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Therapist Assisted Online Treatment for Anxiety (TAO-anxiety)

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ClinicalTrials.gov Identifier: NCT01816204
Recruitment Status : Completed
First Posted : March 22, 2013
Last Update Posted : August 31, 2016
Information provided by (Responsible Party):
University of Florida

Brief Summary:
Therapist assisted, internet-based cognitive behavioral therapy (TAI-CBT) has been shown to be effective with patients who have Generalized Anxiety Disorder (GAD) in multiple studies from several countries, including: the United Kingdom, Australia, Sweden, and the Netherlands. Despite strong evidence of efficacy, TAI-CBT has not been offered in the USA. TAI-CBT could provide an effective alternative to face-to-face psychotherapy that would expand the availability and convenience of evidence- based treatment anywhere clinical availability is limited. The University of Florida (UF) has historically had greater demand for psychotherapy than the available supply of psychotherapy hours resulting in waiting lists for students needing to receive treatment for anxiety. Anxiety disorders interfere with memory and concentration thus impairing academic functioning. Students who must wait for treatment for 3-4 weeks are at risk for failing courses or dropping out of school. If TAI-CBT proved to be effective with UF students, providing it could increase the number of students who would receive effective and timely treatment. This project will create a 6-8 session therapist assisted on-line treatment for anxiety disorder. The investigators will offer TAI-CBT as an experimental treatment in summer and fall, 2013 comparing outcomes to face-to-face individual therapy, group therapy, and wait-list controls. The investigators hypothesize that students receiving TAI-CBT will have a reduction in anxiety symptoms comparable to face-to-face counseling and greater than wait list controls.

Condition or disease Intervention/treatment
Anxiety Disorders Behavioral: Therapist assisted online treatment Behavioral: face-to-face individual therapy

Detailed Description:

Participation is restricted to currently enrolled students at the University of Florida who have paid the health fee, and who are seeking treatment for anxiety and the Counseling and Wellness Center. Students who meet criteria and agree to participate will select from two treatments, individual face-to-face or therapist assisted on-line treatment. Prior to each session of individual therapy, or on-line treatment participants will complete the Behavioral Health Measure-20 is a normal part of treatment at the CWC.

If a participant is assigned to the Therapist-assisted on-line (TAO) treatment he/she will be asked to complete a seven module on-line treatment. Each module includes interactive, educational materials and weekly assignments. Subjects may participate in an on-line discussion forum with other participants for each module. The forum will use only first names or a pseudonym to protect confidentiality. In addition, participants in the TAO treatment will receive a 10-20 minute video-conference weekly with a doctoral level therapist. Therapists will review assignments, answer questions, and help to apply the educational materials contained in the modules to the subjects life.

The video conference will be on Adobe Connect. This involves a free download for a computer, tablet, or smart phone. Medical records will be kept for ten years, per UF policy. Adobe connect is HIPAA and HITECH compliant. Research records will be de-identified and use an identifier number that cannot be connected to individual participants.

Only 2 arms were actually used, Face-to-face therapy and TAO treatment.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Therapist Assisted Online Treatment for Anxiety
Study Start Date : July 2013
Primary Completion Date : September 2014
Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Therapist assisted online treatment (TAO)
Students assigned to treatment with weekly online modules and weekly 10-15 minute video conference with counselor.
Behavioral: Therapist assisted online treatment
7 weekly interactive online modules with 10-15 minute counselor consultation via video conference.
Active Comparator: face-to-face individual therapy
weekly individual 50 minute psychotherapy sessions.
Behavioral: face-to-face individual therapy
weekly individual counseling as usual.

Primary Outcome Measures :
  1. Behavioral Health Measure-20 (BHM-20) [ Time Frame: The three measures will be administered weekly from initial enrollment in the study for 7 weeks and again at 6 month follow up. The first assessment of patients will begin May 7 and will continue through January, 2014. ]
    twenty item likert-type measure of distress, well-being, overall mental health functioning.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • students,
  • mild to moderate anxiety,
  • has appropriate computer equipment

Exclusion Criteria:

  • Severe depression or anxiety,
  • suicidal in past 12 months,
  • not stable on medications for at least 30 days prior to beginning study treatments

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01816204

United States, Florida
Counseling and Wellness Center, University of Florida
Gainesville, Florida, United States, 32611-2662
Sponsors and Collaborators
University of Florida
Principal Investigator: Sherry A Benton, Ph.D. University of Florida

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01816204     History of Changes
Other Study ID Numbers: 539-2012
First Posted: March 22, 2013    Key Record Dates
Last Update Posted: August 31, 2016
Last Verified: April 2015

Keywords provided by University of Florida:
anxiety treatment
anxiety online treatment
anxiety electronic treatment
anxiety therapist assisted

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders