NCT00635999

Brief Summary

This study will evaluate the effectiveness of three adaptive coping treatments in lessening anxiety in adults with generalized anxiety disorder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 1991

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

October 1, 1991

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 1998

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 1998

Completed
9.5 years until next milestone

First Submitted

Initial submission to the registry

March 12, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 14, 2008

Completed
9.9 years until next milestone

Results Posted

Study results publicly available

January 25, 2018

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

7 years

First QC Date

March 12, 2008

Results QC Date

May 23, 2012

Last Update Submit

January 24, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • High End State Function

    Percentage of participants meeting high end state functioning (e.g., within 1 standard deviation of mean of nonanxious samples on Hamilton Anxiety Rating Scales, Spielberger's State-Trait Anxiety Inventory, Penn State Worry Questionnaire, and Reactions to Relaxation and Arousal Questionnaire)

    10-14 days after last therapy session and months 6, 12, and 24 following last therapy session

Secondary Outcomes (1)

  • Within-group Change Represented as Cohen's d Effect Sizes

    10-14 days after last therapy session and months 6, 12, and 24 following last therapy session

Study Arms (3)

Purely Behavioral therapy

EXPERIMENTAL

Participants will receive treatment with progressive and applied relaxation and self-control desensitization.

Behavioral: Applied relaxation and self-control desensitization

Cognitive-Behavioral Therapy

EXPERIMENTAL

Participants will receive treatment with cognitive therapy, progressive and applied relaxation, and self-control desensitization

Behavioral: Cognitive-Behavioral Therapy

Cognitive Therapy (CT)

EXPERIMENTAL

Participants will receive purely cognitive therapy including identification of maladaptive thought processes and training in cognitive restructuring.

Other: Cognitive therapy (CT)

Interventions

Applied relaxation and self-control desensitization sessions will teach participants relaxation techniques and the use of imagery for coping with anxiety. Treatment will include 14 weekly sessions.

Purely Behavioral therapy

CT sessions will teach participants to identify ways in which they perceive themselves and the world and how to modify these thoughts to reduce anxiety. CT will include 14 weekly sessions.

Cognitive Therapy (CT)

Includes all of the techniques in the other 2 interventions.

Cognitive-Behavioral Therapy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary diagnosis of GAD

You may not qualify if:

  • Diagnosis of any of the following: panic disorder, subclinical GAD, severe depression, psychosis, or organic brain syndrome
  • Currently receiving therapy for GAD or has previously received CBT
  • Medical contributions to anxiety
  • Currently taking antidepressant medication
  • Current substance abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State University

University Park, Pennsylvania, 16802, United States

Location

Related Publications (11)

  • Roemer L, Molina S, Borkovec TD. An investigation of worry content among generally anxious individuals. J Nerv Ment Dis. 1997 May;185(5):314-9. doi: 10.1097/00005053-199705000-00005.

    PMID: 9171808BACKGROUND
  • Roemer L, Molina S, Litz BT, Borkovec TD. Preliminary investigation of the role of previous exposure to potentially traumatizing events in generalized anxiety disorder. Depress Anxiety. 1996-1997;4(3):134-8. doi: 10.1002/(SICI)1520-6394(1996)4:33.0.CO;2-G.

    PMID: 9166642BACKGROUND
  • Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.

    PMID: 11132119BACKGROUND
  • Schut AJ, Castonguay LG, Borkovec TD. Compulsive checking behaviors in generalized anxiety disorder. J Clin Psychol. 2001 Jun;57(6):705-15. doi: 10.1002/jclp.1043.

    PMID: 11344459BACKGROUND
  • Stöber, J., & Borkovec, T. D. (2002). Reduced concreteness of worry in generalized anxiety disorder: Findings from a therapy study. Cognitive Therapy and Research, 26, 89-96.

    BACKGROUND
  • Behar E, Alcaine O, Zuellig AR, Borkovec TD. Screening for generalized anxiety disorder using the Penn State Worry Questionnaire: a receiver operating characteristic analysis. J Behav Ther Exp Psychiatry. 2003 Mar;34(1):25-43. doi: 10.1016/s0005-7916(03)00004-1.

    PMID: 12763391BACKGROUND
  • McLaughlin KA, Behar E, Borkovec TD. Family history of psychological problems in generalized anxiety disorder. J Clin Psychol. 2008 Jul;64(7):905-18. doi: 10.1002/jclp.20497.

    PMID: 18509873BACKGROUND
  • Cassidy J, Lichtenstein-Phelps J, Sibrava NJ, Thomas CL Jr, Borkovec TD. Generalized anxiety disorder: connections with self-reported attachment. Behav Ther. 2009 Mar;40(1):23-38. doi: 10.1016/j.beth.2007.12.004. Epub 2008 Jun 24.

    PMID: 19187814BACKGROUND
  • Newman MG, Przeworski A, Fisher AJ, Borkovec TD. Diagnostic comorbidity in adults with generalized anxiety disorder: impact of comorbidity on psychotherapy outcome and impact of psychotherapy on comorbid diagnoses. Behav Ther. 2010 Mar;41(1):59-72. doi: 10.1016/j.beth.2008.12.005. Epub 2009 Jun 8.

    PMID: 20171328BACKGROUND
  • Newman MG, Fisher AJ. Expectancy/Credibility Change as a Mediator of Cognitive Behavioral Therapy for Generalized Anxiety Disorder: Mechanism of Action or Proxy for Symptom Change? Int J Cogn Ther. 2010 Sep;3:245-261. doi: 10.1521/ijct.2010.3.3.245.

    PMID: 21132075BACKGROUND
  • Borkovec TD, Newman MG, Pincus AL, Lytle R. A component analysis of cognitive-behavioral therapy for generalized anxiety disorder and the role of interpersonal problems. J Consult Clin Psychol. 2002 Apr;70(2):288-98.

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Michelle G. Newman
Organization
Penn State University

Study Officials

  • Michelle G. Newman, PhD

    Penn State University

    STUDY DIRECTOR
  • Thomas D. Borkovec, PhD

    Penn State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

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

March 12, 2008

First Posted

March 14, 2008

Study Start

October 1, 1991

Primary Completion

October 1, 1998

Study Completion

October 1, 1998

Last Updated

January 25, 2018

Results First Posted

January 25, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Summary data has been shared.

Locations