NCT00951340

Brief Summary

This study will test the feasibility and safety of adding interpersonal and emotional processing techniques to standard cognitive behavioral therapy for generalized anxiety disorder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 1996

Typical duration for phase_1

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, 1996

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 1998

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 1998

Completed
10.7 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

September 20, 2017

Status Verified

September 1, 2017

Enrollment Period

2 years

First QC Date

August 3, 2009

Last Update Submit

September 18, 2017

Conditions

Generalized Anxiety Disorder

Keywords

CBTEmotional-Focused TherapyInterpersonal Therapy

Outcome Measures

Primary Outcomes (1)

  • Feasibility of delivering emotional processing and interpersonal therapeutic techniques

    Measured at baseline, post-treatment, and after 6, 12, and 24 months

Study Arms (2)

CBT with listening therapy

ACTIVE COMPARATOR

Participants will receive CBT with listening therapy.

Other: Cognitive behavioral therapy (CBT)Behavioral: Listening therapy

CBT with emotional processing and interpersonal therapy

EXPERIMENTAL

Participants will receive CBT with emotional processing and interpersonal therapy.

Other: Cognitive behavioral therapy (CBT)Behavioral: Emotional processing and interpersonal therapy

Interventions

Cognitive behavioral therapy (CBT)OTHER

15 weekly therapy sessions, the first hour of which will be devoted to standard CBT techniques

Also known as: CBT for GAD
CBT with emotional processing and interpersonal therapyCBT with listening therapy
Emotional processing and interpersonal therapyBEHAVIORAL

15 weekly therapy sessions, the second hour of which will be devoted to interpersonal and emotional processing therapy techniques

CBT with emotional processing and interpersonal therapy
Listening therapyBEHAVIORAL

15 weekly therapy sessions, the second hour of which will be directed by the participant's questions and discussion

CBT with listening therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Pennsylvania State University

University Park, Pennsylvania, 16802-3103, United States

Location

Related Publications (1)

  • Newman MG, Castonguay LG, Borkovec TD, Fisher AJ, Nordberg SS. AN OPEN TRIAL OF INTEGRATIVE THERAPY FOR GENERALIZED ANXIETY DISORDER. Psychotherapy (Chic). 2008 Jun 1;45(2):135-147. doi: 10.1037/0033-3204.45.2.135.

    PMID: 19881891RESULT

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

Cognitive Behavioral Therapyglutamate decarboxylase 1

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Michelle G. Newman, PhD

    Penn State University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology

Study Record Dates

First Submitted

August 3, 2009

First Posted

August 4, 2009

Study Start

July 1, 1996

Primary Completion

July 1, 1998

Study Completion

December 1, 1998

Last Updated

September 20, 2017

Record last verified: 2017-09

Locations

US(1)