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Cognitive Behavioral Therapy for Generalized Anxiety Disorder
N/A
Waitlist Available
Led By Gretchen Brenes, PhD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 6, week 11
Awards & highlights
Study Summary
This trial will test if a cognitive-behavioral therapy program for older adults with Generalized Anxiety Disorder is acceptable and feasible to implement.
Who is the study for?
This trial is for older adults who have seen an Atrium provider and have anxiety or depression, symptoms of these conditions, or are taking related medications. It's not open to those with dementia or significant cognitive impairment.Check my eligibility
What is being tested?
The study is testing how well Cognitive Behavioral Therapy (CBT) works for treating Generalized Anxiety Disorder in the elderly. It looks at whether this therapy can be effectively implemented and maintained.See study design
What are the potential side effects?
Since CBT is a non-medical treatment involving talking and behavior change strategies, it typically doesn't cause physical side effects but may sometimes lead to temporary emotional discomfort.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 6, week 11
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 6, week 11
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility-Expectancy Rating Scale
Feasibility-Intervention adherence
Feasibility-Number of participants who complete at least 75% of sessions
Secondary outcome measures
Feasibility-Client Satisfaction Questionnaire
Feasibility-Working Alliance Inventory, Client
Feasibility-Working Alliance Inventory, Therapist
+4 moreOther outcome measures
Healthcare Utilization-Costs for outpatient encounters, ED visits and inpatient stays
Healthcare Utilization-Number of ED visits
Healthcare Utilization-Number of Outpatient encounters
+2 moreSide effects data
From 2018 Phase 4 trial • 95 Patients • NCT0104127418%
Weight increase
10%
Tachycardia
6%
Psychiatric Hospitalization
6%
Hypertension
6%
Loss of libido
4%
Concentration impaired
4%
Appetite increase
4%
Memory impaired
4%
Rash
4%
Restlessness
4%
Amenorrhea
2%
Dizziness upon standing
2%
Apathy
2%
Sleep disturbed
2%
Anorgasmia
2%
Blurred vision
2%
Drug abuse
2%
Akathisia
2%
Drooling
2%
Appetite decrease
2%
Drug-related hospitalization
2%
Cellulitis
2%
Hot flashes
2%
Medical Hospitalization
2%
Fatigue
2%
Hiccup
2%
Hit by a motorcycle
2%
Hurt when riding a bike
2%
Mental activity decreased
2%
Muscle twitch
2%
Sleeplessness
2%
Pneumonia
2%
Nightmares
2%
Teeth grating
2%
Incarceration
2%
Sensory hallucinations
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Citalopram
Trial Design
1Treatment groups
Experimental Treatment
Group I: CBTExperimental Treatment1 Intervention
All subjects enrolled received CBT for 10 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavioral Therapy (CBT)
2008
Completed Phase 4
~3620
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,241 Previous Clinical Trials
1,004,227 Total Patients Enrolled
2 Trials studying Generalized Anxiety Disorder
201 Patients Enrolled for Generalized Anxiety Disorder
Gretchen Brenes, PhDPrincipal InvestigatorAtrium Health Wake Forest Baptist
3 Previous Clinical Trials
564 Total Patients Enrolled
1 Trials studying Generalized Anxiety Disorder
60 Patients Enrolled for Generalized Anxiety Disorder
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with or have symptoms of anxiety, depression, or sleep issues.I have been diagnosed with dementia or cognitive impairment.I have been diagnosed with or have symptoms of anxiety, depression, or sleep issues.
Research Study Groups:
This trial has the following groups:- Group 1: CBT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the primary aims of this clinical investigation?
"This trial's primary measure of success within a Week 11 period will be the Feasibility-Number of participants who complete at least 75% of sessions. Secondary targets encompass Client Satisfaction, PROMIS (an 8-item evaluation of general anxiety symptoms), and Insomnia Sleep Index (a 7-question self assessment for gauging insomnia severity). Scores on these metrics range from 8 to 40 with higher scores representing greater satisfaction or gravity in relation to the respective disorder."
Answered by AI
Is there still room for participants in this research project?
"Clinicaltrials.gov has reported that this clinical trial, which was initially posted on May 2nd 2022, is presently enrolling participants and has recently been updated in late July of the same year."
Answered by AI
How many participants have been accepted to take part in this clinical trial?
"Affirmative. The documentation on clinicaltrials.gov indicates that this medical trial, which was initially presented on May 2nd 2022, is actively enrolling volunteers. 10 individuals are required to be recruited from a single institution."
Answered by AI
Who else is applying?
What state do they live in?
Nebraska
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
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