures the patient refused to complete during the session.
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
Early Treatment Termination (Feasibility Measure)
Information will be collected regarding whether the patient terminated treatment early (before session 9)
Change in Homework Completion (Feasibility Measure)
Therapist will record the number of exposure sessions for which the patient completed homework
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
November 28, 2017
Last Updated
December 16, 2020
Sponsor
University of Colorado, Denver
search

1. Study Identification

Unique Protocol Identification Number
NCT03372915
Brief Title
Test of an Inhibitory Learning Model of Extinction in Treatment of Anxious Youth
Official Title
Testing an Inhibitory Learning Model of Extinction in Exposure-Based Anxiety Treatment for Youth: Feasibility, Acceptability, and Efficacy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
January 31, 2018 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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: Design exposures that maximally violate a patient's expectations about how bad an outcome would be or how often it will occur. In clinical practice, an exposure that maximally violates expectancies is one that is terminated not when fear habituates or reduces by a certain amount (e.g., "What is your fear rating?") but rather when the patient's expectancy of a bad outcome is significantly reduced. (e.g., "What do you think the chances are that X will happen?). Do not instruct patients to change their thinking about a feared situation before or during and exposure. The principle of maximum violation of expectancies dictates that participants should not be encouraged to use cognitive reappraisal (e.g., strategies for thinking more realistically or accurately) during an exposure, as such strategies reduce the expectation that a negative outcome will occur and thus prevent maximum violation of expectancy. Introduce variability of stimuli into exposure tasks by moving up and down a fear ladder randomly. Inhibitory learning theory suggests that clinicians should frequently vary the difficulty of exposure to stimuli to create a consistently high level of emotion, which has been associated with superior extinction learning. This guideline means that, instead of moving up a fear hierarchy or ladder in a systematic way from least to most difficult over time, and moving on to more difficult items after habituation to easier ones has occurred, clinicians should design exposures that will allow patients to achieve variable but generally high levels of fear or anxiety over the full course of an exposure. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Exposure
Arm Type
Active Comparator
Arm Description
This arm will receive exposure therapy conducted according to standard care practices.
Arm Title
Exposure + Inhibitory Learning
Arm Type
Experimental
Arm Description
This arm will receive exposure therapy conducted according to principles of inhibitory learning.
Intervention Type
Behavioral
Intervention Name(s)
Standard Exposure
Intervention Description
Exposure therapy conducted according to standard clinical care practices
Intervention Type
Behavioral
Intervention Name(s)
Exposure + Inhibitory Learning
Intervention Description
Exposure therapy conducted according to practice recommendations based derived from research on inhibitory learning theories of fear extinction
Primary Outcome Measure Information:
Title
Change in Percentage of Exposure Refusals (Feasibility Measure)
Description
Therapists will record the percentage of exposures the patient refused to complete during the session.
Time Frame
Treatment weeks 5, 6, 7, and 8
Title
Change in Latency to Initiating Exposure (Feasibility Measure)
Description
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
Title
Early Treatment Termination (Feasibility Measure)
Description
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
Title
Change in Homework Completion (Feasibility Measure)
Description
Therapist will record the number of exposure sessions for which the patient completed homework
Time Frame
Treatment weeks 6, 7, 8, and 9
Title
Client Satisfaction Questionnaire-8 (CSQ-8)
Description
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)
Secondary Outcome Measure Information:
Title
Change in Distress Tolerance Scale--Child (DTS-C)
Description
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)
Title
Change in Child Avoidance Measure, Self and Parent Report (CAMS/P)
Description
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)
Title
Change in Avoidance and Fusion Questionnaire--Youth (AFQ-Y)
Description
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)
Title
Change in Parent Acceptance and Action Questionnaire (PAAQ)
Description
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)
Title
Change in Screen for Child Anxiety Related Disorders (SCARED), Self and Parent Report
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Primary or secondary diagnosis of an anxiety disorder Ability of both child and caregiver to read and understand English Ability of child and at least one caregiver to attend weekly sessions Exclusion Criteria: Diagnosis of autism spectrum disorder, intellectual development disorder, or limited cognitive functioning (i.e., documented Intelligence Quotient [IQ]<80). Diagnosis of a psychotic disorder or bipolar disorder Severe and current suicidal ideation, history of suicide attempt in past six months, or frequent and persistent self-injurious behavior Diagnosis of a substance use disorder or significant, recent substance use Any youth receiving concurrent individual therapy will also be excluded from the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Hawks, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
Citation
Arch, J. J., & Abramowitz, J. S. (2015). Exposure therapy for obsessive-compulsive disorder: An optimizing inhibitory learning approach. Journal of Obsessive-Compulsive and Related Disorders, 6, 174-182.
Results Reference
background
PubMed Identifier
9100430
Citation
Birmaher B, Khetarpal S, Brent D, Cully M, Balach L, Kaufman J, Neer SM. The Screen for Child Anxiety Related Emotional Disorders (SCARED): scale construction and psychometric characteristics. J Am Acad Child Adolesc Psychiatry. 1997 Apr;36(4):545-53. doi: 10.1097/00004583-199704000-00018.
Results Reference
background
PubMed Identifier
19280337
Citation
Cheron DM, Ehrenreich JT, Pincus DB. Assessment of parental experiential avoidance in a clinical sample of children with anxiety disorders. Child Psychiatry Hum Dev. 2009 Sep;40(3):383-403. doi: 10.1007/s10578-009-0135-z. Epub 2009 Mar 12.
Results Reference
background
PubMed Identifier
18005936
Citation
Craske MG, Kircanski K, Zelikowsky M, Mystkowski J, Chowdhury N, Baker A. Optimizing inhibitory learning during exposure therapy. Behav Res Ther. 2008 Jan;46(1):5-27. doi: 10.1016/j.brat.2007.10.003. Epub 2007 Oct 7.
Results Reference
background
PubMed Identifier
24864005
Citation
Craske MG, Treanor M, Conway CC, Zbozinek T, Vervliet B. Maximizing exposure therapy: an inhibitory learning approach. Behav Res Ther. 2014 Jul;58:10-23. doi: 10.1016/j.brat.2014.04.006. Epub 2014 May 9.
Results Reference
background
PubMed Identifier
23872701
Citation
Deacon B, Kemp JJ, Dixon LJ, Sy JT, Farrell NR, Zhang AR. Maximizing the efficacy of interoceptive exposure by optimizing inhibitory learning: a randomized controlled trial. Behav Res Ther. 2013 Sep;51(9):588-96. doi: 10.1016/j.brat.2013.06.006. Epub 2013 Jul 6.
Results Reference
background
Citation
Ehrenreich-May, J., Kennedy, S. M., Sherman, J., Bilek, E. L., Buzzella, B., Bennett, S., & Barlow, D. H. (In press). Unified protocols for transdiagnostic treatment of emotional disorders in children and adolescents. New York: Oxford University Press.
Results Reference
background
PubMed Identifier
2871574
Citation
Foa EB, Kozak MJ. Emotional processing of fear: exposure to corrective information. Psychol Bull. 1986 Jan;99(1):20-35. No abstract available.
Results Reference
background
PubMed Identifier
18557686
Citation
Greco LA, Lambert W, Baer RA. Psychological inflexibility in childhood and adolescence: development and evaluation of the Avoidance and Fusion Questionnaire for Youth. Psychol Assess. 2008 Jun;20(2):93-102. doi: 10.1037/1040-3590.20.2.93.
Results Reference
background
PubMed Identifier
26087438
Citation
Higa-McMillan CK, Francis SE, Rith-Najarian L, Chorpita BF. Evidence Base Update: 50 Years of Research on Treatment for Child and Adolescent Anxiety. J Clin Child Adolesc Psychol. 2016;45(2):91-113. doi: 10.1080/15374416.2015.1046177. Epub 2015 Jun 18.
Results Reference
background
PubMed Identifier
10245370
Citation
Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.
Results Reference
background
PubMed Identifier
19748076
Citation
Milad MR, Pitman RK, Ellis CB, Gold AL, Shin LM, Lasko NB, Zeidan MA, Handwerger K, Orr SP, Rauch SL. Neurobiological basis of failure to recall extinction memory in posttraumatic stress disorder. Biol Psychiatry. 2009 Dec 15;66(12):1075-82. doi: 10.1016/j.biopsych.2009.06.026. Epub 2009 Sep 12.
Results Reference
background
Citation
Muris, P., Merckelbach, H., van Brakel, A., Mayer, B., & van Dongen, L. (1998). The Screen for Child Anxiety Related Emotional Disorders (SCARED): Relationship with anxiety and depression in normal children. Personality and Individual Differences, 24(4), 451-456.
Results Reference
background
PubMed Identifier
19625997
Citation
Shin LM, Liberzon I. The neurocircuitry of fear, stress, and anxiety disorders. Neuropsychopharmacology. 2010 Jan;35(1):169-91. doi: 10.1038/npp.2009.83.
Results Reference
background
Citation
Simons, J. S., & Gaher, R. M. (2005). The Distress Tolerance Scale: Development and validation of a self-report measure. Motivation and Emotion, 29(2), 83-102.
Results Reference
background
PubMed Identifier
26275761
Citation
Whiteside SP, Ale CM, Young B, Dammann JE, Tiede MS, Biggs BK. The feasibility of improving CBT for childhood anxiety disorders through a dismantling study. Behav Res Ther. 2015 Oct;73:83-9. doi: 10.1016/j.brat.2015.07.011. Epub 2015 Jul 29.
Results Reference
background
PubMed Identifier
23611081
Citation
Whiteside SP, Gryczkowski M, Ale CM, Brown-Jacobsen AM, McCarthy DM. Development of child- and parent-report measures of behavioral avoidance related to childhood anxiety disorders. Behav Ther. 2013 Jun;44(2):325-37. doi: 10.1016/j.beth.2013.02.006. Epub 2013 Mar 4.
Results Reference
background

Learn more about this trial

Test of an Inhibitory Learning Model of Extinction in Treatment of Anxious Youth

We'll reach out to this number within 24 hrs