Therapist Assisted Online Treatment for Anxiety

NCT01816204 | Completed

• 1 other identifier: 539-2012
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders

Keywords

anxiety treatment; anxiety online treatment; anxiety electronic treatment; anxiety therapist assisted

Outcome Measures

Primary Outcomes (1)

• Behavioral Health Measure-20 (BHM-20)

  twenty item likert-type measure of distress, well-being, overall mental health functioning.

  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.

Study Arms (2)

Therapist assisted online treatment (TAO)

EXPERIMENTAL

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

Behavioral: Therapist assisted online treatment

face-to-face individual therapy

ACTIVE COMPARATOR

weekly individual 50 minute psychotherapy sessions.

Behavioral: face-to-face individual therapy

Interventions

Therapist assisted online treatment BEHAVIORAL

7 weekly interactive online modules with 10-15 minute counselor consultation via video conference.

Therapist assisted online treatment (TAO)

face-to-face individual therapy BEHAVIORAL

weekly individual counseling as usual.

face-to-face individual therapy

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

Counseling and Wellness Center, University of Florida

Gainesville, Florida, 32611-2662, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Sherry A Benton, Ph.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2013
• First Posted: March 22, 2013
• Study Start: July 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: August 31, 2016

Record last verified: 2015-04

Locations

US (1)