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ABMT Augmentation of CBT

Primary Purpose

Anxiety Disorders, Children, Only

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Attention Bias Modification Training
Placebo Attention Bias Modification Training
Sponsored by
National Institutes of Health Clinical Center (CC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring anxiety, cbt, abmt

Eligibility Criteria

8 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age: 8 - 17 (subjects who consent as 17- year-olds but turn 18 during the course of the study will be eligible to complete all procedures completed by other subjects who consent as 17- year- olds but do not turn 18).
  • Consent: can give consent/assent (Parents will provide consent; minors will provide assent)
  • IQ: all subjects will have IQ > 70 (Assessment relies on WASI)
  • Language: all subjects will speak English

Exclusion Criteria:

  • Any serious medical condition or condition that interferes with fMRI scanning. (All patients will have complete physical examination and history.
  • Pregnancy
  • Current use of any psychoactive substance; current suicidal ideation; current diagnosis of attention deficit hyperactivity disorder (ADHD) of sufficient severity to require pharmacotherapy
  • Current diagnoses Tourette's Disorder, OCD, post-traumatic distress disorder, conduct disorder, major depressive disorder
  • Past or current history of mania, psychosis, or severe pervasive developmental disorder
  • Recent use of an SSRI; all subjects must have been free of any SSRI-use for at least one month (fluoxetine six months)

Sites / Locations

  • NIH Clinical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active ABMT

Placebo

Arm Description

Active attention bias modification will be provided in addition to individual cognitive behavioral therapy

Placebo attention bias modification will be provided in addition to individual cognitive behavioral therapy

Outcomes

Primary Outcome Measures

The Pediatric Anxiety Rating Scale (PARS)
Clinical Global Impression Scale (CGI)

Secondary Outcome Measures

Full Information

First Posted
September 13, 2017
Last Updated
April 4, 2022
Sponsor
National Institutes of Health Clinical Center (CC)
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1. Study Identification

Unique Protocol Identification Number
NCT03283930
Brief Title
ABMT Augmentation of CBT
Official Title
Attention Bias Modification Training as Augmentation of Cognitive Behavioral Therapy for Anxiety in Youth
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institutes of Health Clinical Center (CC)

4. Oversight

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

5. Study Description

Brief Summary
This study examines a computer-based attention bias modification training as an augmentation of individual cognitive behavioral therapy for pediatric anxiety. All participants will receive interviews to assess how they are doing in general, including general mood, degree of nervousness, and behavior. Each participant and one of his or her parents will be interviewed separately and together. Participants are asked to complete tasks involving problem-solving, attention, and emotion that involve looking at pictures, remembering things, testing reaction times, and making simple choices. Participants with anxiety will first meet with a psychologist for 12 weeks of individual cognitive behavioral therapy. In addition, participants will be randomly and blindly assigned to receive either an active computer-based attention bias modification training task or an inactive/placebo version of this task, administered as part of their therapy treatment. The active training is thought to help anxiety whereas the inactive training is thought to have no effect. The purpose of this part of the study is to understand the best way to help children and adolescents who are having problems with anxiety. However, more research is needed to find the best way to help such children and adolescents. During and after the treatment, each participant will complete verbal and written symptom ratings. Those who have not improved by the end of the study will be offered other treatment for 1 to 3 months, and the clinicians will help with finding subsequent aftercare. Those who improve with treatment will continue therapy at NIH until an outside physician is able to assume responsibility for monitoring medication. FOR MORE INFORMATION REGARDING THIS STUDY CALL THE CORE PHONE NUMBER: 301-496-5645
Detailed Description
Objective: The goal of this protocol is to test the efficacy of a computer-based attention bias modification training (comparing active vs. placebo) as an augmentation of individual cognitive behavioral therapy for youth with anxiety disorders. Study Population: A total of 120 children and adolescents (8-17 years old) will be recruited to participate in this treatment trial. Design: Participants' psychiatric symptoms and diagnoses will be assessed by clinical interview. Participants will engage in 12 weeks of individual cognitive behavioral therapy in addition to being randomized to receive either an active or placebo version of a computer-based attention bias modification training. Outcome Measures: The primary outcome measures to be examined are change in scores on the Pediatric Anxiety Rating Scale and Clinical Global Impression Scale across treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders, Children, Only
Keywords
anxiety, cbt, abmt

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active ABMT
Arm Type
Experimental
Arm Description
Active attention bias modification will be provided in addition to individual cognitive behavioral therapy
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo attention bias modification will be provided in addition to individual cognitive behavioral therapy
Intervention Type
Behavioral
Intervention Name(s)
Active Attention Bias Modification Training
Intervention Description
Computer-based attention bias modification training administered at weekly CBT session aimed at re-training attentional biases
Intervention Type
Behavioral
Intervention Name(s)
Placebo Attention Bias Modification Training
Intervention Description
Placebo version of a computer-based attention bias modification training administered at weekly CBT session thought to not influence attentional biases
Primary Outcome Measure Information:
Title
The Pediatric Anxiety Rating Scale (PARS)
Time Frame
Every 4 weeks
Title
Clinical Global Impression Scale (CGI)
Time Frame
Weekly

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 8 - 17 (subjects who consent as 17- year-olds but turn 18 during the course of the study will be eligible to complete all procedures completed by other subjects who consent as 17- year- olds but do not turn 18). Consent: can give consent/assent (Parents will provide consent; minors will provide assent) IQ: all subjects will have IQ > 70 (Assessment relies on WASI) Language: all subjects will speak English Exclusion Criteria: Any serious medical condition or condition that interferes with fMRI scanning. (All patients will have complete physical examination and history. Pregnancy Current use of any psychoactive substance; current suicidal ideation; current diagnosis of attention deficit hyperactivity disorder (ADHD) of sufficient severity to require pharmacotherapy Current diagnoses Tourette's Disorder, OCD, post-traumatic distress disorder, conduct disorder, major depressive disorder Past or current history of mania, psychosis, or severe pervasive developmental disorder Recent use of an SSRI; all subjects must have been free of any SSRI-use for at least one month (fluoxetine six months)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel S Pine, M.D.
Phone
(301) 594-1318
Email
pined@mail.nih.gov
Facility Information:
Facility Name
NIH Clinical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Pine, M.D.
Phone
301-594-1318
Email
pined@mail.nih.gov

12. IPD Sharing Statement

Citations:
PubMed Identifier
25344944
Citation
Britton JC, Suway JG, Clementi MA, Fox NA, Pine DS, Bar-Haim Y. Neural changes with attention bias modification for anxiety: a randomized trial. Soc Cogn Affect Neurosci. 2015 Jul;10(7):913-20. doi: 10.1093/scan/nsu141. Epub 2014 Oct 24.
Results Reference
background
PubMed Identifier
28407726
Citation
White LK, Sequeira S, Britton JC, Brotman MA, Gold AL, Berman E, Towbin K, Abend R, Fox NA, Bar-Haim Y, Leibenluft E, Pine DS. Complementary Features of Attention Bias Modification Therapy and Cognitive-Behavioral Therapy in Pediatric Anxiety Disorders. Am J Psychiatry. 2017 Aug 1;174(8):775-784. doi: 10.1176/appi.ajp.2017.16070847. Epub 2017 Apr 14. Erratum In: Am J Psychiatry. 2018 Jan 1;175(1):83.
Results Reference
background
PubMed Identifier
32167803
Citation
Lewis KM, Matsumoto C, Cardinale E, Jones EL, Gold AL, Stringaris A, Leibenluft E, Pine DS, Brotman MA. Self-Efficacy As a Target for Neuroscience Research on Moderators of Treatment Outcomes in Pediatric Anxiety. J Child Adolesc Psychopharmacol. 2020 May;30(4):205-214. doi: 10.1089/cap.2019.0130. Epub 2020 Mar 11.
Results Reference
derived
PubMed Identifier
31391027
Citation
Linke JO, Jones E, Pagliaccio D, Swetlitz C, Lewis KM, Silverman WK, Bar-Haim Y, Pine DS, Brotman MA. Efficacy and mechanisms underlying a gamified attention bias modification training in anxious youth: protocol for a randomized controlled trial. BMC Psychiatry. 2019 Aug 7;19(1):246. doi: 10.1186/s12888-019-2224-2.
Results Reference
derived

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ABMT Augmentation of CBT

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