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Behavioral Intervention

Cognitive Behavioral Therapy for Social Anxiety Disorder (I-FOCUS Trial)

N/A
Recruiting
Led By Angela Fang, PhD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Must not have
Previous CBT non-responder or current CBT
Timeline
Screening 3 weeks
Treatment Varies
Follow Up across the span of 3 1/2 months: baseline (t-2weeks), repeat baseline (t0), week 6, post-treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to figure out why some people benefit from cognitive behavioral therapy while others do not. Researchers will look at different types of information, like brain activity, cognitive abilities, clinical assessments, and self

Who is the study for?
This trial is for individuals with conditions like Body Dysmorphic Disorder, Social Anxiety Disorder, or Generalized Anxiety Disorder. It aims to understand why Cognitive Behavioral Therapy (CBT) works well for some but not others.
What is being tested?
The study investigates the effectiveness of Cognitive Behavioral Therapy in treating various anxiety-related disorders by examining brain activity, cognitive function, clinical evaluations, and personal reports from participants.
What are the potential side effects?
Cognitive Behavioral Therapy generally does not have physical side effects; however, it can sometimes cause temporary increases in distress due to discussing and confronting anxieties.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have tried cognitive behavioral therapy without success or am currently undergoing it.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~across the span of 3 1/2 months: baseline (t-2weeks), repeat baseline (t0), week 6, post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and across the span of 3 1/2 months: baseline (t-2weeks), repeat baseline (t0), week 6, post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Anxiety symptom severity, assessed by the Generalized Anxiety Disorder (GAD-7)
Anxiety symptom severity, assessed by the Structured Interview Guide for Hamilton Anxiety Scale (SIGH-A) and the Generalized Anxiety Disorder (GAD-7)
DSM5 Cross Cutting Form
+4 more
Secondary study objectives
Alerting, orienting, and attentional control reaction time scores on the Attention Network Test (ANT)
Credibility and expectancies for treatment, assessed by the Credibility and Expectancies Questionnaire (CEQ)
Depression severity, as assessed by the Patient Health Questionnaire-9 (PHQ-9)
+8 more

Side effects data

From 2021 Phase 4 trial • 12 Patients • NCT04135937
8%
irritability
100%
80%
60%
40%
20%
0%
Study treatment Arm
MESH

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Cognitive behavioral therapyExperimental Treatment1 Intervention
Twelve weekly sessions of individual cognitive behavioral therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavioral Therapy
2016
Completed Phase 4
~3120

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,918 Previous Clinical Trials
2,739,756 Total Patients Enrolled
University of WashingtonLead Sponsor
1,817 Previous Clinical Trials
1,914,223 Total Patients Enrolled
Angela Fang, PhDPrincipal InvestigatorUniversity of Washington
1 Previous Clinical Trials
120 Total Patients Enrolled
~107 spots leftby Sep 2028
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