Generalized Anxiety DisorderNCT00601965
Antidepressant Treatment Plus Cognitive Behavioral Therapy for Generalized Anxiety Disorder in Older Adults
A study testing Escitalopram and Cognitive behavioral therapy (CBT) in people with Generalized Anxiety Disorder, run by Veterans Medical Research Foundation at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Escitalopram and Cognitive behavioral therapy (CBT)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2007to Sep 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
UCSD Outpatient Psychiatric Services
San Diego, California, 92103
Washington University
St Louis, Missouri, 63110
About this study
Official title: 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.
Read the 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.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Escitalopram, Placebo, Cognitive behavioral therapy (CBT)
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EscitalopramDrug
Also called Lexapro
20 mg daily oral escitalopram
PlaceboDrug
Also called Sugar pill
Placebo pill of daily oral escitalopram
Cognitive behavioral therapy (CBT)Behavioural
Also called CBT
16 weekly 1-hour sessions
| Study group | Role | What they receive |
|---|---|---|
| CBT/Escitalopram | Experimental | 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. Receives: Drug: Escitalopram; Behavioral: Cognitive behavioral therapy (CBT) |
| No CBT/escitalopram | Active comparator | 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. Receives: Drug: Escitalopram |
| CBT/placebo | Placebo comparator | 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. Receives: Drug: Placebo; Behavioral: Cognitive behavioral therapy (CBT) |
| No CBT/placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Anxiety Rating Scale
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).
Measured: 56 weeks
Penn State Worry Questionnaire
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.
Measured: 56 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startOct 2007
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Veterans Medical Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Julie L. Wetherell, PhD, Principal investigator, UCSD and VMRF/VASDHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00601965
- Sponsor's protocol ID
- R34MH080151
- Other IDs
- R34MH080151, NCT00601965
- Status last verified
- Jul 2016
- First submitted
- 15 Jan 2008
- Last updated
- 25 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Wetherell JL, Petkus AJ, White KS, Nguyen H, Kornblith S, Andreescu C, Zisook S, Lenze EJ. Antidepressant medication augmented with cognitive-behavioral therapy for generalized anxiety disorder in older adults. Am J Psychiatry. 2013 Jul;170(7):782-9. doi: 10.1176/appi.ajp.2013.12081104.
PubMed 23680817
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CBT Augmentation of SSRI Treatment for Geriatric GAD
- ClinicalTrials.gov ID
- NCT00601965
- Acronym / sponsor ID
- R34MH080151
- Conditions
- Generalized Anxiety Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Veterans Medical Research FoundationUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Oct 2007
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 28 Jan 2008 (estimated)
- Results
- Posted 25 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CBT/Escitalopram | Experimental | Drug: Escitalopram, Behavioral: Cognitive behavioral therapy (CBT)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. |
| No CBT/escitalopram | Active comparator | Drug: Escitalopram12 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. |
| CBT/placebo | Placebo comparator | Drug: Placebo, Behavioral: Cognitive behavioral therapy (CBT)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. |
| No CBT/placebo | Placebo comparator | Drug: Placebo12 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EscitalopramAlso: Lexapro20 mg daily oral escitalopram | Drug | CBT/Escitalopram, No CBT/escitalopram |
| PlaceboAlso: Sugar pillPlacebo pill of daily oral escitalopram | Drug | CBT/placebo, No CBT/placebo |
| Cognitive behavioral therapy (CBT)Also: CBT16 weekly 1-hour sessions | Behavioural | CBT/Escitalopram, CBT/placebo |
Primary outcome
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).
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23680817Wetherell JL, Petkus AJ, White KS, Nguyen H, Kornblith S, Andreescu C, Zisook S, Lenze EJ. Antidepressant medication augmented with cognitive-behavioral therapy for generalized anxiety disorder in older adults. Am J Psychiatry. 2013 Jul;170(7):782-9. doi: 10.1176/appi.ajp.2013.12081104.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie L. Wetherell, PhD principal investigator
UCSD and VMRF/VASDHS
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Escitalopram and Cognitive behavioral therapy (CBT) in people with Generalized Anxiety Disorder, run by Veterans Medical Research Foundation at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Anxiety Rating Scale (time frame: 56 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00601965, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2016.