Therapist Assisted Online Treatment for Anxiety (TAO-anxiety)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01816204|
Recruitment Status : Completed
First Posted : March 22, 2013
Last Update Posted : August 31, 2016
|Condition or disease||Intervention/treatment||Phase|
|Anxiety Disorders||Behavioral: Therapist assisted online treatment Behavioral: face-to-face individual therapy||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Therapist Assisted Online Treatment for Anxiety|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2014|
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.
- 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.
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|
|Principal Investigator:||Sherry A Benton, Ph.D.||University of Florida|