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ABMT Augmentation of CBT

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ClinicalTrials.gov Identifier: NCT03283930
Recruitment Status : Recruiting
First Posted : September 14, 2017
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC)

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


Condition or disease Intervention/treatment Phase
Anxiety Disorders Children, Only Behavioral: Active Attention Bias Modification Training Behavioral: Placebo Attention Bias Modification Training Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Attention Bias Modification Training as Augmentation of Cognitive Behavioral Therapy for Anxiety in Youth
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Active ABMT
Active attention bias modification will be provided in addition to individual cognitive behavioral therapy
Behavioral: Active Attention Bias Modification Training
Computer-based attention bias modification training administered at weekly CBT session aimed at re-training attentional biases

Placebo Comparator: Placebo
Placebo attention bias modification will be provided in addition to individual cognitive behavioral therapy
Behavioral: Placebo Attention Bias Modification Training
Placebo version of a computer-based attention bias modification training administered at weekly CBT session thought to not influence attentional biases




Primary Outcome Measures :
  1. The Pediatric Anxiety Rating Scale (PARS) [ Time Frame: Every 4 weeks ]
  2. Clinical Global Impression Scale (CGI) [ Time Frame: Weekly ]


Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03283930


Contacts
Contact: Daniel S Pine, M.D. (301) 594-1318 pined@mail.nih.gov

Locations
United States, Maryland
NIH Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: Daniel Pine, M.D.    301-594-1318    pined@mail.nih.gov   
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)

Publications:
Responsible Party: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT03283930     History of Changes
Other Study ID Numbers: 0192A
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017

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

Keywords provided by National Institutes of Health Clinical Center (CC):
anxiety, cbt, abmt

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders