Desensitization and Cognitive Therapy in General Anxiety.

NCT ID: NCT00951340

Last Updated: 2017-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-07-31

Study Completion Date

1998-12-31

Brief Summary

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

Detailed Description

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Generalized anxiety disorder (GAD) is characterized by chronic worry that interrupts normal functioning. Some research has shown cognitive behavioral therapy (CBT) as 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 safety and feasibility of training therapists to deliver a version of CBT with additional therapeutic techniques for addressing interpersonal interactions and emotional processing.

Participation in this study will include 14 weekly, 2-hour, individual therapy sessions. During the first hour of each session, all participants will receive standard CBT for GAD. 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 taking medications will be required to 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 15 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 hour-long portion of 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.

Conditions

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Generalized Anxiety Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CBT with listening therapy

Participants will receive CBT with listening therapy.

Group Type ACTIVE_COMPARATOR

Cognitive behavioral therapy (CBT)

Intervention Type OTHER

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

Listening therapy

Intervention Type BEHAVIORAL

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

CBT with emotional processing and interpersonal therapy

Participants will receive CBT with emotional processing and interpersonal therapy.

Group Type EXPERIMENTAL

Cognitive behavioral therapy (CBT)

Intervention Type OTHER

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

Emotional processing and interpersonal therapy

Intervention Type BEHAVIORAL

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

Interventions

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Cognitive behavioral therapy (CBT)

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

Intervention Type OTHER

Emotional processing and interpersonal therapy

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

Intervention Type BEHAVIORAL

Listening therapy

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

Intervention Type BEHAVIORAL

Other Intervention Names

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CBT for GAD

Eligibility Criteria

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Inclusion Criteria

* Principal diagnosis of generalized anxiety disorder (GAD), as defined by the DSM-IV and agreed on by two diagnostic interviewers

Exclusion Criteria

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

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Penn State University

OTHER

Sponsor Role lead

Responsible Party

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Michelle G. Newman

Professor of Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michelle G. Newman, PhD

Role: STUDY_DIRECTOR

Penn State University

Locations

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The Pennsylvania State University

University Park, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 19881891 (View on PubMed)

Other Identifiers

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R01MH039172-02

Identifier Type: NIH

Identifier Source: secondary_id

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2R01MH039172-12

Identifier Type: NIH

Identifier Source: secondary_id

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R01MH039172-02

Identifier Type: NIH

Identifier Source: org_study_id

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