Generalized Anxiety Disorder, Panic Disorder, Post-traumatic Stress Disorder, Social Anxiety Disorder
Conditions
Keywords
Anxiety Disorders, Post-traumatic Stress Disorder, Generalized Anxiety Disorder, Panic Disorder, Social Anxiety Disorder, Stress, Stress Disorders, Traumatic, Stress Disorders, Post-Traumatic, Mental Health Disorders
Brief summary
This study will compare the effectiveness of an intervention strategy for the treatment of people with post traumatic stress disorder, generalized anxiety disorder, panic disorder, and social anxiety disorder in the primary care setting.
Detailed description
Anxiety disorders are highly prevalent, distressing, and disabling. Most patients with anxiety disorders who do receive mental health treatment receive it in primary care settings, where the quality of care is generally insufficient. This intervention is geared towards testing the clinical effectiveness of a care-manager assisted chronic disease management program for four common anxiety disorders (post-traumatic stress disorder, generalized anxiety disorder, panic disorder, and social anxiety disorder) in the primary care setting. This approach has been shown to be effective for the treatment of depression. Participants in this randomized, controlled trial will either be assigned to the control group: treatment-as-usual (TAU) from their primary care provider (PCP); or to the intervention group: CALM (Coordinated Anxiety Learning and Management). Intervention subjects will choose to receive CBT, medication, or both for the treatment of their anxiety. Those who choose CBT will receive it from a study-trained Anxiety Clinical Specialist (ACS) in their respective clinic. For those who choose medication, the ACS will facilitate the delivery of, and adherence to, anti-anxiety medication which will be prescribed by the participant's PCP. In this stepped-care design, subject progress will be formally re-evaluated at 8-12 week intervals. If treatment progress is not satisfactory, options include: additional or modified treatment with current modality, switching to the other treatment modality, or adding the other modality. When remission is attained, the ACS will follow-up with participants on a monthly basis to review progress and practice anxiety-reduction strategies. Treatment will continue for up to 12 months. Participants in both study arms will undergo formal baseline and outcome assessment interviews conducted at the 6, 12, and 18 month follow-up time-points.
Interventions
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.
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.
Participants in the control group will receive standard treatment from their PCP.
Sponsors
Study design
Eligibility
Inclusion criteria
* MINI diagnosed Anxiety Disorder (PTSD, GAD, SAD, PD) * Speak English or Spanish (English only at UAMS site)
Exclusion criteria
* Diagnosis of Bipolar 1 * Drug and alcohol dependence; or abuse of any substance other than marijuana and alcohol * Acute suicidality or homicidality Eligible subjects must be current patients at one of the participating primary care clinics which include: University of Washington: * Harborview's Adult Medicine Clinic * Harborview's Family Medicine Clinic * UWMC's General Internal Medicine Clinic at Roosevelt Clinic * PSNHC's 45th Street Clinic * Country Doctor Community Clinic * Carolyn Downs Family Medical Center UCLA: * Desert Medical Group, Palm Springs CA * High Desert Medical Group, Lancaster, CA UCSD: * Kaiser Permanente, Bonita Medical Offices * Kaiser Permanente, Otay Mesa Outpatient Medical Center * UCSD Medical Center, Scripps Ranch Medical Office * UCSD Medical Center, Fourth and Lewis Medical Office * UCSD Medical Center, Perlman Ambulatory Care Center * Sharp Rees-Stealy Medical Group, El Cajon * Sharp Rees-Stealy Medical Group, Mira Mesa UAMS: * UAMS UPMG * Little Rock Diagnostic Clinic * St. Vincent's Family Clinic South
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BSI-12 (Anxiety and Somatization Subscales) | Measured at Month 18 | 12 items from the Brief Symptom Inventory that measure anxiety and anxiety0related physical symptoms |
Secondary
| Measure | Time frame |
|---|---|
| Functioning Outcomes as Measured by 3-item Sheehan Disability Scales and SF-12 and Disorder-specific Severity Scales as Measured by the ASI, PDSS-SR, GADS (Modified), SPIN, PCL-C, and the PHQ-9 | Measured at Month 18 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 503 |
| 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. | 501 |
| Total | 1,004 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 3 |
| Overall Study | Lost to Follow-up | 74 | 65 |
| Overall Study | Withdrawal by Subject | 18 | 38 |
Baseline characteristics
| Characteristic | CALM Intervention | Total | Treatment as Usual (TAU) |
|---|---|---|---|
| Age, Continuous | 43.3 years STANDARD_DEVIATION 13.2 | 43.4 years STANDARD_DEVIATION 13.4 | 43.7 years STANDARD_DEVIATION 13.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 104 Participants | 196 Participants | 92 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 399 Participants | 808 Participants | 409 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants | 9 Participants | 4 Participants |
| Race (NIH/OMB) Asian | 11 Participants | 18 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 40 Participants | 97 Participants | 57 Participants |
| Race (NIH/OMB) More than one race | 72 Participants | 133 Participants | 61 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 40 Participants | 79 Participants | 39 Participants |
| Race (NIH/OMB) White | 333 Participants | 664 Participants | 331 Participants |
| Region of Enrollment United States | 503 participants | 1004 participants | 501 participants |
| Sex: Female, Male Female | 359 Participants | 714 Participants | 355 Participants |
| Sex: Female, Male Male | 144 Participants | 290 Participants | 146 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 503 | 3 / 501 |
| other Total, other adverse events | 0 / 503 | 0 / 501 |
| serious Total, serious adverse events | 0 / 503 | 0 / 501 |
Outcome results
BSI-12 (Anxiety and Somatization Subscales)
12 items from the Brief Symptom Inventory that measure anxiety and anxiety0related physical symptoms
Time frame: Measured at Month 18
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CALM Intervention | BSI-12 (Anxiety and Somatization Subscales) | 325 number of responders |
| Treatment as Usual (TAU) | BSI-12 (Anxiety and Somatization Subscales) | 258 number of responders |
Functioning Outcomes as Measured by 3-item Sheehan Disability Scales and SF-12 and Disorder-specific Severity Scales as Measured by the ASI, PDSS-SR, GADS (Modified), SPIN, PCL-C, and the PHQ-9
Time frame: Measured at Month 18