Trial Outcomes & Findings for Primary Care Intervention Strategy for Anxiety Disorders (NCT NCT00347269)
NCT ID: NCT00347269
Last Updated: 2017-05-19
Results Overview
12 items from the Brief Symptom Inventory that measure anxiety and anxiety0related physical symptoms
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
1004 participants
Primary outcome timeframe
Measured at Month 18
Results posted on
2017-05-19
Participant Flow
Participant milestones
| Measure |
CALM Intervention
Participants assigned to coordinated anxiety learning and management (CALM)--
CALM consists of: patient choice of Cognitive Behavioral Therapy (CBT), psychotropic (anti-anxiety) medication optimization or both.
Optimization: 8 weeks of an evidence based anxiety medication at appropriate dose
Cognitive-behavioral therapy: Participants in CALM will choose to receive CBT, medication, or both for the treatment of their anxiety. CBT includes computer-assisted CBT with an anxiety clinical specialist.
Psychotropic medication optimization: For those participants in CALM who choose medication, the ACS will facilitate the delivery of, and adherence to, anti-anxiety medication which will be prescribed by the participants' PCP.
|
Treatment as Usual (TAU)
Participants assigned to TAU with their primary care provider (PCP)
Treatment as Usual: Participants in the control group will receive standard treatment from their PCP.
|
|---|---|---|
|
Overall Study
STARTED
|
503
|
501
|
|
Overall Study
COMPLETED
|
409
|
395
|
|
Overall Study
NOT COMPLETED
|
94
|
106
|
Reasons for withdrawal
| Measure |
CALM Intervention
Participants assigned to coordinated anxiety learning and management (CALM)--
CALM consists of: patient choice of Cognitive Behavioral Therapy (CBT), psychotropic (anti-anxiety) medication optimization or both.
Optimization: 8 weeks of an evidence based anxiety medication at appropriate dose
Cognitive-behavioral therapy: Participants in CALM will choose to receive CBT, medication, or both for the treatment of their anxiety. CBT includes computer-assisted CBT with an anxiety clinical specialist.
Psychotropic medication optimization: For those participants in CALM who choose medication, the ACS will facilitate the delivery of, and adherence to, anti-anxiety medication which will be prescribed by the participants' PCP.
|
Treatment as Usual (TAU)
Participants assigned to TAU with their primary care provider (PCP)
Treatment as Usual: Participants in the control group will receive standard treatment from their PCP.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
74
|
65
|
|
Overall Study
Withdrawal by Subject
|
18
|
38
|
|
Overall Study
Death
|
2
|
3
|
Baseline Characteristics
Primary Care Intervention Strategy for Anxiety Disorders
Baseline characteristics by cohort
| Measure |
CALM Intervention
n=503 Participants
Participants assigned to coordinated anxiety learning and management (CALM)--
CALM consists of: patient choice of Cognitive Behavioral Therapy (CBT), psychotropic (anti-anxiety) medication optimization or both.
Optimization: 8 weeks of an evidence based anxiety medication at appropriate dose
Cognitive-behavioral therapy: Participants in CALM will choose to receive CBT, medication, or both for the treatment of their anxiety. CBT includes computer-assisted CBT with an anxiety clinical specialist.
Psychotropic medication optimization: For those participants in CALM who choose medication, the ACS will facilitate the delivery of, and adherence to, anti-anxiety medication which will be prescribed by the participants' PCP.
|
Treatment as Usual (TAU)
n=501 Participants
Participants assigned to TAU with their primary care provider (PCP)
Treatment as Usual: Participants in the control group will receive standard treatment from their PCP.
|
Total
n=1004 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.3 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
43.7 years
STANDARD_DEVIATION 13.7 • n=7 Participants
|
43.4 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
359 Participants
n=5 Participants
|
355 Participants
n=7 Participants
|
714 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
144 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
290 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
104 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
196 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
399 Participants
n=5 Participants
|
409 Participants
n=7 Participants
|
808 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
40 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
333 Participants
n=5 Participants
|
331 Participants
n=7 Participants
|
664 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
72 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
40 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
503 participants
n=5 Participants
|
501 participants
n=7 Participants
|
1004 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at Month 1812 items from the Brief Symptom Inventory that measure anxiety and anxiety0related physical symptoms
Outcome measures
| Measure |
CALM Intervention
n=503 Participants
Participants assigned to coordinated anxiety learning and management (CALM)--
CALM consists of: patient choice of Cognitive Behavioral Therapy (CBT), psychotropic (anti-anxiety) medication optimization or both.
Optimization: 8 weeks of an evidence based anxiety medication at appropriate dose
Cognitive-behavioral therapy: Participants in CALM will choose to receive CBT, medication, or both for the treatment of their anxiety. CBT includes computer-assisted CBT with an anxiety clinical specialist.
Psychotropic medication optimization: For those participants in CALM who choose medication, the ACS will facilitate the delivery of, and adherence to, anti-anxiety medication which will be prescribed by the participants' PCP.
|
Treatment as Usual (TAU)
n=501 Participants
Participants assigned to TAU with their primary care provider (PCP)
Treatment as Usual: Participants in the control group will receive standard treatment from their PCP.
|
|---|---|---|
|
BSI-12 (Anxiety and Somatization Subscales)
|
325 number of responders
|
258 number of responders
|
SECONDARY outcome
Timeframe: Measured at Month 18Outcome measures
Outcome data not reported
Adverse Events
CALM Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Treatment as Usual (TAU)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Peter Roy-Byrne MD Professor of Psychiatry
University of Washington
Phone: 206-313-8504
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place