Clinical Trials Directory

Trials / Completed

CompletedNCT00951340

Desensitization and Cognitive Therapy in General Anxiety.

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
21 (actual)
Sponsor
Penn State University · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers

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.

Conditions

Interventions

TypeNameDescription
OTHERCognitive behavioral therapy (CBT)15 weekly therapy sessions, the first hour of which will be devoted to standard CBT techniques
BEHAVIORALEmotional processing and interpersonal therapy15 weekly therapy sessions, the second hour of which will be devoted to interpersonal and emotional processing therapy techniques
BEHAVIORALListening therapy15 weekly therapy sessions, the second hour of which will be directed by the participant's questions and discussion

Timeline

Start date
1996-07-01
Primary completion
1998-07-01
Completion
1998-12-01
First posted
2009-08-04
Last updated
2017-09-20

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00951340. Inclusion in this directory is not an endorsement.