Search > Anxiety Disorder
72 Participants NeededMy employer runs this trial

CBM-I + CR for Anxiety Disorders

MR
Overseen ByMichelle Rozenman, Ph.D.
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of Denver
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Anxiety is chronic, debilitating, and the most common mental health problem across development, costing the U.S. over $42 billion annually. This phased innovation grant will test a symptom-personalized cognitive bias modification for interpretation bias (CBM-I) as a mechanistic intervention to reduce interpretation bias and, subsequently, anxiety, in clinically anxious youth. In this R33 trial, participants will be youth ages 10 to 17 (N=72) with a primary "big three" anxiety disorder (i.e., Generalized, Separation, Social). Youth will be randomly assigned to receive either 16 sessions of personalized CBM-I (the optimal dose identified in the R61 Phase of this study) or equivalent time (four one-hour sessions) over four weeks of a cognitive restructuring (CR), intervention. Both interventions aim to modify threat-focused thinking. Please note that the first phase of the trial (R61: NCT04245501 under NIMH award R61MH121552) has been completed and currently this record summary only reflects the R33 phase.

Are You a Good Fit for This Trial?

This trial is for youth ages 10 to 17 who have been diagnosed with a main anxiety disorder, such as generalized anxiety, separation anxiety, or social anxiety. Participants should not have other major mental health issues that would interfere with the study.

Inclusion Criteria

Youth must have access to a desktop or laptop computer and internet at home, school, or local library for at-home computer training program, or families agree to complete all trainings at the BRAVE Lab if no access
Provision of signed and dated informed consent form by parent/legal guardian and signed youth assent, with reconsent required if youth turns 18 after study entry
My child and I can speak and understand English well enough for the study.
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Exclusion Criteria

Requires treatment other than CBM-I/CR including severe anxiety needing higher level of care, primary major depressive disorder, bipolar disorder, psychosis, acute suicidal ideation with plan/intent/attempt, PTSD, substance dependence, current physical or sexual abuse, or intellectual disability as determined during Visit 1 ADIS interview
Significant uncorrected vision impairment precluding participation in computerized assessment and intervention components
I have had cognitive bias modification therapy before.
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What Are the Treatments Tested in This Trial?

Interventions

  • Cognitive Bias Modification for Interpretations (CBM-I)
  • Cognitive Restructuring (CR)

Trial Overview

The study compares two ways of helping anxious youth change their thinking: one group gets personalized computer-based training (CBM-I) over 16 sessions; the other receives four sessions of talk therapy called cognitive restructuring (CR). Both aim to reduce threat-focused thoughts.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Cognitive Bias Modification for Interpretations (CBM-I)Experimental Treatment1 Intervention
Group II: Cognitive Restructuring (CR)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Denver

Lead Sponsor

Trials
25
Recruited
10,600+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

University of California, Los Angeles

Collaborator

Trials
1,594
Recruited
10,430,000+

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