Attention Bias Modification Training as Augmentation of Cognitive Behavioral Therapy for Anxiety in Youth

ABMT Augmentation of CBT



Sponsors


Source

National Institutes of Health Clinical Center (CC)

Oversight Info

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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.

Overall Status

Recruiting

Start Date

2017-02-01

Completion Date

2021-01-01

Primary Completion Date

2021-01-01

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

The Pediatric Anxiety Rating Scale (PARS)
Every 4 weeks
Clinical Global Impression Scale (CGI)
Weekly

Enrollment

120

Conditions


Intervention

Intervention Type

Behavioral

Intervention Name


Description

Computer-based attention bias modification training administered at weekly CBT session aimed at re-training attentional biases

Arm Group Label

Active ABMT


Intervention Type

Behavioral

Intervention Name


Description

Placebo version of a computer-based attention bias modification training administered at weekly CBT session thought to not influence attentional biases

Arm Group Label

Placebo



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)

Gender

All

Minimum Age

8 Years

Maximum Age

17 Years

Healthy Volunteers

No


Overall Contact

Last Name

Daniel S Pine, M.D.

Phone

(301) 594-1318

Email



Location

Facility

Status

Contact

NIH Clinical Center
Bethesda Maryland 20892 United States
Recruiting
Last Name: Daniel Pine, M.D.
Phone: 301-594-1318
Email: [email protected]

Location Countries

Country

United States


Verification Date

2017-09-01

Lastchanged Date

2017-09-13

Firstreceived Date

2017-09-13

Responsible Party

Responsible Party Type

Sponsor


Keyword


Has Expanded Access

No

Condition Browse


Number Of Arms

2

Arm Group

Arm Group Label

Active ABMT

Arm Group Type

Experimental

Description

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


Arm Group Label

Placebo

Arm Group Type

Placebo Comparator

Description

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



Firstreceived Results Date

N/A

Reference

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.

PMID

25344944


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.

PMID

28407726



Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Treatment

Masking

Triple (Participant, Care Provider, Outcomes Assessor)



ClinicalTrials.gov processed this data on September 14, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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