Disseminating a Waitlist Treatment for Anxiety With Velibra

NCT03913676 | Terminated

• 1 other identifier: 2018-11-0128
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

• Feasibility (Percentage of participants who complete at least one module)

  Percentage of participants who complete at least one module of Velibra (out of the total number of participants offered access to the program).

  [assessed at 6-week follow-up]

Secondary Outcomes (6)

• System Usability Scale (Brooke, 1996)

  [assessed at 6-week follow-up]

• Client Satisfaction Questionnaire (Larsen, Attkisson, Hargreaves, & Nguyen, 1979)

  [assessed at 6-week follow-up]

• Treatment-Seeking Behavior

  [assessed at 6-week follow-up]

• Overall Anxiety Severity and Impairment Scale (Norman, Hammi Cissell, Means-Christensen, & Stein, 2006)

  [assessed at baseline and 6-week follow-up]

• Generalized Anxiety Disorder Scale-7 (Spitzer, Kroenke, Williams, & Lowe, 2006)

  [assessed at baseline and 6-week follow-up]

Study Arms (1)

Velibra

EXPERIMENTAL

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

Interventions

Velibra BEHAVIORAL

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.

Velibra

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

Related Publications (9)

• Berger T, Urech A, Krieger T, Stolz T, Schulz A, Vincent A, Moser CT, Moritz S, Meyer B. Effects of a transdiagnostic unguided Internet intervention ('velibra') for anxiety disorders in primary care: results of a randomized controlled trial. Psychol Med. 2017 Jan;47(1):67-80. doi: 10.1017/S0033291716002270. Epub 2016 Sep 22.

  PMID: 27655039 BACKGROUND

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

  BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.

  PMID: 10245370 BACKGROUND

• Norman SB, Cissell SH, Means-Christensen AJ, Stein MB. Development and validation of an Overall Anxiety Severity And Impairment Scale (OASIS). Depress Anxiety. 2006;23(4):245-9. doi: 10.1002/da.20182.

  PMID: 16688739 BACKGROUND

• Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, Currier GW, Melvin GA, Greenhill L, Shen S, Mann JJ. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011 Dec;168(12):1266-77. doi: 10.1176/appi.ajp.2011.10111704.

  PMID: 22193671 BACKGROUND

• Priester MA, Browne T, Iachini A, Clone S, DeHart D, Seay KD. Treatment Access Barriers and Disparities Among Individuals with Co-Occurring Mental Health and Substance Use Disorders: An Integrative Literature Review. J Subst Abuse Treat. 2016 Feb;61:47-59. doi: 10.1016/j.jsat.2015.09.006. Epub 2015 Oct 31.

  PMID: 26531892 BACKGROUND

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

  PMID: 16717171 BACKGROUND

• Hofmann SG, Smits JA. Cognitive-behavioral therapy for adult anxiety disorders: a meta-analysis of randomized placebo-controlled trials. J Clin Psychiatry. 2008 Apr;69(4):621-32. doi: 10.4088/jcp.v69n0415.

  PMID: 18363421 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Jasper A.J. Smits, Ph.D.

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 10, 2019
• First Posted: April 12, 2019
• Study Start: November 5, 2019
• Primary Completion: March 2, 2020
• Study Completion: March 2, 2020
• Last Updated: November 12, 2020

Record last verified: 2020-11

Locations

US (1)