Three broad goals underlie this continuation application for a multicenter collaborative study of the treatment of panic disorder: 1) completion of the originally proposed study, comparing cognitive behavioral panic control treatment (PCT), imipramine or placebo administered double blind (MED) and the combination (COM), 2) comparison of treatment durability over 6 or 24 month maintenance with further 24 month follow-up, and 3) cross-over treatment of MBD and PCT nonresponders to the opposite treatment. It is clearly important to complete enrollment of the remaining 37% of 480 patients needed to answer key questions related to the relative efficacy of PcT, MED and COM. Study enrollment began somewhat later than we predicted because of rigorous attention to state-of-the-art assessment and quality control procedures. Careful thought about essential assessment domains appears to have been well worth the effort. Not only are the procedures we developed working well, but they have been used already by other investigators in the field and have influenced recent consensus on assessment of panic disorder. We devoted great care to training and certifying therapists and to developing extensive quality assurance procedures, essential to a cross site study. PCT adherence ratings are among the most detailed and rigorous in the field, while our procedures for MED training, certification and adherence monitoring reflect to a level of quality control rarely undertaken in psychopharmacology trials. Study of long term maintenance and follow-up is a natural and important extension of the efficacy study. With efficacy of short term treatment for panic disorder well established, there is growing recognition of the need to address durability of treatment, especially medication. Naturalistic follow-up of patients who participated in efficacy trials document continued intermittent symptoms and ongoing functional impairment even with continued naturalistic treatment, and a high rate of relapse following medication discontinuation. However, there are no prospective studies of long term outcome using rigorous, blinded assessment procedures and quality controlled maintenance treatment. There is a need to determine course and outcome during and after optimal long term maintenance treatment. A second natural extension is to examine whether nonresponders to one treatment modality will respond to the other. Although this is an obvious question, few studies to date have investigated sequential treatment strategies. Such approaches could provide considerable useful information. Our original study will provide definitive information for clinicians regarding the best choices for acute treatment of panic disorder. We now recognize that the cohort of subjects we have assembled also provide a unique opportunity to conduct the first large scale study of treatment durability and the first systematic study of effectiveness of cross-over treatment for nonresponders. Thus, we are proposing to add these aims.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Research Project (R01)
Project #
5R01MH045966-10
Application #
6351683
Study Section
Treatment Assessment Review Committee (TA)
Program Officer
Niederehe, George T
Project Start
1999-02-01
Project End
2004-01-31
Budget Start
2001-02-01
Budget End
2002-01-31
Support Year
10
Fiscal Year
2001
Total Cost
$295,202
Indirect Cost
Name
Yale University
Department
Psychiatry
Type
Schools of Medicine
DUNS #
082359691
City
New Haven
State
CT
Country
United States
Zip Code
06520
Payne, Laura A; White, Kamila S; Gallagher, Matthew W et al. (2016) SECOND-STAGE TREATMENTS FOR RELATIVE NONRESPONDERS TO COGNITIVE BEHAVIORAL THERAPY (CBT) FOR PANIC DISORDER WITH OR WITHOUT AGORAPHOBIA-CONTINUED CBT VERSUS SSRI: A RANDOMIZED CONTROLLED TRIAL. Depress Anxiety 33:392-9
Cassiello-Robbins, Clair; Conklin, Laren R; Anakwenze, Ujunwa et al. (2015) The effects of aggression on symptom severity and treatment response in a trial of cognitive behavioral therapy for panic disorder. Compr Psychiatry 60:1-8
Huppert, Jonathan D; Kivity, Yogev; Barlow, David H et al. (2014) Therapist effects and the outcome-alliance correlation in cognitive behavioral therapy for panic disorder with agoraphobia. Behav Res Ther 52:26-34
Lutz, Wolfgang; Hofmann, Stefan G; Rubel, Julian et al. (2014) Patterns of early change and their relationship to outcome and early treatment termination in patients with panic disorder. J Consult Clin Psychol 82:287-97
White, Kamila S; Payne, Laura A; Gorman, Jack M et al. (2013) Does maintenance CBT contribute to long-term treatment response of panic disorder with or without agoraphobia? A randomized controlled clinical trial. J Consult Clin Psychol 81:47-57
Gallagher, Matthew W; Payne, Laura A; White, Kamila S et al. (2013) Mechanisms of change in cognitive behavioral therapy for panic disorder: the unique effects of self-efficacy and anxiety sensitivity. Behav Res Ther 51:767-77
Boswell, James F; Gallagher, Matthew W; Sauer-Zavala, Shannon E et al. (2013) Patient characteristics and variability in adherence and competence in cognitive-behavioral therapy for panic disorder. J Consult Clin Psychol 81:443-54
White, Kamila S; Allen, Laura B; Barlow, David H et al. (2010) Attrition in a multicenter clinical trial for panic disorder. J Nerv Ment Dis 198:665-71
Allen, Laura B; White, Kamila S; Barlow, David H et al. (2010) Cognitive-Behavior Therapy (CBT) for Panic Disorder: Relationship of Anxiety and Depression Comorbidity with Treatment Outcome. J Psychopathol Behav Assess 32:185-192
Furukawa, Toshi A; Katherine Shear, M; Barlow, David H et al. (2009) Evidence-based guidelines for interpretation of the Panic Disorder Severity Scale. Depress Anxiety 26:922-9

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