TAO Outpatient Trial for Anxiety and Depression

NCT03390218 | Unknown

• 1 other identifier: TAO001
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Access to effective treatment resources is a ubiquitous problem in behavioral health. There is a need for effective interventions that are more easily accessed at a lower cost. This study will compare outcomes for two models of treatment: 1) The experimental group, Therapy Assistance Online (TAO), and 2) the comparison group, treatment as usual.

Conditions

Anxiety Disorders; Depression

Outcome Measures

Primary Outcomes (1)

• Outcome Questionnaire-45

  45 question survey, assessing symptom change, the OQ-45 is the most commonly used measure of change in psychotherapy. The OQ-45 has one general scale and 3 sub-scales. 1. The symptom distress scale scores range from 0-100 with a clinical cut-off of 36. Reliable change is indicated when a client's score changes by 10 points or more. 2. The Interpersonal relations scale scores range from 0-44, the clinical cut-off is 15, reliable change when a client's score changes by 8 points or more. 3. Social role scale, scores range from 0-36, clinical cut-off is 12 or more, reliable change is a change of 7 points or more

  At intake, 8 weeks, 12 weeks- change in scores

Study Arms (2)

TAO (Therapy Assisted Online)

EXPERIMENTAL

TAO participants will attend a once weekly group in a computer lab. Each participant will complete an interactive educational module using an evidence based protocoled treatment for anxiety and/or depression, and have a brief session with the group leader to discuss application of the content. Participants will have access to a companion app they may use between sessions to practice skills and reinforce learning.

Behavioral: Therapy Assistance Online

Treatment as usual

ACTIVE COMPARATOR

After the completion of a psychosocial assessment, and development of a treatment plan, clients are offered individual and group therapy sessions, case management services, and medication management services depending on the diagnoses. Individual and group therapy is often generic in nature as well, although some structured, evidence-based treatments are offered such as Psycho-Education Multi-Family Group and Illness Management Recovery.

Behavioral: Treatment as usual

Interventions

Therapy Assistance Online BEHAVIORAL

protocoled on-line educational modules, with brief therapist interaction and practice support with a mobile app.

TAO (Therapy Assisted Online)

Treatment as usual BEHAVIORAL

Individual and group therapy, generic in nature

Treatment as usual

Eligibility Criteria

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

You may qualify if:

• Clients in their first month of treatment with any primary or secondary diagnosis of depression or anxiety. This includes all forms of depression and/or anxiety disorder.

You may not qualify if:

• Chronic depression with a Likely Utilization of Services Instrument (LUSI) designation of "high" or "consistent user" of services. These clients should be referred to Illness Management Recovery.
• Clients with schizophrenia, or any other form of active psychosis.
• Clients with substance dependence disorder.
• Clients with personality disorders.
• Clients whose intellectual functioning would prevent understanding the TAO system and materials.
• Client must not have been in treatment for anxiety and depression in the past three months.

Sponsors & Collaborators

• TAO Connect, Inc.: lead

Study Sites (1)

Weber Human Services

Ogden, Utah, 84401, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Science Officer

Model Details: Randomized control trial

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: January 4, 2018
• Study Start: January 15, 2018
• Primary Completion: November 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 4, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)