Desensitization and Cognitive Therapy in General Anxiety.
Primary Purpose
Generalized Anxiety Disorder
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cognitive behavioral therapy (CBT)
Emotional processing and interpersonal therapy
Listening therapy
Sponsored by
About this trial
This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring CBT, Emotional-Focused Therapy, Interpersonal Therapy
Eligibility Criteria
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
Sites / Locations
- The Pennsylvania State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
CBT with listening therapy
CBT with emotional processing and interpersonal therapy
Arm Description
Participants will receive CBT with listening therapy.
Participants will receive CBT with emotional processing and interpersonal therapy.
Outcomes
Primary Outcome Measures
Feasibility of delivering emotional processing and interpersonal therapeutic techniques
Secondary Outcome Measures
Full Information
NCT ID
NCT00951340
First Posted
August 3, 2009
Last Updated
September 18, 2017
Sponsor
Penn State University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00951340
Brief Title
Desensitization and Cognitive Therapy in General Anxiety.
Official Title
Desensitization and Cognitive Therapy in General Anxiety.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
July 1996 (undefined)
Primary Completion Date
July 1998 (Actual)
Study Completion Date
December 1998 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penn State University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
Keywords
CBT, Emotional-Focused Therapy, Interpersonal Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CBT with listening therapy
Arm Type
Active Comparator
Arm Description
Participants will receive CBT with listening therapy.
Arm Title
CBT with emotional processing and interpersonal therapy
Arm Type
Experimental
Arm Description
Participants will receive CBT with emotional processing and interpersonal therapy.
Intervention Type
Other
Intervention Name(s)
Cognitive behavioral therapy (CBT)
Other Intervention Name(s)
CBT for GAD
Intervention Description
15 weekly therapy sessions, the first hour of which will be devoted to standard CBT techniques
Intervention Type
Behavioral
Intervention Name(s)
Emotional processing and interpersonal therapy
Intervention Description
15 weekly therapy sessions, the second hour of which will be devoted to interpersonal and emotional processing therapy techniques
Intervention Type
Behavioral
Intervention Name(s)
Listening therapy
Intervention Description
15 weekly therapy sessions, the second hour of which will be directed by the participant's questions and discussion
Primary Outcome Measure Information:
Title
Feasibility of delivering emotional processing and interpersonal therapeutic techniques
Time Frame
Measured at baseline, post-treatment, and after 6, 12, and 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle G. Newman, PhD
Organizational Affiliation
Penn State University
Official's Role
Study Director
Facility Information:
Facility Name
The Pennsylvania State University
City
University Park
State/Province
Pennsylvania
ZIP/Postal Code
16802-3103
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19881891
Citation
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.
Results Reference
result
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Desensitization and Cognitive Therapy in General Anxiety.
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