What side effects are associated with this type of intervention?

Cognitive-Behavioral Therapy (CBT) for Generalized Anxiety Disorder (GAD) generally has minimal side effects, primarily involving temporary increases in anxiety as patients confront their fears. Pharmacological treatments, such as benzodiazepines and antidepressants, are also common. Benzodiazepines can cause side effects like psychomotor impairment, amnesia, dependence, withdrawal symptoms, and rebound anxiety. Antidepressants, such as SSRIs, may cause nausea, weight gain, sexual dysfunction, and increased risk of fractures in older adults.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Generalized Anxiety Disorder (GAD), including Selective Serotonin Reuptake Inhibitors (SSRIs) like sertraline and fluoxetine, and Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) such as duloxetine and venlafaxine. These medications are often used in combination with Cognitive-Behavioral Therapy (CBT), which is a psychosocial treatment that modifies dysfunctional thoughts and behaviors. Other medications like buspirone and gabapentin are also used as adjunctive treatments for patients who have a partial response to initial therapies.

What other types of research exist?

Promising novel alternatives to Cognitive-Behavioral Therapy (CBT) for Generalized Anxiety Disorder (GAD) include Metacognitive Therapy (MCT) and Intolerance-of-Uncertainty Therapy (IUT). Both therapies have shown effectiveness in randomized controlled trials for GAD patients. Additionally, mindfulness meditation has demonstrated efficacy in reducing anxiety and stress reactivity in GAD patients.

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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

Must not have

Diagnosis of dementia or cognitive impairment in the problem list

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 6, week 11

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a type of talk therapy called CBT for older adults with anxiety. Participants will use a workbook, do daily assignments, and have regular calls with a coach to learn new ways to manage their worries.

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been diagnosed with dementia or cognitive impairment.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 6, week 11 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility-Expectancy Rating Scale

Feasibility-Intervention adherence

Secondary study objectives

Feasibility-Client Satisfaction Questionnaire

Feasibility-Working Alliance Inventory, Client

Feasibility-Working Alliance Inventory, Therapist

+4 more

Other study objectives

Qualitative Interviews

Side effects data

From 2018 Phase 4 trial • 95 Patients • NCT01041274

18%

Weight increase

10%

Tachycardia

Psychiatric Hospitalization

Hypertension

Loss of libido

Appetite increase

Concentration impaired

Memory impaired

Rash

Restlessness

Amenorrhea

Cellulitis

Appetite decrease

Hot flashes

Apathy

Akathisia

Dizziness upon standing

Anorgasmia

Drug-related hospitalization

Drug abuse

Blurred vision

Drooling

Sleep disturbed

Medical Hospitalization

Fatigue

Hiccup

Hit by a motorcycle

Hurt when riding a bike

Mental activity decreased

Muscle twitch

Sleeplessness

Pneumonia

Nightmares

Teeth grating

Incarceration

Sensory hallucinations

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Citalopram

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: 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

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Generalized Anxiety Disorder (GAD) include Cognitive-Behavioral Therapy (CBT) and pharmacotherapy. CBT works by modifying dysfunctional thoughts and behaviors that contribute to anxiety. It involves techniques such as cognitive restructuring to challenge and change negative thought patterns, and behavioral interventions to reduce avoidance behaviors and increase coping skills. This is crucial for GAD patients as it addresses the root causes of anxiety, leading to long-term improvement in symptoms. Pharmacotherapy, often involving selective serotonin reuptake inhibitors (SSRIs) or benzodiazepines, works by altering neurotransmitter levels in the brain to reduce anxiety symptoms. Understanding these mechanisms helps patients and providers choose the most effective treatment plan tailored to individual needs.