TAO Outpatient Trial for Anxiety and Depression

• ClinicalTrials.gov Identifier: NCT03390218
• Recruitment Status: Unknown
• First Posted: January 4, 2018
• Last Update Posted: January 4, 2018
• Sponsor: TAO Connect, Inc.
• Information provided by (Responsible Party): Sherry Benton, TAO Connect, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Anxiety Disorders; Depression	Behavioral: Therapy Assistance Online; Behavioral: Treatment as usual	Not Applicable

Detailed Description:

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 stud will compare outcomes for two models of treatment: 1) The experimental group, Therapy Assistance Online (TAO), and 2) the comparison group, treatment as usual.

TAO group TAO is a suite of tools for providing patient education, support, and accountability delivered digitally. Educational materials are organized in an evidence based-protocolled treatment for anxiety or depression. TAO participants will attend a once weekly group in a computer lab. Each participant will complete an interactive educational module 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.

Treatment as Usual Group - 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.

Potential participants will receive an initial evaluation and screening to determine diagnosis, appropriateness for the study, and level of care required. Informed consent will include a statement indicating that agreement to participate will not affect access to treatment. Those who do not wish to participate will receive care as usual. Patients who agree to participate will be randomly assigned to either treatment as usual or treatment augmented with TAO.

Referral and Randomization Process -

1. Therapist identifies a client who meets the inclusionary criteria.
2. Clinician explains the availability of the TAO support services and the current study and invites the client to participate.
3. If the client agrees to participate, the clinician will explain the study and have the client sign the consent to participate form and call customer care to determine if the client will be in the experimental group (A) or control group (B).
4. If client is assigned to the experimental group, the clinician will help the client select a time to participate in the TAO support services each week. The clinician will again explain the benefits of participation, seek a commitment to attend, and help resolve any ambivalence of the client to participate.
5. If client is assigned to treatment as usual, the clinician will help the client select a time to participate in group session.
6. The referring clinician will then email the group therapist to inform him/her of the referral.

Introducing the TAO Support Services to Potential Clients -

1. Ask permission to share information about the TAO Support Services
2. Explain that the TAO system provides mental health services through an electronic system completed on a computer. Clients watch videos and complete modules on a computer for approximately 45 minutes to an hour, one time each week for 8 weeks.
3. Explain that participation in these support services has been shown in other studies to reduce symptoms, and that a current study is underway to determine if this will prove helpful to clients at WHS.
4. Invite the client to participate in the study letting him/her know that agreeing to participate in the study does not guarantee access to the TAO system.

5. If client agrees -

   1. Have client sign the consent to participate form.
   2. Contact customer care to find out if the client is assigned to the TAO system or the control group.
6. If assigned to the TAO system, help the client know when and where to meet for the TAO session. Contact the group leader with client information.

Measures

Participants in both the experimental group (TAO) and the control group treatment as usual (TAU) will complete the OQ-45 at intake, and in each subsequent session. TAO participants will also complete the Behavioral Health Measure-20 just prior to each group session on the computer in the computer lab.

Participants in both the experimental group (TAO) and the control group (TAU) will complete the OQ-45 at intake and at each group session. WE Well-being scale.

Sessions completed. Demographics.

Subjects

Subjects will be clients seeking treatment for anxiety and depression at Weber Human Services. All participants will be adults (18 and over) who meet inclusion criteria. Clients who agree to participant will be randomly assigned to a treatment condition. We will enroll fifty clients per treatment condition and enrollment will be ongoing until the number is reached. Active treatment will be 8 weeks, with follow-up at 3 months. Participants will not receive renumeration for participation.

Researchers at (TAO Connect, Inc.) TCI will have no direct contact with the subjects. All data collection will occur through the computer system. TCI technical support staff will have minimal PHI: name, login, email address if the client requires any technical support.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized control trial
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison of Treatment for Anxiety and Depression Augmented With TAO to Treatment as Usual (TAU) in the Weber Human Services
• Estimated Study Start Date: January 15, 2018
• Estimated Primary Completion Date: November 2018
• Estimated Study Completion Date: December 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: TAO (Therapy Assisted Online); 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; protocoled on-line educational modules, with brief therapist interaction and practice support with a mobile app.
Active Comparator: Treatment as usual; 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; Individual and group therapy, generic in nature

Outcome Measures

Primary Outcome Measures :

1. Outcome Questionnaire-45 [ Time Frame: At intake, 8 weeks, 12 weeks- change in scores ]

   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

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

United States, Utah

Weber Human Services

Ogden, Utah, United States, 84401

Sponsors and Collaborators

TAO Connect, Inc.

More Information

• Responsible Party: Sherry Benton, Chief Science Officer, TAO Connect, Inc.
• ClinicalTrials.gov Identifier: NCT03390218
• Other Study ID Numbers: TAO001
• First Posted: January 4, 2018
• Last Update Posted: January 4, 2018
• Last Verified: January 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Sharing individual participant data in behavioral health is prohibited by law.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Depression; Depressive Disorder; Anxiety Disorders; Behavioral Symptoms; Mood Disorders; Mental Disorders