Clinical trial NCT00951652: Efficacy of Adding Interpersonal and Emotional Processing Therapy Techniques to Cognitive Behavioral Therapy to Treat Generalized Anxiety Disorder
Official title: Cognitive and Interpersonal Therapies for Generalized Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Generalized Anxiety Disorder
Keywords: CBT
GAD
Interpersonal Therapy
Emotion-Focused Therapy
Lead sponsor: Penn State University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2009-08-04
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will test a version of cognitive behavioral therapy for generalized anxiety disorders that incorporates interpersonal and emotional processing techniques.

Detailed description: Generalized anxiety disorder (GAD) is characterized by chronic worry that interrupts normal functioning. Some research has shown cognitive behavioral therapy (CBT) to be an effective treatment for GAD, but only half of people treated with CBT for GAD experience treatment benefits long-term. Standard CBT for GAD may lose effectiveness over time because it does not address interpersonal and emotional processing problems. This study will determine the efficacy of a version of CBT with additional therapeutic techniques for addressing interpersonal interactions and emotional processing among adults with GAD.

Participation in this study will include 14 weeks of treatment and 2 years of follow-up visits. All participants will receive 14 weekly, 2-hour, individual therapy sessions and one maintenance session scheduled after completing treatment. During the first hour of each session, all participants will receive standard CBT. Participants will be randomly assigned to receive one of two therapies during the second hour: training in interpersonal and emotional processing techniques or listening therapy. Participants may continue taking their current medications if they maintain a fixed dosage and keep a daily dairy of medication use, starting 2 weeks before study entry and lasting throughout treatment.

In-depth study assessments will take place at baseline and after completing the 14 weeks of therapy. Assessments will include clinical interviews, self-report questionnaires, and a physiological measurement session. Questions will pertain to anxiety symptoms, self-perceptions, emotional experience, and perceptions of the world. The physiological measurement session will involve recording bodily reactions, including brain waves, heart rate, eye movement, and breathing, while performing simple perceptual tasks. Brief psychological assessments will also follow each therapy session. Follow-up assessments conducted 6, 12, and 24 months after completing treatment will involve interviews and questionnaires as well as recording a week's worth of medication diaries.

Eligibility criteria: Inclusion Criteria:

* Principal diagnosis of generalized anxiety disorder (GAD), as defined by the DSM-IV and agreed on by two diagnostic interviewers
* Clinician's Severity Rating for GAD of 4 (moderate) or greater

Exclusion Criteria:

* Concurrent psychosocial therapy or past adequate dosage of CBT
* Any medical contributions to anxiety
* Current substance abuse, psychosis, or organic brain syndrome

Primary outcomes:
measure: Anxiety symptoms
timeFrame: Measured at baseline, post-treatment, and at 6-, 12-, and 24-month follow-ups
Secondary outcomes:
Other outcomes:
Locations:
city: University Park
country: United States
facility: Penn State University
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Michelle G. Newman, PhD
role: STUDY_DIRECTOR
affiliation: Penn State University
name: Thomas D. Borkovec, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Newman MG, Llera SJ. A novel theory of experiential avoidance in generalized anxiety disorder: a review and synthesis of research supporting a contrast avoidance model of worry. Clin Psychol Rev. 2011 Apr;31(3):371-82. doi: 10.1016/j.cpr.2011.01.008. Epub 2011 Jan 26.
citation: Newman MG, Castonguay LG, Borkovec TD, Fisher AJ, Boswell JF, Szkodny LE, Nordberg SS. A randomized controlled trial of cognitive-behavioral therapy for generalized anxiety disorder with integrated techniques from emotion-focused and interpersonal therapies. J Consult Clin Psychol. 2011 Apr;79(2):171-81. doi: 10.1037/a0022489.
citation: Przeworski A, Newman MG, Pincus AL, Kasoff MB, Yamasaki AS, Castonguay LG, Berlin KS. Interpersonal pathoplasticity in individuals with generalized anxiety disorder. J Abnorm Psychol. 2011 May;120(2):286-98. doi: 10.1037/a0023334.
citation: Boswell JF, Llera S, Newman MG, Castonguay LG. A Case of Premature Termination in a Treatment for Generalized Anxiety Disorder. Cogn Behav Pract. 2011 Aug 1;18(3):326-337. doi: 10.1016/j.cbpra.2010.09.001.