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Disseminating a Waitlist Treatment for Anxiety With Velibra

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ClinicalTrials.gov Identifier: NCT03913676
Recruitment Status : Not yet recruiting
First Posted : April 12, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Jasper A. Smits, University of Texas at Austin

Brief Summary:

Cognitive Behavioral Therapy (CBT) is a gold standard treatment for a wide spectrum of anxiety-related concerns. However, long waitlist times can serve as a substantial barrier to those seeking treatment. Internet delivered psychotherapy, such as internet-based CBT (I-CBT) may present an affordable option for disseminating empirically supported treatments. Velibra, an web-based I-CBT intervention, has shown initial promise in treating anxiety disorders.

Velibra has been used to treat anxiety-related disorders in European samples with participants recruited from general practitioner's offices and diagnosed with a specific subset of anxiety disorders. While these effects are encouraging, additional research is needed toevaluate whether Velibra could be implemented in a community mental health clinic in the U.S. Specifically, if Velibra could be successfully implemented within the context of mental health clinic waitlists, it may be capable of providing evidence-based treatment to larger groups of people at a faster rate than mental health clinics can structurally support.

The purpose of this study is to assess the feasibility of implementing Velibra into an American community clinic waitlist. We plan to offer free access to the Velibra program to members of the Anxiety and Stress Clinic (ASC) waitlist at the University of Texas at Austin experiencing anxiety. We will evaluate interest in the program, user data from the program, and opinions of the program post-completion. We hypothesize ASC patients will find utility in Velibra's ability to offer them mental health resources faster than the traditional waitlist can provide.


Condition or disease Intervention/treatment Phase
Anxiety Behavioral: Velibra Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Disseminating a Waitlist Treatment for Anxiety With Velibra
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Velibra
All treatment will be provided via the Velibra website: https://velibra.broca.io/en/registration/voucher. While the Velibra treatment is only six weeks long, participants will have free access to the program for 24 weeks. They can access this website as often as they would like. The Velibra program is self-guided, so participants determine how often they access the material (the program encourages participants to complete one of six sessions per week for six weeks).
Behavioral: Velibra
Velibra is grounded in a cognitive-behavioral theoretical orientation and consists of six treatment modules representing different skills and therapeutic techniques. Each of the first five modules is followed by a "training session", and contains activities related to training attention biases (CBM-I). All sessions plus trainings are designed to be completed in 1 - 2 hours, depending on the user's reading speed, interest, motivation, and individual path through the program. The modules cover a variety of therapeutic content that is broadly consistent with a cognitive-behavioral perspective. The modules' content draws from therapeutic strategies: (1) Cognitive Modification, (2) Mindfulness, Acceptance, and Relaxation techniques (4) Exposure, (5) Interpersonal Skills, (6) Psychoeducation and Relapse Prevention.




Primary Outcome Measures :
  1. Feasibility (Percentage of participants who complete at least one module) [ Time Frame: [assessed at 6-week follow-up] ]
    Percentage of participants who complete at least one module of Velibra (out of the total number of participants offered access to the program).


Secondary Outcome Measures :
  1. System Usability Scale (Brooke, 1996) [ Time Frame: [assessed at 6-week follow-up] ]
    Measures quality of a program's interface; final scores determined by summing all 10-items of self-report scale, with higher totals reflecting higher interface quality; minimum score = 10; maximum score = 50

  2. Client Satisfaction Questionnaire (Larsen, Attkisson, Hargreaves, & Nguyen, 1979) [ Time Frame: [assessed at 6-week follow-up] ]
    Measures participant satisfaction with the program; final scores determined by summing all 8-items of self-report scale, with higher totals reflecting higher satisfaction with the program; minimum score = 8; maximum score = 32

  3. Treatment-Seeking Behavior [ Time Frame: [assessed at 6-week follow-up] ]
    Percentage of participants who would like to enroll in traditional CBT treatment at 6 week follow-up (out of the total number of participants who completed at least one module of Velibra).

  4. Overall Anxiety Severity and Impairment Scale (Norman, Hammi Cissell, Means-Christensen, & Stein, 2006) [ Time Frame: [assessed at baseline and 6-week follow-up] ]
    Measures anxiety symptoms and impact on functioning; final scores determined by summing all 5-items of self-report scale, with higher totals reflecting larger levels of anxiety symptoms; minimum score = 0; maximum score = 20

  5. Generalized Anxiety Disorder Scale-7 (Spitzer, Kroenke, Williams, & Lowe, 2006) [ Time Frame: [assessed at baseline and 6-week follow-up] ]
    Measures anxiety symptoms; final scores determined by summing all 7-items of self-report scale, with higher totals reflecting larger levels of anxiety symptoms; minimum score = 0; maximum score = 21

  6. Patient Health Questionnaire (Kroenke, Spitzer, & Williams, 2001) [ Time Frame: [assessed at baseline and 6-week follow-up] ]
    Measures depressive symptoms; final scores determined by summing all 9-items of self-report scale, with higher totals reflecting larger levels of depressive symptoms; minimum score = 0; maximum score = 27



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Currently on the Anxiety and Stress Clinic waitlist
  • At least 18 years old
  • Fluent in English
  • Have access to a computer or web device

Exclusion Criteria:

  • Active suicidal ideation with intent to harm oneself in the past week (e.g., endorses "Yes" toC-SSRS item 4 or higher).
  • A formal diagnosis of Bipolar I disorder without current utilization of stabilizing medications.
  • Present or past psychosis

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): NCT03913676


Contacts
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Contact: Aliza T Stein, B.A. 5124717694 atstein@utexas.edu

Locations
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United States, Texas
University of Texas at Austin
Austin, Texas, United States, 78712
Sponsors and Collaborators
University of Texas at Austin
Investigators
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Principal Investigator: Jasper A.J. Smits, Ph.D. University of Texas at Austin

Publications:
Brooke, J. (1996). SUS-A quick and dirty usability scale. Usability Evaluation in Industry, 189(194), 4-7.

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Responsible Party: Jasper A. Smits, Professor, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT03913676     History of Changes
Other Study ID Numbers: 2018-11-0128
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders