Antidepressant Treatment Plus Cognitive Behavioral Therapy for Generalized Anxiety Disorder in Older Adults
Generalized Anxiety Disorder
About this trial
This is an interventional treatment trial for Generalized Anxiety Disorder
Eligibility Criteria
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
Sites / Locations
- UCSD Outpatient Psychiatric Services
- Washington University
- University of Pittsburgh
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Active Comparator
Placebo Comparator
Placebo Comparator
CBT/Escitalopram
No CBT/escitalopram
CBT/placebo
No 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 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.
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.
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.
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.