Antidepressant Treatment Plus Cognitive Behavioral Therapy for Generalized Anxiety Disorder in Older Adults

Generalized Anxiety Disorder Clinical Trial

Official title: CBT Augmentation of SSRI Treatment for Geriatric GAD

Status Completed

Clinical Trial Summary

This study will assess whether adding cognitive behavioral therapy to the antidepressant escitalopram is effective in reducing anxiety in older adults with generalized anxiety disorder.

Clinical Trial Description

Generalized anxiety disorder (GAD) affects nearly 6.8 million adults in the United States. GAD is diagnosed when a person spends at least 6 months excessively worrying over everyday problems to the point that carrying out normal life becomes difficult. People with GAD face each day with intense anxiety and tension and are unable to alleviate their worries. Physical symptoms of GAD include muscle aches, nausea, sweating, exhaustion, irritability, frequent urination, shaking, and hot flashes. People with GAD often experience other anxiety disorders, depression, or substance abuse, all of which can worsen symptoms of GAD. This makes early and appropriate treatment for GAD important. Current treatments for GAD include medication and/or types of psychotherapy. This study will assess whether adding cognitive behavioral therapy (CBT) to the antidepressant escitalopram is effective in reducing anxiety in older adults with GAD.

Participation in this double-blind study will last up to 13 months. Participants will be asked to stop any current treatments for anxiety or depression for the duration of the study. Participants will begin taking one pill of the medication escitalopram daily for 12 weeks. Dosage will be increased to two pills each day if symptoms do not improve within 4 weeks. After 12 weeks, all participants will continue taking escitalopram for an additional 16 weeks. In addition, some participants will be randomly assigned to receive 16 weekly sessions of CBT, lasting 1 hour each. CBT sessions will involve learning relaxation techniques and other skills to manage anxiety and completing 30-minute at-home practice assignments each day. A family member will accompany participants to the first four CBT sessions. All participants will be asked to provide information for a close contact, who will be interviewed at baseline, Month 3, and Month 7 about how the participant's anxiety is affecting his or her relationships.

After the 16-week period, participants will again be randomly assigned to receive either continued escitalopram or a placebo for an additional 28 weeks. Participants assigned to the placebo will be gradually tapered off escitalopram over a 6-week period. Participants who were receiving CBT will receive three more sessions. Throughout the study, participants will be asked to complete various assessments, including questionnaires, memory and thinking tests, and attention evaluations. Blood samples will be taken at Weeks 2 and 8, and saliva samples will be taken at baseline and Weeks 12, 28, and 56. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

• NCT number: NCT00601965
• Study type: Interventional
• Source: Veterans Medical Research Foundation
• Status: Completed
• Phase: N/A
• Start date: October 2007
• Completion date: September 2011