CovidResearchTrials by Shray Alag


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Report for D000379: Agoraphobia NIH

(Synonyms: Agora, Agoraphobia)

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (7)


Name (Synonyms) Correlation
drug343 BI 764198 Wiki 0.71
drug342 BI 706321 Wiki 0.71
drug1050 Exposure Therapy Wiki 0.71
drug2411 Relaxation Therapy Wiki 0.71
drug696 Cognitive Behavioral Therapy Wiki 0.50
drug1690 Matching placebo Wiki 0.41
drug2122 Placebo Wiki 0.04

Correlated MeSH Terms (9)


Name (Synonyms) Correlation
D001010 Anxiety, Separation NIH 1.00
D000072861 Phobia, Social NIH 1.00
D016584 Panic Disorder NIH 0.82
D009155 Mutism NIH 0.71
D009771 Obsessive-Compulsive Disorder NIH 0.50
D003193 Compulsive Personality Disorder NIH 0.50
D010698 Phobic Disorders NIH 0.50
D004194 Disease NIH 0.24
D001008 Anxiety Disorders NIH 0.22

Correlated HPO Terms (3)


Name (Synonyms) Correlation
HP:0000756 Agoraphobia HPO 1.00
HP:0002300 Mutism HPO 0.71
HP:0000722 Obsessive-compulsive behavior HPO 0.41

There are 2 clinical trials

Clinical Trials


1 Dimensional Brain Behavior Predictors of CBT Outcomes in Pediatric Anxiety

Anxiety is among the most prevalent, costly and disabling illnesses and tends emerge early in childhood. Cognitive behavioral therapy (CBT) is the first-line treatment for early life anxiety, but as many as 40% of young patients who receive CBT fail to get better. The proposed study will examine brain changes marking positive response to CBT for anxiety and how these changes may differ in children compared adolescents. By helping us to understand how CBT works, this study will pave the way for new treatments to stop anxiety early.

NCT02810171 Anxiety Disorders Social Anxiety Disorder Social Phobia Generalized Anxiety Disorder Separation Anxiety Disorder Specific Phobia Phobia Agoraphobia Panic Disorder Panic Attack Anxiety Behavioral: Cognitive Behavioral Therapy Behavioral: Relaxation Therapy
MeSH:Disease Anxiety Disorders Phobic Disorders Panic Disorder Phobia, Social Agoraphobia Anxiety, Separation
HPO:Agoraphobia

Primary Outcomes

Description: Pre- to post-CBT changes in functional, connectivity and structural MRI measures of brain networks relevant for anxiety. Brain regions include the amygdala, anterior insula, dorsal anterior cingulate cortex (dACC) and ventrolateral prefrontal cortex (vlPFC). Functional activation and connectivity of these brain regions are assessed using simple computer tasks performed during MRI scanning. Tasks engage threat reactivity, self-regulatory control and the interaction of these processes. Structural connections between regions will be measured using a MRI technique that measures water diffusion in the brain.

Measure: Brain function/structure as assessed by Magnetic Resonance Imaging scans

Time: Baseline and 12-weeks

Secondary Outcomes

Description: The Pediatric Anxiety Rating Scale (PARS) is a clinician-administered assessment to rate the severity of anxiety symptoms associated with common DSM-V anxiety disorders (social phobia, separation anxiety disorder, and generalized anxiety disorder) in children. The investigators are looking for decreases in anxiety severity ratings from pre- to post-treatment.

Measure: Pediatric Anxiety Rating Scale

Time: weeks 0, 3, 6, 9, 12

2 Comparison of Patient-Centered Versus Provider-Centered Delivery of Cognitive Behavioral Treatment (CBT) for Pediatric Anxiety and Obsessive Compulsive Disorder (OCD)

There is strong evidence that cognitive behavioral therapy (CBT) with exposure is the preferred treatment for youth with anxiety disorders, but outpatient services that provide this type of treatment are limited. Even for those who do have access to anxiety-specific treatment, a traditional outpatient model of treatment delivery may not be suitable. Among the numerous logistical barriers to treatment access and response is the inability to generalize treatment tools to settings outside of the office. Patient-centered (home-based or telehealth) treatment models that target symptoms in the context in which they occur could be more effective, efficient, and accessible for families. The present study aims to compare the efficacy, efficiency, and feasibility of patient centered home-based CBT and patient centered telehealth CBT with a traditional office-based model of care. The question proposed, including proposed outcomes, have been generated and developed by a group of hospital, payer, patient and family stakeholders who will also contribute to the iterative process of protocol revision. The investigators anticipate 379 anxious youth to be randomized to receive outpatient treatment using telehealth, home-based services, or treatment as usual using a traditional outpatient model. Results of this study are expected to provide evidence for the efficacy and efficiency of patient-centered treatment, as well as increase treatment access and family engagement in the treatment process.

NCT03528109 Obsessive-Compulsive Disorder Anxiety Disorders Pediatric Disorde Pediatric Disorder Anxiety OCD Phobia Agoraphobia Generalized Anxiety Generalized Anxiety Disorder Selective Mutism Separation Anxiety Social Anxiety Social Anxiety Disorder Panic Disorder Behavioral: Exposure Therapy
MeSH:Mutism Disease Anxiety Disorders Compulsive Personality Disorder Obsessive-Compulsive Disorder Panic Disorder Phobia, Social Agoraphobia Anxiety, Separation
HPO:Agoraphobia Mutism Obsessive-compulsive behavior

Primary Outcomes

Description: The CY-BOCS is a measure of obsessive compulsive symptoms and severity. The Obsession Rating Scale measures 5 domains of obsessional severity on a scale from 0 (no impairment) to 4 (extreme impairment.) The Compulsion Rating Scale measures 5 domains of compulsion severity on a scale from 0 (no impairment) to 5 (extreme impairment.) The total range of OCD severity is reported on a scale from 0-40, with a higher score indicating greater severity.

Measure: Children's Yale-Brown Obsessive-Compulsive Scale

Time: In-treatment and follow-up (6-12 months)

Description: The PARS is a measure of anxiety symptoms and severity. The Anxiety Severity Items are 7 questions meant to assess the frequency of anxiety symptoms and associated impairment. Items are measured on a scale from 0 (none) to 5 (extreme).The total range of anxiety severity is reported on a scale from 0-35, with a higher score indicating greater severity.

Measure: Pediatric Anxiety Rating Scale

Time: In-treatment and follow-up (6-12 months)

Secondary Outcomes

Description: The CSQ-8 measures consumer satisfaction with mental health services; satisfaction is measured using 8 items on a scale from 1 (Poor) to 4 (Excellent). Total satisfaction ranges from 8-32, with a high score indicating greater satisfaction.

Measure: Client Satisfaction Questionnaire-8

Time: In-treatment and follow-up (6-12 months)

Description: The CGI is a clinician-rated measures of global severity and improvement. The Severity of illness scale reports the severity of current symptoms on a scale from 1 (not at all ill) to 7 (among the most extremely ill patients.) The Global Improvement Scale tracks improvement since treatment initiation on a scale from 1 (very much improved) to 7 (very much worse). The highest possible score on either scale is 7, indicating extreme severity or worse treatment outcome.

Measure: Clinical Global Impression Scales

Time: In-treatment and follow-up (6-12 months)

Description: The CSDS measures the extent to which anxiety symptoms interfere with functioning. The Disability Scale measures the degree to which anxiety impacts school, social, and home life on a scale from 0 (Not at all) to 10 (very, very much.) Total anxiety-related impairment ranges from 0-30, with higher scores indicating greater impairment.

Measure: Child Sheehan Disability Scale

Time: In-treatment and follow-up (6-12 months)

Description: The measure tracks both the quality and quantity of homework completed between treatment sessions. This form has been used previously by our research group in large-scale treatment trials, and has been helpful in determining barriers to homework completion.

Measure: Homework Compliance Form

Time: Up to 6 months

Description: The Exposure Guide is a exposure therapy fidelity/quality tool completed by study therapists. This tool collects information regarding the use of specific therapeutic tools during exposures.

Measure: Exposure Guide

Time: Up to 6 months

Description: The TASCP is a 12-item measure of therapeutic alliance between a caregiver and his/her child's therapist. This measure assesses the bond and collaboration between caregiver and therapist. Each item is rated using a scale from 0: "not true" to 4: "very much true."

Measure: Therapeutic Alliance Scales for Caregivers and Parents (TASCP)

Time: Up to 6 months

Description: 75 The TASC-r is a 12-item measure of therapeutic alliance between a child and his/her therapist. This measure assesses the degree of affective bond between child and therapist, as well as amount of therapeutic task collaboration. Each item is rated using a scale from 0: "not true" to 4: "very much true."

Measure: Therapeutic Alliance Scales for Children-Revised (TASC-r)

Time: Up to 6 months

Description: The PQ-LES-Q is a 13-item measure of child functioning in life that uses a 5-point ratings scale, with higher scores indicating better quality of life. This measure has both parent and child versions, assessing the same items from both child and parent perspectives. The measure assesses quality of the child's life in a variety of domains.

Measure: Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q)

Time: In-treatment and follow-up (6-12 months)

Description: The TPA is designed to independently solicit from youth and parent the top 3 problems they feel are most important to address in treatment. This is an idiographic measure of impairment that is driven by the individual needs and desires of the consumer. Respondents rate how much each problem bothers them from 0 ("not at all") to 10 (very, very much).

Measure: Top Problems Assessment (TPA)

Time: In-treatment and follow-up (6-12 months)

Description: The CSQ assesses parent perceptions of the extent to which caring for a child with emotional problems affects several domains, including family life and relationships, demands on time, financial strain, disruption of social life, worry, guilt, and fatigue. This is a 21-item self-report measure that calls for parents to rate the extent of strain for each item using a 0 ("not at all") to 4 ("very much") scale.

Measure: Caregiver Strain Questionnaire (CSQ)

Time: In-treatment and follow-up (6-12 months)

Description: The BTQ-P is a 28-item measure adapted from the BTQ to assess parent perceptions of barriers to accessing treatment for their child's anxiety. The measure is completed at the outset of treatment and assesses such domains as logistic and financial barriers, stigma, and aspects of treatment. Items are rated on a 0 ("not at all true") to 2 ("mostly true") scale.

Measure: Barriers to Treatment Questionnaire - Parent Version (BTQ-P)

Time: In-treatment and follow-up (6-12 months)

Description: The PAS-PR is a 5-item questionnaire assessing the frequency and interference associated with accommodating the child's anxiety. Each item is followed by a series of common examples to illustrate the principle of accommodation for parents. Responses for frequency include 0 (never), 1 (rarely), 2 (occasionally), 3 (often), and 4 (always). Response options for interference due to accommodation include 0 (none), 1 (mild), 2 (moderate), 3 (severe), and 4 (extreme).

Measure: Pediatric Accommodation Scale-Parent Report (PAS-PR)

Time: In-treatment and follow-up (6-12 months)

Description: We will record reactions from caregivers and child to treatment assignment using this clinician-rated measure. It includes capturing both verbatim responses from caregivers and child, as well as asking for interviewer impressions reactions from caregivers and child to treatment group assignment following randomization. The clinician also records the likelihood that the family will remain in the study and adhere to study protocols.

Measure: Randomization Debrief

Time: Administered at baseline

Description: This measure is a 3-item self-report questionnaire that captures parental beliefs about the efficacy about each treatment condition (office-based or home/community-based) using a scale from 1:"I expect my child will be very much improved," to 7: "I expect my child will be very much worse." The parent is also asked to select which treatment option would be best for their family. There is also a patient version of this measure used to capture patient beliefs about the efficacy about each treatment condition (office-based or home/community-based) using the same scale. The patient is asked to select which treatment option they believe would be best for them and their family. The patient version of this measure will be completed by youth 12+.

Measure: Treatment Expectancy

Time: Administered at baseline

Description: The SRS-2 is a 65-item self-report measure administered to caregivers or teachers to assess their perception of the presence of a child's social impairment. This measure is used to evaluate children aged 4-18 years old. Items are rated on a scale from 1 ("not true") to 4 ("almost always true").

Measure: The Social Responsiveness Scale, Second Edition (SRS-2)

Time: Administered at baseline and at discharge (up to 6-months)

Description: The ARI-P is a 7-item parent report questionnaire assessing child's irritability. The items are each given a rating of: "not true," "somewhat true" or "certainly true".

Measure: Affective Reactivity Index - Parent Version (ARI-P)

Time: In-treatment and follow-up (6-12 months)

Description: The ARI-S is a 7-item self-report report questionnaire assessing irritability. The items are each given a rating of: "not true," "somewhat true" or "certainly true".

Measure: Affective Reactivity Index - Self Report (ARI-S)

Time: In-treatment and follow-up (6-12 months)

Description: The Distress Intolerance Index is a 10-item self-report report questionnaire assessing the inability to tolerate negative somatic and emotional states. Items are rated on a 5-point scale from "very little" (0) to "very much".

Measure: Distress Intolerance Index

Time: In-treatment and follow-up (6-12 months)

Description: The PAS is a 12-item questionnaire assessing the frequency of and beliefs about parental accommodation. The frequency of parental accommodation is measured on a scale from "Never/Almost Never" (0), to "Always/Almost Always" (3). The beliefs about parental accommodation are measured on a scale from "Strongly Disagree" (0), to "Strongly Agree" (3).

Measure: Parent Accommodation Scale (PAS)

Time: In-treatment and follow-up (6-12 months)

Description: The feedback form is a 3-item self-report questionnaire that asks caregivers or child which treatment group their family was in and for open-ended feedback about their experience in the study (i.e. what did they really like, what would they change, general suggestions/ comments). All responses on this survey are received anonymously. Caregivers and children complete separate feedback forms. Children 8+ will complete the child version of this measure.

Measure: Feedback Forms - Caregiver and Child Versions

Time: Administered only at discharge, up to 6-months into study

Description: This form captures whether the patient ended treatment before or at 6 months, as well as the reasons for discontinuation (e.g., scheduling, transportation, financial, treatment fit, symptoms) that apply. This form also gathers information about whether referrals were provided to the family upon study discharge.

Measure: End of Treatment Form

Time: Administered only at discharge, up to 6-months into study

Description: This 7-item measure asks for participants' caregivers to discuss to whom they would like the findings of the study to be disseminated (i.e., local policy makers, educators, etc.). Additionally, it asks for information on how they would like findings to be shared (i.e., via social media, presentations, etc.) as well as caregivers to share highlights of their experience in the study.

Measure: Sharing Study Findings

Time: Administered only at discharge, up to 6-months into study

Description: We will record the rate of session reschedules, cancellations and no-shows, along with the overall number of sessions attended. We will also document the reason why a scheduled appointment does not occur using the Treatment Cancellation Form.

Measure: Treatment Attendance

Time: Up to 6 months

Description: This is a case record form that documents any change in patient status (e.g., drop-out and premature termination) and the reasons for such changes.

Measure: Reasons for Treatment Discontinuation form

Time: Administered only at discharge, up to 6-months into study


HPO Nodes


Protein Mutations 0
SNP 0