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Status unknownNCT03390218Updated Jan 4, 2018

TAO Outpatient Trial for Anxiety and Depression

An interventional study of Therapy Assistance Online and Treatment as usual in Anxiety Disorders and Depression, sponsored by TAO Connect, Inc.. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-04.

Sponsored by TAO Connect, Inc. · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Enrolling by invitation — may be out of date.

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Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 2,269 studies in Anxiety Disorders with a site in United States — 398 open to participants now, 503 under way, 13 of them phase 3. Anxiety Disorders · United States.

Planned enrollment
267th of 2,045
300 · median 68
Started
2018
with 119 others
No phase
1,609 of 2,269
295 open now
Registered
847th of 2,269
by date

Among the 2,269 studies in Anxiety Disorders with a site in United States, this one is the 267th largest by planned enrollment of the 2,045 interventional ones that give a count, is one of 120 that started in 2018, is one of 1,609 with no phase, and was the 847th registered.

Anxiety Disorders

7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.

Browse Anxiety Disorders studies →

Open to participants now

398 of the 2,269 studies in Anxiety Disorders with a site in United States are open now. Recruiting first, the newest first:

393 more — sign in →

All 398 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 944 Anxiety Disorders studies recruiting now, 417 (44%) set no upper age limit and 460 (49%) stop at 75 or younger; 233 take children under 18; 317 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Anxiety Disorders
  • Depression
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • BehavioralTherapy Assistance Online

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

  • BehavioralTreatment as usual

    Individual and group therapy, generic in nature

06

What researchers measure

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

    Time frame: At intake, 8 weeks, 12 weeks- change in scores

07

Study locations

1 site
  • Weber Human Services
    Ogden, Utah 84401, United States
08

References and documents

Individual participant data

Plan to share: No — Sharing individual participant data in behavioral health is prohibited by law.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jan 2018; primary completion for Nov 2018, 10 months later.

Of 102 industry-sponsored interventional studies with no phase under Anxiety Disorders, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 15. This study's planned 10 months is above that.

Counting every sponsor, half of 3,943 studies reached it within 12 months; a quarter within 5 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 27, 2017
First posted
Jan 4, 2018
StartEst.
Jan 15, 2018
Primary completionEst.
Nov 2018
CompletionEst.
Dec 2018
Last update
Jan 4, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 4, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03390218
Lead sponsor
TAO Connect, Inc.
Responsible party
Sherry Benton (Chief Science Officer, TAO Connect, Inc.) — Principal investigator
First posted
Jan 4, 2018
Start date
Jan 15, 2018 (estimated)
Primary completion
Nov 2018 (estimated)
Completion
Dec 2018 (estimated)
Last update
Jan 4, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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