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

July 14, 2016 updated by: Veterans Medical Research Foundation

CBT Augmentation of SSRI Treatment for Geriatric GAD

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Actual)

73

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92103
        • UCSD Outpatient Psychiatric Services
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CBT/Escitalopram
12 weeks open-label escitalopram (10-20mg/day as tolerated), followed by 16 weeks individual cognitive behavioral therapy plus continuation escitalopram at same dose as end of first 12 weeks, followed by 28 weeks maintenance escitalopram at same dose as at end of first 12 weeks. Up to 3 booster sessions of CBT allowed during the 28 week maintenance phase. CBT consists of 16 sessions of relaxation training, cognitive restructuring, and problem-solving skills training.
Drug: Escitalopram
20 mg daily oral escitalopram
Other Names:
  • Lexapro
Behavioral: Cognitive behavioral therapy (CBT)
16 weekly 1-hour sessions
Other Names:
  • CBT
Active Comparator: No CBT/escitalopram
12 weeks open-label escitalopram (10-20 mg/day as tolerated), followed by 16 weeks continuation escitalopram at same dose as at end of first 12 weeks, followed by 28 weeks maintenance escitalopram at same dose as at end of first 12 weeks.
Drug: Escitalopram
20 mg daily oral escitalopram
Other Names:
  • Lexapro
Placebo Comparator: CBT/placebo
12 weeks open-label escitalopram (10-20mg/day as tolerated), followed by 16 weeks individual cognitive behavioral therapy plus continuation escitalopram at same dose as end of first 12 weeks, followed by 28 weeks of pill placebo. 28 weeks of pill placebo includes a taper period of a duration dependent on the initial dose of escitalopram, but in all cases taper to placebo is complete after 8 weeks. Up to 3 booster sessions of CBT allowed during the 28 week maintenance phase. CBT consists of 16 sessions of relaxation training, cognitive restructuring, and problem-solving skills training.
Behavioral: Cognitive behavioral therapy (CBT)
16 weekly 1-hour sessions
Other Names:
  • CBT
Drug: Placebo
Placebo pill of daily oral escitalopram
Other Names:
  • Sugar pill
Placebo Comparator: No CBT/placebo

12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks pill placebo

12 weeks open-label escitalopram (10-20 mg/day as tolerated), followed by 16 weeks continuation escitalopram at same dose as at end of first 12 weeks, followed by 28 weeks of pill placebo. 28 weeks of pill placebo includes a taper period of a duration dependent on the initial dose of escitalopram, but in all cases taper to placebo is complete after 8 weeks.
Drug: Placebo
Placebo pill of daily oral escitalopram
Other Names:
  • Sugar pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hamilton Anxiety Rating Scale
Time Frame: 56 weeks
The Hamilton Anxiety Rating Scale is a clinician-rated measure of cognitive and somatic anxiety symptoms. It consists of 14 items, each of which is scored on a 0-4 scale, summed for a total score ranging from 0 to 56. Inclusion criteria for this study included a Hamilton score >= 17. The Hamilton, administered by blind raters, will be used to test hypotheses number 1 and 2. The outcome of interest is the number of participants who relapse, defined as having a Hamilton increase of >=5, for a total Hamilton >=14, relative to the end of the continuation phase (week 28), for a duration of at least 2 weeks, plus both clinician's and participant's judgment that the participant is experiencing a recurrence of anxiety symptoms. HAMA scores range from 0 (no anxiety) to 56 (high anxiety).
56 weeks
Penn State Worry Questionnaire
Time Frame: 56 weeks
The Penn State Worry Questionnaire is a 16-item measure of pathological worry. Scores range from 16-80, with higher scores indicating higher levels of worry.
56 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Veterans Medical Research Foundation

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Julie L. Wetherell, PhD, UCSD and VMRF/VASDHS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

January 15, 2008

First Submitted That Met QC Criteria

January 15, 2008

First Posted (Estimate)

January 28, 2008

Study Record Updates

Last Update Posted (Estimate)

August 25, 2016

Last Update Submitted That Met QC Criteria

July 14, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R34MH080151 (U.S. NIH Grant/Contract)
  • NCT00601965 (Registry Identifier: Clinicaltrials.gov)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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