Medication Plus CBT Effective for Anxiety in Primary Care

April 14, 2011 — Cognitive behavior therapy (CBT) in combination with psychotropic medication is highly effective for treating most anxiety disorders in primary care, new research suggests.

In a study of more than 1000 patients, those who underwent the Coordinated Anxiety Learning and Management (CALM) collaborative care program had significantly decreased symptoms of principal generalized anxiety disorder (GAD), panic disorder (PD), and social anxiety disorder (SAD), and comorbid SAD than did those randomized to receive usual treatment from their primary care physician.

"The purpose of this study was to address disorder-specific outcomes for each participant's constellation of anxiety disorders," write Michelle Craske, PhD, from the Department of Psychology at the University of California, Los Angeles, and colleagues.

They note that the study was designed to compare the CALM intervention and usual care for both principal and comorbid disorders "while mimicking real-world conditions" — and is the first to do so in a generalizable sample population.

The study is published in the April issue of Archives of General Psychiatry.

Learning to Stay CALM

The investigators note that it is common for people with anxiety disorders to seek treatment in primary care, "where evidence-based mental health treatments often are unavailable or suboptimally delivered."

For this study, 1004 patients (70.9% female; mean age, 43.7 years) diagnosed as having GAD (n = 549), PD (n = 262), SAD (n = 132), or posttraumatic stress disorder (PTSD; n = 61) were enrolled at 1 of 17 primary care clinics in Seattle, Washington, San Diego, California, Los Angeles, California, or Little Rock, Arkansas, between 2006 and 2008.

The patients were randomized to receive either the CALM intervention (n = 503) for up to 12 months or usual care (n = 501).

Usual care consisted of continued treatment of medication and/or counseling by the current primary care physician and referral to a mental health specialist, if needed.

The CALM intervention included pharmacotherapy, computer-assisted CBT, or both, depending on patient preference.

"Given the relative dearth of highly trained mental health providers available in primary care settings, we designed the CBT program to be used by persons with minimal or no training in mental health," report the researchers, adding that that the computerized program was developed to guide both the provider and patient.

The collaborative care pharmacotherapy model allowed patients to continue being treated by their primary care physicians while healthcare managers or anxiety clinical specialists relayed advice from psychiatrists and helped manage medications.

All study participants were evaluated at baseline and at follow-ups conducted by telephone survey 6, 12, and 18 months later.

Measurement tools included the Generalized Anxiety Disorder Severity Scale, Panic Disorder Severity–Self-report Scale, Social Phobia Inventory, and PTSD Checklist–Civilian Version. These tools for used to assess both GADs and comorbidities.

Strong Benefit

Results showed that 53% to 82% of all participants had more than 1 anxiety disorder.

Overall, the CALM intervention was significantly superior to usual care in decreased principal anxiety measurement scores for GAD at 6, 12, and 18 months, PD at 6 and 12 months, and SAD at 6 months.

Table. Adjusted Treatment Outcome Scores by Principal Anxiety Disorder

Anxiety Disorder Measure	CALM	Usual Care	Score Difference	P Value
GAD
6 months	8.8	10.46	−1.61	<.001
12 months	7.66	9.99	−2.34	<.001
18 months	7.27	9.64	−2.37	<.001
PD:
6 months	6.05	8.05	−2.00	.04
12 months	5.64	8.35	−2.71	.003
SAD
6 months	27.42	34.48	−7.05	.03

CALM = Coordinated Anxiety Learning and Management; GAD = generalized anxiety disorder, PD = panic disorder, SAD = social anxiety disorder

In addition, the CALM treatment showed significant effect size (ES) differences for comorbid SAD at 6, 12, and 18 months compared with usual care.

However, no significant between-group differences were found for any comorbid disorder other than SAD, although the ESs favored the CALM group, or at any checkpoint for principal PTSD.

"The statistical significance for PTSD comparisons was mitigated by the relatively small sample size, as the ESs for PTSD were actually equivalent to those for the other principal anxiety disorders," the study authors explain.

Patients in the CALM treatment group with GAD also had significantly greater response and remission rates at all 3 follow-ups compared with the group receiving usual care (all P < .001), whereas those with PD had greater remission rates at 12 months only (P < .03), and those with SAD had significantly greater response rates at 6 months only (P < .04).

"Although the overall improvement in comorbid symptoms is good news for clinical practice, future research may address whether sequential treatment initially targeting a principal anxiety disorder followed by targeting comorbid disorders yields even stronger benefits for comorbid symptoms," write the investigators.

'Fantastic Trial'

"This is a fantastic trial. It's a much needed study that I think will have significant impact with some very clear clinical implications," Stefan G. Hofmann, PhD, professor of psychology at Boston University in Massachusetts and director of the university's Psychotherapy and Emotion Research Laboratory, told Medscape Medical News.

Dr. Stefan G. Hofmann

"This is one of the very few trials that have examined the efficacy of [CBT] for anxiety disorders in a real-world setting. That has always been a major criticism when it comes to clinical trials, whether the strong treatment effects found could also be seen in a clinical setting. And this trial clearly shows that it's possible to transport [CBT] and to provide some basic, effective training," he added.

Dr. Hofmann, who was not involved with this study, noted that he expected to see good results with CBT but was surprised at just how well it really did.

"This ties nicely into the general efforts that have been going on around the world to disseminate [CBT], including a big initiative to provide increased training for it in the United Kingdom," he reported.

"However, the United States is lagging behind. I assume that's because of how our healthcare system works and will hopefully improve with changes in the healthcare delivery system. It's important for policymakers to realize that providing patients with adequate treatment decreases overall costs to society."

Dr. Hofmann voiced concerns, which were mentioned by the study authors, with the some of the measurements used and said he "would have loved to have been shown some of the differences" between the various levels of training given to the providers.

"Still, I think the main study takeaways for clinicians are that [CBT] for anxiety disorders is effective in clinical practice, it can be effectively and easily trained even in people who have not been trained before in this approach, and it can have long-lasting and positive consequences.

"Also, I would hope that it's not only consumers and physicians that are affected by these findings but also policymakers who determine where the money goes and what kind of changes we need to undertake in our healthcare system," he concluded.

The study was funded by grants from the National Institute of Mental Health (NIMH). All but 1 study author disclosed no relevant financial relationships. Coinvestigator Peter Roy-Byrne, MD, reports being on the editorial boards of UpToDate Psychiatry, Depression and Anxiety, and Journal Watch for Psychiatry. Dr. Hofmann disclosed no direct financial conflicts but reported being funded by the NIMH and a consultant for Merck Shering Pharmaceuticals.