The principal goal of this R21 study is to test, using patients with a diagnosis of generalized anxiety disorder (GAD), whether psychotherapy emphasizing therapist focus on core conflictual relationship themes (CCRT-Focused Therapy) can be implemented successfully and discriminated from a Reflective Listening Control (RLC) condition designed to provide non-specific elements of psychotherapy. In addition, preliminary (pilot) data on the relative efficacy of the two treatment conditions will be obtained in order to plan a larger efficacy trial. Sixteen weeks of manual-driven CCRT-Focused Therapy will be compared to a Reflective Listening Control (RLC). GAD has relatively high prevalence (lifetime approximately 3%), chronicity (2/3 with duration longer than 2 years), and associated psychosocial impairment. Benzodiazepine therapy is the most widely used treatment, but one-third of patients do not achieve remission, and the psychological and behavioral adverse effects, most notably the dependence and withdrawal liability, substantially reduce the benefit-risk ratio. Cognitive-behavioral therapy has demonstrated some efficacy with GAD, but considerable numbers of patients remain with residual symptomatology. Recent research implicates the relevance of interpersonal/psychodynamic factors in GAD, but no studies have investigated the efficacy of a manual-guided interpersonally oriented therapy with GAD patients. Treatment integrity and discrimination will be assessed through revised versions of adherence/competence scales developed for the respective treatments. Outcome will be assessed at 16 weeks and over a two year follow-up using three primary outcomes measures: the Hamilton Anxiety Rating Scale (assessing general anxiety symptoms), the Penn State Worry Questionnaire (assessing the core features of GAD, namely worry), and the Quality of Life Inventory (assessing the impact of treatment on a broad range of domains of life). The impact of treatment on a variety of secondary outcome measures, including interpersonal functioning and depressive symptoms will also be assessed. We also plan to collect pilot data on mediators of response for CCRT-Focused Therapy. We hypothesize that CCRT-Focused Therapy will be mediated by changes in self-understanding of interpersonal problems. Furhter, we will conduct exploratory analyses of the relation of comorbid Axis I and II disorder, trauma history and symptoms, and gender and ethnicity as main effect predictors and in interaction with treatment modality. To collect data on these hypotheses we propose to randomize 36 patients to 16 weeks of CCRT-Focused Therapy or RLC treatment. Patients will be eligible if they meet DSM-IV criteria for a primary diagnosis of GAD, but without comorbid substance abuse or psychotic disorders.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Exploratory/Developmental Grants (R21)
Project #
1R21MH056018-01A1
Application #
2034877
Study Section
Treatment Assessment Review Committee (TA)
Project Start
1997-06-01
Project End
2000-05-31
Budget Start
1997-06-01
Budget End
1998-05-31
Support Year
1
Fiscal Year
1997
Total Cost
Indirect Cost
Name
University of Pennsylvania
Department
Psychiatry
Type
Schools of Medicine
DUNS #
042250712
City
Philadelphia
State
PA
Country
United States
Zip Code
19104
Present, Julie; Crits-Christoph, Paul; Connolly Gibbons, Mary Beth et al. (2008) Sudden gains in the treatment of generalized anxiety disorder. J Clin Psychol 64:119-26