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OpenTrials
Completed

NCT Number: NCT00951340

Desensitization and Cognitive Therapy in General Anxiety.

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Pennsylvania State University

University Park, Pennsylvania, 16802-3103, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive behavioral therapy (CBT)

Other

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

Other names: CBT for GAD

Emotional processing and interpersonal therapy

Behavioral

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

Listening therapy

Behavioral

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

Primary outcomes

  1. Feasibility of delivering emotional processing and interpersonal therapeutic techniques

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

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
1996
Primary completion
1998
Study completion
1998
First posted
Aug 4, 2009
Registry last updated
Sep 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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