CALM used a web-based monitoring system,16 modeled on the IMPACT intervention,2 (link) with newly developed anxiety content, and a computer-assisted CBT program.17 (link) ACSs received six half days of didactics, which focused on mastering the CBT program, plus motivational interviewing (modified for anxiety concerns) to enhance engagement, outreach strategies for ethno-racial and impoverished minorities, and a medication algorithm for anxiety.21 (link) CBT training also included role-playing, and required successful completion of two training patients over several months.
CALM patients initially received their preferred treatment, either medication, CBT, or both, over 10 to 12 weeks. Since the effects of CBT delivered for one disorder are known to generalize to co-morbid disorders,22 patients with multiple anxiety disorders were asked to choose the most disabling or distressing disorder to focus on with the expectation that their co-morbid disorders would also improve. The CBT program, a “repackaging” based on already validated CBT treatments,23 included 5 generic modules (education, self-monitoring, hierarchy development, breathing training, relapse prevention) and 3 modules (cognitive restructuring, exposure to internal and external stimuli) tailored to the four specific anxiety disorders. CBT was administered by the ACS (typically in 6 to 8 weekly sessions), while medication was prescribed. A local study psychiatrist provided single session medication management training to providers using a simple algorithm, as needed consultation by phone or e-mail, and very rarely, a face to face assessment for complex or treatment refractory patients. The algorithm emphasized first line use of SSRI or SNRI antidepressants, dose optimization, side effect monitoring, followed by second and third step combinations of two antidepressants or an antidepressant and benzodiazepine for refractory patients.21 (link) For medication management, the ACS provided adherence monitoring, counseling to avoid alcohol and optimize sleep hygiene and behavioral activity, and relayed medication suggestions from the supervising psychiatrist to the PCP.
The ACS tracked patient outcomes on a web-based system by entering scores for the OASIS and a 3-item version of the Patient Health Questionnaire-9 (PHQ-9), and examining graphical progress over time. The goal was either clinical remission, defined as an OASIS < 5 = “mild”, sufficient improvement such that the patient did not want further treatment, or improvement with residual symptoms or other emergent problems requiring a non-protocol psychotherapy (ie, DBT, family or dynamic psychotherapy). Symptomatic patients thought to benefit from additional treatment with CBT or medication could receive more of the same modality (“stepping up”) or the alternative modality (“stepping over”), for up to three more steps of treatment. After treatment completion, patients were entered into “continued care” and received monthly follow-up phone calls to reinforce CBT skills and/or medication adherence. ACSs interacted regularly with PCPs in person and over the phone. PCPs remained the clinician of record and prescribed all medications. All ACSs received weekly supervision from a psychiatrist and psychologist.
UC patients continued to be treated by their physician in the usual manner with no intervention, ie, with medication, counseling (7 of 17 clinics had limited in-clinic mental health resources, usually a single provider with limited familiarity with evidence based psychotherapy24 (link)) or referral to a mental health specialist. After the eligibility diagnostic interview, the only contact UC patients had with study personnel was for assessment by phone.
CALM patients initially received their preferred treatment, either medication, CBT, or both, over 10 to 12 weeks. Since the effects of CBT delivered for one disorder are known to generalize to co-morbid disorders,22 patients with multiple anxiety disorders were asked to choose the most disabling or distressing disorder to focus on with the expectation that their co-morbid disorders would also improve. The CBT program, a “repackaging” based on already validated CBT treatments,23 included 5 generic modules (education, self-monitoring, hierarchy development, breathing training, relapse prevention) and 3 modules (cognitive restructuring, exposure to internal and external stimuli) tailored to the four specific anxiety disorders. CBT was administered by the ACS (typically in 6 to 8 weekly sessions), while medication was prescribed. A local study psychiatrist provided single session medication management training to providers using a simple algorithm, as needed consultation by phone or e-mail, and very rarely, a face to face assessment for complex or treatment refractory patients. The algorithm emphasized first line use of SSRI or SNRI antidepressants, dose optimization, side effect monitoring, followed by second and third step combinations of two antidepressants or an antidepressant and benzodiazepine for refractory patients.21 (link) For medication management, the ACS provided adherence monitoring, counseling to avoid alcohol and optimize sleep hygiene and behavioral activity, and relayed medication suggestions from the supervising psychiatrist to the PCP.
The ACS tracked patient outcomes on a web-based system by entering scores for the OASIS and a 3-item version of the Patient Health Questionnaire-9 (PHQ-9), and examining graphical progress over time. The goal was either clinical remission, defined as an OASIS < 5 = “mild”, sufficient improvement such that the patient did not want further treatment, or improvement with residual symptoms or other emergent problems requiring a non-protocol psychotherapy (ie, DBT, family or dynamic psychotherapy). Symptomatic patients thought to benefit from additional treatment with CBT or medication could receive more of the same modality (“stepping up”) or the alternative modality (“stepping over”), for up to three more steps of treatment. After treatment completion, patients were entered into “continued care” and received monthly follow-up phone calls to reinforce CBT skills and/or medication adherence. ACSs interacted regularly with PCPs in person and over the phone. PCPs remained the clinician of record and prescribed all medications. All ACSs received weekly supervision from a psychiatrist and psychologist.
UC patients continued to be treated by their physician in the usual manner with no intervention, ie, with medication, counseling (7 of 17 clinics had limited in-clinic mental health resources, usually a single provider with limited familiarity with evidence based psychotherapy24 (link)) or referral to a mental health specialist. After the eligibility diagnostic interview, the only contact UC patients had with study personnel was for assessment by phone.
