ABMT Augmentation of CBT

  • STATUS
    Recruiting
  • End date
    Dec 24, 2024
  • participants needed
    120
  • sponsor
    National Institutes of Health Clinical Center (CC)
Updated on 24 April 2022
anxiety
behavior therapy
cognitive therapy
abmt

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

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.

Details
Condition Anxiety Disorders, Children, Only
Treatment Active Attention Bias Modification Training, Placebo Attention Bias Modification Training
Clinical Study IdentifierNCT03283930
SponsorNational Institutes of Health Clinical Center (CC)
Last Modified on24 April 2022

Eligibility

Yes No Not Sure

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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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