NCT00951652

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 1998

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1998

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2009

Completed
Last Updated

April 25, 2022

Status Verified

April 1, 2022

Enrollment Period

7.4 years

First QC Date

August 3, 2009

Last Update Submit

April 18, 2022

Conditions

Generalized Anxiety Disorder

Keywords

CBTGADInterpersonal TherapyEmotion-Focused Therapy

Outcome Measures

Primary Outcomes (1)

  • Anxiety symptoms

    Anxiety measures

    Measured at baseline, post-treatment, and at 6-, 12-, and 24-month follow-ups

Study Arms (2)

CBT plus supportive listening

EXPERIMENTAL

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

Behavioral: CBTBehavioral: supportive listening

CBT plus Interpersonal and emotional processing therapy

ACTIVE COMPARATOR

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

Behavioral: CBTOther: Interpersonal and emotional processing therapy

Interventions

CBTBEHAVIORAL
CBT plus Interpersonal and emotional processing therapyCBT plus supportive listening
Interpersonal and emotional processing therapyOTHER
CBT plus Interpersonal and emotional processing therapy
supportive listeningBEHAVIORAL
CBT plus supportive listening

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State University

University Park, Pennsylvania, 16802, United States

Location

Related Publications (4)

  • 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.

    PMID: 21334285BACKGROUND

  • 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.

    PMID: 21443321BACKGROUND

  • 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.

    PMID: 21553942BACKGROUND

  • 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.

    PMID: 21731410RESULT

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Study Officials

  • Michelle G. Newman, PhD

    Penn State University

    STUDY DIRECTOR

  • Thomas D. Borkovec, PhD

    Penn State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Study Director

Study Record Dates

First Submitted

August 3, 2009

First Posted

August 4, 2009

Study Start

July 1, 1998

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

April 25, 2022

Record last verified: 2022-04

Locations

US(1)