Generalized Anxiety Disorder Study

For the General Public

Of all major mood and anxiety disorders, Generalized Anxiety Disorder (GAD) represents one of the most common, but least studied disorders. Although medications and cognitive-behavioral therapies (CBT) have demonstrated efficacy in GAD treatment, a substantial number of patients fail to achieve an adequate clinical response during acute phase treatment. Thus, it is important to attempt to improve outcomes in GAD.

Investigators at the Center for Psychotherapy Research are currently conducting a study of state-of-the-art cognitive behavioral therapy in combination with medication in the treatment of GAD. Karl Rickels, MD is the Principal Investigator of this study funded by the National Institute of Mental Health (NIMH). In this study, some of the patients receiving medication treatment for their Generalized Anxiety Disorder will also be offered the option of adding cognitive behavioral therapy to their medication treatment.

For Health Care Professionals

The “Combined Treatment for Generalized Anxiety Disorder” study is a preliminary randomized clinical trial evaluating the efficacy of combined medication and psychotherapy for Generalized Anxiety Disorder (GAD). The general goals of the current study are to conduct a late stage treatment development study. The goal of this stage of research is to provide a preliminary answer to the question of whether combined treatment is more efficacious than medication alone in the treatment of GAD and to gather data to estimate intervention parameters (e.g., effect size, attrition rates, response rates) that would assist in planning further research.

The current study proposes to randomize 160 patients to either venlafaxine XR alone (N=120) or combined CBT plus venlafaxine (N=40) and assess outcomes over a 12 week acute phase treatment period. The accomplishment of this study will be greatly facilitated by an ongoing NIMH-funded study of long-term strategies for venlafaxine XR treatment of GAD (Karl Rickels, PI). GAD patients are randomized to either combined treatment or venlafaxine XR alone, with the venlafaxine alone provided in the context of Dr. Rickels’ ongoing long-term treatment grant. Thus, this study requires only the addition of 40 new patients who will be randomized into combined treatment. This strategy is a very cost-efficient way to collect preliminary data relevant to our primary hypothesis which states that combined CBT plus medication (COMB) will be superior to medication (MED) alone. We also speculate that the COMB treatment condition will be superior to the MED condition on a number of secondary outcomes, including the core feature of GAD (worry), depressive symptoms, quality of life, and functional impairment. Finally we will explore comparative relapse rates for both the COMB and MED treatment conditions at a 6 month follow-up assessment visit.

Symptoms of Generalized Anxiety Disorder include:

• Feelings of uncontrollable worry and anxiety most of the time
• Experiencing some of the following symptoms for at least 6 months:
• Restlessness
• Fatigue
• Difficulty concentrating
• Muscle tension
• Irritability
• Sleep disturbance

Contact Us

This study is now closed for recruitment.

If you wish to learn more about our current treatment programs or ask specific questions about this study, please call 1-800-422-7000.

Principal Investigator:  Paul Crits-Christoph, PhD (NIMH funded)