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Efficacy of Adding Interpersonal and Emotional Processing Therapy Techniques to Cognitive Behavioral Therapy to Treat Generalized Anxiety Disorder

Primary Purpose

Generalized Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBT
Interpersonal and emotional processing therapy
supportive listening
Sponsored by
Michelle G. Newman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring CBT, GAD, Interpersonal Therapy, Emotion-Focused Therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Penn State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CBT plus supportive listening

CBT plus Interpersonal and emotional processing therapy

Arm Description

14 weekly therapy sessions, the first hour of which will be devoted to standard CBT techniques and the second hour will be supportive listening

14 weekly therapy sessions, the first hour of which will be devoted to standard CBT techniques and the second hour will be Interpersonal and emotional processing therapy

Outcomes

Primary Outcome Measures

Anxiety symptoms
Anxiety measures

Secondary Outcome Measures

Full Information

First Posted
August 3, 2009
Last Updated
April 18, 2022
Sponsor
Michelle G. Newman
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00951652
Brief Title
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
July 1998 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michelle G. Newman
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
Keywords
CBT, GAD, Interpersonal Therapy, Emotion-Focused Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT plus supportive listening
Arm Type
Experimental
Arm Description
14 weekly therapy sessions, the first hour of which will be devoted to standard CBT techniques and the second hour will be supportive listening
Arm Title
CBT plus Interpersonal and emotional processing therapy
Arm Type
Active Comparator
Arm Description
14 weekly therapy sessions, the first hour of which will be devoted to standard CBT techniques and the second hour will be Interpersonal and emotional processing therapy
Intervention Type
Behavioral
Intervention Name(s)
CBT
Intervention Type
Other
Intervention Name(s)
Interpersonal and emotional processing therapy
Intervention Type
Behavioral
Intervention Name(s)
supportive listening
Primary Outcome Measure Information:
Title
Anxiety symptoms
Description
Anxiety measures
Time Frame
Measured at baseline, post-treatment, and at 6-, 12-, and 24-month follow-ups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle G. Newman, PhD
Organizational Affiliation
Penn State University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Thomas D. Borkovec, PhD
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State University
City
University Park
State/Province
Pennsylvania
ZIP/Postal Code
16802
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21334285
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.
Results Reference
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PubMed Identifier
21443321
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.
Results Reference
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PubMed Identifier
21553942
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.
Results Reference
background
PubMed Identifier
21731410
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.
Results Reference
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Efficacy of Adding Interpersonal and Emotional Processing Therapy Techniques to Cognitive Behavioral Therapy to Treat Generalized Anxiety Disorder

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