Therapist Assisted Online Treatment for Anxiety (TAO-anxiety)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01816204
First received: March 11, 2013
Last updated: October 14, 2014
Last verified: October 2014
  Purpose

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 Intervention
Anxiety Disorders
Behavioral: Therapist assisted online treatment
Behavioral: face-to-face individual therapy
Behavioral: Group face-to-face counseling

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Therapist Assisted Online Treatment for Anxiety

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    twenty item likert-type measure of distress, well-being, overall mental health functioning.


Estimated Enrollment: 300
Study Start Date: July 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Active Comparator: Group face-to-face counseling
Weekly group psychotherapy for anxiety.
Behavioral: Group face-to-face counseling
weekly group psychotherapy

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 three treatments, individual face-to-face, group therapy, or therapist assisted on-line treatment. Prior to each session of individual therapy, group therapy, or on-line treatment participants will complete three short measures of psychological symptoms, one of these, the Behavioral Health Measure-20 is a normal part of treatment at the CWC. In addition participants will complete the GAD-7, which contains seven, 4-point Likert-type items, and the Penn State worry questionnaire (PSWQ), which consists of 16 Likert-type items. These additional instruments will take about 2-5 minutes to complete prior to each session.

In addition, the researchers will contact participants by e-mail 6 months after completion of treatment to ask them to complete the instruments as a follow-up. If a participant is assigned to individual or group therapy he/she will receive this mode of treatment as usual at the Counseling and Wellness Center at the University of Florida.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01816204

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

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01816204     History of Changes
Other Study ID Numbers: 539-2012
Study First Received: March 11, 2013
Last Updated: October 14, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 23, 2014