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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00601965
• Other study ID #: R34MH080151
• Secondary ID: R34MH080151DATR
• Status: Completed
• Phase: N/A
• First received: January 15, 2008
• Last updated: June 13, 2013
• Start date: October 2007
• Est. completion date: September 2011

Study information

• Verified date: April 2009
• Source: Veterans Medical Research Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Principal (i.e., most severe or pressing problem) or co-principal current diagnosis of generalized anxiety disorder

• Pretreatment score of at least 17 on Hamilton Anxiety Rating Scale

Exclusion Criteria:

• Principal diagnosis other than GAD

• Clinically judged too psychiatrically unstable to participate in the study

• Cognitive impairment or dementia

• Alcohol or other substance use disorder within 6 months prior to study entry

• Lifetime diagnosis of schizophrenia, schizoaffective disorder, delusional disorder, or bipolar disorder

• Serious, unstable, or terminal medical condition that would compromise study participation or preclude the use of escitalopram, as determined by a review of medical records

• Use of psychotropics that could not be safely tapered and discontinued for at least 2 weeks prior to study entry

• Use of depot neuroleptics within 6 weeks prior to study entry

• Unwillingness to terminate other forms of psychotherapy

• Already received adequate trial of escitalopram or CBT

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

Intervention

Drug:
• Escitalopram
20 mg daily oral escitalopram
• Placebo
Placebo pill of daily oral escitalopram

Behavioral:
• Cognitive behavioral therapy (CBT)
16 weekly 1-hour sessions

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	UCSD Outpatient Psychiatric Services	San Diego	California
United States	Washington University	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Veterans Medical Research Foundation	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Anxiety Rating Scale	The Hamilton Anxiety Rating Scale will be used to test hypotheses number 1 and 2.	56 weeks	No
Primary	Penn State Worry Questionnaire	The Penn State Worry Questionnaire will be used to test hypothesis number 3.	56 weeks	No
Secondary	Hamilton Depression Rating Scale		56 weeks	No
Secondary	Quality of life and functioning (SF-36, FDI)		56 weeks	No
Secondary	Neuropsychological functioning (RBANS, DKEFS Sorting Test, Stroop, LNS)		28 weeks	No
Secondary	HPA axis functioning (salivary cortisol)		56 weeks	No
Secondary	Generalized Anxiety Disorder Symptom Scale		56 weeks	No