CALM: Improving Primary Care Anxiety Outcomes

OBJECTIVE(S): The primary objective was to use quantitative methods to examine clinical effectiveness of CALM for anxiety disorders (PD, GAD, SAD, and PTSD) by randomly assigning subjects (N=1042) to CALM or to treatment as usual (TAU) and assessing them at baseline, 6, 12, and 18 months. The study will be powered to determine effectiveness of the intervention for both the individual anxiety disorders and the aggregate group of disorders. In addition, quality of care will be compared between CALM and TAU. Another objective was to use qualitative methods to examine acceptability and perceived effectiveness of the intervention for low SES whites, African Americans, and Hispanics. Additionally, the secondary objectives include: using quasi experimental methods to estimate the effect of appropriate anxiety treatment on clinical and functioning outcomes; finally, to estimate health care costs and the cost-effectiveness of CALM relative to TAU.

METHODS: This study was randomized within site by major depression status: 1042 subjects from 4 sites (approximately 260 per site). Participants included those between the ages 18-75 with positive diagnosis of GAD, SAD, PD or PTSD. Major inclusion and exclusion criteria: Willing to participate in CALM; Able to speak English or Spanish; Able to read at the 6th grade level; Cognitively capable of participating in study and giving informed consent; Must have a telephone number where they can be contacted; Does not have a life threatening condition; Is not on psychiatric disability or pursing psychiatric disability claim; Is not under current care of a psychiatrist or in ongoing individual psychotherapy (marital therapy and group therapy may be permitted); Does not have a psychotic, Bipolar 1, or dementia diagnosis; Is not acutely suicidal or homicidal/dangerous behavior; Does not have active alcohol or substance dependence in past 3 months; Does not have substance abuse (other than alcohol or marijuana abuse) in past 3 months; There is no other disorder (aside from SAD, GAD, PTSD, or PD) that is clinically predominant (e.g., OCD, Anorexia nervosa etc.). Major Assessments and Measures: All subjects (intervention and usual care) will complete 4 telephone assessments conducted by RAND's Survey Research Group at 00,6, 12 and 18 months. The telephone assessments will consist of measures of (1) global symptom severity (BSI 18), (2) disorder-specific symptom severity (ASI, SPIN, PCL-C; PDSS-SR, PHQ-9), (3) functioning (SF-12v2; Sheehan Disability; EQ- 5D, Healthy Days Core Module-CDC HRQOL-4)), and (4) other relevant measures (e.g., cost, beliefs about medication and psychotherapy and treatment relevance, satisfaction with anxiety/depression treatment, stigma beliefs, use of health care services, medication use; alternative medication and therapies, alcohol use, social support, insurance status, demographic characteristics).

FINDINGS / RESULTS: This is a new project and field work has not yet begun.

STATUS: During the first 8 months of this project, we have been busy completing those activities and tasks which are a prerequisite to conducting the intervention in the clinical sites. Study investigators have been meeting in-person, on weekly phone conferences, and by Email to coordinate and standardize all study plans and deal with issues as they arise. Manuals, videos, a computerized CBT program, the web-based system, and other study materials have been developed and are in the process of refinement. Clinical sites have hired study personnel and are in the process of training the anxiety clinical specialists. In addition to cross-site activities, the RAND site has been finalizing the content of the baseline questionnaire, requesting licenses for the use of the BSI-18 symptom items and the 12-item short form survey (SF-12v2), and developing preliminary specifications for data files (e.g., naming of items, content descriptions, scoring of multi item scales, etc.). We are also working with our web programmer to be sure all items needed for reports and DSMB documentation are included in the web and easily transferable to the RAND site. We have started translation of the baseline instrument into Spanish for those subjects who prefer to be interviewed in Spanish rather than English. We have begun programming of the Computer assisted baseline telephone interview and will be testing the instrument for errors and for timing related to response burden. We are hiring and training our survey interviewers and are setting up the record management system and randomization scheme.

IMPACT: Building on previous depression studies, our recent primary care panic study, and key informant interviews of primary care providers, patients and clinic administrators, we have designed a definitive effectiveness study for primary care anxiety disorders that will establish the foundation needed for future dissemination of quality of care improvements for primary care anxiety. To maximize generalizability, we will include diverse populations in community-based settings and monolingual Spanish speakers. Responding to the needs of patients for individually tailored treatment and to the significant, but limited effects, of our CCAP panic study, the model has been improved to enhance the effectiveness of care (by providing patients a choice of their preferred treatment, using techniques to maximize treatment engagement, and addressing therapeutic non-response with use of stepped care algorithms). Finally, to facilitate future intervention uptake, the study will gather key informant information to document acceptability of the service delivery model for disadvantaged populations and for clinic organization and personnel.