Cognitive Behavioral Therapy (CBT) for Anxiety Disorders

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Anxiety Disorders+1 More
Cognitive Behavioral Therapy (CBT) - Behavioral
Eligibility
65+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Anxiety Disorders

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 7 Secondary · Reporting Duration: baseline, week 6, week 11

Week 1
Feasibility-Expectancy Rating Scale
Week 11
Feasibility-Client Satisfaction Questionnaire
Feasibility-Intervention adherence
Feasibility-Number of participants who complete at least 75% of sessions
Feasibility-Working Alliance Inventory, Client
Feasibility-Working Alliance Inventory, Therapist
Qualitative Interviews
Week 37
Healthcare Utilization-Costs for outpatient encounters, ED visits and inpatient stays
Healthcare Utilization-Number of ED visits
Healthcare Utilization-Number of Outpatient encounters
Healthcare Utilization-Number of inpatient stays
Week 6
Generalized Anxiety Disorder scale (GAD-7)
Week 11
Insomnia Sleep Index
Patient-Reported Outcomes Measurement Information System (PROMIS)
week 6
Penn State Worry Questionnaire-Abbreviated (PSWQ-A)

Trial Safety

Side Effects for

Citalopram
18%Weight increase
10%Tachycardia
6%Hypertension
6%Loss of libido
6%Psychiatric Hospitalization
4%Amenorrhea
4%Restlessness
4%Memory impaired
4%Rash
4%Appetite increase
4%Concentration impaired
2%Cellulitis
2%Akathisia
2%Appetite decrease
2%Pneumonia
2%Drug-related hospitalization
2%Drooling
2%Mental activity decreased
2%Dizziness upon standing
2%Sleeplessness
2%Fatigue
2%Blurred vision
2%Hot flashes
2%Medical Hospitalization
2%Apathy
2%Hit by a motorcycle
2%Sensory hallucinations
2%Nightmares
2%Sleep disturbed
2%Incarceration
2%Muscle twitch
2%Anorgasmia
2%Hiccup
2%Drug abuse
2%Hurt when riding a bike
2%Teeth grating
This histogram enumerates side effects from a completed 2018 Phase 4 trial (NCT01041274) in the Citalopram ARM group. Side effects include: Weight increase with 18%, Tachycardia with 10%, Hypertension with 6%, Loss of libido with 6%, Psychiatric Hospitalization with 6%.

Trial Design

1 Treatment Group

CBT
1 of 1
Experimental Treatment

10 Total Participants · 1 Treatment Group

Primary Treatment: Cognitive Behavioral Therapy (CBT) · No Placebo Group · N/A

CBT
Behavioral
Experimental Group · 1 Intervention: Cognitive Behavioral Therapy (CBT) · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavioral Therapy (CBT)
2008
Completed Phase 4
~3620

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, week 6, week 11

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,113 Previous Clinical Trials
1,129,659 Total Patients Enrolled
15 Trials studying Anxiety Disorders
987 Patients Enrolled for Anxiety Disorders
Gretchen Brenes, PhDPrincipal InvestigatorAtrium Health Wake Forest Baptist
3 Previous Clinical Trials
580 Total Patients Enrolled
1 Trials studying Anxiety Disorders
60 Patients Enrolled for Anxiety Disorders

Eligibility Criteria

Age 65+ · All Participants · 2 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 18th, 2021

Last Reviewed: October 25th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Nebraska100.0%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%