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
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|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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|
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
- The Pediatric Anxiety Rating Scale (PARS) [ Time Frame: Every 4 weeks ]
- Clinical Global Impression Scale (CGI) [ Time Frame: Weekly ]
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
|Contact: Daniel S Pine, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|NIH Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: Daniel Pine, M.D. 301-594-1318 email@example.com|