TAO Outpatient Trial for Anxiety and Depression

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.

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.