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Therapist Assisted Online Treatment for Anxiety (TAO-anxiety)

Primary Purpose

Anxiety Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Therapist assisted online treatment
face-to-face individual therapy
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders focused on measuring anxiety treatment, anxiety online treatment, anxiety electronic treatment, anxiety therapist assisted

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Counseling and Wellness Center, University of Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Therapist assisted online treatment (TAO)

face-to-face individual therapy

Arm Description

Students assigned to treatment with weekly online modules and weekly 10-15 minute video conference with counselor.

weekly individual 50 minute psychotherapy sessions.

Outcomes

Primary Outcome Measures

Behavioral Health Measure-20 (BHM-20)
twenty item likert-type measure of distress, well-being, overall mental health functioning.

Secondary Outcome Measures

Full Information

First Posted
March 11, 2013
Last Updated
August 29, 2016
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT01816204
Brief Title
Therapist Assisted Online Treatment for Anxiety
Acronym
TAO-anxiety
Official Title
Therapist Assisted Online Treatment for Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders
Keywords
anxiety treatment, anxiety online treatment, anxiety electronic treatment, anxiety therapist assisted

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapist assisted online treatment (TAO)
Arm Type
Experimental
Arm Description
Students assigned to treatment with weekly online modules and weekly 10-15 minute video conference with counselor.
Arm Title
face-to-face individual therapy
Arm Type
Active Comparator
Arm Description
weekly individual 50 minute psychotherapy sessions.
Intervention Type
Behavioral
Intervention Name(s)
Therapist assisted online treatment
Intervention Description
7 weekly interactive online modules with 10-15 minute counselor consultation via video conference.
Intervention Type
Behavioral
Intervention Name(s)
face-to-face individual therapy
Intervention Description
weekly individual counseling as usual.
Primary Outcome Measure Information:
Title
Behavioral Health Measure-20 (BHM-20)
Description
twenty item likert-type measure of distress, well-being, overall mental health functioning.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherry A Benton, Ph.D.
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Counseling and Wellness Center, University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611-2662
Country
United States

12. IPD Sharing Statement

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Therapist Assisted Online Treatment for Anxiety

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